WO1997012220A2

WO1997012220A2 - Method for the identification and therapeutic use of disease-associated organisms, elements and forces

Info

Publication number: WO1997012220A2
Application number: PCT/IB1996/001006
Authority: WO
Inventors: Samir Chachoua
Original assignee: Individual
Current assignee: Individual
Priority date: 1995-09-15
Filing date: 1996-09-13
Publication date: 1997-04-03
Anticipated expiration: 1998-03-15
Also published as: AU6191398A; CA2232086A1; US20030103900A1; WO1997012220A3; EP0914607A2; AU6941196A

Abstract

A method for the identification, production and use of disease and condition specific diagnostic, therapeutic and preventative agents from naturally occurring microorganisms, organisms, extracts or modifications thereof, and from other chemical or physical agents. Diagnostic, screening and therapeutic devices are also disclosed.

Description

METHOD FOR THE IDENTIFICATION AND THERAPEUTIC USE OF DISEASE-ASSOCIATED ORGANISMS, ELEMENTS AND FORCES

REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Serial No. 60/003.686, filed September 15, 1995. All references are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to methods for disease prevention, diagnosis, treatment, prognosis and monitoring. More particularly, the present invention relates to the identification and use of disease-associated organisms, elements and forces which may be used, whole or in part, in the diagnoses, therapy and prevention of a targeted disease or other unwanted bodily condition and/or facilitate a desired state.

BACKGROUND OF THE INVENTION

A wide variety of chemically and physically based treatments for cancer and other tumorous conditions have been developed and are well known, including inter alia, various types of chemotherapy, photodynamic therapy, radiotherapy,

immunotherapy and combinations of various treatments. Although it is desirable that such treatments be generally toxic only to cells of a targeted disease, it has been difficult to identify agents having such specificity. To the contrary, the use of known anti-tumor therapeutic agents such as chemotherapy and radiotherapy is typically designed with the hope that the agent being used is more toxic to cells of the targeted disease than to the normal cells of the patient's body. In fact, many such agents and therapies rely almost solely on an increased rate of cell division or other mitotic activity in cancer cells, which leads to increased absorption for overcoming the problem of general toxicity, and thereby enabling the subsequent toxic efficacy of the agents and techniques. Unfortunately, there are also normal cells in the body which have high mitotic activity, such as cells of the bone marrow and intestines, which often suffer from such therapeutic agents and therapies.

Indeed, many chemically based therapies for tumorous conditions involve the use of antimitotic drugs such as adriamycin, vincristine. cisplatin and methotrexate, all of which exhibit strong undesirable side-effects on the normal cells of the patient. Such adverse side effects include hair loss, extreme nausea, vomiting, fatigue, weakness, sterility, and damage to the kidneys and heart. Because such side effects can impact severely on the ability of a body's immune system to focus on the original pathogenic agents, and on the body's ability to rebound from the effects of both the targeted disease and the chemotherapy, there is a strong need for anticancer agents having greater specificity in their targeting capabilities. Conventional chemotherapeutic treatments, furthermore, are not often able to circumvent the protective barriers built by most cancers against a host immune system. Indeed, most cancers are able to develop resistance to specific chemotherapeutic agents before such agents are able to completely penetrate such protective barriers.

In addition to conventional therapies which target the destruction of diseased tissue through the absorption of toxic agents, more recently, the patient's own immune system has been stimulated to prevent the formation of micrometastases or eliminate metastases already formed. Such attempts have generally precipitated the formation by the patient's body of tumor specific T-killer cells by immunizing the patient with oncolysates, or lysates from tumor cells. With this approach, the problem arises that cell lysates tend not to be sufficiently immunogenic and therefore, fail to induce sufficient stimulation ofthe patient's immune system to effectively prevent the formation of metastases and that they may be stimulating a depleted response.

It is generally believed that tumor specific T-lymphocytes. when they are present, occur only at low frequency among the lymphocytes, and that the antigenicity and immunogenicity of tumor agents is generally weak. It is further believed that these tumor specific cells are usually not fully activated in tumor-bearing animals, needing, therefore, additional activation signals. Furthermore, autoimmune diseases are thought to be caused by microorganisms and their products/extracts so well camouflaged that the immune system has difficulty distinguishing the said microbes and their products/extracts from normal tissue components which such diseases attack. In a patient infected with AIDS, an infected T-cell will ordinarily be attacked only by another T-cell, which itself will become subsequently infected. Indeed, some physicians have attempted to overcome the body's tendency to continue providing only susceptible T-cells at the disease by using immunosuppressive agents to keep the body from being flooded with infected T-cells. It is not difficult even for those unskilled in the medical arts to recognize the conflicting logical errors inherent in such an approach.

A related problem associated with many known anti-disease therapies concerns the components typically used in vaccines made in accordance with the teachings of the prior art. With a few exceptions, vaccines for use in the prevention or treatment of a targeted disease are generally made from either the targeted disease itself, diseased tissue or other material which is similar to the targeted disease. For example, current AIDS vaccines tend to be made from fragments of the HIV membrane or other relatively stable viral fragment. Unfortunately, there are several problems associated with such practice. First, such vaccines may serve merely to amplify an already ineffective or inappropriate immune response, or further deplete an immune response. AIDS vaccines may lead to the production of more T-cells which are susceptible to the HIV virus.

Another problem associated with such vaccines is the inherent risk of administering to the body pathogenic material which may have an activity toward the body beyond that which is known. Consequently, in addition to stimulating the body to increase its natural immune response to such a vaccine, there may be other consequences of vaccinating the body with such pathogenic material. Also, it is well known by medical practitioners that the disease strains from which many vaccines are made are actually grown on "continuous cell lines," which, for the sake of economy, tend to be cancer-like tissue. It is not fully known whether such practice may or may not cause the transfer into the patient's body of dynamic pathogenic material which may be "hidden" in the selected deactivated and "benign" disease fragments (e.g., a temporarily dormant element of genetic code).

Another such problem associated with the use of vaccines made from pathogenic material of. or similar to the targeted disease, is that such use with a patient already infected by the targeted disease involves further taxing of an already weakened immune system. Such attempted stimulation of a weakened immune system by disease material may actually cause or aggravate what is known as "threshold inhibition phenomenon," in which the immune system is unable to produce additional immunological agents due to its having already reached its maximum capacity for such production or due to immunologic inhibition by factors often related to the total bulk of disease manifestation. A still further problem with using vaccines made in accordance with teachings of the prior art. is that a targeted disease is often able to develop a resistance to such vaccines, just as it may develop a resistance toward components ofthe body's naturally stimulated immune system. One ofthe known defense mechanisms of many organisms which cause or stimulate disease is the capability of mutating with extreme rapidity in order to build such resistance.

With regard to solid tumor masses, it is generally believed that the dormant cellular center which typically comprises the central core of such masses, is protected by a growing barrier of diseased cells, making the dormant core, thereby,

unsusceptible to current chemical absorption therapies their relative metabolic stasis and dormancy also places them in a state of resistance to radiotherapy .The mainstays of conventional therapy,radiation and chemotherapy exert maximal effects against rapidly dividing cellsxancer cells not only are possessed of adaptive and mutational capacity which promotes their survival but also resist toxic agents by relative metabolic inactivity in their central core. The dormant cellular center may further provide for the production of tumor clones, which are resistant to toxic absorption therapies or radiation when the center is awakened following partial destruction of the tumor mass. It is readily apparent, therefore, that in addition to the need for anti-tumor treatments having greater specificity in their targeting capability is a need for activity not based on metabolic/physical/chemical toxicity.

One system which may overcome this situation involves the selective

immunological targeting of the cells;this has proven difficult but in theory would not favor survival of the dormant disease cells. The problem seems amplified by the apparent ability of the outer cancer layers to repel most routine immune responses. There is another system which can turn the therapeutic dilemma of dormant cells and immunologic repulsion/evasion by tumor masses into a therapeutic advantage. This involves the isolation and identification of specific organisms with specific cancer affinity such that they or extracts thereof may be used to specifically attack or mark the cancer cells and mass(the process of marking or tagging involves the use of infections or other agents/ factors/products/extracts thereof to mark a previously non-immunogenic tissue with immunologically reactive antigens. lnfections may access the dormant cancer centre with greater ease if anaerobic or microaerophilic;viral infection may infect certain cancer cells with ease as many of the latter lack effective anti-viral responses. A large range of micro-organisms may access cancer tissue due to its apparent resistance to immune function. The large number of infections with apparent affinity for cancer would suggest that infections may be found in cancer in its natural state. There have been numerous reports of this observation; ranging from Scott and Glover earlier this century to Livingston-Wheeler in the middle part of the century. Most of the early observers believed that the infections were the cause of the cancer; it is also known, however, that certain infections such as malaria, Newcastle's disease virus and even mumps (1974, Teruo Asada, Cancer 34:1907-1928) may bring about or extend a remission. Many infections are now said to be contaminants whereas some such as schistosomycetes (human bladder); hepatitis (human liver); human papilloma virus and cervical cancer are of recognized importance in the generation of human cancers; viruses are undisputable causative agents of many induced animal cancers.

Infections may therefore be implicated in the cause, the healing or seemingly exert no input on the overall clinical picture. Part of this mystery may be resolved by categorizing all infections that occur in cancer patients so that follow-up of cases can indicate if improvement or deterioration result.

There is also a need for treatments which are capable of inducing into action against an infectious or other agent a broad range of elements in the body's total immune system (e.g., neutrophils, eosinophils, basophils, etc.) which may not be as susceptible to the targeted infection, and which may have the ability to overcome any protective anti-immune barriers established by the targeted disease.

There is a long felt need for therapeutic methods which are effective in eliminating less massive, non-tumor pathogenic cellular materials, such as

independent microorganisms contained in bodily fluids. Since chemical application is normally an effective way to contact such targeted cellular material, current therapies for such conditions are generally based on a chemical treatment which focuses on either producing cellular lysis of such pathogenic materials or inhibiting vital nutrient pathways or other processes vital to the life of the targeted disease or diseased material. Unfortunately, current chemotherapeutic treatments which attack diseased cells, also tend to affect non-targeted cells. An example of such treatment is the use of broad spectrum antibiotics which not only affect disease bacteria, but may affect the normal intestinal flora of "friendly" organisms, leading to further pathology such as diarrhea and other malabsorption phenomena. Most chemically based therapies involve the use of purified nonliving substances. Similar to that found in the treatment of tumorous diseases, a well known problem often associated with the treatment of non-tumor pathogenic materials with non-living chemically based therapies, is the tendency of the targeted disease to develop a resistance to the chemical agent. Current methods for manufacturing such chemical agents are both slow in response to the development of such chemical agent resistance, and are cost prohibitive for the specific targeting of a wide variety of diseases. One example of how the prior art deals with the rapidity with which such diseases can develop chemical resistance, is illustrated in the treatment of

tuberculosis. Because the development of anti-tuberculosis agents using current methods is expensive, physicians often use a combination of therapeutic agents, hoping that the combined effect of such agents, each of which has become ineffective against the targeted disease when applied singly, will overcome such ineffectiveness. Similar logic has followed in general cancer therapy, where it is common practice to use a combination of chemotherapy with or without radiation. It is interesting to note, however, that on a broad scale such practice has not led to significant increased patient survival, which is indicative that such combination therapy of the prior art is ineffective in causing extension of survival in cancer patients.

Another example of how current methods for developing anti-disease therapeutic agents can impact society is the development of chemically based remedies targeting viruses. Unfortunately, the time and expense involved in the development of such remedies are too great for duplication across a wide spectrum of known diseases. As a result, drug companies tend to target only the most common diseases in their research and development efforts. Because each such effort may take years using current techniques of drug development, many diseases are allowed to run their course without the introduction of modern medical therapy. Indeed, the general public tends to believe that viruses (which are merely microorganisms too small to be observed through a light microscope) are not generally treatable by the use of modern medicine, only because such treatments have not been made available on a large scale. Such non-living chemically based treatments fail to incorporate the significant advantages attendant through the use of living organisms in the creation of such remedies and therapeutic systems. Another problem associated with many known anti-disease therapies concerns the inability of such therapies to identify and target a true causative agent of the targeted disease. An example of this may be seen in the treatment of auto-immune diseases such as pemphigus. With pemphigus, there are painful sterile pustules, which are believed to be generated by an increased, altered, or overstimulated immunological response. Since no microorganism has been heretofore associated with the introduction of the pustules. Current anti-pemphigus therapy includes using cortisone for diminishing the increased immune activity. Although this therapy may be palliative and add comfort to a patient, it is by no means curative. A parallel may be drawn between this therapy and that which is commonly used in the treatment of cancer, wherein an unknown agent has stimulated an uncontrolled division of normal cells into cancerous material. Instead of applying steroids for reducing the diseased material, however, chemotherapy and radiotherapy are used, producing results similar to that of the treatment for pemphigus. Because neither therapy actually targets the disease causative agent(s), they are equally unsuccessful in their efficacy against the targeted disease, which efficacy may be only minimal at best.

A related dilemma commonly associated with known cancer therapies is a general inability to rid the body of the key cancer causing factor or factors, even when the cancerous-tissue is removed. Often times, a cancer therapy will include the surgical removal of various diseased cells, in hopes of removing the disease causative factor with such cells. Unfortunately, such surgical "detoxification" of the body is generally capable of possibly slowing down continuing cancer growth. There have been cases of leukemia recurrence following remission and bone marrow transplant where the leukemia cells bore more resemblance to the donor's cells than those of the patient; these were reported sporadically in the late 70's and early 80's in

conversations with inventor and colleagues. This suggests a causative agent acting within the patient to convert normal cells to cancer cells as opposed to simple recurrence of the original cancer. The idea that cancer the disease may consist of more than just cancer the cells seemed to be borne out by the failure of leukophoresis to extend significantly patient survival time (leukophoresis is a process of selectively removing white blood cells (largely leukemic ones from the peripheral blood). If the leukemia disease process was largely represented by the leukemic cells then leukophoresis should have been expected to impact more significantly on the disease process. The concept of cancer spread being facilitated by loose cancer cells circulating was also challenged by the process of ascitic shunting.

Ascites is usually a terminal development in the progress of a cancer patient; it represents the accumulation of several litres of peritoneal fluid around the cancer which has usually spread extensively in that cavity at the time. Such fluid contains variable quantities of free cancer cells and cancer fragments. drainage of such fluid is often done weekly or as needed for patient comfort. Such a process is not only tiring but also cardiovascularly compromising.there is also repeated risk of

hemorrhage, perforation of some organ, infection, loculation of fluid etc.; ascitic shunts were designed to minimize patient discomfort by passing a catheter from the peritoneal cavity into the right atrium or major vein. There was a theoretic fear that pumping cancer-rich fluid would result in increased cancer seeding in areas such as the lungs and other organs that may not have been already involved. Cases reviewed by the inventor did not seem to manifest any such changes; there are no widespread reports of this anticipated consequence. lt may be that such patients simply do not live long enough for such metastases to manifest but at one autopsy attended by inventor, no evidence of even micrometastases could be found in the lungs although ascitic fluid was rich in cellular content. It appeared that ascitic fluid may somehow alter cancer cells or that cancer cellular showers in the blood were not the only prerequisite for metastases.

Another problem associated with anti-disease therapies of the prior art concerns the diagnosis of various diseases. Because many diseases, especially cancers, have the ability to hide themselves from, or even to suppress a host immune system, such diseases are not detected until such time as prominent symptoms occur and the disease has become an immediate threat to the life of the host. One such disease is adenocarcinoma, or cancer of the ovaries, which has been referred to often by the general population as the "silent killer." Unfortunately, the diagnosis of such diseases via conventional methods does not include the use of disease-associated agents which can detect the presence of. and therefore facilitate the diagnosis of such diseases long before they become an immediate threat to human life.

Although a basic assumption in the medical arts is that every disease has at least a causative agent, no one method has been heretofore proposed for the ready identification of such causative agents across a wide spectrum of diseases. Still further, no one method has been proposed for developing effective treatments for the sundry diseases having unknown etiologies. In his research regarding the etiology of various diseases, the inventor has found that many fungal, bacterial and viral organisms which are normally treated as foreign matter by a healthy patient's immune system are often found unchallenged in the bodies of cancer patients. Others have investigated and reported on an apparent antagonistic relationship between certain infections and cancer. (See Microbiology and Cancer Therapy: A Review. H.

Christine Reilly, 1953.; Nauts, H. et al., ACTA MED Scandinavia, 278, 145; 1-103. 1953.; Nauts, H. et al.. Cancer Research 6, 205-216.1946.; Beebe et al. J.A.M.A.49, 1495-1498. 1907.; Baroni. Arch Roumaines Path Expert et Micro. 11.125-142, 1938.; Comsia, Compt Rend Soc de Biol.99:900-901,1928.; and Daels, Arch Hyg,

72:257-300, 1910.)

In Pathogenesis of Cancer (The Freemont Foundation, 1955), Dr. John E.

Gregory discloses findings concerning the potential relationship between cancer and unchallenged foreign microorganisms isolated in the bodies of diseased patients. Dr. Gregory teaches that most of the organisms are merely natural contaminants which may be disregarded as insignificant since, according to Dr. Gregory, there can be only one cancer virus and, thus, only one effective method of conquering a cancer. Since the work of Dr. Gregory, similar conclusions have been drawn by Dr. Virginia Livingston of the San Diego based Livingston-Wheeler Clinic. Dr. Livingston identified a microorganism. Progenitor cryptocides, which she believed is the main cause of cancer.

Although much knowledge has been acquired during the past century regarding the identification of various viral, bacterial and fungal organisms which are somehow related to various diseases, many questions have remained unanswered regarding the relationship between such organisms. The inability of researchers to either link directly organisms to the disease's etiology, or to link directly the various types of such organisms to each other (e.g., linking a certain virus to a certain bacteria, both of which have been identified in patients having the same or similar diseases) has resulted in great confusion regarding the potential use of such knowledge. Indeed, vaccines prepared and used against such organisms have often resulted in only limited success. Studies have been conducted to determine whether anti-disease characteristics can be transferred into other organisms. A bacterial extract containing Clostridium hystolyticum was incubated with cancer tissue. (See Connell, Canadian M.A. J. 33:363-370, 1935.) In 1947, the same organism was used in an attempt to mark cancer cells with bacterial antigens, which were then treated successfully with an antitoxin. (See Parker et al., Proc Soc Exper Biol and Med, 66:461-467, 1947.) More recently, Volker Schirrmacher disclosed in U.S. Patent No.5,273.745 and German Patent No.3806565. a similar technique in which inactivated autologous tumor cells are marked by incubating same with similarly inactivated Newcastle Disease Virus (NDV) in a serum-free medium. Because of the natural ability of the NDV to activate tumor specific T-cells, the number of such T-cells which are ultimately activated against the tumor subsequent to inoculation with the NDV vaccine created in accordance with the Schirrmacher teaching, is sufficiently greater than the number of cells the tumor itself is able to activate.

A particular problem which Parker et al. and Schirrmacher attempted to address is the capability of a cancerous malignancy to mask itself from the defenses of an immune system. Parker demonstrated that such a defensive mechanism might be overcome in some circumstances by using an antitoxin which can readily identify tagged cancer cells. Schirrmacher demonstrated that in certain circumstances a portion of the patient's immune system could also be stimulated to react to tagged cancer cells. However, neither the teaching of Parker et al.. nor that of Schirrmacher has been replicated effectively in the ongoing war against cancer and other diseases of unknown etiology.

Regarding further Schirrmacher's teaching that a portion of the patient's immune system may be stimulated to react to the tagged cancer cells, such portion which the Schirrmacher vaccine is able to raise comprises less than one percent of the body's total known immune system. The Schirrmacher teaching fails to include eliciting a greater portion of a body's defense system against the targeted disease, or utilizing the benefits of disease-associated therapeutic agents, such as those made directly from a living microorganism for attacking the targeted disease. Furthermore, killed and tagged tumor cells which have been thus inactivated by virus and radiation, as taught by Schirrmacher. may bear only minimal resemblance to the living cancer cells inside a patient; and hence, can have only minimal overlap in resultant immunostimulation. Even if such minimal overlap results in an immune response which is greater than that stimulated by the presence of only the targeted disease, such overlap may still enable the targeted disease to mutate into a clone which is resistant to the anti-disease agents, thereby nullifying the overlapping response. The prior art practice of presenting the body with a vaccine constructed partially of the targeted disease and partially of other agents, without altering the living disease at the same time and without fortifying significantly the patient's immunological abilities, may result in dividing the body's immunological response against both the disease and the vaccine. This could be a more significant problem that that of minimal overlapping anti-genicity.

SUMMARY OF THE INVENTION

A primary objective of the present invention is to provide a method for creating disease- and condition- specific diagnostic, therapeutic and preventative agents from naturally occurring microorganisms, organism extracts or modifications thereof, and from other chemical or physical agents, which overcomes the aforementioned problems associated with therapeutic agents, therapies and methods for producing same in the prior art. Not only does the instant invention lead to maximum overlap between vaccine and living disease tissue, but some embodiments of the invention even cause the tagging of a vaccine directly to living disease tissue, for providing maximum specificity. Also, various embodiments of the therapeutic agents made via the method of the present invention have demonstrated an ability to stimulate an amplification of the host's known immunological functions, both specifically and non-specifically, and have even raised a hitherto unknown immunological therapeutic mechanism which relates to the red blood cells. The following three naturally occurring phenomena are indicative of the sources for the isolation of such disease- and condition-specific therapeutic agents: 1) Spontaneous remission; 2) Organ and Species resistance; and 3) Cellular redifferentiation.

The spontaneous remission of cancer and other incurable diseases in the form of miraculous healing has been described as a "healing crisis" ranging in duration from a few hours to several days, during which time dramatic symptoms of an acute infection (e.g., fever, chills and perspiration) were exhibited. Further, it is known that certain organs and systems of the body, such as the spleen, small intestine and muscular system, are rarely infected by metastatic diseases which readily encroach upon more susceptible bodily organs and systems, such as the lungs, liver and skeletal system. By practicing the method of the present invention, the disease resistance of these bodily organs and tissues as well as microorganisms isolated therefrom may be used in the production of disease-specific therapeutic agents for use in other, more susceptible areas of the body.

Certain non-microscopic, non-human, life forms are known to be resistant to the ravages of cancer and various other diseases. Great difficulty has been found in using anti-disease sera in humans, which has been extracted from animals. The limitation of this method lies in the nonspecificity of antisera developed from non-patient-specie life forms, especially with regard to the tendency of such sera to include high levels of an anti-patient-specie factor, which has often proven to be quite toxic. In practicing the method of the present invention, however, it has been discovered that various tumor specific therapeutic agents can be raised in vivo in different-specie life forms, subsequently "washed" and filtered for removing any anti-patient-specie factors. Indeed, such therapeutic agents have been used by the inventor in the treatment of humans without any attendant anti-human side effects.

Regarding cellular redifferentiation, there are reports of cases in which malignant tumors have suddenly redifferentiated into normal cells. Such reports often have noted the association of the redifferentiating tumors with some other abnormal occurrence within or about the body. For example, such redifferentiation has been reported in leukemia after the occurrence of a staphylococcal infection. Also.

redifferentiation of cancer cells has been observed in tumor masses which were placed in proximity to a developing notochord, or grafted onto a salamander^'s regenerating stump. The association of such diverse occurrences with

redifferentiation in various tumor types suggests that cancer cells are not irreversible, but rather, under certain conditions, can be returned to a normal state. (See Laclau, Compt Rend Soc de Biol 92:840-842, 1925.: Nevorojkin. Vestnik Roentgenol Radiol 15:344-345, 1935.: Maisin, Compt Rend Soc de Biol 127:1477-1478. 1938.: Protti. Tumori 22:222-229, 1948.: Protti. Tumori 24:14-24. 1950.: Lewisohn. Science 94:70-71, 1941.: Lewisohn. Cancer Research 1:799-8066, 1941.: and Suiguira. AAAS Approaches to Tumor Chemotherapy. 208-213. 1947.) The present invention provides a comprehensive method for identifying various disease-associated agents for use in treating a targeted disease. The agents include organisms, organism extracts and modifications thereof, chemical and mineral elements, and physical forces. The present invention further includes a method for producing various therapeutic agents from the disease-associated agents, and the use of such therapeutic agents in the prevention, diagnosis, treatment, prognosis and monitoring of a targeted disease or other unwanted bodily condition.

The present invention is particularly concerned with the treatment and prevention of diseases which compromise the body's ability to mount an effective

immunological response. Such immunologically inhibiting diseases include, but are not limited to, Acquired Immune Deficiency Syndrome ("AIDS"), cancer, pathogenic angiogenesis and vascularization, systematic lupus erythromatosis, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, Alzheimer's disease, muscular dystrophy, asthma, chronic fatigue syndrome, A.L.S., I.T.P, etc.. Such illnesses which are treatable in accordance with the present invention include those that are caused by either an original infectious agent (e.g., Epstein Barr virus as it relates to Burkitt's lymphoma. Human Immunodeficiency Virus ("HIV") as it is believed to relate to AIDS), or an opportunistic infectious agent attacking the body of a host which has been already weakened by an original infectious agent (e.g., pneumocystis pneumonia, cytomegalo virus, herpes. etc., as they relate to AIDS). More particularly, this invention relates to the identification and therapeutic use of various organisms, elements and forces which exhibit at least one of the following associative characteristics regarding a targeted disease: 1) a causative affinity toward a targeted disease; 2) a synergistic affinity toward a targeted disease; 3) a neutral affinity toward a targeted disease; 4) an infective affinity toward a targeted disease; 5) a regression-stimulating antagonism toward a targeted disease; or 6) a nemesis antagonism toward a targeted disease.

The present invention is also directed to the use of such organisms, elements and forces in the treatment and prevention of various naturally occurring conditions that are degenerative, for example, bodily conditions which are associated with "old age." In each of these diseases or conditions, use of the disease-specific therapeutic agents resulting from the method of the present invention appears to exert a regenerative effect on the treated individual, a regulatory effect on the individual's immune system as well as exhibit the desired anti-disease activity. The therapies of the present invention have also demonstrated remarkably few side-effects, especially when compared with existing cancer and immunodeficient therapies, such as adjuvant chemotherapy, the high-dose application of lymphokines or the application of AZT. As such, the general purpose of the present invention is to provide a new and improved method for producing therapeutic agents for use in treating a targeted disease or condition, which method incorporates various disease-associated organisms, elements and forces in the creation of the therapeutic agents for overcoming the aforementioned problems associated with diagnostic, therapeutic and preventative agents and therapies of the prior art.

It is another object of the present invention to provide a method for producing therapeutic agents from organisms, extracts or modifications thereof, which demonstrate antagonistic activity toward a targeted disease.

It is another object of the present invention to provide a method for producing therapeutic agents from various chemical or mineral agents, which demonstrate antagonistic activity toward a targeted disease.

It is another object of the present invention to provide a method for producing therapeutic agents from various forces or energies, such as electromagnetically induced frequencies, which demonstrate antagonistic activity toward a targeted disease.

It is still another object of the present invention to provide a method for producing therapeutic agents from various chemical or mineral agents, biological organisms, extracts or modifications thereof, which demonstrate an affinitive activity toward a targeted disease.

It is another object of the present invention to provide a method for producing therapeutic agents from various chemical or mineral agents, organisms, organism extracts or modifications thereof, which demonstrate an affinitive activity toward a targeted disease, such that the various agents, organisms, organism extracts or modifications thereof, will attach themselves to cells of the targeted disease so as to enhance the visibility of the disease cells to the host immune system.

It is another object of the present invention to provide a method for producing therapeutic agents from various chemical or mineral agents, biological organisms, organism extracts or modifications thereof, which demonstrate an affinitive activity toward a targeted disease and which are capable of carrying intracellular genetic information, such that the various agents, organisms, organism extracts or modifications thereof, will attach themselves to cells of the targeted disease and transfer genetic information to the disease cells or diseased tissue.

It is still another object of the present invention to provide a method for producing therapeutic agents from various chemical or mineral agents, biological organisms, extracts or modifications thereof, which demonstrate a synergistic affinitive activity toward a targeted disease such that the organisms may be found living in harmony with the targeted disease in a host organism.

It is still another object of the present invention to provide a method for producing therapeutic agents from various forces or energies, such as

electromagnetically induced frequencies.

It is a further object of the present invention to provide a method for producing therapeutic agents which are effective for treating an illness arising from, or exacerbated by, the failure of a human's immune system to mount an adequate immune response to the illness.

It is still another object of the present invention to provide a method for producing therapeutic agents for a patient from various chemical or mineral agents, biological organisms, extracts or modifications thereof, which have been raised in a different specie than that of the patient.

It is still another object of the present invention to provide a method for producing therapeutic agents from various chemical or mineral agents, biological organisms, extracts or modifications thereof, which have been raised in vitro.

It is still further an object of the present invention to provide a method for producing therapeutic agents from various chemical or mineral agents, biological organisms, organism extracts or modifications thereof, which demonstrate antagonistic activity toward a targeted disease, the method including enhancing the antagonism of such agents or organisms toward cells of the targeted disease or diseased tissue such that the effectiveness of the therapeutic agent is increased.

It is still further an object of the present invention to provide a method for producing therapeutic agents from various chemical or mineral agents, biological organisms, organism extracts or modifications thereof, which demonstrate an affinity toward the targeted disease, the method including enhancing the affinity of such agents or organisms toward cells of the targeted disease or diseased tissue, such that the effectiveness of the therapeutic agent is increased.

It is still another object of the present invention to provide a method for producing a disease-specific antagonistic activity in cells with a selected chemical or mineral agent, or biological organism, extract or modification thereof, which agent or organism has not heretofore demonstrated antagonistic activity toward a targeted disease.

It is still another object of the present invention to provide a method for producing regenerative therapeutic agents from various chemical or mineral agents, biological organisms, extracts or modifications thereof, for use in therapies targeting the restoration of various tissues or bodily functions.

It is yet another object of the present invention to provide a method for treating a patient suffering from an illness which arises from, or is exacerbated by, the failure of his or her immune system to mount an adequate response to the illness, the method including the use of at least a therapeutic agent produced in accordance with the method of the present invention.

It is another object of the present invention to provide a method for treating a tumorous disease in a patient, the method including the use of at least a therapeutic agent created in accordance with the method of the present invention.

It is another object of the present invention to provide a method for treating naturally occurring degenerative conditions such as old age, the method including the use of at least a therapeutic agent produced in accordance with the method of the present invention.

It is yet another object of the present invention to provide a method for treating a patient suffering from an illness, the method including the application of various electro-magnetic frequencies to the patient, which frequencies are associated with the targeted disease.

It is yet another object of the present invention to provide a method for treating a patient suffering from an illness, the method including the application of various electro-magnetic frequencies to the patient, which frequencies are not associated with the targeted disease. It is another object of the present invention to provide a method for producing beneficial changes to the immune responsiveness of patients having illnesses which compromise the ability of the body to mount an effective immunological response.

It is still another object of the present invention to provide a method for transferring from a microorganism to cells of the human body, various desirable characteristics of the microorganism.

It is still further an object of the present invention to provide a method for producing therapeutic agents for use in vaccinating, or otherwise treating, a patient in order to prevent the patient from acquiring a targeted disease, the therapeutic agent comprising a material which is neither the targeted disease, nor an extract or modification of the targeted disease.

Furthermore, during application of the method of the present invention, it has been discovered that red blood cells may be stimulated to play an active role in a patient's immunological defense system. While current genetic engineering efforts have concentrated generally on the modification of various cells having intricate pre-existing nuclear structure, the red blood cell has been heretofore overlooked by such efforts. Indeed, because the red blood cell has no nucleus and is normally in more abundant supply throughout the body than any other cell, it has been found that this cell is extremely useful as an ideal empty vessel for responding to, or expressing, desirable physical, chemical or genetic information. It is, therefore, another object of the present invention to provide a method for producing therapeutic agents from various chemical or mineral agents, biological organisms, organism extracts or modifications thereof, or physical forces, which therapeutic agents can illicit use of a patient's red blood cells for treating a targeted disease.

It is therefore another object of the present invention to provide a method for producing therapeutic agents from various chemical or mineral agents, physical forces, biological organisms, organism extracts or modifications thereof, which therapeutic agents can illicit use of a patient's red blood cells for inhibiting metastases,attacking cancer and other diseases.

It is still further an object of the present invention to provide a method for diagnosing various diseases which have an ability to hide from, or suppress, a host immune system, the method including the use of at least a therapeutic agent created in accordance with the method of the present invention. It is still further an object of the present invention to provide a system for creating therapeutic agents from various chemical or mineral agents, physical forces, biological organisms, extracts or modifications thereof, which system can be used to effectively anticipate the development of specific resistive changes in a targeted disease, such that therapeutic agents can be created for specifically and timely countering such anticipated resistive changes, thereby allowing for the economic creation and timely delivery of effective disease-specific therapeutic agents to the patient.

It is yet another object of the present invention to provide a method for applying therapeutic agents created in accordance with the method of the present invention that is economical to replicate and use.

These together with other objects of the present invention, are pointed out with particularity in the claims appended hereto and forming part of this disclosure. The more important objects of the present invention have been outlined rather broadly in order that the detailed description thereof which follows may be better understood, and in order that the present contribution to the art may be better appreciated. For a better understanding of the present invention, its operational advantages and the specific objects attained by its uses, reference should be made to the ensuing descriptive matter and appended illustrations, in which there are disclosed various embodiments of the invention.

Those versed in the art will readily ascertain, however, that the present invention is capable of other embodiments and of being practiced and carried out in various other ways. In this respect, the various embodiments disclosed herein, and the arrangements of the various components of the instant invention set forth in the following description are for illustrative purposes, only, and are not intended to be limiting in scope. Those skilled in the art will appreciate, as well, that the conception upon which this disclosure is based, may be utilized readily as a basis for the designing of other methods and systems for carrying out the several purposes of the present invention. Said other methods may include, but are not limited to. those which include the substitution of other material sources as they become available, and which substantially perform the same function in substantially the same manner with substantially the same result as the various described components of the present invention. It is important, therefore, that the claims appended hereto be regarded as including such equivalent components, methods and systems insofar as these do not depart from the spirit and scope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Figures 1 and 2 illustrate two vials in which such in vitro reaction tests were conducted.

Figure 2 shows a lymph node extracted from the same patient and cultured with penicillium fungus; filaments surrounding the cancer began to develop within days.This organism demonstrated affinity to the cancer and could not be washed off the surface easily;within days of co-culture,it could be recovered from the surface and from fragments deep within the mass.

As shown in Figure 3, a Russel body marked by arrow, such bodies have often been noted in cancer biopsies.early researchers thought them to indicate

blastomycetes, inventor believes them to be yeast or fungal aetiology.

Figure 4 shows several coccoid forms forming a nest in a biopsy of breast cancer. In both Figures 3 and 4, note the total lack of any immune response.

For example, Figure 5 shows a sample of mixed coccal culture which was grown from such a "clean" blood culture of an AIDS patient.

Figure 6 shows a culture of tubercule bacilli grown from a "clean" skin sample of a scleroderma patient.

Morphological changes are illustrated in Figure 7. in which red central blood cells show extending proboscis.

Figure 8. in which are shown spicules in the membrane of several red blood cells, two of which cells have also taken on a ring-like form with an apparent hole in the center.

Figures 9 and 10 show two groups of red blood cells in which inclusions have formed in their cytoplasm where inclusions appear to be matter removed from leukemia cells.

Figure 14 is a blood sample plate from a 59 year old female having chronic lymphocytic leukemia.

Figure 15 is a blood sample from the same patient taken within two hours of the Figure 14. during which time the patient was administered vaccines prepared in accordance with the method of the present invention halving of leukemia count is evident.

Figure 16 is a blood sample plate from a 24 year old male having granulocytic leukemia.

Figure 17 is a blood sample from the same patient taken 7 days later, during which time the patient was treated with vaccines prepared in accordance with the method of the present invention showing remission.

Figure 18 illustrates 2 leukemia cells in proximity to the red blood cells and other blood constituents.

Figure 19 shows total lysis of leukemic and red blood cells within minutes of addition of antiserum raised against the leukemia cells.

Figure 20 shows a leukemic cell surrounded by red blood cells.

Figure 21 shows coccal organisms in a sarcoma biopsy. Antisera raised against these are used to treat the leukemia (also a sarcoma) blood in Figure 20.

Figure 22 shows lysis of cancer cytoplasm, membrane and nucleus with no harm to surrounding red blood cells.

Figure 23 illustrates both precision and potential of this technology in a leukemia cell treated by antiserum raised against genetic and other fragments of associated organisms inducing removal of cancer genetic component.

Figure 24 shows a large breast cancer with central ulceration as seen in the mammogram of a 72 year old female.

Figure 25 is the same patient showing dramatic reduction in mass after 2 weeks of therapy. Arrows indicate cancer margins in Figures 24 and 25.

Figure 26 is of a squamous cell carcinoma indicated by the arrow, stretching to the apex of the right lung.

Figure 27 shows collapse of that mass within 2 weeks of therapy.

Figure 28 is of a bone scan demonstrating prostate cancer metastases. These can be seen as the dark marks on the ribs indicated by the arrows.

Figure 29 shows drastic resolution of the rib lesions following 3 weeks of therapy. Figure 30 demonstrates brain metastases in the right hemisphere from a small cell carcinoma [lung primary] indicated by arrows.

Figure 31 demonstrates the lung primary referred to above and its mediastinal spread. Figure 32 represents a CAT scan of breast cancer metastasized to the left lung with mass and fluid marked by the arrow.

Figure 33 demonstrates resolution within 5 weeks of therapy.

Figure 34 is of an adenocarcinoma of the breast.

Figure 35 demonstrates a metastasis from breast cancer into the liver.

Figure 36 demonstrates resolution of breast cancer after 2 weeks of therapy.

Figure 37 is of a primary hepatoma perforating the right hemidiaphragm and surrounding the right lung.

Figure 38 shows cancer eliminated from the right lung field. Figure 39 is of a adenocarcinoma ofthe breast in a 42 year old female as shown by mammogram.

Figure 40 shows massive shrinkage after 4 weeks of therapy.

Figure 41 shows a large mass obstructing the esophagus in a male age 60 suffering from esophageal cancer marked by the arrow. Patient is unable to swallow food or water at this stage.

Figure 42 shows that after only 4 weeks treatment the cancer shrunk massively.

Patient's esophagus is patent, and he is able to eat and swallow easily.

Figure 43 illustrates giant cell lymphoma in a 32 year old female, 16 cm in diameter as measured on chest x-ray.

Figure 44 shows the same tumor after 1 week of treatment shrunk to 3 cm.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

DEFINITIONS

Various terms used herein by the inventor are defined as follows:

Agent: See Disease-Associated Agent.

Antagonistic Agent: A biological, chemical or physical agent which carries anti- disease activity, such that a regression, whether partial or complete, of the targeted disease may be stimulated by the activity. As used herein, the term "antagonistic" refers to the activity of an agent toward a targeted disease, rather than the effect said agent may have upon the host organism. Such antagonistic or anti-disease activity may be either direct, affecting a targeted disease via contact with the disease or diseased tissue, or indirect, stimulating immunological or other disease-inhibitive activity in a host, and thereby indirectly affecting the targeted disease. Such direct anti-disease activity may include cellular membrane-to-membrane contact between a chemical or biological antagonistic agent and a disease or diseased tissue, ingestion of portions of disease cells or diseased tissue by an antagonistic agent which is an organism (an "antagonistic organism"), direct bombardment of a disease or diseased tissue by a physical agent which is radiological in form, or the like. Antagonistic agents may act indirectly against a targeted disease by precipitating immunostimulant activity beyond that which has been already activated in a host's response to the targeted disease. Additionally, an antagonistic agent may stimulate other indirect anti-disease activity, including changes in the host which are physiological, metabolic, biological or chemical in nature. Such changes tend to help antagonistic agents which compete with the targeted disease for substrate, nutrition, or metabolic products. An antagonistic organism may further secrete compounds which may inhibit disease metabolism, function and growth. The term "antagonistic" has also been used broadly herein, to refer to both antagonistic and nemesis agents (see Nemesis Agent, below).

Antagonistic Organism: An antagonistic agent which is an organism.

Antagonistic organisms may further include organisms, extracts and modifications thereof, which are normally independent of a patient, such as targeted disease antibodies raised in a non-patient-specie host, or which are normally found in the patient, such as various components of a patient's immune system.

Beneficial Agent: A biological, chemical or physical agent which may demonstrate causative or synergistic activity toward a targeted disease. As used herein, the term "beneficial" refers to the activity of an agent toward a targeted disease, rather than the effect the agent may have upon the host organism. Such beneficial or pro-disease agents may also include those which are infective toward a targeted disease, if, for example, the overall result of the infection is that the effectiveness of the host organism's immune response against the disease is lessened as a result of dealing with by-products of the infective agent.

Beneficial Organism: A beneficial agent which is an organism. Beneficial organisms may further include organisms, extracts and modifications thereof, which are normally independent of a patient, or which are normally found in the patient.

Biological Agent: See Organism.

Causative Agent: A biological, chemical or physical agent which causes or evolves a targeted disease under specified conditions. Causative Organism: A causative agent which is an organism. Causative organisms may further include organisms, extracts and modifications thereof, which are normally independent of a patient, or which are normally found in the patient.

Detrimental Agent: A biological, chemical or physical agent which exhibits a negative affect on a targeted disease. As used herein, the term "detrimental" refers to the activity of an agent toward a targeted disease, rather than the effect said agent may have upon the host organism. Such detrimental or anti-disease agents may include antagonistic agents, infective agents and nemesis agents.

Detrimental Organism: A detrimental agent which is an organism. Detrimental organisms may further include organisms, extracts and modifications thereof, which are normally independent of a patient, or which are normally found in the patient.

Different-Specie: A specie other than that of the patient or host organism.

Disease: A sickness, ailment or otherwise undesirable bodily condition. This term is used rather broadly herein to include naturally occurring bodily conditions which may be undesirable, such as those degenerative conditions occurring attendant to old age. and other pathogenic bodily conditions which may have been caused or otherwise stimulated by non-biological agents. This term is used further herein to include both disease-causative agents and diseased tissue.

Disease-Associated Agent: A chemical, mineral or physical agent, biological organism, extract or modification thereof, which demonstrates at least one of the following associative characteristics or activities regarding a targeted disease: a causative affinity toward the targeted disease: a synergistic affinity toward the targeted disease; a neutral affinity toward the targeted disease; an infective affinity toward the targeted disease; an antagonism toward cells of the targeted disease or diseased tissue; or a regression-stimulating nemesis antagonism toward the targeted disease or diseased tissue. Such disease-associative characteristics may be either naturally inherent in the agent, or may be induced in accordance with the method of the present invention. As used herein, this term may further refer to agents which demonstrate at least one of said associative characteristics toward another disease- associated agent, which another disease-associated agent demonstrates at least one of said associative characteristics toward the targeted disease or diseased tissue.

Disease-Associated Organism: A disease-associated agent which is an organism. Disease-associated organisms may further include organisms, extracts and modifications thereof, which are either normally independent of a patient, or which are normally found in the patient.

Disease-Specific Agent: Another term for disease-associated agent.

Host: An organism in which is located either a disease, diseased tissue or a disease-associated organism or condition we wish to alter. At times, this term is used herein as another term for "patient."

Infective Organism: An organism which lives within a host in an infective relationship to a targeted disease, which relationship may be either harmful to the targeted disease (in which state it is antagonistic toward the targeted disease), beneficial to the targeted disease (in which state it is synergistic toward the disease), or neutral to the targeted disease. For example, Escherichia coli (or "E. coli") may infect a cancer and cause breakdown of diseased tissue: however, the toxins which are produced from such breakdown may cause further weakening of the host immune system, which weakening may result in assisting the disease process. The E. coli is, therefore, indirectly synergistic toward the disease (and antagonistic toward the host) its infective relationship to the cancer; unless, for example, toxins produced by the E. coli interacting with the cancer can be prevented from affecting the host and E. coli and toxin exert activity only locally in the cancer.

Neutral Organism: An organism which may live within a host in a relationship to a targeted disease, which relationship is apparently neither beneficial nor harmful to the disease. For purposes of brevity, this term is also used in the ensuing description in reference to both neutral and infective organisms. Neutral organisms may further include organisms, extracts and modifications thereof, which are normally found independent of a patient, or which are normally found in the patient.

Nemesis Agent, or Nemesis Antagonistic Agent: A biological, chemical or physical agent which carries curative anti-disease activity. Nemesis agents or factors can often overlap with those of other categories. Similar to the activity of antagonistic agents, such anti-disease activity can be either direct, affecting a targeted disease via direct contact with the disease, or indirect, stimulating other activity in a host which detrimentally affects the targeted disease. Features of nemesis agents which may be shared with antagonistic agents further include the ability to precipitate host immunostimulant activity beyond that which has been already activated in response to the targeted disease. Additionally similar to antagonistic agents, nemesis agents may stimulate other activity against a targeted disease. A distinguishing feature of nemesis agents which are organisms is their high affinity for

disease-causing organisms or the disease process. Nemesis organisms may secrete compounds which inhibit disease metabolism, function and growth. Nemesis organisms may be used as a source for a wide variety of biological and chemical disease-associated antagonistic agents.

Nemesis Organism: A nemesis agent which is an organism. Nemesis organisms may further include organisms, extracts and modifications thereof, which organisms are normally independent of a patient, or which are normally found in the patient.

Organism: The ensuing description uses this term in two senses. When reference is made to types of organisms, the term is meant to include all forms of life composed of mutually dependent parts that maintain various life processes, including animal, plant and microscopic life forms. When reference is made to the creation of various therapeutic agents from an organism or organisms, the intention is that any and all components or forms of the organism or organisms in question may be used in such creation, including, but not limited to, the whole organism, extracts or fractions of the organism, modifications of the organism or products of the organism.

Patient: An organism in which is located a disease that is targeted for therapeutic treatment. A patient may be a human, an animal, a plant or other organism.

Patient-Specie: Same specie as the patient.

Raise: The action of isolating antibodies or other organisms which have an affinity toward, or are otherwise antagonistic toward, a particular disease or disease-associated organism, extract or modification thereof. Said isolating may include various in vivo and in vitro techniques which are known or which are otherwise described herein.

Synergistic Agent: A biological, chemical or physical agent which carries activity that is beneficial to a targeted disease. As used herein, the term "synergistic" refers to the activity of an agent toward a targeted disease, rather than the effect said agent may have upon the host organism. A synergistic or pro-disease organism lives within a host in a beneficial relationship to a targeted disease, either within, or at a distance from, disease cells or diseased tissue. Such organisms include those which are usually susceptible to the immunological system of a host when the targeted disease is not present in the host, but which live with impunity with regard to the host immunological system when the targeted disease is present in the host.

Therapeutic Agents: A biological, chemical or physical agent which

demonstrates certain therapeutic and other beneficial activity toward a host organism when applied to the organism, including the prevention, diagnosis, treatment.

prognosis, and monitoring of a targeted disease. Such other beneficial activity may include the enhancement of various life functions, biological systems and processes of the organism.

The inventor has developed a unique method for identifying and using various disease-associated agents for the production and use of a wide spectrum of therapeutic remedies. Such remedies include the use of therapeutic agents produced from various biological organisms, organism extracts or modifications thereof, which organisms have demonstrated at least one of the following disease-associative types of activity regarding a targeted disease or other unwanted bodily condition: causative activity regarding the targeted disease; synergistic activity toward the targeted disease; neutral activity toward the targeted disease; infective activity toward the targeted disease; antagonistic activity toward the targeted disease; or nemesis antagonistic activity toward the targeted disease. The method of the present invention further includes the use of biological, chemical or mineral agents, such as extracts and products of both biological and synthetic processes, and physical agents, such as radiant energy, which have demonstrated substantially similar disease-associative activities or characteristics regarding a targeted disease. Causative and synergistic agents are beneficial to a targeted disease, while antagonistic and nemesis agents are detrimental toward a targeted disease. Although neutral and infective agents may appear to be neither beneficial nor detrimental toward a targeted disease, they may be ultimately either beneficial or detrimental toward the disease, depending on how the effect they have on the targeted disease balances with the overall operation of the host system. Each of these categories of disease-associated agents is listed in the table, below, from left to right, in order of antagonism toward a targeted disease, from those agents demonstrating the least antagonism to those agents demonstrating the greatest antagonism.

Causative agents evolve the disease, while nemesis agents carry activity against the disease of such a nature that the activity is curative.

The present invention further provides for the use of such disease-associated agents in the prevention, diagnosis, treatment, prognosis and monitoring of a targeted disease or other unwanted bodily condition.

The method of the present invention provides for a high degree of specificity with regard to the effects of various therapeutic agents upon selected cellular material in a host, due to the use of a microbial affinity between the therapeutic agents and a targeted disease or other cellular material. Such microbial affinity may be either natural or induced. The method of the present invention further provides for an extremely high degree of therapeutic efficacy, due to the use of living organisms in the creation of therapeutic agents, and to the use of other disease-associated agents whose activity toward a targeted disease can be selected for providing a degree of synergism with other therapeutic agents which has been heretofore unknown.

One embodiment of the method of the present invention comprises the following steps: 1) conducting a spectrum search for various potential disease-associated agents which exhibit at least one of the fore-mentioned associative characteristics regarding a targeted disease; 2) testing each potential disease-associated agent found in step 1) to gauge the type and level of its activity toward the targeted disease; and 3) preparing a therapeutic agent using at least a disease-associated agent.

In accordance with the method of the present invention, the activity of such disease-associated organisms and other agents related to a targeted disease is first identified and then classified into one of the aforementioned associative

characteristics. Such identification and classification is accomplished through in vitro or in vivo evaluation of various potential disease-associated agents. Simple models may be designed in-vitro to qualify and quantify agents in relation to disease association per given conditions;one simple example of this is the counting of leukemia cells suspended in trypticated soy broth and evaluation of viability after addition of various agents. It may be possible to demonstrate that under such conditions certain staphylococcal phage lysates may cause amplification of numbers and greater cellular viability, whereas others decrease number and/or viability. Some fungi added to the leukemia suspension will produce agents lethal to the cancer cells. It can therefore be seen that such in-vitro systems can address any targeted disease (cancer, bacteri. virus, etc.) and qualify the relationships of other organisms and agents to it by gross measures of survival and numbers; more refined measures such as those of metabolism and infective/invasive aggression may also be evaluated in- vitro, however, in-vivo testing is more indicated in evaluation of absolute disease association definition. The statement that a certain organism synergizes with or supports a disease, for example, can best be demonstrated by augmentation or aggravation of disease condition upon introduction of organism into the living system. Agents may differ in their in-vitro and in-vivo classification depending on host effects. Certain chemotherapeutic agents, for example, may cause total cancer destruction in-vitro and therefore be classified as nemeses but have strong or even stronger effects against the host and therefore may be in-vivo classified as synergistic to the disease by its secondary deleterious effects against the host. There are several living systems where application of chemotherapy may predispose to the generation of cancer in which case it may be termed a causative agent or at least involved in the causative process. Various therapeutic agents with attendant treatment pathways and protocols are then prepared from the disease-associated agents based on the cfassification. Further in vitro and in vivo evaluation of the various therapeutic agents may be conducted for determining which such agents, pathways, protocols, or combinations thereof, may work best for a particular patient.

Also, such further in vitro testing of the therapeutic agents can provide an accurate basis upon which a prognosis concerning the targeted disease may be made, because many therapeutic agents produced according to the method of the present invention do not depend on stimulating the patient's immune system, but rather have an inherent ability to attack a targeted disease directly, apart from any assistance which may be available via elements of the patient's immune system. For example, in accordance with the instant invention, if a disease-associated organism is classified as being detrimental toward a targeted disease (i.e.. the activity of the organism is infective, antagonistic or nemesis antagonistic toward the targeted disease), a form of said organism is then isolated for effective use in targeting the disease. A therapeutic agent is made from the isolated antagonistic or nemesis organism, which agent enhances the patient's existing defensive response against the disease via adding its independent anti-disease activity to the patient's body. An example here may be made of the use of phages and their use as nemesis organisms in the treatment of bacterial infection. A host suffering of staphylococcal infection, for example, may have such organism cultured and nemesis phages may be identified from stock cultures or from the same staphylococcal culture by exposing it to stress in the form of metabolic (nutrition), oxidative (peroxide, ozone), or any other physical, chemical or biological stress including UV light exposure amongst many other known processes or those to be discovered. The phage isolated will exist in vitro as a nemesis in that phages will be found that will destroy almost all of the bacteria in culture.Phages have been used previously as antibiotic agents but largely were not as effective in-vivo. This was at least in part due to the lysogenic potential of many phages despite initial lytic activity and the ability of bacteria to develop immunity to infection, inventor has created a lysogenic coefficient indicating likelihood and time needed for lysogeny to develop between certain phages and bacteria as well as mechanisms designed to deal with bacterial resistance which include use of pharmaceutical agents such as antibiotics to deal with resistant bacteria and maximize destruction of those sensitive to phages,specific antisera can also be used to do the same and plasmid therapy to mark the bacteria antigenically for antisera etc. and maintain or induce bacterial sensitivity to phage or other therapy. A major difference between this and prior art is the use by the author of lytic phages without significant lysogenic potential so that lytic effect is maintained. Samples of disease are also taken regularly to gauge phage and other sensitivities.

Phages also may be used to prepare and augment immune response to the phage-lysed bacteria by introducing the phage-lysed bacterial fragments into the body so that it may anticipate it and respond strongly to the challenge; phages and phage lysates also are strong immune stimulants and therefore may have both direct anti-disease activity as well as secondary characteristics beneficial to host. Prior preparation of the host against the lysed bacteria and use of multiple generations of lytic phage, the use of plasmids and phage to confer required properties to the target organisms or to prevent the acquisition of unwanted ones along with the use of antibiotics, antisera. etc. (including the use of transfer factor.a cellular extract that can educate the host's immune response), patent introduces the concepts of anticipation (preparing the host for a change about to arise as natural progress of disease or subsequent to treatment), multiphasic therapy where stages of treatment are planned according to resistance that arises in disease; eg the use of multiple phases of phage designed to deal with anticipated or actual resistance that develops following the use of each solely or in combination. Patent also introduces multimodal or polyvalent therapy alone or in combination with the polyphasic and anticipatory models to optimize therapeutic efficacy.

Those skilled in the art will recognize that this type of therapy may be significantly more advantageous to a patient than current therapies which merely attempt to stimulate the patient's immune response by vaccinating the patient with fractions of a targeted disease. If, on the other hand, a disease-associated organism is found within the body of a patient, which organism is classified as beneficial regarding a targeted disease (i.e., the activity of the organism is either causative or synergistic toward the disease), a therapeutic agent which is antagonistic toward such beneficial organism may be administered to the patient for aiding the patient's immune system in fighting against such causative or synergistic organism. Organisms have often been reported to exist in cancer patients both in tumor biopsies and in overt disease, in the treatment of a non-Hodgkins lymphoma patient suffering from mixed bacterial pneumonia, inventor prescribed broad spectrum antibiotic cover-Penicillin 1 million units three times a day, chloramphenicol 1.25 g three times a day and flagyl 400 mg three times a day; the first two by intramuscular route and the flagyl orally, following one week cancerous lymph nodes shrank and softened suggesting that the antibacterial action of the antibiotics was having anti-cancer activity. Similar protocols have not altered disease conditions in other patients of same cancer type, suggesting different organism targets in different individuals. Indeed, it has been found that challenging such causative or synergistic organisms often results in simultaneously challenging the targeted disease. Again, the patient's ability to fight the disease is enhanced by administration of a therapeutic agent, such as an anti-causative or an anti-synergistic organism, rather than by the attempted stimulation of what may be an already weakened or suppressed immune response. Although practicing the method of the instant invention involves the application of extracts or other modifications of organisms which are normally pathogenic toward a host of the patient's specie (e.g., they are fractions of another disease), such application is not generally accomplished without the additional application of other disease-associated agents or organisms which are capable of enhancing the patient's own anti-disease response beyond that which is achievable via merely stimulating the patient's immune system with fragments of the targeted or a similar disease. For example, in the case where disease fractions are administered to a patient in accordance with the method of the present invention, it is generally preferred that such disease fragments are either nonpathogenic toward the patient, or that other disease-associated agents or organisms or parts thereof which are antagonistic toward the disease fractions are subsequently administered to the patient, for neutralizing the pathogenesis of such disease fractions after they have accomplished their intended purpose.

The instant invention further involves manipulation of the affinity between a disease-associated agent and a targeted disease in order to increase the specificity and decrease the toxicity of therapeutic agents made from such disease-associated agents. The method of the present invention also includes the use of disease-associated agents already having a high degree of affinity toward a targeted disease and further includes increasing or enhancing the affinity toward a targeted disease. Still further, the method of the present invention includes inducing such affinity in organisms which initially demonstrate no affinity toward a targeted disease.

The method of the present invention includes decreasing such affinity between a disease-associated agent and other cellular material, which material the therapeutic agent to be derived from the disease-associated agent is not intended to affect. The inventor has found that such manipulation of affinity between disease-associated agents and a targeted disease or other bodily material can significantly increase the specificity of therapeutic agents which are ultimately derived from such

disease-associated agents. Simultaneously, there is a decrease in the toxicity of such therapeutic agents, which often results in a significant decrease in the occurrence of undesirable side-effects. As well as increasing the affinity of a disease-associated agent toward a targeted disease, the method of the present invention may also be used to increase the efficacy of various antagonistic and nemesis disease-associated agents by increasing the antagonism of such agents toward a targeted disease, and even stimulating the antagonism in disease-associated agents which initially demonstrate no such activity toward a targeted disease. It has been found that such antagonism enhancing can be accomplished even with components of a patient^'s own immune system. As well as manipulating the affinity or antagonism of a disease-associated agent, and even stimulating such characteristics in a disease-associated agent which has not yet demonstrated such activity, the inventor has found that various other

characteristics may be transferrable between various disease-associated agents and other organisms or agents. Indeed, the method of the present invention further includes transferring various desirable characteristics from a first organism to a second, in order to biologically enhance the second organism. It has been

demonstrated that such biological enhancement may be beneficial in assisting an organism in recovering from the ravaging effects of a disease. It has been demonstrated further that such biological enhancement may be beneficial in adding whole new dimensions of capability to an organism.

The method of the present invention further makes use of the affinity of disease- associated agents toward a targeted disease by using disease-associated agents as tagging mechanisms or tagging agents. The inventor has found that the tagging agents may be useful not only for making a targeted disease more visible to a patient's immune system, but that they may be useful also for making the disease more visible to other disease-associated agents or anti-disease factors, which other agents or factors do not have as great an affinity toward the targeted disease and, therefore, may be directed to the targeted disease indirectly via their attraction to the tagging agents. One approach to accomplishing this includes the use of a tagging agent to carry an anti-disease agent with it to a targeted disease. Alternatively, other disease-associated agents may be used which are antagonistic toward the tagging agent, antagonistic toward the tagging-agent-and-disease complex, or antagonistic toward products of the complex for challenging the disease after such tagging agents are in place.

The method of the present invention also provides for the use of radiant energy generating devices in the prevention, diagnosis, treatment, prognosis and monitoring of a targeted disease. The inventor has found that various body tissues resonate at various natural frequencies, which can be identified, enhanced, and monitored. It has been found that tissue which has been affected by disease cannot carry the same dominant frequency patterns as its healthy counterpart. The inventor has developed several devices which capitalize on this phenomenon in treating a targeted disease.

Various embodiments of the invention are described in greater detail, below. Example 1

Therapeutic agents are produced from organisms, organism extracts or modifications thereof, which demonstrate detrimental activity toward a targeted disease (i.e., the detrimental organisms are antagonistic or nemesis organisms). The organisms may include those which have demonstrated a natural antagonism toward a targeted disease, as well as those in which such an antagonism is induced or raised in accordance with the method of the present invention.

The initial step in producing a therapeutic agent is to perform a spectrum search for potential disease-associated organisms, which demonstrate such detrimental activity. The spectrum search should include an epidemiological search for organisms which are known to exist in geographical areas having a low incidence of the targeted disease. It can be deduced that some disease-inhibiting element or organism exists within the low-diseased areas, and may be identified for use in treating the disease. A wide range of organisms should be reviewed for the search, including bacteria, viruses, fungi, parasites and plants. Correlating the incidence of viral, bacterial, fungal, parasitic and other types of infections with the incidence of the targeted disease on a global geographical basis will yield further information on potential detrimental organisms (suggested by the high incidence of these organisms and their clinical manifestations with the scarcity of the targeted disease). For example, in geographical areas having a high incidence of malaria, cancer is scarce. The incidence of cancer is also known to increase in such areas where malaria is eliminated. This suggests a possible antagonism between malaria and cancer, thereby qualifying malaria as a potential disease-associated organism with regard to cancer.

Also, non-geographical statistical surveys should be performed to identify potential disease-associated organisms which are not normally affiliated with specific pathogenic states. Such non-affiliation may indicate an antagonistic or nemesis activity between such organisms and the pathogenic states with which they are not affiliated. Examples of diseases and microorganisms which have such statistical indications of an antagonism toward various cancers include syphilis(treponema pallidum), measles, mumps(and measles and mumps viruses) and staphylococci often in skin infections, erysipelas (streptococci); tuberculosis (mycobacteria). malaria (plasmodia) - all may in whole or in part possess direct or indirect action and are potential sources for anticancer therapeutic agents. Still other statistical information indicates that cardiovascular disease and cancer are opposing maladies, in that the incidence of one in an individual reduces the likelihood of the other also

occurring, Initial work by inventor suggests that similar organisms or mechanisms may be associated with both, cholesterol and triglyceride levels with cancer patients receiving therapy as per patent would usually improve dramatically. Applying the concepts and therapies described here in whole or part drastically reduced cholesterol levels and often reversed cardiovascular disease to some degree.

One particular phenomenon which should be considered during this part of the search is that of biological interference, wherein organisms of the same specie (i.e., virus to virus, bacteria to bacteria, fungus to fungus, cancer to cancer, etc.) normally interfere with each other's ability to survive in a shared host. For example, it is extremely rare for a single individual to be infected with two viruses or two cancers simultaneously. It has also been found that certain plant and animal viruses when used in accordance with the present invention can negatively impact the HIV virus. Indeed, the use of certain organisms like types of Staphylococci and their or other phages in the method of the present invention significantly interferes with the HIV virus. Preparations tested cause considerable interference both with viral replication as well as its ability to destroy T cells. In a study of 10 AIDS patients treated with vaccines made from staphylococcal phage lysates (10 to the 9 plaque forming units per ml; 2.5 cc administered intramuscularly) 8 showed 10 fold drop in their viral load as measured by PCR analysis and greater than 50%increase in their T cell counts over the same time period. Still further, it has been found that some tumors elicit strong responses against unrelated tumors. Accordingly, if the targeted disease is a cancer, the spectrum search should also include a review of other cancers as potential disease-associated organisms, since most cancer hosts carry only one form of cancer.

Regarding concerns about treating one disease with another which will ultimately also need treating, the inventor has discovered that use of non-disease tissue from a host infected with the corresponding disease can carry sufficient anti-similar-disease factor for use as therapeutic agents against the similar targeted disease. For example, it has been found that therapeutic agents made from the ascitic fluid of a breast cancer patient may exert very powerful anti-cancer activity against prostrate cancer, as indicated by the pronounced shrinkage of tumor masses within minutes to hours of application in accordance with the method of the present invention. Ascitic fluid may provide a bank of, amongst other things, human anticancer antiserum. Inventor has found dramatic anticancer activity in others of similar disease and even moreso in some cases of different cancers. In vitro, ascites from breast cancer may cause a 100% cancer cell kill in lines of leukemia and melanoma, for example. In vivo cancer-related fluid (some activity has also been observed by author where fluid in tissue space such as pleura or peritoneum have been of cardiac, hepatic or other origin) needs some caution in use as carcinoma-related fluid may cause initial improvement followed by aggravation in sarcoma-bearing animals and vice-versa.

It is preferred that the epidemiological search for potential disease-associated detrimental organisms be a continuous effort for the purpose of creating a library of potential disease-associated organisms which can be readily accessible for therapeutic use against a wide variety of pathogenic agents. Antagonistic organisms which are identified in other aspects of the spectrum search, as described hereafter, should also be added to this library for therapeutic use with future patients having a similar disease. In the inventor's development of such a library, he has found many organisms, including disease-associated extracts and components of host immune responses, which are readily useful in the creation of therapeutic agents against diseases and other non-desirable bodily conditions that have been heretofore classified as incurable. For example, penicillin's usefulness as an anti-bacterial therapeutic agent is well known. By adding the parent organism Penicillium notatum to the library for identifying other potential uses of this organism, the inventor has discovered that enzymes extracted from Penicillium notatum have an apparent therapeutic effect upon the HIV virus. Penicillium notatum cultured whole with or without subsequent physical/chemical or biological lysing exerted 65% inhibition of viral growth in T cell culture over 48 hours. With specific culture characteristics, to be described in patent, inhibition was raised to 99%: other penicillia and yeasts and fungi are also capable of this.

The spectrum search for potential disease-associated detrimental organisms should also include a search for organisms which may be found in vivo. An in vivo search should include looking within a patient-specie host, especially such a host which is undergoing a remission from the targeted disease or a disease similar to the targeted disease. A blood sample or a biopsy of diseased tissue from the remissive host will likely reveal an organism which is actively attacking the disease, attacking another agent that has "tagged" the disease, attacking a complex comprising a tagging agent and diseased tissue, attacking by-products of such a complex, or attacking another organism that is in a synergistic relationship to the targeted or similar disease. A search in the remissive patient's blood, nose, throat, ears, ascitic fluid, urine and stool should also be made for organisms not normally associated with the patient's body, paying special attention to those organisms for which no apparent

immunological activity has been precipitated.

The spectrum search for potential disease-associated detrimental organisms should further include a search for organisms which may be found in vivo within a patient-specie host which is infected by a different disease, which has demonstrated an antagonism toward the targeted disease, as indicated in prior geographical or statistical correlations, or as may be indicated as a result of anticipated biological interference. It has been found by the inventor that effective sources of antigens and disease specific antibodies exist in ascites, plural effusions and other tumor effusions of remissive patients and of still other patients having a similar, or otherwise biologically interfering, disease along with a factor of accelerated cancer cell death,assumed to be but not restricted to a genetic code, possibly a ribonucleic acid termed dsRNA (referring to death sequence RNA). In reality, several death sequence compounds may be defined including enzymes and co-factors. DsRNA was postulated to account for the rapid, non-inflammatory cancer cell death seen upon addition of such fluid to cancer cells in vitro and in-vivo. lt appears to exist in higher concentration where the fluid is not cell-free. Contents of such fluid also appear to have strong antimicrobial.anti-inflammatory and regenerative

capacity, Preliminary work even suggests the possible use of cancer fluid and cancer cell extract in the increase of cellular division beyond the Hayflik limit. Death sequence agents may have counterpart life-sequence agents and may vary in their role depending on target. They may represent the cellular version of bacterial phages and plasmids. Preliminary animal studies point to the possibility of using these agents in disease prevention, treatment and life-extension (death sequence nay represent or promote life sequence in other circumstances and/or targets.

Ascitic fluid from a carcinoma or sarcoma patient has been found to have general anti-cancer activity. In humans, for example, it has been found that therapeutic agents comprising sterile human effusions or ascites from such other human hosts are not only effective against various diseases, but induce only a few side-effects when administered intramuscularly, subcutaneously, intradermally, or intratumorally with doses up to and exceeding 150cc. It is further believed that treating a patient with a therapeutic agent made from an identical cancer type from another patient-specie host in accordance with the present invention may stimulate the patient's immune system against the foreign tissue. In so doing, the patient's immune system may be induced into recognizing its own cancer cell material which has been previously "hidden" from the immune system as being similar to the foreign material and, thus, attacking the previously hidden cancer cell material.

GRAFT REJECTION

Rejection of foreign, implanted tissue by the host body has been a long-studied immunologic phenomenon and a dreaded consequence of transplant surgery. Recent success in transplantation has been in part due to better matching of donor but largely due to application of immunosuppressant technology and agents. There has been minimal, if any work on the use of such rejection mechanisms in a therapeutic format.

There have been many attempts to raise an immune response against cancer by various genetic or membrane manipulations to alter its structure to one more antigenic or to secrete/express immune-attracting complexes.

Occasionally, spontaneous remission follows some localized or systemic infection and this has led to the use of viral/bacterial/other micro-organism preparations in the treatment of cancer; those of note include Coley's toxins, the Newcastle's disease vaccine as well as the recent use of Herpes viruses to sensitize and target cancer cells. There have also been researchers who have claimed that certain organisms cause cancer and designed vaccines to deal with them such workers have included Glover. Scott as well as Livingston in more recent times. The latter two

recommended the use of killed "causative" organism vaccines whereas Glover actually developed a specific antiserum-his approach is probably more logical in view of the "clonal depletion" section of this patent (but as all others, limited by one causative target).

Viruses, bacteria and other micro-organisms eliciting major immune responses tend to be too deadly for use whereas others are often capable of causing a temporary response but often become incorporated in the matrix of the cancer cell and directly or indirectly aggravate its growth. During the 50's and 60's many researchers experimented on patients with a plethora of viral and other microbial agents to attempt to treat a wide array of cancers. The results never matched the spectacular responses occasionally reported after random infection. The pattern of remission events, the phenomenon of reactivation and one of the most powerful immunological phenomena, graft rejection was to suggest some answers to this apparent paradox.

Remissions from cancer had been observed following a range of viral and bacterial as well as other micro-organism infections (malaria, trypanosoma cruzi, syphilis, etc.). Bacterial and higher organisms have been considered in other parts of the patent, most of the work done with the higher organisms has concentrated on preparations and extracts of the whole and therefore, the experimental situation could not be said to mimic the live infection scenarios; viruses, however, have been used in their entirety in many trials, the culturing and purification of viral organisms and the attempt to increase their efficacy, specificity, etc., by standard culture methods (unlike those of patent) as well as others and their use in ever-increasing concentrations usually failed t duplicate their reported success as a natural event. Even the use of steroids to immunsuppress the patient during the infective phase to allow for optimal viral infection of cancer cells failed to improve efficacy. The paradox, therefore, was that the remissions observed occasionally with clinical viral infections could not be equalled, let alone surpassed by the use of higher infective dose and controlled immunosuppression to allow for higher viral saturation of cancer.

Resolution of the paradox lay in that the occasional tumor-resolving effect of viral infections could not simply be attributed to pure viral effects of pure antiviral immune or other defense mechanisms. Natural infections also did not always result in automatic remission. Other factors must have been involved.

Work in the mid-seventies (1974, Teruo Asada, cancer 34:1907-1928) yielded promising results in the use of mumps in the treatment of breast and other cancers. The virus was isolated fresh from human donors and introduced into the patient. Tumor regression occurred within days to weeks. Attempts by the author to duplicate the work using attenuated vaccine failed to yield any positive response, clearly, freshly donated virus carried factors not contained in the attenuated vaccine.

Interestingly, regression occurred even in patients previously immunized or had suffered mumps in their youth. The ability to infect the cancer cells appeared unaffected and/or the infective dose was not an essential factor (explaining the failure of steroid therapy to improve effect).

There appeared to be a fundamental difference in infections acquired naturally which could cause remissions and attenuated forms of the same virus as used in vaccines or repeatedly passaged through cancer cells in order to stimulate specificity and efficacy. The latter two preparations share more than just inefficacy. MOST ATTENUATED VIRAL VACCINES ARE CULTURED ON EITHER EMBRYONIC CELLS OR IMMORTAL (CANCER) CELL LINES. This is done so as to minimize the risk of introducing strong foreign antigens by the culture medium, amongst other reasons.

Many infective agents cannibalize fragments of their host and may express them in an antigenically significant form in the initial phase and/or throughout the infection. Cancer cells may also carry other infections or mechanisms for

amplification of such antigens once introduced into the system-this may be of assistance but is not an essential requirement of the theorized model; it however, may explain how effect may be elicited by inactive or dead extracts of infection or of foreign tissue it also opens a new realm of possibilities including genetic

manipulation of cancer to induce expression of foreign antigens.

The one hallmark, repeatable experiment in cancer immunology is the grafting of cancers across species or even in different members of the same species. The greater the difference genetically between recipient and donor, the more aggressive the rejection phenomenon. Prior art in application of this observation involved the implanting of one person's cancer into another cancer patient. The implant would be quickly reflected and it was hoped that the patient's own tumor would suffer from some form of crossover effect where an angered immune response hopefully recognizes some common "caner antigen" in both rejected graft and recipient's tumor and then attacks the patient's cancer.

Upon studying cases treated in this manner, it is easy to see where this theory is flawed.

1. There appears to be almost instant destruction of transplant as would be expected from a graft refection yet the patient's own tumor also may undergo rapid breakdown (within hours). This would suggest a much more rapidly activated phenomenon then a crossover effect. Part may be due to DSRNA and other DS factor activity, part may be due to a direct cancer vs cancer activity or even antibodies/other immune response transplanted with tumor. Work earlier this century involving injection of ascitic fluid into cancer patients led to significant tumor regression and improvement both in length and quality of life (111 and Miningham, 1912; Hodenpyl 1910). Ascites and other effusions such as pleural cancer- related effusions have more recently been shown to carry significant titres of anticancer antibodies. It is thought that in cell-suspension form that the cancer cells express antigens more openly and antibodies are therefore easier to manufacture (non-cancer effusions, however, also seem to carry anticancer activity). It appears that ascitic fluid from long term survivors carried more beneficial effects than that isolated from others. In vitro data demonstrated that several ascitic fluids (breast, bowel, hepatoma) could destroy cancer cell cultures; both leukemia and melanoma cells were tested at the University of Colorado School of Medicine-see attached.

Work by inventor demonstrated that in-vivo results were best if the fluid used was from the same broad group of sarcoma or carcinoma as the treated animal. Despite efficacy of fluid from either source against a wide range of cancers from both classifications in-vitro; treatment of sarcoma with carcinoma fluid or vice-versa met with very transient alleviation of symptoms followed by rapid growth and death of animal. The relative shortage of sarcoma fluid allowed for heavier documentation of catastrophe following sarcoma treatment by carcinoma fluid in view of the in-vitro findings, it appeared that sarcoma cells and associated fluids are capable of destroying carcinoma cells and vice-versa to at least equal efficacy as various carcinomas and related fluids and sarcomas and related fluids could. The in-vivo data seems to indicate that sarcoma and carcinoma may destroy each other factors lead to shortened life span, perhaps the unchecked release of disease cause. Then a carcinoma/related fluid or a sarcoma/related fluid causes shrinkage of a same-group cancer effects in-vivo are longer lastine-and more dramatic. Inventor has also found evidence that interchange of cellular structures is more marked when dealing within the same broad heading of cancer type. 2. Ascites/pleural effusions etc. from a patient who is stable or who is undergoing tumor regression have been shown to exert beneficial action on patients of similar cancers to whom it was administered. It is likely that the mechanism involves antibody responses of some potency in the fluid and one would therefore expect optimal responses from patients with identical tumor types and related antigens.

If the above was the only mechanism involved then the following observation should not be possible; fluid from cancer patients doing poorly also exerted an antitumor effect; most marked when the tumors belonged to the same broad heading of carcinoma or sarcoma but were markedly different within those headings.

A case demonstrating this was the rapid disappearance of a 5cm diameter skin metastasis from a prostate cancer patient upon application of ascitic fluid from an ovarian cancer patient. Its disintegration and resorption occurred over a few hours. Other, distant sites began to recede over a few days. Ovarian cancer and prostate cancer are not antigenically related in any manner worthy of such a response, it should be further noted that even in absence of ascitic fluid, even washed cancer cells from one patient were able to cause at least temporary tumor regression when injected into another. Part of this may be explained by the DEATH SEQUENCE FACTORS as described previously. Even should the theory of spillover from immunological angering be a factor: antigenic stimulation of implanted tumor is greater, the greater the difference from one donor to host (effects have been noted by inventor both with implants of the same of different species, however, same specie implants may have greater spillover effect). Cancer-related organisms from one patient may infect the cancer of the host and may be recognizable antigenically by the new host).

It is also possible that cellular exchange or donation of antigen occurs between implanted cancer and that of the host leading to the cancers both being rejected as foreign. While it is also possible that we are witnessing some cancer vs cancer phenomenon or even antitumor antibody more specific to causative organisms than cancer cell type the more the cancer antigens vary. There is evidence that cancer-specific antibodies/compounds exist secreted against or even by cancer cells in body fluids. The ability of ascitic fluid to effect cancer breakdown in-vitro without other blood factor indicates a direct effect yet the inability to produce carcinoma fluid vs sarcoma or vice-versa benefits in-vivo as opposed to excellent responses in-vitro indicates that the antibody component may not be the major therapeutic one.

Work by the inventor demonstrating the efficacy of male vs female tumors and tumor responses suggests that rejection phenomena may be active.

Use of the graft rejection response may help explain the difference in efficacy between natural infection and vaccines attenuated and cultured. Other than the implications of vaccine attenuation on cancer cells (or continuous cell lines as is common practice) leading to weakened anticancer ability (see cancer attenuation factor); natural infections carry antigens of their previous host and upon infecting cancer may express both viral and graft rejection antigens.

The following pictures demonstrate a zone of separation between cancer cells and normal tissue suggestive of graft rejection following inoculation of Newcastle's virus in its natural form; suggestive of graft rejection.

Prior art in this field includes the passaging of virus/other micro-organisms through cancer tissue cultures to attempt to increase specificity and efficacy. This has usually been either without effect or. worse, induced tolerance eg. pushing a virus into a lysogenic form. (See cancer attenuation factor-also discovered by inventor).

A simple explanation for the logic to follow is that when the existing options are attenuation or extinction, synergistic or attenuated forms of the virus will be selected for A system to isolate specific and destructive viruses must therefore provide conditions which promote its survival and propagation. Serial passages through cancer cultures will select for virus that can synergize with the cancer cell unless the capacity for cancer cell lysis is selected for by culture technique serial or continuous passaging or even static culture mechanisms are unlikely to select for aggressive viral strains or amplify them; the viral strain that survives best in this format is one with inherent or acquired cancer synergy and amplification and survival occur best for viruses which do not destroy their cellular host. One technique for selection of deadly viral particles (DVP) is Timed Culture Techniques (TCT). Theory here assumes that the rate of growth and viral release is higher in aggressive viruses than in synergistic ones.

A times aggression coefficient can be defined whereby studies indicate the length of time needed for cell lysis to start and collection of viral particles from culture medium at this point yields high titres of destructive virus.

This, however, does not rule our fast replicating synergistic viruses that bud or release without cancer cell destruction.

The above problem is resolved simply by repeated centrifugal separation of lysed cellular body and/or filtration and culture of associated virus. Separation along a centrifugal or sugar or other gradient should separate living cells from dead ones and even fractionate the divisions. Viruses existing within the living cells can also be used as antigen carriers particularly upon cellular stress. This model applies equally well for bacteria as it does for cancer and other cells.

The in vivo portion of the spectrum search for potential disease-associated agents should include isolating organisms or other disease-related factors which are residing within the patient. This aspect of the search should include looking for any organisms which may be found in non-infected portions of the patient's own body. Areas of the body not infected by the targeted disease would strongly indicate the existence of a disease-associated organism or other immune agent, for example, an immune factor produced by a disease-associated organism, or even an immune factor which is produced by the uninfected body portion. As previously noted, there are often many parts of a patient's body which normally remain unaffected by a particular disease.

With regard to cancer in humans, unaffected areas often include the spleen, small intestine and muscular system. It has been found, for example, that Peyers Patches from a human patient or donor may be extremely useful in the method of the present invention, due to the inherent ability of such tissue to withstand a large variety of diseases. It has still further been found that extracts of a muscle biopsy when activated by enzymatic stimulation, biological fortification or amplification by any other means exhibit a strong anti-cancer therapeutic effect. Challenging balb-c mice with mop-c myeloma at the same time as injection of lysed rat muscle extract delayed the period of onset of disease. Furthermore, intramuscular injection of a hypo-osmotic solution also releases some components of muscle cells so that they exert some anti-cancer therapeutic action. If, however, it is not otherwise desirable to investigate such disease resistant areas of the patient's body, areas of another patient-specie organism may be examined for the disease-associated organisms or immune factors.

The in vivo portion of the spectrum search for potential disease-associated detrimental organisms should further include a search for organisms occurring in, or raised in, the bodies of hosts of a different specie than the patient, such as non-human hosts when the patient is human. Different-specie hosts include those which are susceptible to the targeted patient-specie disease, or a similar disease, and may further include those hosts which are known to be resistant to the targeted disease. Although a wide variety of non-human hosts may be useful in this regard, the inventor has found especially useful hosts selected from the group of non-human host orders or families consisting of: Bovidae, Canidae, Cricetidae, Equidae, Felidae, Lagomorpha, Muridae, Primates, Suidae. and Tayassuidae.

A very accessible type of detrimental organism which can be raised in different-specie hosts which demonstrate an immune response to the targeted disease are antibodies created by the host for attacking the targeted disease. Such targeted disease antibodies may be raised in a first non-patient-specie host by inoculating said first host with any targeted disease related elements which have been extracted from either the patient or another patient-specie host that is infected with the targeted or a similar disease. Such extracted disease related elements may include, but should not be limited to, the following: 1) cells of the targeted or similar disease; 2) lysed fragments of diseased tissue (especially that which is from cellular membrane, mitochondria, golgi apparatus, lysosome. or the like); or 3) any disease-associated beneficial or synergistic organisms which may be identified (as discussed later in greater detail).

After being inoculated with such disease related elements, the first

different-specie host will raise antibodies against the inoculated disease related elements. After such antibodies to the inoculated disease related elements are raised, sera containing such antibodies should then be extracted from the first

different-specie host. The next step in preparing a therapeutic agent from antibodies raised in a different-specie host is to "wash" any anti-patient-specie factor from the first host sera. A method of conducting such washing is to inoculate a second different-specie host of the same specie as the first host with normal, uninfected cells of the patient or other patient-specie organism. This will raise antibodies to the normal cells of the patient or patient-specie organism, which antibodies can then be extracted and applied in vitro to the first host sera, for precipitating any anti-patient-specie factor out of the first host sera, thereby leaving the anti-disease antibodies in the sera for use as a therapeutic agent for the patient. The remaining anti-disease antibodies may be further washed repeatedly against healthy cells of the patient for precipitating out any remaining anti-patient factor.

An alternative method of washing any anti-patient-specie factor from the antibodies to the targeted disease which were raised in a different-specie host is to inoculate a third different-specie host with the antibodies to the targeted disease raised in the first different-specie host. Such inoculation will transfer memory of anti-targeted-disease activity to the third host immune system. The third

different-specie host should then be intentionally challenged at a later date by a second disease which is common to the different-specie, which second disease is also substantially similar to the patient-specie targeted disease. The initial "memory" immune response of the third different-specie host against the second disease will be anti-second-disease activity. However, such immune response may also include anti-patient-specie targeted-disease activity, and may also, therefore, include antibodies or other factors which may be effective as a therapeutic agent prepared against the patient-specie targeted disease. Of course, the actual activity of said immune response antibodies or factors should be tested to determine the specific type and level of its activity toward the targeted disease and the patient-specie before being made or used as a therapeutic agent. The selected antibodies and immune factors may be further washed repeatedly against healthy cells of the patient, for precipitating out any remaining anti-patient factor.

Another alternative method of raising in a non-patient-specie host antibodies to a targeted disease, which antibodies are free of any anti-patient-specie factor, is to inoculate a first non-patient-specie host with normal, uninfected cells of the patient or other patient-specie organism. This will raise antibodies to the normal cells of the patient or patient-specie organism, which antibodies can then be extracted and applied in vitro to patient specie sera which contains targeted disease related elements that have been extracted from either the patient or another patient-specie host that is infected with the targeted disease or a similar disease. This will precipitate any patient-specie factor out of the sera, and thereby leaving in the sera disease related elements which are free of any patient-specie-factor. Some of the sera which has been thus "washed" of patient-specie-factor is then inoculated into a second non-patient-specie host, for raising antibodies to the disease related elements in said sera. The antibodies raised in the second non-specie-host should then be useful for producing a therapeutic agent for applying to the patient against the targeted disease. Such antibodies may be further washed repeatedly against healthy cells of the patient for precipitating out any remaining anti-patient factor.

Raise organisms having a high affinity toward healthy cells either in vitro or in vivo. Once raised, wash such organisms against organisms having an affinity toward a targeted disease to ensure that any affinity between the diseased-cell-affinitive organisms and healthy cells is eliminated prior to introduction of therapeutic agents made from the diseased-cell-affinitive organisms into the patient. Furthermore, the diseased-cell- affinitive organisms, extracts or modifications thereof, may be similarly washed repeatedly against disease cells in order to extract from the sera only those cells which have the greatest affinity toward diseased cells. The diseased cells may then be removed from such cells having the greatest affinity toward the disease via chemical, physical or biological separation methods which leave the diseased-cell- affinitive organisms, extracts or modifications thereof, intact and substantially ready for introduction into the patient. Such diseased-cell-affinitive organisms, extracts or modifications thereof, raised and washed in this manner will have both a high affinity toward the targeted disease and a high specificity regarding the type of cells to which they are attracted. Indeed, it has been the inventor^'s experience that patients treated with such diseased-cell-affinitive organisms, extracts or modifications thereof, have developed only minimal, if any, side effects.

Once the spectrum search has determined the existence of various potential disease-associated organisms which are detrimental to the targeted disease, tests should be conducted to determine the type and level of activity which exists between the organisms and the targeted disease. Perhaps the simplest tests to conduct are antibiograms and antichemograms. in which various potential disease-associated organisms and chemical agents are blotted on an enriched or minimal media which includes elements of the targeted disease. Such media blotting or petri dish tests will yield results which are both quick and reliable.

Another test which is most helpful in gauging the affinity of potential disease-associated organisms toward a targeted disease is an in vitro reaction test using cell homogenate of the targeted disease in combination with each potential disease-associated organism. Indeed, the inventor has found that the in vitro tests may be a reliable indicator of disease-associated organisms when no other indication of a particular potential disease-associated organism exists, beyond the statistical indication that a particular geographical area may be a potential source of such a disease-associated organism. In such case, a reliable indicator concerning particular disease-associated organisms can be found by preparing antibiograms or

antichemograms, or otherwise conducting in vitro reaction tests using cell

homogenate of the targeted disease, in combination with dense complexes of organisms as may be readily available in the indicated geographical area. Such organism complexes may include plate soil, manure, compost samples, or the like.

Similarly, diseased tissue samples co-incubated with such organism complexes in vitro may also indicate some disease-associated organisms. Figures 1 and 2 illustrate two vials in which such in vitro reaction tests were conducted. Figure 2 shows a lymph node extracted from the same patient and cultured with penicillium fungus; filaments surrounding the cancer began to develop within days. This organism demonstrated affinity to the cancer and could not be washed off the surface easily; within days of co-culture, it could be recovered from the surface and from fragments deep within the mass. Note in figure one a lymph node biopsy in a patient with non-Hodgkins lymphoma, floating freely in a test tube containing several microorganisms of low cancer affinity. After 48 hour incubation and three washes with sterile saline.no organisms could be recovered from the tumor mass.

Samples of the patient's blood or diseased tissue should also be tested in vitro against the potential disease-associated organisms. Any precipitation may indicate the presence of free-floating antigens associated with the disease, and may further indicate a potential association between such disease and the tested disease-associated organism. Also, in vitro testing of antibodies from the patient's immune system may indicate that some of the patient's own antibodies may be useful as disease-associated organisms against the targeted disease. Indeed, the antagonistic activity of such antibodies may be enhanced in vitro, as discussed in greater detail herein, and subsequently re-inoculated into the patient for transferring such enhanced antagonistic activity to the patient's immune system.

Unusually low titers from the in vitro tests of potential disease-associated organisms with the patient's blood or diseased tissue may indicate that the patient's immune system has been suppressed with regard to a particular potential

disease-associated organism. If so, the organism should be considered as a possible synergistic or causative organism. Such indication would be confirmed with significant antigen titers in serum. Conversely, high titers of antibody (or dermal reactivity, when tested in vitro) may indicate previous exposure of the patient to the potential disease-associated organism, which may again be indicative of a possible disease-associated organism. Confirmation of this possibility would be given by the occurrence of significant antigen titers in serum.

In tests where there is a low antigen titer, a high reactivity may indicate the presence of a very useful tagging or immuno-stimulating organism. Titers of antibodies or antigens in response to any of the potential disease-associated organisms are indicative of the presence or susceptibility of the patient to another disease which is associated with such organisms. Thus, in vitro testing of components of the patient's body may be further useful as a method for monitoring the potential threat to the patient by a previously undiagnosed disease.

In vitro testing may be used still further to diagnose the presence of various diseases in a patient's body, which diseases can be subsequently treated by use of various identified disease-associated organisms including those which may be in an existing library of known disease-associated organisms. For example, various anti-bacterial antibodies which have been raised or developed for known diseases may be added to a patient's blood sample. Any precipitation will indicate the presence of a bacteria or its products in the patient's blood stream). The extent of the

precipitation reaction can indicate the extent of the disease. Such in vitro testing may be used even further to monitor the status of a targeted disease in a patient.

Once the spectrum search is complete, and various tests have indicated various disease-associated organisms, it may be desirable to enhance the affinity of one or more of the disease-associated organisms toward the targeted disease. Such affinity enhancing may be accomplished through in vitro or in vivo techniques. It has been found, for example, that co-incubating organisms in alternating minimal and enriched media can be an effective method of stimulating various desirable organism characteristics, such as an increased affinity or antagonism between such co-incubated organisms.

In cases where no apparent attraction exists between a neutral organism and a targeted disease, such attraction may be trained or bred into the organism via co-incubating the neutral organism with cells of the targeted disease in a minimal or partially deprived media. It has been found that after the nutrition in the media is exhausted, the neutral organism will attempt to adapt to its surroundings and develop any attraction which may be needed for procuring nutrients which might be available to it by some activity toward the targeted disease. Such nutrients may be made available to the once neutral organism through ingestion of the disease, as in the case of the development of antagonistic activity in the organism, or the nutrients may be made available through the development of some type of synergistic relationship with the disease.

It has been found, for example, that some bacteriophages will emerge from various bacteria which have been partially ingested by another organism, and will then infect the organism that destroyed the original host bacteria. The attacking organism acquired the nutrients of the ingested bacteria, and the bacteria-phage acquired a new host. This particular characteristic of phages makes them especially powerful when used as therapeutic agents. When a phage that demonstrates anti-agonistic activity toward a targeted disease is used as a therapeutic agent, its nucleic acid may actually move into the body's lymphocytes, allowing the phage's behavior toward the disease to reside as part of the body's long-term immune memory. The body is then able to re-generate either the phage or activity in the lymphocytes similar to that of the phage whenever the body is subsequently exposed to the targeted disease.

After the disease-associated organism has demonstrated such an antagonistic or affinitive activity toward the disease in the minimal media, it should be transferred to an enriched media in which there may or may not be cells of the disease, for stimulating growth in the now changed organism. It is preferred that such media enriched cultures are also stimulated by various mutant-precipitating factors in order to induce continued changes on the part of the disease-associated organism. After sufficient time for allowing the desirable growth by the disease-associated organism, various portions of it should be tested again for identifying the portions having the greatest affinity or attraction for the disease cells or diseased tissue. Such affinity testing may include those tests described earlier herein, or other tests. It is preferred that such portions having the greatest attraction be still further subjected to co-incubation with fresh cells of the disease in minimal media, for stimulating an even greater attraction toward the disease. It has been found that several iterations of this minimal-media-to-enriched-media cycle can induce a significant antagonism or affinity in a disease-associated organism toward a targeted disease.

Further, it has also been found that such bred-in attraction becomes a

substantially permanent characteristic of the disease-associated organism. This method may be useful for both enhancing the degree of any antagonism or affinity which may already exist in a naturally antagonistic or affinitive organism, and for creating a disease-specific antagonism or affinity in cells of a selected organism, which cells have not heretofore demonstrated such antagonism or affinity toward a targeted disease. Also, the creation or enhancing of such antagonistic or affinitive activity toward a targeted disease may be accomplished with cells of the patient's own immune system, as will be described later, herein. A variation of affinity enhancing involves similar testing and raising techniques in vivo with animals not having natural immune systems, such as skid rats and nude mice. Such in vivo testing is especially useful when it is desirable that the ultimate therapeutic agents do not depend at all upon the patient's immune system for overcoming the targeted disease.

It has also been found, regarding the purposeful increasing of disease-affinity or antagonism in a disease-associated organism, that a plurality of mutations may occur in the targeted disease, resulting from the disease's attempt to defend itself from the disease-associated organism. Such stimulated in vitro to in vivo mutating on the part of the disease has been found to be quite useful in preventing the occurrence of similar mutations in the patient, and in establishing an accurate basis upon which a prognosis regarding the targeted disease can be made. Further, the inventor has found that continuing the minimal-media-to-enriched-media cycle will provide a plurality of mutants to a disease-associated organism which may be useful as therapeutic agents against corresponding mutants of the targeted disease. When such agents are used in coordination with versions of the disease-associated organism having a strong attraction for current forms of the disease, it has been found that the targeted disease has great difficulty in developing a resistance to the

disease-associated organism. In military terms, it is not dissimilar from placing mine fields and ambush teams along the potential paths of a retreating enemy.

It has also has been found that vaccines prepared from detrimental disease╌associated organisms which do not have a great affinity toward a targeted disease, can be effective when administered via direct injection into diseased tissue. This type of administration may also be helpful for insuring that a patient's immune system is not able to block a particular therapeutic agent from contacting the disease. The therapeutic agents which have a low affinity toward a targeted disease may also be linked to other organisms which have been found to have a strong microbial-affinity to the targeted disease, as is addressed further, below.

The next step in the method of the present invention is to prepare a therapeutic agent or agents from the disease-associated organisms. It is preferred that each found and tested detrimental organism is crushed, lysed or otherwise fractioned via means which are known (e.g., physical lysis, chemical lysis, biological lysis, radiological lysis or the like) in order to reduce each organism to fractions which are sufficiently small such that when placed inside the patient a general systematic immune response against the antagonistic organism is prevented [need details here]. For example, with human patients it is desirable to filter any non-human sera via means which are known or which have been described herein, for preventing any potential allergic reactions. It has been observed that when prepared as a vaccine, therapeutic agents made in accordance with the present invention and having no component thereof which is greater in size than 0.2 microns, will elicit only little, if any, systematic immune response. A further advantage beyond that of size which may be gained in not using entire disease-associated organisms in a vaccine, includes the ability to have a more controlled breakdown or die-off rate of the targeted disease, and the attendant occurrence of fewer side effects resulting from such breakdown.

Prior to full application of the therapeutic agents, it is preferred that they are tested in vivo for potency. Phage-lysed Staphylococcus albus. for example, has been found to be well tolerated when used as a therapeutic agent in doses of 2.5cc every second or third day. Should the attending medical practitioner have experience with the particular targeted disease, he may wish to begin such testing with therapeutic agents of disease-associated organisms that experience has indicated precipitate strong antigenic responses. It is recommended that initial in vivo testing be conducted intradermally, in order to observe the cutaneous reaction to the vaccine. Initial dosage should be in the 0.1cc range. This dosage may be increased by doubling daily until the size of the local reaction is six inches or greater. The patient's temperature will often rise to 103° F. and last a few hours.

Depending on the size and activity of the compounds, continuing administration of each therapeutic agent may be accomplished via a wide variety of administration means which are known. Decline of the targeted disease, such as tumor shrinkage, should be demonstrable in blood tests within a few days after the initial vaccination. Tumor shrinkage should be demonstrable on X-ray within two or three weeks. If such disease decline is not observed, the same treatment should be repeated with alternate therapeutic agents or vaccines from other of the cultured pathogens until such effect is observed. A more detailed explanation of what actions are available in accordance with the method of the present invention for overcoming a highly resistant disease, is provided below.

As discussed, therapeutic agents prepared in accordance with the method of the present invention may be introduced to a patient by any of a wide variety of administration means, such as those selected from the group consisting of topical administration, injection directly to diseased tissue, oral administration, rectal administration, intraurethral administration, intravesical administration, inhalation. intradermal administration, intradermal administration, intrathecal administration, catheter administration, intravenous administration, intramuscular administration, sub-cutaneous administration, intravenous administration, and intradermal administration. Those skilled in the art will recognize other means of administration which may also be used in accordance with the present invention.

Toxicity studies have failed to demonstrate oral toxicity at 5 mg/kg in mice.

Similar safety is demonstrated for agents prepared in accordance with the instant invention in subcutaneous, intramuscular, or intervenous application at 1 mg/kg. The intradermal method is preferred when dealing with lysed bacterial fragments, filtered extracts of bacteria or other organisms which have been biologically, chemically or physically lysed. When whole organisms are utilized as therapeutic agents, it is preferred that they are administered orally or applied extradermally. Oral

administration may be in the form of enhanced foods and food supplements.

Extradermal administration may be in the form of a cosmetic. For example, the inventor has combined in one cosmetic solution an organism which is antagonistic toward human dead skin cells, and fragments of another organism which has rejuvenating characteristics. The antagonistic organism works as an exfoliant. taking off layers of dead and hardened skin which many exfoliants cannot touch.

Simultaneously, the organism gives a rejuvenating effect to the living skin cells below the outer layer of dead skin. Since the exfoliant in this cosmetic is a living organism, its effect upon the skin tends to be much longer lasting than other skin conditioners.

Example 2

Another method for producing therapeutic agents according to the present invention involves the identification and use of either those organisms which demonstrate a beneficial relationship toward a targeted disease (i.e., causative or synergistic organisms) or those organisms whose activity toward a targeted disease is substantially neutral (i.e., neutral or infective organisms). Like most antagonistic and nemesis organisms, beneficial and neutral organisms usually demonstrate a microbial affinity toward cells of a targeted disease or diseased tissue. However, some beneficial and neutral organisms may demonstrate a type of synergism toward a targeted disease which is remote from the disease, and which synergism may not be demonstrated by a microbial attraction between cells of the beneficial or neutral organisms and cells of the disease or diseased tissue. Rather, the remote synergism is generally demonstrated in that such beneficial and neutral organisms live in an apparent harmony with the patient's body, even though such beneficial and neutral organisms may be foreign to the patient and may normally elicit an immunological response in such a patient-specie host.

As shown in Figure 3 a Russel body marked by arrow, such bodies have often been noted in cancer biopsies.early researchers thought them to indicate

blastomycetes, inventor believes them to be yeast or fungal aetiology. Figure 4 shows several coccoid forms forming a nest in a biopsy of breast cancer. In both Figures 3 and 4, note the total lack of any immune response.

Although such an observation might be expected in AIDS patients as a result of dealing with an exhausted or otherwise suppressed immune system, substantially similar observations have been made by the inventor in a wide variety of other diseases. It is believed that such harmony between this living foreign matter and the patient's body, is due to a shared immune barrier between the beneficial or neutral organisms and the disease. Furthermore, the inventor has discovered, that breaching such barrier by attacking the beneficial or neutral organisms can also result in destruction to a targeted disease. Accordingly, the spectrum search for potential disease-associated beneficial and neutral organisms should include looking throughout the patient's body, or the body of another patient-specie host infected with the same or a similar disease, for any organism which is not naturally associated with such a host.

A spectrum search for beneficial and neutral organisms should be conducted simultaneously with the spectrum search for detrimental organisms, and should also include an epidemiological search. However, the epidemiological search for beneficial and neutral organisms should focus on agents which thrive in geographical areas having a high incidence of the targeted disease. Statistical indicators which point to higher correlations of various agents and a targeted disease should also be noted. An in vivo search should follow, beginning in the patient's body, and extending to the bodies of other patient-specie hosts having the same or a similar disease. As noted, above, a blood sample or biopsy of the patient's diseased tissue may reveal a beneficial or neutral organism which is attracted to. or otherwise living in a synergistic relationship with, disease cells or diseased bodily tissue. Because an effective attack made against beneficial or neutral organisms may also be effective in defeating anti-immune factors which may be present in the targeted disease, special attention should be given to such organisms found in a patient's body which are not being attacked by the immune system. In looking for such beneficial or neutral organisms, it should be noted, that some stains will not readily differentiate particular bacteria from diseased tissue, while other stains have no difficulty in providing a sufficient visual difference for such differentiation. Beneficial or neutral potential disease-associated organisms usually can be found within the protective encapsulation of diseased tissue such as a tumor. As noted earlier, such beneficial or neutral potential disease-associated organisms often can be found in locations of a patient's body which are remote from the targeted disease.

Still further, the inventor has found that such synergistic harmony between a targeted disease and a beneficial or neutral organism which is not eliciting an immunological response, may also exist outside of physically apparent boundaries. For example, it has been found that the bacteria, staphylococcus albus will grow readily from what appears to be a "clean" tissue sample of a patient having carcinoma. When the inventor first noticed such an occurrence, the tissue sample had been fractioned and filtered through a 0.2 micron filter, which is sufficiently small to prevent the transfer of any staphylococcus albus cells. For example, Figure 5 shows a sample of mixed coccal culture which was grown from such a "clean" blood culture of an AIDS patient. Figure 6 shows a culture of tubercule bacilli grown from a "clean" skin sample of a scleroderma patient. Repeated occurrences of this phenomenon have led the inventor to believe that various diseases may be

transmitted, or even may lie dormant, in non-cellular forms, such as in the form of cell-wall deficient bacteria or of genetic information in various phages or plasmids, and that such forms will ultimately materialize as cellular structure once the right conditions exist. Accordingly, patient blood samples and biopsies of diseased tissue should be cultured by culture techniques such as those which are described elsewhere herein in order to isolate any potential disease-associated organisms which may not be readily identifiable. When the targeted disease is of the type which precipitates the production of blocking antibodies for coating diseased cells in order to protect them from the remainder of a host's immune system, the search for such beneficial or neutral organisms should include attempts to isolate the blocking antibodies using pH precipitation techniques. As described further herein, "disease-friendly" antibodies of a host's immune system which are attracted to a targeted disease may be used even to carry antagonistic agents to cells of the targeted disease.

Once such beneficial or neutral potential disease-associated organisms have been found, in vitro or in vivo testing of the type described earlier should be performed to verify that the organisms are indeed disease-associated organisms of the targeted disease, and to further verify or determine the type and level of the affinity or synergism the organisms may demonstrate toward the targeted disease. Therapeutic agents using the beneficial or neutral disease-associated organisms may then be prepared and utilized.

A general therapeutic approach in using beneficial or neutral disease-associated organisms involves identifying other disease-associated agents which demonstrate antagonistic or nemesis activity toward such beneficial or neutral disease-associated organisms, including the extracts, by-products or modifications of the beneficial or neutral organisms. The disease-associated agents therapeutic agents which are useful for attacking the beneficial or neutral agents in order to break down the targeted disease's anti-immune factors which may be shared with the beneficial or neutral disease-associated organisms. It has been found that such other therapeutic agents can often be used to mount an effective attack against the beneficial or neutral agents, and that such an attack can also result in destruction to the targeted disease.

The next step in the method is to identify disease-associated agents which are antagonistic toward the beneficial or neutral disease-associated organisms. The disease-associated agents can normally be located through epidemiological searches, in vitro testing or in vivo raising in different-specie hosts. Once such agents are found, the next step is to determine the type and level of activity such agents demonstrate toward the beneficial or neutral organisms. In making this

determination, it is preferred to use substantially the same type tests as described in the first embodiment of the method of the present invention. Any affinity or antagonism a disease-associated organism may demonstrate toward a beneficial or neutral organism may be increased by the incubation of the disease-associated organism in alternating minimal and enriched media with cells of the beneficial or neutral organism, or cells of other organisms it may be desirable to increase such affinity or antagonism toward. For example, these may include disease-associated organisms that are useful as tagging agents for the disease due to their existing high affinity toward the disease. If, for example, a spectrum search results in the identification of a disease-associated organism which is only slightly antagonistic toward a beneficial organism found living with impunity inside a large tumor mass, it may be desirable to increase the microbial affinity and antagonism between the disease-associated organism and the beneficial organism. This enhances the ability of the disease-associated organism to penetrate the outer walls of the tumor for attacking the beneficial organism, thereby causing collateral destruction to the tumor mass. As an alternative to petri dishes and in vitro reaction test vials, in vivo testing with animals not having an immune systems should also be considered as a viable means to further accomplish such affinity or antagonism enhancing.

Once the disease-associated organisms and other agents have been isolated and any desirable level of affinity or antagonism between such agents and other organisms has been attained, the next step is to prepare a therapeutic agent or agents from each of the disease-associated organisms, using methods substantially similar to those described in the first embodiment. As with the first embodiment, it is preferred that each vaccine is prepared from organism fractions rather than from whole organisms. This reduces the possibility of any systematic immune response against the vaccine, even though there are times when the use of whole organisms in various suitable applications may be desirable. Administration of the therapeutic agents may be accomplished by means which are substantially similar to those of the first embodiment. For protocols involving the administration of both therapeutic agents made from beneficial or neutral organisms and therapeutic agents which are antagonistic to such beneficial or neutral agents, it is preferred that the patient is administered the beneficial or neutral agents in a sufficient amount of time before the administration of the antagonistic agents. This will allow a sufficient synergism to develop between the beneficial or neutral therapeutic agents and the targeted disease for allowing attacks against the beneficial or neutral agents by the antagonistic agents to be most effective in producing collateral damage to the disease. A sufficient amount of time may be anywhere from about several hours to about several days, depending on the level of synergism which is desired. Once the antagonistic organisms are effective in breaking through any immune factor which any beneficial or neutral organisms may have shared with a targeted disease, it has been found that the immune system of the body will also be stimulated to help fight both the beneficial or neutral organisms and the targeted disease.

Example 3

A third embodiment of the method for producing therapeutic agents according to the present invention involves using therapeutic agents made from disease-associated organisms having a microbial affinity toward the disease cells or diseased tissue as tagging agents. Such affinitive disease-associated agents, or disease- affinitive agents, include any of the disease associated organisms already discussed (i.e., causative organisms, synergistic organisms, neutral organisms, infective organisms, antagonistic organisms and nemesis organisms), including whole, part or extracts thereof. Any of these organisms, extracts or modifications thereof, which demonstrate a microbial affinity or attraction for the targeted disease or diseased tissue may be useful as tagging agents. Such tagging agents may be useful for making disease affected areas of a patient's body more visible to the patient's own immune system or to another therapeutic agent which is antagonistic toward the tagging agent, the tagged material or by-products of the tagging agents or the tagged material. Similar to organisms which have developed a symbiotic relationship with a targeted disease, it has been found that attacks which are instigated on such tagging agents by either the patient's immune system or other antagonistic therapeutic agents, can also result in destruction of the tagged disease or diseased tissue. Also, tagging agents may be useful for carrying other agents (such as those which are antagonistic toward the targeted disease but which lack a microbial affinity toward the disease. Other tagging agents may include those which have been used without great specifity in conventional therapy, such as chemotherapeutic agents or radio-active isotopes) or intra-cellular information directly to disease cells.

The initial steps of this embodiment include identifying or raising

disease-affinitive organisms by techniques substantially similar to those used in identifying and raising detrimental and beneficial organisms. The steps of identifying and raising disease-associated organisms should include looking for and raising both organisms which have a high affinity for diseased tissue and organisms which have a high affinity for healthy cells, via minimal and enriched media culturing techniques. substantially similar to those techniques earlier described herein. In raising organisms having a high affinity toward healthy cells via this manner, organisms which are antagonistic to these healthy-cell- affinitive organisms are subsequently raised either in vitro or in vivo. Once raised, the anti-healthy-cell-affinitive organisms may be applied, or "washed." against organisms having an affinity toward a targeted disease, for insuring that any affinity between the diseased-cell-affinitive organisms and healthy cells is eliminated prior to introduction of the diseased-cell-affinitive organisms into the patient. It is preferred that the diseased-cell-affinitive organisms, extracts or modifications thereof, are washed in this manner repeatedly against the anti-healthy-cell-affinitive organisms, extracts or modifications thereof, for insuring that any cells of the diseased-cell--affinitive organisms are eliminated prior to introduction of the diseased-cell-affinitive organisms into the patient Furthermore, the diseased-cell-affinitive organisms, extracts or modifications thereof, may be similarly washed repeatedly against disease cells in order to extract from the sera only those cells which have the greatest affinity toward disease cells The disease cells may then be removed from such cells having the greatest affinity toward the disease via chemical, physical or biological separation methods which leave the diseased-cell-affinitive organisms, extracts or modifications thereof, intact and substantially ready for introduction into the patient Such disease-cell-affinitive organisms, extracts or modifications thereof, raised and washed in this manner will have both a high affinity toward the targeted disease and a high specificity regarding the type of cells to which they are attracted Indeed, it has been the inventor's experience that patients treated with such diseased-cell-affinitive organisms, extracts or modifications thereof, have developed only minimal, if any, side effects Also, it may be desirable to raise the affinity of such affinitive organisms toward the targeted disease via the in vitro and in vivo methods already discussed As well, oncolysates of the disease (which are discussed in greater detail further herein) may be used to enhance the affinity of a tagging agent for a targeted disease, via allowing fragments of the targeted disease to be attached to the tagging agents in vitro before the tagging agents are introduced to the body

Since a main purpose of tagging agents is to make the targeted disease more visible to the patient's immune system, or to other therapeutic agents which are antagonistic toward the tagging agents or tagging-agent-disease complex, the next step is to raise an immunity in the patient against such affinitive organisms or against a combination of such affinitive organisms and tissue of the targeted disease, including any of their extracts or by-products Raising such immunity in the patient may include stimulating the production of various antibodies to the tagging agents in the patient's immune system, or. as in cases in which a patient s immune system is alreadv severely taxed, adding to the patient therapeutic agents made from organisms which are antagonistic toward the tagging agents or the tagging agent and targeted disease complex Stimulating the production of anti-bodies may include the conventional means of vaccinating the patient with dead or inactivated forms of the tagging agents prior to inoculating the patient with active forms thereof. In vitro or in vivo testing may reveal, however, that such vaccination is not necessary; or physician judgment may determine that stimulation of the production of patient antibodies against the tagging agents may not be warranted at this time. Organisms or agents which are antagonistic toward the selected tagging agents or complexes of the tagging agents and diseased tissue, may be identified and tested via methods substantially similar to those already described herein. Enhancing the antagonism of such antagonistic agents toward the tagging agents or tagged diseased complex should also be explored, via methods described earlier herein.

Once the disease-associated organisms and other tagging and anti-tagging agents have been isolated and any desirable level of affinity or antagonism between such agents and other organisms has been attained, the next step is to prepare a therapeutic agent or agents from each of the disease-associated organisms, using methods substantially similar to those described earlier herein. Similar to the first

embodiment, it is preferred that each vaccine is prepared from organism fractions rather than from whole organisms, in order to reduce the possibility of any systematic immune response against the vaccine; although there are times when the use of whole organisms in various suitable applications may be desirable.

Administration of the therapeutic agents may be accomplished by means which are substantially similar to those of the first embodiment. It is preferred that the patient is administered the tagging agents in a sufficient amount of time before the administration of the antagonistic agents, in order that a sufficient synergism be developed between such tagging agents and the targeted disease for allowing attacks against the tagging agents or the tagged disease complex by the antagonistic agents to be most effective in producing collateral damage to the disease. The amount of time may be anywhere from about several hours to about several days, depending on the level of synergism which is desired. Rather than using general inoculation techniques as earlier described herein, it may be desirable to inject such tagging agents directly into disease tissue, or such anti-tagging agents directly into the tagged disease complex, if, for example, it is found that the patient's immune system will yield an extremely high anti-body response to the selected tagging agents or anti-tagging agents. Such direct injection would prevent the patient's immune system from blocking such affinitive agents from the diseased tissue. For tagging purposes, the amount of the tagging-agent which is used may be sufficiently small (e.g., a tenth or even a hundredth of the normal dose of an antagonistic agent) so as to avoid stimulating an immune response against it before the targeted disease is tagged. Once the disease is tagged, a higher amount or concentration of the tagging-agent may then be applied to the patient, with or without adjutants such as silica or Friend's adjuvant, to stimulate the body's immune system against the tagging agent and the tagged disease.

With regard to the use of using tagging agents for carrying other agents or intracellular information to disease cells or diseased tissue, it has been found that smaller antagonistic organisms, such as viruses and phages. may be carried readily to targeted disease cells by combining them with larger affinitive disease-associated organisms, such as bacteria and fungi. Such combining may be accomplished by culturing in diet restricted media the organisms which are antagonistic to the targeted disease (or extracts or modifications of these antagonistic organisms) with organisms that are attracted to the targeted disease. Elements of the smaller antagonistic organisms may be ingested by the larger organisms, and thereby be available for transport by such larger organisms directly to disease cells. If such carried antagonistic organisms are phages. the phage will often infect the larger affinitive disease-associated organism while in vitro, and be carried to the targeted disease by the larger disease-associated organism upon the application of such organism to the patient. When the affinitive disease-associated organism makes membranous contact with the disease cell, the phage should be transfused from the disease-associated organism, through the membrane of the diseased cell and into the cytoplasm of the targeted cell. It is believed, further, that tagging agents may be useful for carrying other specific nuclear information to disease cells, such as RNA or DNA coding which directs the cells to stop reproducing, to self-destruct, or the like.

Example 4

Chemotherapy and Antibiotic Therapy

A fourth embodiment of the method for producing therapeutic agents according to the present invention involves chemotherapeutic agents which have been used therapeutically by the inventor with some positive results against a targeted disease. A common problem associated with known chemotherapeutic agents is the non- specificity of the agent. The specificity of such chemotherapeutic agents can be enhanced by

incorporation in their application of the use of affinitive organisms which have been identified as having a high affinity for the targeted disease. Such affinitive organisms include disease-associated organisms selected from the group consisting of causative organisms, synergistic organisms, neutral organisms, infective organisms, antagonistic organisms, and nemesis organisms. Instead of vaccinating a patient directly with a chemotherapeutic agent, such agent is rather applied in vitro to an affinitive organism, thereby tagging the affinitive organism with the chemotherapeutic agent. A vaccine of the tagged affinitive organism is then prepared in accordance with the method of the present invention and administered to the patient. The affinitive organism, extracts or modifications thereof, used in the vaccine will then carry the

chemotherapeutic agent directly to cells of the targeted disease. Should it be desirable to further limit the effect of such chemotherapeutic agent on the patient's body, organisms which are antagonistic to the chemotherapeutic agent may be raised for preparing vaccines in accordance with the method of the present invention, which vaccines may be used to shorten the life of the chemotherapeutic agent inside the patient's body.

Example 5

A fifth embodiment of the method for creating therapeutic agents according to the present invention involves in vitro phage destruction of antagonistic organisms, beneficial or neutral organisms, cells of the disease, diseased tissue or any

combination thereof, for yielding an oncolysate which may be useful as a therapeutic agent against the targeted disease. It has been found that denaturing of such antagonistic organisms, beneficial or neutral organisms, cells of the disease, diseased tissue or any combination thereof will yield oncolysates that have a high affinity toward cells of the targeted disease. Such phage destruction or denaturing can be stimulated via a variety of means, including, but not limited to, the following:

1) Allowing each isolated organism, disease cell or diseased tissue to grow in vitro in limited media until a phage arises spontaneously out of the culture. 2) Allowing each isolated organism, disease cell or diseased tissue to grow in vitro and inducing a stress upon the culture for precipitating a phage. Such stress may be administered via any of a wide variety of means, including physical, chemical, thermal, biological, ultra-violet light bombardment. p.H. stimulation, or the like.

3) Allowing a combination of targeted disease cells and an organism which demonstrates antagonistic activity toward these cells to grow in vitro until an oncolysate is formed as the targeted disease cells are consumed.

4) Allowing cells of the targeted disease to grow in vitro until the nutrition of the media is outgrown and natural degeneration of the disease cells occurs. Each type of phage or lance fragment resulting from the above noted procedures should then be tested in vitro for its response to the targeted disease. The response may be further enhanced by methods discussed earlier herein. The resulting disease-associated agents should then be prepared as a therapeutic agent for administration to the patient in a manner similar to that of the first and second embodiments. It has been found that presentation of such therapeutic agents made of products of phages and other oncolysates can stimulate an effective immunological function and other therapeutic response concerning the targeted disease.

Example 6

A sixth embodiment of the method for producing therapeutic agents according to the present invention, concerns incorporating the use of erythrocytes. or red blood cells, into the human immunological system. It has long been assumed that the red blood cell has only a minor role, if any. in the body's immune system. This has perplexed the inventor, since the red blood cell is the most abundant cell in the human body. Because the mature red blood cell has a very flexible structure with no nucleus and appears to be little more than a highly resilient empty vessel for carrying water and hemoglobin throughout the circulatory system, the red blood cell appears fully capable of responding to. and even expressing, a wide variety of chemical, physical or genetic information, such as that carried by certain microbial extracts. Indeed, it has been found that certain microbial extracts are capable of producing morphological changes in the appearance of red blood cells which appear to have a therapeutic effect with regard to a targeted disease. Such morphological changes are illustrated in Figure 7, in which are shown red blood cells with tentacles formed in the membrane, and Figure 8. in which are shown spicules in the membrane of several red blood cells, two of which cells have also taken on a ring-like form with an apparent hole in the center. Such morphological changes as those seen in Figure 9 occurred apart from the presence of any such acidity, and were only temporary, resolving within a period of between a few hours and a few days. Although it has been known that red blood cells react to a high level of acidity by swelling into spiked balls (called echinocytes), similar transformation apart from such acidity has not been heretofore observed. The inventor believes that such changes may be functional, such as for example assisting in the movement of the red blood cells or assisting in the perforation of cancer cell membrane. Figures 9 and 10 show two groups of red blood cells in which inclusions have formed in their cytoplasm.

Inclusions appear to have been extracted from attached leukemia cells.

An additional phenomenon which has accompanied such red blood cell changes as those noted above, is illustrated in Figures 9 and 10, in which is seen cell membrane fusion between adjoining red blood cells and between red blood cells and adjoining leukemia cells. Such points of contact between red blood cells and leukemia cells demonstrate areas of cellular fusion whereat the membrane boundary appears to dissolve, and cytoplasmic and nucleic contents of the leukemia cells appear to empty into the red blood cells. (See Figures 9 and 10). These red blood cell changes and activity in these several micro-photographs were observed after application of vaccine created from the feline panleucopenia virus. Substantially similar morphological changes and anti-leukemia cell activity has been observed after application of vaccine created from canine distemper virus. Both of these viruses were identified as disease-associated organisms regarding leukemia and subsequently prepared as vaccines by the inventor, according to the method of the present invention. During in-vitro testing, complete destruction of a sample of leukemia cells in a patient's blood sample was accomplished within a span of between two and three hours, without any pejorative effect whatsoever on the patient's normal cells. The results of subsequent treatment have included marked improvement and complete remission of the leukemia. Application of the therapeutic agent (i.e., the vaccine) in each case was sufficient to raise an effective immunological response in the patient, which response included the noted morphological changes and anti-leukemia cell activity of the red blood cells.

It appears that information which caused such red blood cell activity was either transferred to the red blood cells by the applied therapeutic agents, or was awakened from a genetic memory within the red blood cells via administration of said agents. Such results indicate that the red blood cell may be actively manipulated into functioning as a member of the immune system via genetic programming, even such programming as that involving the transfer of genetic information between cellular materials which are in vivo. As earlier noted, it has been observed that a high number of cases of spontaneous remission have been reported which follow an acute malarial infection, an infection which could feasibly do more to the red blood cell than merely parasite it. It is possible that genetic information from the malarial infection, similar to that transmitted by the feline panleucopenia and canine distemper viruses, can transform red blood cells into an active arm of the immune system. Similar vaccines have shown dramatic preliminary results against HIV in-vitro as well as in-vivo testing even where no living organisms were used. Even dead extracts may cause therapeutic effects by a process of insertion.reactivation and expression as well as possible direct or indirect interference. If living or dead microorganism body or fragment may enter the disease target cell; they may interfere directly with the disease organism's ability to enter and/or multiply in the target cell by competition for binding sites.enzymes, cofactors involved in metabolism and replication of host or disease etc. Other host-related changes may also be induced which may also be therapeutic. Dead microbial extracts may also be inserted or incorporated into the disease organism and/or diseased cell and serve as a direct marker antigenically or otherwise. Incorporation of microorganism fragments including nucleic acid fragments into the disease may give it characteristics of the organism used for

therapy. Successful insertion of living microorganism into disease locale may bring about cross exchange of characteristics and properties or result in direct interference of one with the other. There is a risk of conferring undesirable capacity or resistance on the disease; this is reduced by the use of dead microbial extracts in therapy. Dead extracts may be reactivated to living form where microbial repair and multiplication apparatus occurs;this can often be found in the disease-infected cell.Reactivation of inanimate material and subsequent expression at the site of disease may provide for effective tagging and interference. Application of an antiserum to the reactivated micro-organism can eliminate both it and the diseased cell in a cycle that may be repeated.

Figure 14 is a blood sample plate from a 59 year old female having chronic lymphocytic leukemia. The dark blots are leukemia cells. Figure 15 is a blood sample from the same patient taken within two hours (not a misprint) of the Figure 14, during which time the patient was administered vaccines prepared in accordance with the method of the present invention. The white blood cell count has more than halved. A complete remission further occurred in this patient within several weeks. It is believed that the therapeutic agents made in accordance with the method of the present invention which precipitated these results, also changed many of the cancer cells into normal cells, resulting in the persistence of a higher red blood cell count until such time as the transformed cells had lived out the life-span of a normal cell, which is why the complete remission did not occur sooner.

Figure 16 is a blood sample plate from a 24 year old male having granulocytic leukemia. Figure 17 is a blood sample from the same patient taken 7 days later, during which time the patient was treated with vaccines prepared in accordance with the method of the present invention.

The latter plate reveals a complete remission of the disease. Such a rapid and drastic reduction in the number of white blood cells and cancer cells in these two case histories cannot be explained apart from red blood cell activity, since such reduction had to involve cells of a number which surpassed that of the white blood cells and leukemia cells.

Example 7

A seventh embodiment of the method for creating therapeutic agents according to the present invention involves identifying the genesis of other chemotherapeutic agents which have been used with some positive results against a targeted disease. Although such agents may have been prepared using conventional time-consuming and expensive drug development techniques, an understanding of how said agents were prepared will point most often to an original disease-associated organism from which a particular chemotherapeutic agent was derived. If such an original disease- associated organism can be identified, the original organism may be utilized to develop still other derivatives for therapeutic use against various modifications of a targeted disease that may develop as cells of said disease respond to use of the chemotherapeutic agent by evolving into forms which are resistant to said chemo-therapeutic agent. An antagonism in the original organism from which the chemo-therapeutic agent was derived may be either raised or enhanced via methods earlier described herein pertaining to the culturing of a targeted disease with a disease-associated organism in alternating minimal and enriched media. As mentioned earlier, the disease cells will attempt to mutate further during such culturing process. in order to prevent annihilation by the detrimental disease-associated organism.

Unlike non-living therapeutic agents, the detrimental disease-associated organisms will likewise evolve during such process in order to retain an efficacy against the disease cells. Therapeutic agents using the evolved detrimental disease-associated organism, extracts or modifications thereof, may then be used effectively against the associated mutated strains ofthe targeted disease. Those skilled in the art will readily recognize that accomplishing such mutations in vitro is an economical and aneffective method of preparing therapeutic agents having a continuing efficacy against potential in vivo mutations of a targeted disease.

Indeed, it was the inventor's recognition of the unique ability of microorganisms to adapt quickly to their environment which led him to many of the therapies and methods for creating therapeutic agents according to the present invention. As the inventor has observed, the speed at which disease-associated organisms can adapt to environmental changes, may be used to prepare a library of disease-associated organisms, extracts and modifications thereof, which can be useful for preventing a targeted disease from gaining a perpetuating resistance to therapeutic agents. The inventor has further discovered that the simultaneous, or near-simultaneous, use of such therapeutic agents which are effective against several mutations of a targeted disease, can be very effective in overcoming the disease.

Example 8

An eighth embodiment of the method for producing therapeutic agents according to the present invention involves the genetic transfer of characteristics which have been identified as desirable, from a microorganism to a patient. It is known that various bacteria, viruses, parasites and other simple organisms have capabilities beyond those which are currently available in the body of man. For example, some bacteria have been identified as having sufficient heat resistance for allowing the bacteria to thrive within boiling volcanic pools. Other bacteria have sufficient thermal resistance to allow them to live in arctic regions. Still other bacteria have shown a high resistance to radiation. Yet still other bacteria are capable of photosynthesis, or the ability to transform simple sunlight into oxygen and forms of energy. It may be further deduced that the extra-regenerative capabilities of the salamander can be ultimately identified and linked to either a micro-organism or another biological factor. It is the belief of the inventor that such characteristics can be transferred across specie via methods outlined in the present invention, and thereby create whole new families of therapeutic agents.

Indeed, it has already been observed that certain regenerative characteristics from microorganisms having an extra-regenerative capability, such as those organisms which are thermally resistant or those which are radio-resistant, can be transferred from one specie to another. For example, the inventor has prepared vaccines from various bacteria which demonstrate such an extra-regenerative capability and furtherwhich have a high resistance to radio-activity.

When these vaccines were administered to laboratory rats, the survival stamina of the rats, as demonstrated by their ability to stay afloat unsupported in a body of water, was increased from an average of 45 minutes to well over six hours. Such a vaccine was also administered to a human patient who had undergone extreme digoxin (from digitalis) poisoning, and exhibited extensive damage to the heart and other portions of his circulatory system. Within twenty four hours, the patient (a thirty year-old year old male) had undergone a complete recovery, and demonstrated no sign of damage or scarring in either the heart and or any other portion of his circulatory system. Two lasting side effects have further been exhibited in this patient. The first involves the patient's normal energy level. Prior to undergoing the single dose treatment of the radioduran vaccine, the patient exhibited average sleeping patterns and habits. For three years since the treatment, however, the patient has been able to stay awake continuously for periods of multiple days without any apparent loss of alertness or other mental function, as that which loss normally accompanies prolonged periods without sleep. The second lasting side effect exhibited in the patient also concerns his energy level, but as it is associated with his athletic ability. Without any increase in normal physical activity, such as exercise, the patient has repeatedly demonstrated the ability to lift an amount of weights which exceeds the maximum amount he was able to lift prior to the treatment by as much as two times. Still further, although lifting such amounts of weight has caused tears in various involved muscle groups, such tears have been completely healed within a couple of days.

The inventor has observed similar effects in terminally ill cancer patients using vaccines made from extracts of organisms which demonstrate similar extra╌regenerative characteristics. Two symptoms which are common during the final stages of a cancer are a lack of energy and a high level of pain. When such patients have been treated with vaccines prepared from organisms exhibiting such

extra-regenerative characteristics in accordance with the method of the present invention, the patients have exhibited an exceptional loss of pain and a significant increase in overall energy levels. No negative side effects of the treatment have been observed. The inventor has observed that such effects of this treatment have been highly regarded by both patient and loved ones of the patient.

Transfer of beneficial effects may be by total or partial incorporation of organism into host and may not necessitate genetic transfer to host.

Example 9

A ninth embodiment of the method for producing therapeutic agents according to the present invention involves another common "malady" which the inventor believes may be readily treatable via the method of the present invention: old age. An embodiment of a method for treating a patient against many of the effects of old age in accordance with the method of the present invention involves the initial step of aging in vitro, via methods which are known, various cells which have been extracted from a patient's body. After such cells have been aged, the next steps of this embodiment include: isolating any factors from the aged cells which may be associated with aging; identifying or raising organisms which are antagonistic toward the identified aging factors; preparing therapeutic agents from said antagonistic organisms in similar fashion as with earlier described embodiments of the present invention; testing the therapeutic agents: and treating the patient with the agents. One method of identifying aging factors and raising organisms which are antagonistic toward these factors involves the use of at least a different-specie host. According to this method, a first different-specie host is inoculated with patient cells which have been aged in vitro. Once anti-bodies against the aged cells are raised in the first different-specie host, sera containing the antibodies is extracted via means which are known. In order to "wash" any anti-patient-specie factor from said sera, a second different-specie host of the same specie as the first different-specie host is inoculated with normal, non-aged cells from the patient. This will raise

anti-patient-specie antibodies in the second different-specie host, which can then be extracted and applied in vitro to the sera extracted from the first different-specie host, for precipitating the anti-patient-specie factor out of the first host sera, and thereby leaving anti-age-factor antibodies in the sera for use in preparing therapeutic agents for the patient.

Another method which may be used to monitor the effectiveness of such anti-age-factor therapy in accordance with the present invention involves use of the Haeflic limit, which limit is the maximum number of times a cell may multiply or divide. According to this method, cells from various components of the patient's body are first aged and tested in vitro via means which are known, in order both to determine the number of cell divisions remaining in each cell, and to determine a base mean time-interval between each cell division. As the patient undergoes treatment in accordance with the present invention, which treatment is directed at overcoming aging factors that may appear in the patient^'s body, such Haeflic limit determination tests are subsequently in repeated intervals for identifying any change in either the number of cell divisions of particular cell types, or in the mean time╌ interval between such cell divisions. Such Haeflic limit tests will indicate the effectiveness of the anti-age-factor therapy.

Example 10

A tenth embodiment of the method of the present invention involves the creation and therapeutic use of vaccines. A vaccine is typically composed of the same or similar material as a disease, such as a fragment of the viral membrane, in order to raise an immune response to the disease. For example, popular vaccines such as tetanus, whooping cough or pertussis are made from heat-killed, or otherwise killed, extracts of tetanus, whooping cough or pertussis. Sometimes related organisms are used to create a vaccine rather than the actual disease, such as is done with the small-pox vaccine, which is made from cow-pox.

Unfortunately, we do not know how some of the targeted diseases actually work, which means that there may be great risk that vaccines which use extracts of these diseases are ultimately more harmful to the body than good. For example, current AIDS vaccines are being made from genetically engineered forms of the HIV envelope protein, in order to stimulate the immune system against the AIDS virus. Unfortunately, as previously mentioned, the immunostimulant capability of the HIV virus is highly specific, targeting only T-cells, the very cells which the HIV virus uses to further infect the body. Although the T-cell count in an AIDS patient might be temporarily increased when such vaccines are used therapeutically, the end result is not, therefore, considered by many to be therapeutic.

It is questionable, also, whether such vaccines are useful as a preventative. With HIV, the inherent risk associated with using any part of the HIV virus as a vaccine against the disease, is especially great, since there is yet a universally accepted model which explains how so small amount of a virus can so inhibit a host's immune system. To challenge the immune system of individuals who have not yet been exposed to such a deadly agent, by inoculating them with fragments of such agent, is believed by many to be quite foolish. Indeed, because of the highly resistant nature of the HIV virus, to vaccinate an individual with HIV fragments might lead to the growth of multiple HIV mutations which will each have to be targeted for treatment, resulting in a division of effort in an already deficient immune system. Furthermore, there is a growing number of both medical practitioners and laymen who believe that such vaccine exposure to any pathogen is not good for the immune system.

A situation similar to AIDS exists with the use of current vaccines for cancer.

Like AIDS, the immunostimulant activity of cancer is generally highly specific, activating only a portion of the host immune system which can be used to the benefit of the disease. The portion of the immune system which is generally stimulated by cancer comprises anti-bodies that are used by the disease to coat the diseased cells, for preventing the diseased cells from being visible to the immune system as foreign matter. Therefore, to stimulate the further production of such coating or blocking antibodies, is to promote further proliferation of the cancer, and thereby increasing the load of diseased tissue in the body, which may lead ultimately to threshold inhibition of the immune system. Current research work with cancer involves attempts to extract out from diseased tissue certain proteins and compounds which are capable of inducing a strong immunological response. Unfortunately, by the time the cancer is denatured into extracts which are immunologically active, such extracts bear little resemblance to the diseased tissue in the body which is inherently

immunologically inactive. Therefore, the immune response that is ultimately raised by vaccines of such extracts will logically attack the vaccine, but may not associate the cancer with such vaccines. However, even should the cancer be slightly recognized and attacked by the immune system, such attack is likely to be sufficiently minimal so as to result in the cancer mutating into more resistant strains, rather than being inhibited significantly.

With the method of the present invention, however, a person's immune system can be effectively prepared for dealing with a potential biological threat by inoculation with vaccines which are not comprised of portions of the threatening target disease. Such vaccines are rather comprised of disease-associated organisms, extracts or modifications thereof, which have been raised against the target disease. For example, it has been suggested that the HIV virus blocks CD-4 receptor sites on white blood cells, and therefore, that treatments which block these sites for preventing the HIV virus from attaching to them might have some efficacy. However, again, we do not know what beneficial function such CD-4 site blocking activity might inhibit. Via the method of the instant invention, a Nemesis organism might be isolated for accomplishing such blocking by distorting the shape of the CD-4 receptors, rather than by blocking them completely. Such distortion could inhibit the attachment of the HIV virus without completely blocking the receptor sites. We could also place CD-4 receptor decoys into the patient's blood stream by fragmenting a multitude of CD-4 receptors from the cell membrane of a plurality of white blood cells and inoculating the patient with said CD-4 receptors. As each cell of the HIV virus attaches to such a CD-4 receptor decoy, it becomes enabled from attaching to a live white blood cell. A further method of preventing the attachment of HIV virus to white blood cells by using decoy cellular material includes the step of enucleation. in which the nucleus of a plurality white blood cells is spun out of each cell via centrifugal in-vitro techniques which are known. The resultant nucleus-free white blood cells are then inoculated into the patient's blood stream as decoys for the HIV virus. Because there is no nuclear material in such white blood cells, when cells of the HIV virus attach to their CD-4 receptors, the HIV will be inhibited from causing the white blood cells to transform into diseased tissue. One may also insert into such nucleus-free white blood cells, material which is antagonistic to the HIV virus, such as a chemical or an anti-body, for destroying the HIV cells which attach to the cell decoy. The nuclear-free white blood cells may also be tagged with disease-associated organisms or extracts thereof for making such cells visible to the immune system.

One version of such method involves placing bacterial antigens inside the nuclear free white blood cell, so that when a subsequently attached HIV cell begins to destroy the white blood cell, the bacterial antigens mark each of the CD-4 receptor sites on a surface oppositely disposed to the HIV cell, for the host immune system to identify and destroy. Similar tagging techniques can be used with the decoy HIV membrane fragments mentioned earlier.

The use of Nemesis and antagonistic organisms in vaccine therapy, in accordance with the present invention, depends on the following: 1) the Nemesis phenomenon; 2) an interference phenomenon; and 3) a regenerative rerouting or utilization of moreappropriate organism response phenomena.

In accordance with the method of the present invention, causes of diseases are looked for: therapeutic mechanisms which have not been heretofore available are used; and immunological mechanisms may be regenerated, regulated and rerouted, or even created. Furthermore, in using the method of the present invention, some portions of the host body may be stimulated to perform an entirely different function than that which has heretofore been associated with said body portions. For example, some portions of the blood system which heretofore have not been associated with immunological activity may be stimulated to act immunologically; and, other cells or organs which have not been heretofore associated with the production of hormones, may be stimulated to begin such hormone production in the absence of the main body organ normally associated with such hormone production.

Examples of specificity and efficacy of this technology are provided by the following figures: Figure 18 illustrates 2 leukemia cells in proximity to the red blood cells and other blood constituents. When antiserum is prepared against the leukemia cells by prior art teachings, the antiserum will often contain anti-human antibodies and result in total cell lysis of both leukemia and normal cell constituents. Figure 19 shows total lysis of leukemic and red blood cells within minutes of addition of antiserum raised against the leukemia cells. Figure 20 shows a leukemic cell surrounded by red blood cells. Figure 21 shows coccal organisms in a sarcoma biopsy. Antisera raised against these are used to treat the leukemia (also a sarcoma) blood in Figure 20. Figure 22 shows lysis of cancer cytoplasm, membrane and nucleus with no harm to surrounding red blood cells. This change occurred within minutes. Figure 23 illustrates both precision and potential of this technology in a leukemia cell treated by antiserum raised against genetic and other fragments of associated organisms. When the antiserum is prepared against the organisms associated with leukemia or even certain other sarcomas such as those shown in

Figure 3 and the cocci shown in Figure 20. Nuclear vacuolation can be seen where presumably abnormal cellular genetics have been removed. Cells in culture will now behave more normally. Direct extracts from nemeses and antagonistic organisms may also result in similar changes. Figure 24 shows a large breast cancer with central ulceration as seen in the mammogram of a 72 year old female. Figure 25 is the same patient showing dramatic reduction in mass after 2 weeks of therapy. Arrowsindicate cancer margins in Figures 24 and 25. Figure 26 is of a squamous cell carcinoma indicated by the arrow, stretching to the apex of the right lung. Figure 27 shows collapse of that mass within 2 weeks of therapy. Figure 28 is of a bone scan demonstrating prostate cancer metastases. These can be seen as the dark marks on the ribs indicated by the arrows. Figure 29 shows drastic resolution of the rib lesions following 3 weeks of therapy. Figure 30 demonstrates brain metastases in the right hemisphere from a small cell carcinoma [lung primary] indicated by arrows. Picture showing resolution is beside it and to the right. Total disappearance of the one lesion and shrinkage of the other occurred within 2 months of therapy. Figure 31 demonstrates the lung primary referred to above and its mediastinal spread. Picture to the right demonstrates resolution within 2 months of therapy. Figure 32 represents a CAT scan of breast cancer metastasized to the left lung with mass and fluid marked by the arrow. Figure 33 demonstrates resolution within 5 weeks of therapy. Figure 34 is of an adenocarcinoma of the breast. Mammograms show marked shrinkage within 1 month. Figure 35 demonstrates a metastasis from breast cancer into the liver. Figure 36 demonstrates resolution of breast cancer after 2 weeks of therapy. Figure 37 is of a primary hepatoma perforating the right hemidiaphragm and surrounding the right lung. Figure 38 shows cancer eliminated from the right lung field. Figure 38 is of a adenocarcinoma of the breast in a 42 year old female as shown by mammogram. Figure 39 shows massive shrinkage after 4 weeks of therapy. Figure 40 shows a large mass obstructing the esophagus in a male age 60 suffering from esophageal cancer marked by the arrow. Patient is unable to swallow food or water at this stage. Figure 41 shows that after only 4 weeks treatment the cancer shrunk massively. Patient's esophagus is patent, and he is able to eat and swallow easily. Figure 42 illustrates giant cell lymphoma in a 32 year old female, 16 cm in diameter as measured on chest xray. Figure 43 shows the same tumor after 1 week of treatment shrunk to 3 cm. The above cases are marked not only by the dramatic response time, but also by the fact that most cancers represented had already failed from conventional radiotherapy and chemotherapy. The inventor has given a non-limiting description of several embodiments of the present invention, to which many changes may be made without deviating from the spirit of the inherent inventive concept. While this invention has been described with reference to such illustrative embodiments, this description is not intended to be construed in a limitingsense. Various modifications and combinations of the various embodiments as well as other embodiments of this invention will be apparent to a person skilled in the art upon reference to this description. It is therefore contemplated that the appended claims cover any such modifications and/or embodiments that fall within the true scope of the present invention.

TECHNOLOGY FOR INCREASING

SPECIFICITY/DECREASING SIDE-EFFECTS .

THERE ARE THREE BROAD GUIDELINES WHICH CAN ACCOMPLISH THIS;

1- ISOLATE, DEFINE AND USE DISEASE-SPECIFIC(DS) F/A/P'S ETC. TO USE FOR RAISING AND OR ISOLATING IMMUNE OR OTHER RESPONSES WITH SPECIFIC ANTI-DS F/A/P'S ETC.

2- ISOLATE,DEFINE AND USE HEALTHY-CELL/TISSUE/ORGANISM

SPECIFIC(HS) F/A/P'S TO SCREEN /FILTER/ISOLATE IMMUNE OR OTHER RESPONSE COMPONENTS WITH SPECIFIC ANTI-HS F/A/P'S ETC . THIS CAN BE USED TO MINIMISE THE RISK ,FOR EXAMPLE, OF SPECIFIC

ALLERGY/REJECTION PHENOMENA.

3- ISOLATE, DEFINE AND USE DISEASE AND HEALTHY

CELL/TISSUE/ORGANISM SHARED (DHSh)F/A/P'S ETC. AMONGST MANY USES IN UNDERSTANDING, DIAGNOSING AND TREATING CONDITIONS(AS CAN THE ABOVE), DHSh F/A/P'S ETC. CAN BE USED TO MINIMISE CHANCES OF SIDE-EFFECTS, OR HOST TOXICITY BECAUSE OF THERAPY THAT MAY TARGET SHARED F/A/P'S.

(IT IS FOOTNOTED AT THIS POINT THAT ISOLATION AND DEFINITION OF ALL SUCH F/A/P'S , BY TECHNIQUES WHICH INCLUDE THOSE WHICH WILL BE MENTIONED BELOW; AS WELL AS GUIDELINES FOR THEIR USE AND

MODIFICATION WILL IMPACT GREATLY ON FIELDS AS VARIED AS CANCER, AIDS , LONGEVITY, TRANSPLANTATION, AUTOIMMUNE DISEASE AS WELL AS NUMEROUS OTHER APPLICATIONS BOTH WITHIN AND WITHOUT THE MEDICAL MODEL.)

A BASIC UNDERSTANDING OF SOME USES UNDER THE MEDICAL MODEL CAN BE

SUMMARISED AS FOLLOWS;

-DS F/A/P'S ETC CAN BE USED TO RAISE SPECIFIC THERAPY.

-HS F/A/P'S ETC. CAN BE USED TO SCREEN OUT THERAPY DETRIMENTAL TO

HEALTHY CELLS/TISSUES/ORGANISMS ETC. OR TO REINFORCE/SUPPORT

/AUGMENT HS F/A/P'S ETC. IN PREVENTION AND/OR TREATMENT OF

DISEASE.

-DHSh F/A/P'S ETC. CAN BE USED ,FOR EXAMPLE TO SCREEN OUT THERAPY

WHICH COULD ADVERSELY EFFECT HEALTHY AS WELL AS DISEASED TISSUE;

ALTERNATIVELY, AUGMENTING/SUPPORTING/ENHANCING DHSh F/A/P'S ETC.

INTRODUCES A TOTALLY NEW FIELD OF THERAPY, CONCEPT OF APPROACHING

AND SOLVING SITUATIONS BOTH WITHIN AND WITHOUT THE MEDICAL MODEL.

BOTTLE 4-CRUDE PENICILLIN EXTRACT PHASE 1 5CC AND PHASE 2 5CC WERE ADDED . CLEAR ING OCCURRED IN 24 HOURS BUT RETURNED TO A LESSER EXTENT WITHIN 48 HOURS

CULTURE SHOWED PURE STAPHYLOCOCCUS AUREUS, PENICILLIN RESISTANT.

BOTTLE 5-ACTIVATED PENICILLIN EXTRACT PHASE 1,2,- 3.33 CC OF EACH

WERE ADDED

TOTAL CLEARANCE WITHIN 24 HOURS . NO RETURN OF CLOUDINESS

CULTURE NEGATIVE.

BOTTLE 6-CRUDE PENICILLIN EXTRACT PHA8ES 1,2 AND 3 WERE ADDED. TOTAL CLEARING WITHIN 24 HOURS . NO RECURRENCE

CULTURE NEGATIVE.

BOTTLE 7- ACTIVATED PENICILLIN EXTRACT PHASES 1,2 AND 3 WERE ADDED . TOTAL CLEARANCE WITHIN 24 HOURS . NO RECURRENCE .

CULTURE NEGATIVE.

EACH TEST WAS REPEATED 3 TIMES WITH IDENTICAL RESULTS.

I DROP OF BOTTLES 3 OR 5 OR SEVEN WERE CAPABLE OF CAUSING PLAQUE FORMATION IN STAPHYLOCOCCAL CULTURES AS DID A DROP OF ACTIVATED PENICILLIN OF ANY PHASE . THIS SUGGESTS THAT AT LEAST PART OF THE EFFICACY OF SUCH PREPARATIONS IS DUE TO PRESENCE OF PHAGES IN THE PREPARATIONS

TESTS OF ANY SINGLE PHASE DID NOT PROVE AS EFFECTIVE NOR AS FAST NOR AS LASTING AS MULTIPLE PHASE THERAPY IN EITHER CRUDE PENICILLIN EXTRACT OR ACTIVATED PENICILLIN EXTRACT,

PENICILLIN-RESISTANT STRAINS RAISED IN BOTTLES 1 , 2 AND 4 WERE ELIMINATED BY ANY OF THE FOLLOWING;CPE123 , ACPE1.2 ACPE123.

BOTTLE 4-CRUDE PENICILLIN EXTRACT PHASE 1 5CC AND PHASE 2 5CC WERE ADDED. CLEARING OCCURRED IN 24 HOURS BUT RETURNED TO A LESSER EXTENT WITHIN 48 HOURS.

CULTURE SHOWED PURE STAPHYLOCOCCUS AUREUS , PENICILLIN RESISTANT.

BOTTLE 5-ACTIVATED PENICILLIN EXTRACT PHASE 1 , 2 , - 3 .33 CC OF EACH

WERE ADDED.

TOTAL CLEARANCE WITHIN 24 HOURS . NO RETURN OF CLOUDINESS

CULTURE NEGATIVE.

BOTTLE 6-CRUDE PENICILLIN EXTRACT PHASES 1,2 AND 3 WERE ADDED. TOTAL CLEARING WITHIN 24 HOURS.NO RECURRENCE

CULTURE NEGATIVE.

BOTTLE 7- ACTIVATED PENICILLIN EXTRACT PHASES 1,2 AND 3 WERE ADDED. TOTAL CLEARANCE WITHIN 24 HOURS . NO RECURRENCE.

CULTURE NEGATIVE.

EACH TEST WAS REPEATED 3 TIMES WITH IDENTICAL RESULTS.

I DROP OF BOTTLES 3 OR 5 OR SEVEN WERE CAPABLE OF CAUSING PLAQUE FORMATION IN STAPHYLOCOCCAL CULTURES AS DID A DROP OF ACTIVATED PENICILLIN OF ANY PHASE . THIS SUGGESTS THAT AT LEAST PART OF THE EFFICACY OF SUCH PREPARATIONS IS DUE TO PRESENCE OF PHAGES IN THE PREPARATIONS.

PENICILLIN-RESISTANT STRAINS RAISED IN BOTTLES 1 , 2 AND 4 WERE ELIMINATED BY ANY OF THE FOLLOWING; CPE123 , ACPE1, 2 ACPE123.

USE OF HYPERTHERMIA IN COMBINATION WITH VACCINE THERAPY INDIVIDUALLY/AS PART OF PRECURSOR/INTERMEDIATE/ENDPRODUCT

THERAPY.

INTRODUCTION

AN IMPORTANT ISSUE NOT ADDRESSED BY CURRENT IMMUNOTHERAPEUTIC REGIMENS IS THAT CHANGES MADE TO TARGETS WHICH ENABLE THE GENERATION OF AN IMMUNOLOGICAL RESPONSE MAY CHANGE THE TARGET TO A POINT WHERE IT LOSES AND/OR ALTERS CHARACTERISTICS TO THE POINT WHERE THE VACCINE EFFICACY WHERE IT RELATES TO THE OVERLAP OR RESEMBLANCE TO THE IN-VIVO APPEARANCE OF DISEASE.

IN PREPARING AN ANTIBACTERIAL VACCINE, FOR EXAMPLE, IT MAY BE POSSIBLE TO DECREASE THE POSSIBILITY OF FUTURE INFECTION BY RAISING SOME DEGREE OF PROTECTIVE IMMUNITY, WHERE THIS FAILS IT MAY BE BECAUSE OF INSUFFICIENT OVERLAP BETWEEN ANTIGENICITY OF VACCINE AND OF DISEASE., IT MAY BE THAT THE ALTERATIONS TO

STRUCTURE CAUSED BY INACTIVATION OR OTHER PROCESS IN PREPARATION OF VACCINE LOSES, ALTERS AND/OR ADDS STRUCTURES/CONFIGURATIONS NOT INTRINSIC IN THE ACTUAL DISEASE.

TO OVERCOME THIS ONE OR ALL OF THREE MODIFICATIONS NEED TO TAKE PLACE

1 -MAKING THE VACCINE RESEMBLE THE

DISEASE MORE CLOSELY .

2-MAKING THE DISEASE RESEMBLE THE

VACCINE MORE CLOSELY.

3-MAKING THE HOST SYSTEM/ IMMUNE SYSTEM

RECOGNISE VACCINE/DISEASE WITH

IDENTICAL EFFECTIVE RESPONSES.

ANOTHER SHORTCOMING OF VACCINES AND RELATED IMMUNOTHERAPlES IS THAT WHEREAS SUCH MEASURES MAY BE OF BENEFIT IN PREVENTION OR IN DEALING WITH A SMALL AMOUNT OF DISEASE; PROCESSES SUCH AS THE WELL DEFINED THRESHHOLD INHIBITION PHENOMENON RESTRICT IMMUNOLOGICAL RESPONSE WHEN THE CHALLANGING LOAD 18 OVERWHELMING.

THIS POINT MAY BE DEALT WITH BY DIRECTING THE RESPONSE AGAINST PART OF THE DISEASE WHICH IS IN MINIMAL EXPRESSION AND/OR WHICH IS GRADUALLY MADE TO ATTATCH/EXPRESS AT A RATE WITH WHICH THE HOST SYSTEM MAY COPE.

1-MAKING THE VACCINE RESEMBLE THE

DISEASE MORE CLOSELY.

THIS IS ACCOMPLISHED AT LEAST IN PART IN SOME VIRAL DISEASES SUCH AS MEASLES AND MUMPS BY USE OF LIVE ATTENUATED VIRUSES AS OPPOSED TO HEAT KILLED VERSIONS.

USE OF TECHNOLOGIES IN THE PRECURSOR/INTERMEDIATE/ENDPRODUCT PATENT CATERS FOR POTENTIALLY EVEN MORE SPECIFIC/PRECISE VACCINES BY METHODS INCLUDING THOSE OUTLINED BELOW;

1-RAISING VIRUS IN TARGET AND/OR OTHER CELLS OF HOST TO BE

VACCINATED-THIS ENABLES SCREENING FOR AND REJECTION OF ANY

VARIANTS WHICH MAY BE GROSSLY PATHOLOGICAL TO THE RECIPIENT.

USE OF TEMPORAL EXTRAPOLATION PATENT CAN ALSO TEST

FOR SPECIFIC SYSTEMS/SITUATIONS/INTERACTIONS IN

NORMAL/REDUCED/ACCELERATED TIME FORMATS TO PREDICT FUTURE

EFFECTS. (CELL DIVISION MAY BE ACCELERATED IN VITRO/OTHER ANIMAL SYSTEMS TO STUDY FURTHER GENERATION IMPACT, SLOWED DOWN TO STUDY CELLULAR IMPACT; SIMILAR PROCEDURES WITH DISEASE PROCESS CAN ACCELERATE OR RETARD ITS GROWTH SO ITS INTERPLAY MAY BE STUDIED WITH OTHER FACTORS , CELLS, DISEASES ETC. )

CULTURING VACCINES ON THE CELLS OF RECIPIENT DOES NOT ONLY PERMIT MORE ACCURATE IDENTIFICATION AND REJECTION OF GROSSLY PATHOLOGIC

VARIABLES BUT IN-VITRO AND DED ICATYED ANIMAL

TECHNOLOGY ALSO ENABLES THE VACCINE TO BEST RESEMBLE THE ACTUAL APPEARANCE OF INFECTION IN THIS PARTICULAR INDIVIDUAL AS WELL AS ALLOWING FOR THE RAISING OF IMMUNITY AGAINST INTERMEDIATE STAGES SUCH AS INFECTED CELLS AS WERLL AS PREPARING ENDPRODUCT IMMUNE RESPONSES TO ELIMINATE DISEASE.

2-MAKING THE DISEASE RESEMBLE THE

VACCINE MORE CLOSELY.

THIS IS THE MAIN POINT TO BE DEMONSTRATED AND EXPLOITED BY THIS

PATENT.

MAKING THE DISEASE RE6EMBLE THE VACCINE MORE CLOSELY AT A GRADUAL

PACE CAN BE AVCCOMPLI8HED IN SEVERAL WAYS,ONE WILL BE OUTLINED

BELOW;

THE CONCEPT IS TO TREAT THE DISEASE IN THE SAME MANNER USERD TO

GENERATE THE VACCINE AND THEN TO ALLOW AN IMMUNE SY8TEM HONED BY

PRIOR ADMINISTRATION OF VACCINE TO ATTACK THE DISEASE.

VACCINES PREPARED BY HEAT INACTIVATION WILL BE USED TO

DEMONSTRATE THE APPLICATION OF THESE GUIDELINES BUT ARE NOT

INTENDED TO LIMIT PATENT APPLICATION . PATENT APPLIES TO ANY METHODOLOGY WHICH AIMS TO TREAT THE DISEASE CONDITION IN A MANNER WHICH ALTERS IT TO A FORM THAT CAN BE BETTER DEALT WITH BY THE BODY; PARTICULARLY A BODY PREPARED TO DEAL WITH SUCH CHANGES. FOR EXAMPLE ,BY PRIOR VACCINATION.

STEP ONE

PREPARE VACCINE BY CULTURING ORGANISM/TARGET THEN HEAT

INACTIVATION.

STEP2

USE VACCINE PREPARATION TO RAISE IMMUNE RESPONSE .

STEP 3

USE HYPERTHERMIA TO EXPOSE/ALTER DISEASE STRUCTURE TO FORMAT

CONFORMING TO THAT OF THE VACCINE USED TO GENERATE IMMUNE

RESPONSE.

AS THE HEAT CAUSES STRUCTURES TO ALTER AND THE EXPOSURE OF

PREVIOUSLY COATED AND/OR OTHERWISE DISGUISED; THE IMMUNE SYSTEM

ALREADY STIMULATED AGAINST THEM BY THE VACCINE WOULD BE ACTIVATED

DEVASTATINGLY.

EASILY SEEN APPLICATIONS THAT FOLLOW FROM THESE GUIDELINES IS THAT IN THE TREATMENT OF CANCER, FOR EXAMPLE; BIOPSIES SHOULD BE TREATED WITH WHATEVER RADIOTHERAPEUTIC OR CHEMOTHERAPEUTIC PROTOCOL ARE TO BE IMPLEMENTED UPON THE PATIENT;THE RESULTANT SURVIVING AND ALTERED CELL STRUCTURES SHOULD THEN BE USED IN THE PREPARATION OF A VACCINE. THIS COULD BE USED AS A SUPERIOR IMMUNE PROTOCOL AND/OR AS AN ADJUNCT TO VACCINES PREPARED FROM INITIAL BIOPSY. FURTHER INACTIVATION PROCEDURE SUCH AS HEAT KILLING OF CELLS MAY ALSO BE USED ON THE DISEASE IN ORDER TO CLOSER M,ATCH THE VACCINE.

WHAT THEN FOLLOWS IS THAT BY USING THIS NEW PATENT FIELD OF

ANTICIPATORY IMMUNOLOGY THE BODY WILL BE

l-ABLE TO MOUNT AN EFFICIENT IMMUNE RESPONSE WITHOUT RESTRICTION BY THRESHOLD INHIBITION. AS IT IS BEING TARGETED AGAINST ANTIGENS AND OTHER COMPLEXES NOT NORMALLY EXPOSED TO ANY GREAT EXTENT BY THE DISEASE.

2-MATCHING OF DISEASE TO VACCINE-THIS HA8 NEVER BEFORE BEEN ATTEMPTED IN THIS MANNER.

IT IS FURTHER POSSIBLE TO VACCINATE WITH ONLY THE NEWLY EXPOSED FRACTIONS AFTER TREATMENT AND REMOVE FROM THE EQUATION NORMAL CELL ALTERATION CAUSED BY HEAT/CHEMO/RADIO ETC OVERLAP AND

POSSIBLY ALSO REMOVING PRIOR DOMINANT /EXPRESSED ANTIGENS AND OTHER STRUCTURES USED TO AVOID THE IMMUNE AND OTHER RESPONSES OR TO CAUSE THEM TO ACT TO THE BENEFIT OF THE DISEASE.

3-THIS TECHNIQUE ALSO ENABLES EFFECTIVE ADJUNCTIVE IMMUNOTHERAPY WHICH AIMS TO ATTACK CELLS ALTERED AND POSSIBLY NOT DESTROYED BY THE THERAPY AS WELL AS RESISTANT CELLS WHICH SURVIVED THE THERAPY PROTOCOL IN THE MANUFACTURE OF THE VACCINE. THE FOLLOWING CASE DEMONSTRATES APPLICATION.

PATIENT N.B. PRESENTED WITH PRIMARY HEPATOMA WHICH HAD PERFORATED

HIS DIAPHRAGM AND ENCIRCLED HIS RIGHT LUNG. CANCER ADVANCED

DESPITE CHEMOTHERAPY, RADIOTHERAPY AND IMMUNOTHERAPY.

THE VACCINE WAS MANUFACTURED FROM BIOPSY TISSUE WHICH HAD BEEN

FRAGMENTED PHYSICALLY AND BOILED FOR 15 MINUTES EVERY DAY FOR 3

DAYS.

HYPERTHERMIA USING RADIOFREQUENCY 'MAGNETRODE' EQUIPMENT WAS APPLIED FOR 3 SESSIONS OF 20 MINUTES EACH . ON CONSECUTIVE DAYS.

WHAT FOLLOWED WAS AS PREDICTED BY THEORY.

IN EACH OF THE HYPERTHERMIA SESSIONS THE BODY WAS HEATED TO 102 DEGREES .

THE FOLLOWING DAY AND FOR 1 WEEK SUBSEQUENTLY PATIENT

SPONTANEOUSLY DEVELOPED A CONTINUEOS FEVER RANGING FROM 100-104 DEGREES. PAIN RAPIDLY SUBSIDED. THERE WAS A MEASUREABLE

LYMPHOCYTOSIS AND LEUKOCUTOSIS BUT NO INFECTIVE FOCUS WAS FOUND AND REPEATED BLOOD CULTURES WERE NEGATIVE. IT WAS AS PREDICTED THAT HYPERTHERMIA EXPOSED STRUCTURES ON THE DISEASE MASS TO WHICH THE .BODY HAD BEEN PREVIOUSLY IMMUNISED AND MASSIVE IMMUNE

REJECTION- THEN RESULTED.

FILMS TAKEN SIX WEEKS APART INDICATE THE DRAMATIC TUMOUR REDUCTION FOLLOWING THIS PROCESS.

INDUCED REMISSION THERAPY WAS PREVIOUSLY DISCUSSED UNDER

INDUCED REMISSION THERAPY PATENT BY SAME

INVENTOR.TO BRIEFLY RECAP AND ILLUSTRATE THE APPLICATION OF SUCH PATENT UNDER THESE GUIDELINES; IT APPEARS THAT THERE ARE

BIOLOGICAL ORGANISMS -VIRUSES , BACTERIA, FUNGI , YEASTS ETC. WHICH CAN BE CLASSIFIED AS EITHER SYNERGISTIC OR ANTAGONISTIC TO THE DISEASE PROCESS.

WHEN VACCINATING AGAINST THE SYNERGISTIC ORGANISMS, INVENTOR HAS USED PHYSICAL(SUCH AS SONICATION) .CHEMICAL(CHLORINE/PHENOL/OTHER) AND BIOLOGICAL MEANS (SUCH AS ENZYMATIC DEGRADATION) TO PREPARE VACCINES. LET US CONSIDER BY EXAMPLE ALTHOUGH IT SHOULD BE

UNDERSTOOD THAT PATENT IS NOT RESTRICTED TO THIS EXAMPLE, THE CASE OF VACCINES WHICH ARE HEAT KILLED.

CAUSATIVE AND SYNERGISTIC ORGANISMS MAY BE FOUND FROM PATIENT'S BLOOD, OTHER SECRETIONS AND DISEASE BIOPSY ONCE SAMPLE HAS BEEN PROPERLY PROCESSED OR CULTURED.

LET US CONSIDER THE DISEASE CANCER.

CANCER BIOPSIES CAN BE SHOWN TO DEMONSTRATE ORGANISMS OF VARIABLE MORPHOLOGY. (CANTWELL ET AL) IT IS INTERESTING THAT ORGANISMS HAVE LONG BEEN REPORTED IN ASSOSCIATION WITH CANCERS BUT HAVE BEEN IGNORED AS INFECTION AND/OR CONTAMINATION. YET SUCH ORGANISMS CAN BE DEMONSTRATED IN EVEN THE MOST STERILE OF BIOPSIES AND ARE NOT ASSOSACIATED WITH ANY LOCAL INFLAMMATORY PROCESS AS WOULD BE EXPECTED OF INFECTIONS.

SUCH ORGANISMS APPEAR INTEGRAL IN THE DISEASE PROCESS . AS

SIGNIFICANT NESTS EXIST WITHOUT ENTICING AN IMMUNE RESPONSE THEY ARE EITHER IMMUNOLOGICALLY INVISIBLE AND/OR PROTECTED BY SOME MECHANISM OF EITHER HOST, DISEASE AND/OR ORGANISM ITSELF.

WHEN THE SAMPLES ARE DISRUPTED BY PHYSICAL , CHEMICAL , BIOLOGICAL AND OR EVEN IMMUNOLOGICAL PATHWAYS SUCH AS BY SPECIFIC OR POOLED ANIMAL/HUMAN/OTHER SERUM, STAPHYLOCOCCAL -LIKE CULTURES MAY

FOLLOW. ACTUALLY, A VARIETY OF ORGANISMS INCLUDING E.COLI AND

ACTINOMYCETES MAY BE CULTURED DEPENDING ON THE MEDIUM AND CONDITIONS USED AS WELL AS TIME.

AS THESE ORGANISMS DO NOT APPEAR TO ATTRACT A SIGNIFICANT IMMUNOLOGICAL RESPONSE FROM THE PATIENTS , PREPARATION OF VACCINE IS BENEFITED BY ALTERATION OF PRESENTATION SUCH AS BY PHYSICAL AND/OR CHEMICAL AND/OR BIOLOGICAL TREATMENT AS PREVIOUSLY

DISCUSSED.

ALLOWING CULTURE OF DISRUPTED BIOPSY/PATIENT SPECIMEN IN TRYPTIC SOY BROTH WILL USUALLY YEILD GROWTH OF STAPHYLOCOCCAL-LIKE

ORGANISM.CULTURE IS GROWN FOR 2-3 DAYS THEN BOILED FOR 15 MINUTES ON 3 CONSECUTIVE DAYS.PREPARATRION IS THEN REPLATED ON BLOOD AGAR AND REINNOCULATED IN TSB TO ENSURE NO GROWTH.

ANIMALS VACCINATED WITH THE HEAT-KILLED VERSION OF THE ORGANISMS WILL GENERATE BOTH LOCAL AND SYSTEMIC REACTIONS WHICH ARE DOSE-DEPENDANT IN TESTING LIVING ORGANISM INNOCULATIONS INTO IDENTICAL ANIMALS, IT IS FOUND THAT THEY RARELY CAUSE AN ACUTE RESPONSE AT LOW DOSEAGE. SIMILAR LOW DOSEAGE OF THE HEAT-KILLED PREPARATIONS YEILDS

SIGNIFICANT LOCAL REDNESS AS WELL AS SYSTEMIC SIDE-EFFECTS SUCH AS HIGH TEMPERATURES. OBVIOUSLY, THEREFORE THE VACCINE DIFFERS IN IMMUNOLOGIC PROPERTIES TO THE ORGANISM. THE PROTECTIVE FACTORS AND/OR AGENTS APPEAR TO BE REMOVED AND/OR NEUTRALISED BY HEAT ,STRONGLY IMMUNOGENIC FACTORS APPEAR TO BE GENERATED/EXPOSED BY HEAT. AS THESE ORGANISMS APPEAR RELATED TO THE CANCER

PROCESS; WHETHER BELIEVED TO BE CAUSATIVE, SYNERGISTIC OR INFECTIVE OR NEUTRAL, THEY OBVIOUSLY DISPLAY AFFINITY FOR THE DISEASE

PROCESS AS THEY CAN CONSTANTLY BE CULTURED FROM PATIENTS AND ROUTINELY ARE RECOVERED FROM DISEASE BIOPSIES. AN IMMUNE RESPONSE AGAINST THESE ORGANISMS WILL THEREFORE IMPACT FAVOURABLY AGAINST DISEASE.

SEVERAL CASES HAVE DEMONSTRATED TEMPORARY BENEFICIAL TUMOUR

SHRINKAGE FOLLOWING ADMINISTRATION OF HEAT-KILLED VACCINES. AGENTS USED TO GENERATE SYSTEMIC HEAT WHICH WOULD PREVIOUSLY ONLY LAST FOR LIMITED DURATION(PHYSICAL/CHEMICAL/BIOLOGICAL)WILL OFTEN GIVE RISE TO LONG LASTING AND GREATER TEMPERATURE RISES ONCE THE VACCINES HAVE GENERATED SIGNIFICANT IMMUNE RESPONSE; AT THAT POINT HYPEDRTHERMIA, EVEN FROM A HIGH DOSE VACCINE OR FROM

MICROWAVE/RADIFREQUENCY APPLIANCE EXPOSES IMMUNOGENIC MATERIAL OF THE TARGET AT A TIME THAT THE BODY CAN EFFECTIVELY DEAL WITH IT.

HYPERTHERMIA ALONE IS KNOWN TO SOMETIMES CAUSE EXCELLENT RESPONSES, OTHER THAN HEAT ' S DESTRUCTIVE ABILITY, THIS EXPLANATION ALSO GIVES ANOTHER MECHANISM OF ALTERATION OF IMMUNOLOGICAL PRESENTATION OF TARGET; UNFORTUNATELY, USE OF HYPERTHERMIA WITH VACCINE THERAPY IS VERY LIMITED.

HYPERTHERMIA IS USUALLY USED ALONE AND/OR IN COMBINATION WITH RADIOTHERAPY AND/OR CHEMOTHERAPY . UNDER THESE CIRCUMSTANCES IT IS VERY LIKELY THAT THE IMMUNE SYSTEM WILL BE FLOODED WITH ANTIGENIC MATERIAL AND MAY SUCCUMB TO THRESHOLD INHIBITION (AT WORST IF HYPERTHERMIA IS USED ALONE). IT IS THEORETICALLY MORE DAMAGING IMMUNOLOGICALLY IF THE HYPERTHERMIA IS USED SIMULTANEOUSLY WITH CHEMOTHERAPY AND/OR RADIOTHERAPY THEN ALTHOUGH SUCH SYSTEMS MAY SYNERGISE IN THEIR TUMOUR-DESTRUCTIVE ABILITY THE IMMUNE SYSTEM WILL ALSO BE WEAKENED BY THE COMBINATION THERAPY AND OVERWHELMED BY THE NEW ANTIGENIC INFORMATION. IT APPEARS PREFERABLE , THEREFORE

TO PRECEDE SUCH PROCEDURES WITH 2 WEEKS OF ANTICIPATORY

IMMUNOTHERAPY WHERE THE BODY IS STIMULATED AGAINST DISEASE PRESENTATION AFTER IT HAS BEEN TREATED OUTSIDE THE BODY BY SUGGESTED PROTOCOLS TO BE INSTITUTED 2 WEEKS LATER . THE 2 WEEK LAG PERIOD IS SELECTED TO ALLOW THE BODY TO GENERATE

SIGNIFICANT SERUM IMMUNITY TO THE CHANGES ABOUT TO OCCUR. SOME DEMONSTRATIVE CASES NOW FOLLOW; SIMILAR LOW DOSEAGE OF THE HEAT-KILLED PREPARATIONS YEILDS

SIGNIFICANT LOCAL REDNESS AS WELL AS SYSTEMIC SIDE-EFFECTS SUCH AS HIGH TEMPERATURES. OBVIOUSLY, THEREFORE THE VACCINE DIFFERS IN IMMUNOLOGIC PROPERTIES TO THE ORGANISM. THE PROTECTIVE FACTORS AND/OR AGENTS APPEAR TO BE REMOVED AND/OR NEUTRALISED BY HEAT .STRONGLY IMMUNOGENIC FACTORS APPEAR TO BE GENERATED/EXPOSED BY HEAT . AS THESE ORGANISMS APPEAR RELATED TO THE CANCER

PROCESS ; WHETHER BELIEVED TO BE CAUSATIVE, SYNERGISTIC OR INFECTIVE OR NEUTRAL, THEY OBVIOUSLY DISPLAY AFFINITY FOR THE DISEASE

PROCESS AS THEY CAN CONSTANTLY BE CULTURED FROM PATIENTS AND ROUTINELY ARE RECOVERED FROM DISEASE BIOPSIES . AN IMMUNE RESPONSE AGAINST THESE ORGANISMS WILL THEREFORE IMPACT FAVOURABLY AGAINST DISEASE.

SEVERAL CASES HAVE DEMONSTRATED TEMPORARY BENEFICIAL TUMOUR SHRINKAGE FOLLOWING ADMINISTRATION OF HEAT-KILLED VACCINES . AGENTS USED TO GENERATE SYSTEMIC HEAT WHICH WOULD PREVIOUSLY ONLY LAST FOR LIMITED DURATION(PHYSICAL/CHEMICAL/BIOLOGICAL)WILL OFTEN GIVE RISE TO LONG LASTING AND GREATER TEMPERATURE RISES ONCE THE VACCINES HAVE GENERATED SIGNIFICANT IMMUNE RESPONSE; AT THAT POINT HYPEDRTHERMIA, EVEN FROM A HIGH DOSE VACCINE OR FROM

HYPERTHERMIA ALONE IS KNOWN TO SOMETIMES CAUSE EXCELLENT RESPONSES , OTHER THAN HEAT'S DESTRUCTIVE ABILITY, THIS EXPLANATION ALSO GIVES ANOTHER MECHANISM OF ALTERATION OF IMMUNOLOGICAL PRESENTATION OF TARGET; UNFORTUNATELY, USE OF HYPERTHERMIA WITH VACCINE THERAPY IS VERY LIMITED.

HYPERTHERMIA IS USUALLY USED ALONE AND/OR IN COMBINATION WITH RADIOTHERAPY AND/OR CHEMOTHERAPY.UNDER THESE CIRCUMSTANCES IT IS VERY LIKELY THAT THE IMMUNE SYSTEM WILL BE FLOODED WITH ANTIGENIC MATERIAL AND MAY SUCCUMB TO THRESHOLD INHIBITION (AT WORST IF HYPERTHERMIA IS USED ALONE). IT IS THEORETICALLY MORE DAMAGING IMMUNOLOGICALLY IF THE HYPERTHERMIA IS USED SIMULTANEOUSLY WITH CHEMOTHERAPY AND/OR RADIOTHERAPY THEN ALTHOUGH SUCH SYSTEMS MAY SYNERGISE IN THEIR TUMOUR-DESTRUCTIVE ABILITY THE IMMUNE SYSTEM WILL ALSO BE WEAKENED BY THE COMBINATION THERAPY AND OVERWHELMED BY THE NEW ANTIGENIC INFORMATION. IT APPEARS PREFERABLE , THEREFORE

TO PRECEDE SUCH PROCEDURES WITH 2 WEEKS OF ANTICIPATORY

IMMUNOTHERAPYWHERE THE BODY IS STIMULATED AGAINST DISEASE PRESENTATION AFTER IT HAS BEEN TREATED OUTSIDE THE BODY BY SUGGESTED PROTOCOLS TO BE INSTITUTED 2 WEEKS LATER . THE 2 WEEK LAG PERIOD IS SELECTED TO ALLOW THE BODY TO GENERATE SIGNIFICANT SERUM IMMUNITY TO THE CHANGES ABOUT TO OCCUR. SOME DEMONSTRATIVE CASES NOW FOLLOW; SIMILAR LOW DOSEAGE OF THE HEAT-KILLED PREPARATIONS YEILDS

SIGNIFICANT LOCAL REDNESS AS WELL AS SYSTEMIC SIDE-EFFECTS SUCH AS HIGH TEMPERATURES . OBVIOUSLY, THEREFORE THE VACCINE DIFFERS IN IMMUNOLOGIC PROPERTIES TO THE ORGANISM. THE PROTECTIVE FACTORS AND/OR AGENTS APPEAR TO BE REMOVED AND/OR NEUTRALISED BY HEAT ,STRONGLY IMMUNOGENIC FACTORS APPEAR TO BE GENERATED/EXPOSED BY HEAT . AS THESE ORGANISMS APPEAR RELATED TO THE CANCER

SEVERAL CASES HAVE DEMONSTRATED TEMPORARY BENEFICIAL TUMOUR SHRINKAGE FOLLOWING ADMINISTRATION OF HEAT-KILLED VACCINES.AGENTS USED TO GENERATE SYSTEMIC HEAT WHICH WOULD PREVIOUSLY ONLY LAST FOR LIMITED DURATION(PHYSICAL/CHEMICAL/BIOLOGICAL)WILL OFTEN GIVE RISE TO LONG LASTING AND GREATER TEMPERATURE RISES ONCE THE VACCINES HAVE GENERATED SIGNIFICANT IMMUNE RESPONSE; AT THAT POINT HYPEDRTHERMIA, EVEN FROM A HIGH DOSE VACCINE OR FROM

HYPERTHERMIA ALONE IS KNOWN TO SOMETIMES CAUSE EXCELLENT RESPONSES , OTHER THAN HEAT ' S DESTRUCTIVE ABILITY, THIS EXPLANATION ALSO GIVES ANOTHER MECHANISM OF ALTERATION OF IMMUNOLOGICAL PRESENTATION OF TARGET; UNFORTUNATELY, USE OF HYPERTHERMIA WITH VACCINE THERAPY IS VERY LIMITED.

HYPERTHERMIA IS USUALLY USED ALONE AND/OR IN COMBINATION WITH RADIOTHERAPY AND/OR CHEMOTHERAPY. UNDER THESE CIRCUMSTANCES IT IS VERY LIKELY THAT THE IMMUNE SYSTEM WILL BE FLOODED WITH ANTIGENIC MATERIAL AND MAY SUCCUMB TO THRESHOLD INHIBITION (AT WORST IF HYPERTHERMIA IS USED ALONE). IT IS THEORETICALLY MORE DAMAGING IMMUNOLOGICALLY IF THE HYPERTHERMIA IS USED SIMULTANEOUSLY WITH CHEMOTHERAPY AND/OR RADIOTHERAPY THEN ALTHOUGH SUCH SYSTEMS MAY SYNERGISE IN THEIR TUMOUR-DESTRUCTIVE ABILITY THE IMMUNE SYSTEM WILL ALSO BE WEAKENED BY THE COMBINATION THERAPY AND OVERWHELMED BY THE NEW ANTIGENIC INFORMATION. IT APPEARS PREFERABLE , THEREFORE

TO PRECEDE SUCH PROCEDURES WITH 2 WEEKS OF ANTICIPATORY

IMMUNOTHERAPY WHERE THE BODY IS STIMULATED AGAINST DISEASE PRESENTATION AFTER IT HAS BEEN TREATED OUTSIDE THE BODY BY SUGGESTED PROTOCOLS TO BE INSTITUTED 2 WEEKS LATER . THE 2 WEEK LAG PERIOD IS SELECTED TO ALLOW THE BODY TO GENERATE SIGNIFICANT SERUM IMMUNITY TO THE CHANGES ABOUT TO OCCUR. SOME DEMONSTRATIVE CASES NOW FOLLOW; SIMILAR LOW DOSEAGE OF THE HEAT-KILLED PREPARATIONS YEILDS

SIGNIFICANT LOCAL REDNESS AS WELL AS SYSTEMIC SIDE-EFFECTS SUCH AS HIGH TEMPERATURES . OBVIOUSLY, THEREFORE THE VACCINE DIFFERS IN IMMUNOLOGIC PROPERTIES TO THE ORGANISM. THE PROTECTIVE FACTORS AND/OR AGENTS APPEAR TO BE . REMOVED AND/OR NEUTRALISED BY HEAT ,STRONGLY IMMUNOGENIC FACTORS APPEAR TO BE GENERATED/EXPOSED BY HEAT . AS THESE ORGANISMS APPEAR RELATED TO THE CANCER

PROCESS; WHETHER BELIEVED TO BE CAUSATIVE, SYNERGISTIC OR INFECTIVE OR NEUTRAL. THEY OBVIOUSLY DISPLAY AFFINITY FOR THE DISEASE

HYPERTHERMIA IS USUALLY USED ALONE AND/OR IN COMBINATION WITH RADIOTHERAPY AND/OR CHEMOTHERAPY . UNDER THESE CIRCUMSTANCES IT IS VERY LIKELY THAT THE IMMUNE SYSTEM WILL BE FLOODED WITH ANTIGENIC MATERIAL AND MAY SUCCUMB TO THRESHOLD INHIBITION (AT WORST IF HYPERTHERMIA IS USED ALONE). IT IS THEORETICALLY MORE DAMAGING IMMUNOLOGICALLY IF THE HYPERTHERMIA IS USED SIMULTANEOUSLY WITH CHEMOTHERAPY AND/OR RADIOTHERAPY THEN ALTHOUGH SUCH SYSTEMS MAY SYNERGISE IN THEIR TUMOUR-DESTRUCTIVE ABILITY THE IMMUNE SYSTEM WILL ALSO BE WEAKENED BY THE COMBINATION THERAPY AND OVERWHELMED BY THE NEW ANTIGENIC INFORMATION. IT APPEARS PREFERABLE ,THEREFORE

TO PRECEDE SUCH PROCEDURES WITH 2 WEEKS OF ANTICIPATORY

IMMUNOTHERAPYWHERE THE BODY IS STIMULATED AGAINST DISEASE PRESENTATION AFTER IT HAS BEEN TREATED OUTSIDE THE BODY BY SUGGESTED PROTOCOLS TO BE INSTITUTED 2 WEEKS LATER . THE 2 WEEK LAG PERIOD IS SELECTED TO ALLOW THE BODY TO GENERATE SIGNIFICANT SERUM IMMUNITY TO THE CHANGES ABOUT TO OCCUR. SOME DEMONSTRATIVE CASES NOW FOLLOW; BIOLOGICAL ENHANCEMENT PATENT

INTRODUCTION

BIOLOGICAL ENHANCEMENT MAY BE ACCOMPLISHED BY IMPROVING PREEXISTING FUNCTIONS IN TARGET SYSTEM AND/OR BY INTRODUCING NEW FUNCTIONS/PATHWAYS IN THE ENHANCEMENT OF OVERALL FUNCTION.

BIOLOGICAL ENHANCEMENT MAY BE ACCOMPLISHED BY

1-SUPPLEMENTATION.

2-EXTRACT

3-INDUCTION

4-DONATION

5-GENERATION-IMMUNOLOGICAL AND OTHER

6-TARGETING

ADJUNCTSF MANY THERAPIES

DON'T FORGET MITO CHLORIO IN INTERMED OPPATENT

PATENT FOR CLASSIFICATION AND UTILIZATION OF FACTORS FOR THERAPY AND OTHER APPLICATIONS,

INTRODUCTION

IN MANY FIELDS, THERE EXISTS CONFUSION AND DELAY IN PROGRESS.

PERHAPS THIS CAN BEST BE SEEN AND MOST NEEDS RESOLUTION IN FIELDS OF MEDICAL THERAPY SUCH AS CANCER AND A.I.D.S.

ALTHOUGH THIS PATENT MAY BE APPLIED TO VIRTUALLY ALL FIELDS; IT IS THE MEDICAL FIELD WHICH WILL BE DISCUSSED BY EXAMPLE.

CONFUSION AND DELAYS IN PROGRESS STEM FROM A LACK OF BASIC PLAN CR COMPREHENSIVE SYSTEM OF CLASSIFICATION AND EVALUATION.

IT IS THE OBJECT OF THIS PATENT TO PROVIDE A SYSTEM BY WHICH FACTORS/AGENTS/SYSTEMS /COMPOUNDS- LIVING OR NON-LIVING WHOLE/ PART/EXTRACT/PRODUCT/DERIVATIVE SINGLY OR IN COMBINATION (W/P/E/ P/D/-S/C) CAN BE CLASSIFIED AND USED .PATENT ALSO INCLUDES

METHODS Or INDUCING CHANGES WHICH CAN STRENGTHEN AND/ OR ALTER CLASSIFICATION.

INCLUDED WILL ALSO BE AN ATTEMPT TO DEFINE TIMES AND CONDITIONS WHERE WHICH MAY ALTER CLASSIFICATIONS AND CHARACTERISTICS. SOME OF THESE WILL BE PRESENTED ALONG WITH SOME FACTORS WHICH CAN STABILIZE CLASSIFICATION.

NEUTRAL

IN THE INTRICATE INTER-RELATIONSHIPS BETWEEN VARIOUS FACTORS AND AGENTS -SUCH AS IN THE COMPLEX INTERPLAY BETWEEN ORGANISMS AND HOST IN DISEASE; IT IS UNLIKELY THAT MANY ABSOLUTELY NEUTRAL FACTORS OR AGENTS EXIST; HOWEVER. THINGS CAN EXIST IN RELATIVE NEUTRALITY AND HENCE THIS LIST IS INCLUDED FOR 'COMPLETIONS' SAKE.

AS WITH ALL OTHER CLASSIFICATIONS MANY OTHER FACTORS OR AGENTS CAN INFLUENCE WHERE PARTICULAR AGENTS CAN BE CLASSIFIED IN THE SCOPE OF THIS PATENT. IT MAY BE ARGUED, FOR EXAMPLE. THAT THE FLU VIRUS OCCURING EARLY IN THE CLINICAL PRESENTATION OF A CASE OF CANCER MAY BE PATHOLOGICALLY NEUTRAL; WHEREAS LATE IN THE COURSE OF THE NEOPLASTIC DISEASE A SIMPLE FLU INFECTION MAY CAUSE DEATH; IN THIS CASE THE CANCER , HAVING WEAKENED THE HOST MAY BE TERMED SYNERGISTIC WHILE THE FLU IS THE CAUSE OF DEATH; IF THE PATIENT IS VERY CLOSE TO DYING FROM CANCER AND THE FLU SIMPLY ACCELERATES THE PROCESS THEN THE VIRUS IS BEING SYNERGISTIC TO THE DISEASE IF THE FLU OCCURS AT SOME STAGE OF THE CANCER DISEASE WHERE IT INDUCES A NON-SPECIFIC IMMUNE RESPONSE STIMULATION, THE VIRUS MAY ACTUALLY ELLICIT AN ANTICANCER RESOPONSE AND THEREFORE BE CLASSIFIED AS ANTAGONISTIC; IF THE VIRUS LODGES IN CANCER CELLS OR TISSUES IT MIGHT BE TERMED INFECTIVE.

INFECTIVE

AS THE TERM SUGGESTS. THIS CLASSIFICATION COVERS FACTORS AND

AGENTS WHICH MAY HARBOUR THEMSELVES IN SOME OTHER ENTITY ; AGAIN ,

LET US TURN TO THE MEDICAL MODEL FOR CLARIFICATION.

AN INJECTION MAY LODGE THROUGHOUT THE BODY, INCLUDING CANCER

CELLS/TISSUE; IF IN THE PROGRESS OF DISEASE THE IMPACT ON THE HOST

AND DISEASE PROCESS DOES NOT SIGNIFICANTLY FAVOUR EITHER THE THE

INFECTION CAN BE SAID TO BE NEUTRAL .; THE SAME COULD BE SAID OF

INSIGNIFICANT INFECTIONS WHICH COEXISTWITH HOST OR DISEASE

PROCESS WITHOUT NOTICEABLY TIPPING THE BALANCE IN EIHER DIRECTION

IF THE INFECTION ASSISTS OR IN ANY WAY POTENTIATES THE DISEASE PROCESS DIRECTLY SUCH AS BY PROVIDING SUBSTRATES OR OTHER OR FACTORS WHICH CAN ASSIST DISEASE PROCESS DIRECTLY, FOR EXAMPLE; OR INDIRECTLY BY WEAKENING THE HOST FOR EXAMPLE; THEN IT CAN BE

TERMED SYNERGISTIC.

IF THE INFECTION DIRECTLY/ INDIRECTLY OR IN ANY OTHER WAY ASSISTS THE HOST OR INHIBITS THE DISEASE PROCESS IT CAN BE CLASSIFIED AS ANTAGONISTIC.

ANTAGONISTIC

THIS CLASSIFICTION NECESSITATES A POINT OR OBJECT OF REFERANCE, THROUGHOUT THE PATENT CLASSIFICATION REFERS TO EFFECT ON DISEASE. ANTAGONISTIC AGENTS OR FACTORS ARE THOSE WHICH DIRECTLY OR INDIRECTLY INHIBIT OR OTHERWISE INTERFERE WITH THE DISEASE PROCESS INCLUDING FACTORS OR AGENTS WHICH PROMOTE THE HOST AND/OR HOST DEFENSES. SUCH FACTORS OR AGENTS CAN BE EITHER UILDLY

ANTAGONISTIC AN EXAMPLE BEING MILDLY EFFECTIVE OR PALLIATIVE CHEMOTHERAPY ; MARKEDLY ANTAGONISTIC .SUCH AS ANY THERAPY OR

COMBINATION OF THERAPIES WHICH CAN CAUSE MARKED REDUCTION IN DISEASE OR EVEN INDUCE TEMPORARY REMISSION . ANTAGONISTIC FACTORS OR AGENTS CAN BE SPECIFIC OR NON SPECIFIC(AS WITH SYNERGISTIC FACTORS AND AGENTS)

FACTORS OR AGENTS WITH PERFECT ANTAGONISM AND WHICH TEND TO BE SPECIFIC ARE TERMED NRMPSPS NEMESIS

A NEMESIS FACTOR OR AGENT IS ONE OR A MIXTURE OF THE ABOVE WHICH TOTALLY NEUTRALIZES/PREVENTS/CURES/REMOVES AND OFTEN EVEN ASSISTS IN REPAIR OF DAMAGE DONE BY TARGET AGENT(S) OR FACTOR(S) EITHER DIRECTLY OR INDIRECTLY. NEMSSIS FACTORS OR AGENTS CAN OFTEN OVERLAP WITH THOSE OF OTHER CATAGORIES . IN THE EXAMPLE OF CANCER, FOR EXAMPLE. A CHEMOTHERAPY OR CHEMOTHERAPEUTIC PROGRAM WHICH LEADS TO COMPLETE RECOVERY FROM CANCER CA BE SAID TO HAVE BEEN THE DISEASE'S NEMESIS.

THIS TERM WAS FIRST APPLIED BY THE INVENTOR WHEN RELATING TO

'ANTI-DISEASE ' OR NEMESIS ORGANISMS; ORGANISMS HE BELIEVED RESPONSIBLE FOR MANY CASES OF SPONTANEOUS REMISSIONS .THE

INVENTOR REFERS TO CASES OF REMISSION FROM CANCER AFTER MALARIA OR ERYSIPELAS. FOR EXAMPLE, AS PROOF THAT CERTAIN STRAIN(S) OF STREPTOCOCCUS PYOGENES (A FREQUENT CAUSE OF ERYSIPELAS) AND PARTICULAR STRAIN(S) OF MALARIA MAY BE CAPABLE OF DIRECTLY OR INDIRECTLY (SUCH AS BY CAUSING HOST RESPONSE) LEAD TO RESOLUTION OF DISEASE AND HENCE ACT AS ITS NEMESIS ORGANISM.

PRECURSOR / INTERMEDIATE AND ENDPRODUCT THERAPY. TECHNOLOGY OF THERAPY

/PREVENTION OF RESISTANCE AND

COMPLICATIONS AS WELL AS DIAGNOSIS, PROGNOSIS AS WELL AS OTHER CLINICAL AND BIOLOGICAL FEATURES.

INTRODUCTION

CURRENT TECHNOLOGY ADDRESSES A PARTICULAR FEATURE OF A SITUATION AND ALTHOUGH OCCASSIONALLY A DISEASE THERAPY MAY BE ADDRESSED BY ATTEMPTING TO EXPLOIT VARIUOS WEAKPOINTS, THE SCOPE OF CURRENT ENDEAVOUR IS SEVERELY RESTRICTED. PICTURE FOR EXAMPLE COMBINATION CHEMOTHERAPY; THE USE OF MULTIPLE POISONS WHEN TRYING TO KILL CANCER, AT ONE END OF THE SPECTRUM THE NARROWNESS OF THE FIELD IS SEEN AS ALL ATTEMPT TO POISON THE CANCER CELL, LARGELY BY

INTERFERACE WITH NUCLEIC ACID METABOLISM HENCE DESPITE YEARS OF FAILURE THE THERAPY AND ITS TARGET REMAIN LIMITED. ON THE

INCREASINGLY FREQUENT PRACTISE OF INCORPORATING 'IMMUNOTHERAPY' (EQUALLY INEFFECTIVE) TO IMPROVE EFFICACY OF THERAPY AND MINIMISE OR OFFSET IMMUNOSUPPRESSIVE ACTIVITY OF CHEMOTHERAPY BY CALLING ON AN ENTIRELY DIFFERENT SYSTEM LEANSA TOWARDS THE OTHER END OF THE SPECTRUM . THE INTERPLAY OF SUPPRESSION AND STIMULATION

EVENTUALLY MAY TOTALLY DEPLETE THE SYSTEM.UNDER THE GUIDELINES VOF THIS PATENT THIS IMMUNOSUPPRESSION MAY BE ADDRESSED BY PRECURSOR/INTERMEDIATE OR ENDPRODUCT PATHWAYS AT THE COMPLICATED LEVEL THIS MAY ENTAIL INHIBITION/PROTECTION/NEUTRALIZATION OF ENZYME PATHWAYS OR OTHER INTRICATE METHODS AT THE SIMPLE LEVEL YHE AT-RISK SYSTEM MAY BE RAISED TO ABOVE NORMAL LEVELS TO

WITHSTAND THE THERAPY(SUCH AS COULD BE ACHIEVED BY MULTIPLICATION OF THE MOST AT-RISK SYSTEM AND ALLOWING THIS AUGMENTATION TO BE EXPOSED TO THE THERAPY IN THE BODY OR IN PARALLEL SYSTEMS AS WILL BE EXPLAINED..

THE OBJECT OF THIS PATENT IS TO PROVIDE A NEW SCIENCE OF LIMITLESS APPLICATIONS . THE MEDICAL MODEL WILL BE USED TO

EXAMPLIFY ONE VEIN OF APPLICATION.

DEFINITION OF TERMS WILL BE FOLLOWED BY AN EXAMPLE AND DEMONSTRATION OF A NEW THERAPEUTIC TECHNOLOGY OUTLINING THE IMPROVEMENT OF EFFICACY OF THIS THERAPY IN MANAGEMENT OF INFECTIONS. SITUATIONS; CHEMOTHERAPY AND ANTIBIOTIC THERAPY.

CHEMOTHERAPY.

MANY CHEMOTHERAPEUTIC AGENTS ARE DERIVED FROM MICROORGANISMS SUCH AS FUNGII, THE FAMILY OF ACTINOMYCETES , FOR EXAMPLE, YEILDS

ACTINOMYCIN-D, AN ANTIBIOTIC AND CHEMOTHERAPEUTIC AGENT.

THE DIFFICULTY WITH MOST CHEMOTHERAPEUTIC REGIMENS STEMS NOT JUST FROM TOXICITY AND GENERAL LACK OF EFFICACY, AND LACK OF

SPECIFICITY BUT ALSO FROM THE FACT THAT EVEN WHERE EFFICACY CAN BE DEMONSTRATED, IT IS GENERALLY SHORT-LASTING . DISEASE RESISTANCE USUALLY EMERGES . CURRENT ART IN OFFSETTING OR POSTPONING THE EMERGENCE OF RESISTANCE INVOLVES COMBINATION THERAPY WHERE A GROUP OF TOXIC AGENTS ARE COMBINED BY SOME PROTOCOL, IN THE HOPE THAT THE CANCER WILL NOT BE ABLE TO DEVELOP RESISTANCE AS EASILY TO A COCKTAIL OF POISONS OF VARIED MECHANISMS AS IT DOES TO A SINGLE POISON. REGARDLESS OF COMBINATIONS AND PROTOCOLS, CANCER USUALLY DEVELOPS RESISTANCE IN A PERIOD OF WEEKS TO MONTHS AND VERY RARELY, YEARS . THE FAILURE OF THIS STRATEGY(COMBINATION

CHEMOTHERAPY) IN ADULT CANCER IS BEST DEMONSTRATED BY THE MINIMAL ALTERATION IN CANCER SURVIVAL RATES OVER THE PAST 60 YEARS.

ONCE CHEMOTHERAPY HAS BEEN PROCESSED INTO AN INANIMATE CHEMICAL , DEAL ING WITH RESISTANCE IS DIFFICULT . IF , HOWEVER , WE RETURN TO. THE FUNGUS OR OTHER ORGANISM OF ORIGIN( EVEN WHJERE THE AGENT IS A BOTANICAL, CELL CULTURES OF THE PLANT OF ORIGIN MAY BE USED, OR AN IN-VIVO MODEL MAY BE DEVISED) .LIVING SYSTEMS MAY BE MANIPULATED SO THAT THEY DEAL WITH RESISTANCE, EITHER BY ALLOWING THE RESISTANT DISEASE TO BE EXPOSED TO THE ORGANISM OR ORGANISMS WHICH PREVIOUSLY DEMONSTRATED ANTI-DISEASE ACTIVITY AND ALLOWING THEM TO TO CHANGE OR MUTATE TO OVERCOME THE DISEASE RESISTANCE. THIS MAY BE DONE BY SERIAL ENRICHED AND RESTRICTED CULTURES WITH OR WITHOUT MUTATING AGENTS OR FACTORS .WHERE THE ORGANISM MAY, FOR EXAMPLE ,BE CULTURED IN RESTRICTED MEDIUM WITH THE RESISTANT CANCER CELLS BEING ITS ONLY OR MAJOR SOURCE OF NUTRITION; THE ORGANISM IS LIKELY TO DEVELOP NEW WAYS TO KILL THE RESISTANT CANCER CELLS IF ITS SURVIVAL DEPENDS ON THAT. PLACING THE CANCER CELLS IN COMPETITION FOR A VITAL SUBSTRATE IS ANOTHER WAY OF INDUCING SUCH A CHANGE IN THE ORGANISM.FOLLOWING THE RESTRICTED CULTURE,THE ORGANISMS WITH IMPROVED CANCER KILLING ABILITY MAY THEN BE CULTURED IN ENRICHED MEDIA TO STRENGTHEN THEM ,WITH OR WITHOUT MUTATING F/A/P'S ETC. BY WHICH TO INCREASE THE ORGANISM POOL; INTRODUCING THE NEW POOL TO THE FORMERLY RESISTANT CANCER CELLS ALLOWS FOR THE SELECTION OF EVEN MORE SUPERIOR STRAINS FOR THE DEVELOPMENT OF ONGOING THERAPY.

DISEASE RESISTANCE CAN BE ANTICIPATED BY ALLOWING EXPOSURE OF DISEASE TO THERAPY IN EITHER IN-VITRO OR IN-VIVO SYSTEMS. FOR EXAMPLE, TO INDUCE CANCER .RESISTANCE TO A PARTICULAR

AGENT, CONTINUOUS .CULTURE WITH THE AGENT AT SUB-LETHAL DOSES MAY ALLOW THE EXPRESSION OF RESISTANT CANCER STRAINS OR THE INDUCTION OF SYSTEMS THAT FASCILITATE TOLERANCE . ALTERNATIVELY , CULTURING CANCER CELLS IN ENRICHED MEDIA WITH INCREASINGLY TOXIC LEVELS OF THE AGENT ..MUTATING F/A/P'S ETC COULD ALSO CAUSE DEVELOPMENT OF PRECURSOR / INTERMEDIATE AND ENDPRODUCT THERAPY. TECHNOLOGY OF THERAPY

/PREVENTION OF RESISTANCE AND

INTRODUCTION

CURRENT TECHNOLOGY ADDRESSES A PARTICULAR FEATURE OF A SITUATION AND ALTHOUGH OCCASSIONALLY A DISEASE THERAPY MAY BE ADDRESSED BY ATTEMPTING TO EXPLOIT VARIUOS WEAKPOINTS, THE SCOPE OF CURRENT ENDEAVOUR IS SEVERELY RESTRICTED. PICTURE FOR EXAMPLE COMBINATION CHEMOTHERAPY; THE USE OF MULTIPLE POISONS WHEN TRYING TO KILL CANCER,AT ONE END OF THE SPECTRUM THE NARROWNESS OF THE FIELD IS SEEN AS ALL ATTEMPT TO POISON THE CANCER CELL, LARGELY BY

EVENTUALLY MAY TOTALLY DEPLETE THE SYSTEM. UNDER THE GUIDELINES VOF THIS PATENT THIS IMMUNOSUPPRESSION MAY BE ADDRESSED BY PRECURSOR/INTERMEDIATE OR ENDPRODUCT PATHWAYS AT THE COMPLICATED LEVEL THIS MAY ENTAIL INHIBITION/PROTECTION/NEUTRALIZATION OF ENZYME PATHWAYS OR OTHER INTRICATE METHODS AT THE SIMPLE LEVEL YHE AT-RISK SYSTEM MAY BE RAISED TO ABOVE NORMAL LEVELS TO

EXAMPLIFY ONE VEIN OF APPLICATION.

DEFINITION OF TERMS WILL BE FOLLOWED BY AN EXAMPLE AND DEMONSTRATION OF A NEW THERAPEUTIC TECHNOLOGY OUTLINING THE IMPROVEMENT OF EFFICACY OF THIS THERAPY IN MANAGEMENT OF INFECTIONS. USE OF VI RUSES , BACTERIA , YEASTS FUNGI I AND OTHER MI CROORGAN I SMS WI TH OR WI THOUT THE INTERPLAY OF HI GHER SYSTEMS AND ORGANI SMS I N THE TREATMENT OF D I SEASE .

HI STORY-

THE USE OF MICROORGANISMS IN THERAPY HAS BEEN LARGELY RESTRICTED TO THE FOLLOWING LIMITED FIELDS;

1-VACCINE MANUFACTURE-

VIRUSES-

THESE AGENTS HAVE BEEN CLASSICALLY USED IN ATTENUATED FORMS TO IMMUNISE AGAINST VIRULENT DISEASE. THIS USUALLY INVOLVES

ATTENUATION OF THE CAUSATIVE ORGANISM SUCH AS IN THE CASE OF MEASLES AND MUMPS VACCINES BUT ALSO INCLUDES THE COWPOX VACCINE BEING USED TO IMMUNISE AGAINST SMALLPOX. OCCASSIONALLY, VIRUSES. HAVE BEEN USED IN THE PREPARATION OF CANCER VACCINES. PREVIOUS ATTEMPTS TO TREAT CANCER BY INFECTION WITH VIRUS HAVE LARGELY FAILED.

THE FOLLOWING PATENT OUTLINES SUPERIOR TECHNIQUES IN THE PREPARATION,AND PURIFICATION OF SUCH VACCINES AS WELL AS

EFFECTIVE METHODS FOR INDIVIDUALISATION OF THERAPY AS WELL AS PRODUCING LONGTERM AND SHORTTERM RESPONSES AND IMMUNISATION WITHOUT EXPOSING HOST TO DANGERS OF LIVING VIRUS/CONTAMINANTS.

BACTERIA

WITH THE EXCEPTION OF ANTI-ALLERGY INJECTIONS AND A FEW VACCINES AGAINST INFECTIONS SUCH AS CHOLERA/TETANUS/PERTUSSIS/PNEUMOCOCCUS/AND THE OCCASIONAL

STREPTOCOCCUS/STAPHYLOCOCCUS/KLEBSIELLA/E.COLI ETC., ALL OF WHICH

ARE LARGELY OF VERY LIMITED EFFICACY.

CURRENT PATENT TECHNIQUES AND GUIDELINES WILL SIGNIFICANTLY

INCREASE SAFETY AND EFFICACY.

ANTIBIOTICS ARE THE MAIN THERAPEUTIC DERIVATIVES OF BACTERIA AND

FUNGI WHEREAS YEASTS HAVE VERY LIMITED THERAPEUTIC USE IN MODERN

MEDICINE. SOME EXTRACT ENZME PREPARATIONS MAY ALSO BE PREPARED

FROM THIS GROUP . AGAIN , IT IS POSSIBLE TO IMPROVE ON ALL OF THE

ABOVE METHODS/APPLlCATIONS, SUGGEST ALTERNATIVES AND INTRODUCE NEW

USES AND TECHNOLOGIES FOR THEM.

HIGHER ORGANI SMS .

THE INTERPLAY BETWEEN THE ADMINISTERED THERAPY AND THE TARGET HOST OR HOST SYSTEM OR PART THEREOF USUALLY TAKES PLACE IN SAID HOST; IN OTHER WORDS . WHEN AN ANTIBIOTIC OR A VACCINE IS APPLIED TO THE BODY, IT IS THE FINAL STEP OF THIS THERAPY OR PRIOR TO

EVALUATION OF EFFICACY .THIS PATENT WILL TEACH IN-VITRO AND IN- ASSAY/DIAGNOSTIC /THERAPY PREPARATION TECHNOLOGY INCLUDING BROAD SPECTRUM DESIGN TECHNOLOGY WITH EMPHASIS ON TAGGING/CARRIER THERAPEUTIC TECHNOLOGY AND CANCER/INFECTION THERAPEUTIC

TECHNOLOGY UNDER THE MEDICAL MODEL.

TECHNOLOGY APPLIES TO ALL APPLICATIONS AND CLASSIFICATIONS OF

F/A/P'S ETC. UNDER GUIDELINES OF PATENT BUT WILL BE DEMONSTRATED BY EXAMPLES UNDER THE MEDICAL MODEL.

BROAD SPECTRUM SCREENING EXAMPLES OF SUCH SCREENING COULD BE ACCOMPLISHED IN A NUMBER OF EMBODYMENTS ; TWO WILL BE DISCUSSED. AGAIN, PATENT TECHNOLOGY AND GUIDELINES CAN BE APPLIED TO A MYRIAD SITUATIONS, F/A/P'S ETC. AND COMBINATIONS BUT DISCUSSION HERE WILL BE RESTRICTED TO A SEARCH FOR ORGANISMS WITH ANTCANCER ABILITY.

SYSTEMATIC SEARCH OF ORGANISMS CAN BE DONE BY A SYSTEMATIC SCREENING OF ORGANISM AND ORGANISM COMBINATIONS AND CANCER CELLS OR MIXINDICATED BY BY SYUDIES/FUNCTIONS ETC . OR COMPLEX OR MIX ETC.

REASONABLY SAFE TO USE TO INTERFERE WITH THE AIDS VIRUS. SUCH VIRAL AND BACTERIAL AGENTS MAY BE SELECTED AND MODIFIED TO HAVE MINIMAL AFFINITY FOR NORMAL HEALTHY TISSUE/CELLS BY TECHNIQUES WE WILL REVIEW AND WHICH ARE DISCUSSED IN THE CLASSIFICATION PATENT BY THE SAME INVENTOR. IT IS ALSO PRUDENT TO HAVE ANTISERA

DEVELOPED AND PURIFIED FOR USE IF NEEDED.

A SIMPLE GUIDELINE TO MINIMISE RISK OF HARM TO PATIENT IS TO USE VIRUS OR INFECTION WHICH IS OF ANOTHER SPECIE AND WHICH WON'T OR RATHER CAN'T ACT ADVERSELY ON HEALTHY HUMAN CELLS AS HUMANS (OR WHATEVER SPECIE OF HOST TO BE TREATED) HAS NO TARGET ORGAN AND/OR NO SPECIFIC RECEPTORS FOR ORGANISM TO ATTATCH TO. FOR EXAMPLE, BACTERIAL PHAGES ARE VIRUSES WHICH SPECIFICALLY INFECT BACTERIA AND ARE LARGELY INCAPABLE OF CAUSING DISEASE IN HIGHER ORGANISMS

(UNLESS INDIRECTLY BY INFECTING SOME BENEFICIAL BACTERIA).THESE WOULD THEREFORE FORM A SAFE EFFICIENT INTERFERANCE GROUP.

INTERFERANCE PHENOMENA-IN

DIAGNOSIS , MONOTORING-PROGRESS OF

DISEASE AND EFFICACY OF THERAPY,

PROGNOSIS AND THERAPY.

AS PREVIOUSLY MENTIONED MICROORGANISMS CAN EXERT INTERFERANCE ON OTHERS. CELLS ARE ALSO CAPABLE OF THIS. INTREFERANCE PHENOMENA HAVE BEEN OBSERVED AND DEMONSTRATED BY THE INVENTOR AMONGST CANCER CELLS , EXTRACTS AND HOST INDUCED RESPONSES . ALTHOUGH USE OF CANCER TISSUE FOR IMPLANTATION INTO CANCER PATIENTS AS A FORM OF THERAPY WAS ATTEMPTED EARLIER THIS CENTURY AND MET WITH SOME SUCCESS ; THIS CRUDE FORM OF THERAPY INITIATED A RANGE OF IMMUNOLOGICAL RESPONSES AMONGST OTHERS NOT RELATED TO INTERFERANCE PHENOMENA; AS A THERAPY, THIS WAS NEVER PATENTED. IT IS THE OBJECT OF THIS PATENT TO INCLUDE METHODS AND CONCEPTS BY WHICH SUCH THERAPY COULD BE MADE SAFE AND EFFECTIVE (SEE CANCER SECTION FOR

PURIFICATION AND IN-VITRO, IN-VIVO MODELS FOR PROCESSING CANCER AND /OR IMMUNE OR OTHER RESPONSE ) . INTERFERANCE THERAPY OFFERS THE POTENTIAL FOR THE PURIFICATION OF F/A/P'S ETC. WHICH CAN SAFELY NEUTRALIZE OTHERS WITH OR WITHOUT INVOLVEMENT OF THE HOST DEFENSE OR OTHER SYSTEMS . METHODS AND TECHNIQUES WILL BE DISCUSSED TO ENABLE THIS; HOWEVER THER EXISTS ANOTHER WAY OF UTILIZING THIS PHENOMENA WITH RELATIVE SAFETY , A DISCUSSION OF THIS WILL FOLLOW WITH AIDS BEING USED AS THE MEDICAL TREATMENT MODEL.

INTERFERANCE CLASSIFICATION AND USE

EARLY THIS CENTURY WORK WAS DONE INVESTIGATING THE INTERFERANCE NOTED BETWEEN SOME ORGANISMS . INVESTIGATION OF THIS PHENOMENON BETWEEN BACTERIA WITH OTHER BACTERIA OR WITH HIGHER ORGANISMS LED TO THE DEVELOPMENT OF SOME EARLY ANTIBIOTICS. THE OBSERVATION THAT SOME VIRUSES INTERFERE WITH OR INHIBIT THE DEVELOPMENT OF OTHER VIRAL INFECTIONS SIMULTANEOUSLY OR SOON AFTER IN ANIMAL OR TEST TUBE MODELS LED TO THE DEVELOPMENT OF INTERFERON NAMED BECAUSE OF THE INTERFERENCE PHENOMENON. IT IS THE INVENTOR'S CONTENTION THAT THE INTERFERENCE PHENOMENON IS FAR MORE COMPLICATED THAN THE SIMPLE PRODUCTION OF INTERFERON . INTERFERENCE PHENOMENA HAVE BEEN OBSERVED BY AUTHOR IN SYSTEMS WHERE INTERFERON GENERATION IS NOT POSSIBLE . LIVING ORGANISMS CAN INTERFERE DIRECTLY WITH OTHERS . AT THIS POINT ONE SHOULD OUTLINE A CLASSIFICATION SYSTEM FOR ALL ORGANISMS WITH INTERFERENCE PHENOMENON IN MIND.

ALL ORGANISMS WILL EITHER SYNERGISE AND ASSIST OTHERS, BE NEUTRAL TO THEM OR SUPPRESS/INHIBIT THEIR GROWTH/SURVIVAL . HENCE

INTERFERENCE CLASSIFICATION CAN BE; SYNERGISTIC

NEUTRAL INHIBITORY VIVO METHODS OF FURTHER DEVELOPING THE THERAPY BY INTERPLAY WITH HOST , HOST SYSTEMS OR PARTS THEREOF AND OF RAISING AN ENTIRELY NEW ARM AND TECHNIQUE OF THERAPY.

INTRODUCTION

IT' IS THE OBJECT OF THIS PATENT TO INTRODUCE NEW MODIFICATIONS OF PREEXISTING TECHNOLOGY AS WELL AS TECHNIQUES FO AMPLIFICATION OF EFFICACY, SPECIFICITY AND SAFETY . WHETHER INDIVIDUALLY OR BY

COMBINATION WITH OTHER MICROORGANISMS, HIGHER ORGANISMS OR BY USE OF BIOLOGICAL FRAGMENTS NOT BEFORE APPLIED IN THERAPY AT LEAST NOT IN THIS MANNER, PATENT WISHES TO INTRODUCE A NEW LINE OF

THERAPIES AND APPLICATIONS INCLUDING DIAGNOSIS, PROGNOSIS WITH GUIDELINES TO DEVELOPING CARRIER SYSTEMS, TAGGING SYTEMS,

INTERPLAY WITH HOST AND HOST SAMPLES TO INCREASE EFFICACY AND SAFETY AND TO PREVENT OR NEUTRALIZE RESISTANCE EITHER BY ANTICIPATION AND DEVELOPMENT OF RESISTANT THERAPY OR BY INTERPLAY WITH OTHER SYSTEM(S) SUCH AS THE IMMUNE SYSTEM.

THE CONCEPT OF INTERFERANCE VIRAL/BACTERIAL/FUNGAL OR OTHER IS ALSO TO BE DEMONSTRATED IN THERAPY. THE ABILITY AND EFFICACY OF GUIDELINES IN CHOOSING BIOLOGICAL ORGANISM FROM POOL OR BY STRINGENT TESTING FOR INHERENT FEATURES OR TO DEVELOP OR CARRY AND REPRODUCE DESIRED FEATURES IN A MANNER DIFFERENT TO THAT OF CURRENT GENETIC ENGINEERING WILL ALSO BE DEMONSTRATED.

INTERFERANCE PHENOMENON AS THERAPY

DEFINITION- TWO OR MORE ORGANISMS MAY IMPACT ON EACH OTHER IN A SYNERGISTIC/NEUTRAL OR INTRFERING MANNER. TYHE LATTER OF THESE DESCRIBES THE PHENOMENON WHEREBY THE EXISTANCE OF ON ORGANISM INHIBITS THE SURVIVAL AND PROLIFERATION OF ANOTHER. THIS EFFECT MAY BE DIRECT OR SECONDARY TO OTHER INTERPLAY WITH SURROUNDING MEDIUM OR HOST.

INTERFERANCE PHENOMENA HAVE BEEN OBSERVED WITH MANY ORGANISMS BOTH WITHIN A PARTICULAR CLASSIFICATION EG BACTERIA AS WELL AS FROM OTHER GENUS/SPECIES. INTERFERANCE PHENOMENA CAN BE DIRECT SUCH AS BY PRODUCTION OF ANTIBIOTIC INHIBITORY OR LETHAL TO OTHER ORGANISMS OR INDIRECT SUCH AS BY COMPETITION FOR A COMMON NUTRIENT OR SUBSTRATE. INTERFERANCE BY THIRD PARTY IS A TERM GIVEN BY INVENTOR TO THE ABILITY OF ONE ORGANISM TO INTERFERE WITH THE SURVIVAL OF ANOTHER BY EITHER DIRECTLY OR INDIRECTLY ALERTING THE HOST TO THE PRESENCE OF THE OTHER (TARGETED INTERFERANCE) OR TO THE PRESENCE OF BOTH SUCH AS BY SHARED ANTIGENICITY(NON-SPECIFIC INTERFERANCE) WHEN BOTH ORGANISMS ARE COEXISTING IN TIME ,THE LATTER MECHANISM MAY ALSO FALL UNDER THE CATEGORY OF SUICIDAL INTERFERANCE, SUICIDAL INTERFERANCE MAY ALSO BE DEMONSTRATED WHEN AN ORGANISM ATTATCHES TO ANOTHER, THE EFFECTS OF WHICH DIRECTLY OR INDIRECTLY(SUCH AS BY IMMUNE MECHANISM) CAUSING THE DESTRUCTION OF BOTH . THIS FIRST MECHANISM WILL BE USED TO DEFINE ONE

APPLICVATION OF THIS PATENT. ALL ORGANISMS WILL FALL SOMEWHERE IN THIS CLASSIFICATION; IT IS IMPORTANT TO NOTE THAT CLASSIFICATION MAY VARY DEPENDING ON WHETHER THE ORGANISMS ARE TESTED ALONE, IN COMBINATION WITH OTHERS OR IN A LIVING SYSTEM.

IN A COMPLEX ENVIRONMENT THERE ARE MANY POSSIBILITIES;

IF ORGANISM A IS SYNERGISTIC WITH B WHEN THE TWO ARE CULTURED ALONE BUT IS MORE SYNERGISTIC WITH C IN A MIXED SETTING, AND IF C IS ANTAGONISTIC TO B THEN IN THIS MIXED SETTING A IS SYNERGISING WITH AN INHIBITOR AND IS THEREFORE NOW CLASSIFIED AS INHIBITORY. SIMILARLY CLASSIFICATIONS MAY CHANGE ONCE INSIDE A LIVING SYSTEM. AN ORGANISM MAY BE NEUTRAL WITH RESPECT TO ANOTHER BUT INDUCE SUCH A MASSIVE IMMUNE RESPONSE THAT BOTH ARE ELIMINATED FROM A LIVING HOST. IN THIS SETTING ITS STRONG IMMUNOGENIC PROPERTIES WOULD CLASSIFY IT AS INHIBITORY.

SOME IMMEDIATE APPLICATION.

THE AIDS MODEL.

AN APPEAL OF INTERFERENCE THERAPY IN THE TREATMENT OF AIDS IS THAT LIVING SYSTEMS OF COMPATIBLE SURVIVAL SKILLS CAN BE USED TO HIV. CAUTION NEEDS TO BE TAKEN THAT SUCH AGENTS ARE PURELY

INHIBITORY AND HAVE NO PROPENSITY FOR SYNERGY WITH DISEASE OR HARM OF HOST . INHIBITORY OR INTERFERENCE -SPECIFIC FRACTIONS OR FRAGMENTS CAN BE PURIFIED OR EXTRACTED BY USE OF SUCH TECHNIQUES AS PRESENTED IN CLASSIFICATION PATENT. (SELECTIVE TESTING OF FILTERED OR CENTRIFUGED FRAGMENTS CAN INDICATE BY TESTING , WHICH PROMOTES MAXIMAL INHIBITION)

IT IS ALSO USEFUL TO TEST IMMUNE COMPETENCE OF HOST IN ABILITY TO HANDLE OR SAFELY WITHSTAND THE INTERFERING ORGANISM OR AGENT.

INVENTOR HAS STUDIED SEVERAL CASES OF AIDS AND GAUGED THEIR RESPONSE TO INFECTIONS ACQUIRED SPONTANEOUSLY AS WELL AS RESPONSE TO INHIBITORY ORGANISMS ADMINISTERED . WE SHALL CONCENTRATE ON SOME ORGANISMS FOUND TO BE INHIBITORY.

STAPHYLOCOCCAL AND STREPTOCOCCAL INFECTIONS CAUSING SIGNIFICANT ERYSIPELAS WERE FOUND TO RAISE T CELL COUNTS IN SOME INSTANCES BUT TO CAUSE THEM TO DROP IN OTHERS. ANTIBIOTIC THERAPY FOR SUCH INFECTIONS OFTEN LESSENED THE DEGREE OF CHANGE INDUCED . WHERE DISAPPEARANCE OF BACTERIA WAS SPONTANEOUS , SOME MAJOR CHANGES WERE NOTED. THIS IS OF PARTICULAR IMPORTANCE LATER IN PATENT.

RE-EXPOSURE TO A VIRAL CONDITION SUCCESSFULLY FOUGHT IN THE PAST AND TO WHICH RESIDUAL MEMORY REMAINS OFTEN RESULTED IN CLINICAL IMPROVEMENT . ONE PARTICULAR SUCH CASE WAS OBSERVED TERMINAL AIDS PATIENT SUFFERING FROM WIDESPREAD KAPOSI'S SARCOMA WAS TREATED WITH THE MUMPS VIRUS. DRAMATIC SHRINKAGE OF THE LESIONS FOLLOWED ALONG WITH IMPROVEMENT IN T-CELL COUNTS .

EVEN IN ADVANCED CASES OF AIDS IT IS LIKELY THAT MEMORY WILL EXIST FOR VIRAL INFECTION OF CHILDHOOD . THESE WOULD THEN BE USE OF VIRUSES , BACTERIA, YEASTS FUNGI I AND OTHER MICROORGANISMS WITH OR WITHOUT THE INTERPLAY OF HIGHER SYSTEMS AND ORGANISMS IN THE TREATMENT OF DISEASE.

HISTORY-

1-VACCINE MANUFACTURE- VIRUSES-

THESE AGENTS HAVE BEEN CLASSICALLY USED IN ATTENUATED FORMS TO IMMUNISE AGAINST VIRULENT DISEASE . THIS USUALLY INVOLVES

ATTENUATION OF THE CAUSATIVE ORGANISM SUCH AS IN THE CASE OF MEASLES AND MUMPS VACCINES BUT ALSO INCLUDES THE COWPOX VACCINE BEING USED TO IMMUNISE AGAINST SMALLPOX . OCCASSIONALLY, VI RUSES HAVE BEEN USED IN THE PREPARATION OF CANCER VACCINES. PREVIOUS ATTEMPTS TO TREAT CANCER BY INFECTION WITH VIRUS HAVE LARGELY FAILED.

THE FOLLOWING PATENT OUTLINES SUPERIOR TECHNIQUES IN THE PREPARATION , AND PURIFICATION OF SUCH VACCINES AS WELL AS

EFFECTIVE METHODS FOR INDIVIDUALISATION OF THERAPY AS WELL AS PRODUCING LONGTERM AND SHORTTERM RESPONSES AND IMMUNISATION WITHOUT EXPOSING HOST TO DANGERS OF LIVING VIRUS/CONTAMINANTS .

BACTERIA

STREPTOCOCCUS/STAPHYLOCOCCUS/KLEBSIELLA/E . COLI ETC . , ALL OF WHICH

ARE LARGELY OF VERY LIMITED EFFICACY.

CURRENT PATENT TECHNIQUES AND GUIDELINES WILL SIGNIFICANTLY INCREASE SAFETY AND EFFICACY.

ANTIBIOTICS ARE THE MAIN THERAPEUTIC DERIVATIVES OF BACTERIA AND FUNGI WHEREAS YEASTS HAVE VERY LIMITED THERAPEUTIC USE IN MODERN MEDICINE. SOME EXTRACT ENZME PREPARATIONS MAY ALSO BE PREPARED FROM THIS GROUP. AGAIN, IT IS POSSIBLE TO IMPROVE ON ALL OF THE ABOVE METHODS/APPLICATIONS, SUGGEST ALTERNATIVES AND INTRODUCE NEW USES AND TECHNOLOGIES FOR THEM.

HIGHER ORGANISMS.

THE INTERPLAY BETWEEN THE ADMINISTERED THERAPY AND THE TARGET HOST OR HOST SYSTEM OR PART THEREOF USUALLY TAKES PLACE IN SAID HOST; IN OTHER WORDS . WHEN AN ANTIBIOTIC OR A VACCINE IS APPLIED TC THE BODY, IT IS THE FINAL STEP OF THIS THERAPY OR PRIOR TO

EVALUATION OF EFFICACY . THIS PATENT WILL TEACH IN-VITRO AND IN- VIVO METHODS OF FURTHER DEVELOPING THE THERAPY BY INTERPLAY WITH HOST , HOST SYSTEMS OR PARTS THEREOF AND OF RAISING AN ENTIRELY NEW ARM AND TECHNIQUE OF THERAPY.

INTRODUCTION

IT IS THE OBJECT OF THIS PATENT TO INTRODUCE NEW MODIFICATIONS OF PREEXISTING TECHNOLOGY AS WELL AS TECHNIQUES FO AMPLIFICATION OF EFFICACY, SPECIFICITY AND SAFETY .WHETHER INDIVIDUALLY OR BY

THE CONCEPT OF INTERFERANCE VIRAL/BACTERIAL/FUNGAL OR OTHER IS ALSO TO BE DEMONSTRATED IN THERAPY . THE ABILITY AND EFFICACY OF GUIDELINES IN CHOOSING BIOLOGICAL ORGANISM FROM POOL OR BY STRINGENT TESTING FOR INHERENT FEATURES OR TO DEVELOP OR CARRY AND REPRODUCE DESIRED FEATURES IN A MANNER DIFFERENT TO THAT OF CURRENT GENETIC ENGINEERING WILL ALSO BE DEMONSTRATED.

INTERFERANCE PHENOMENON AS THERAPY

INTERFERANCE PHENOMENA HAVE BEEN OBSERVED WITH MANY ORGANISMS BOTH WITHIN A PARTICULAR CLASSIFICATION EG BACTERIA AS WELL AS FROM OTHER GENUS/SPECIES. INTERFERANCE PHENOMENA CAN BE DIRECT SUCH AS BY PRODUCTION OF ANTIBIOTIC INHIBITORY OR LETHAL TO OTHER ORGANISMS OR INDIRECT SUCH AS BY COMPETITION FOR A COMMON NUTRIENT OR SUBSTRATE. INTERFERANCE BY THIRD PARTY IS A TERM GIVEN BY INVENTOR TO THE ABILITY OF ONE ORGANISM TO INTERFERE WITH THE SURVIVAL OF ANOTHER BY EITHER DIRECTLY OR INDIRECTLY ALERTING THE HOST TO THE PRESENCE OF THE OTHER (TARGETED INTERFERANCE) OR TO THE PRESENCE OF BOTH SUCH AS BY SHARED ANTIGENICITY(NON-SPECIFIC INTERFERANCE) WHEN BOTH ORGANISMS ARE COEXISTING IN TIME ,THE LATTER MECHANISM MAY ALSO FALL UNDER THE CATEGORY OF SUICIDAL INTERFERANCE, SUICIDAL INTERFERANCE MAY ALSO BE DEMONSTRATED WHEN AN ORGANISM ATTATCHES TO ANOTHER, THE EFFECTS OF WHICH DIRECTLY OR INDIRECTLY(SUCH AS BY IMMUNE MECHANISM) CAUSING THE DESTRUCTION OF BOTH. THIS FIRST MECHANISM WILL BE USED TO DEFINE ONE

APPLICVATION OF THIS PATENT. INTERFERANCE PHENOMENA-IN

DIAGNOSIS, MONOTORING-PROGRESS OF

DISEASE AND EFFICACY OF THERAPY,

PROGNOSIS AND THERAPY.

AS PREVIOUSLY MENTIONED MICROORGANISMS CAN EXERT INTERFERANCE ON OTHERS. CELLS ARE ALSO CAPABLE OF THIS. INTREFERANCE PHENOMENA HAVE BEEN OBSERVED AND DEMONSTRATED BY THE INVENTOR AMONGST CANCER CELLS, EXTRACTS AND HOST INDUCED RESPONSES .ALTHOUGH USE OF CANCER TISSUE FOR IMPLANTATION INTO CANCER PATIENTS AS A FORM OF THERAPY WAS ATTEMPTED EARLIER THIS CENTURY AND MET WITH SOME SUCCESS; THIS CRUDE FORM OF THERAPY INITIATED A RANGE OF IMMUNOLOGICAL RESPONSES AMONGST OTHERS NOT RELATED TO INTERFERANCE PHENOMENA; AS A THERAPY, THIS WAS NEVER PATENTED. IT IS THE OBJECT OF THIS PATENT TO INCLUDE METHODS AND CONCEPTS BY WHICH SUCH THERAPY COULD BE MADE SAFE AND EFFECTIVE (SEE CANCER SECTION FOR

PURIFICATION AND IN-VITRO, IN-VIVO MODELS FOR PROCESSING CANCER AND /OR IMMUNE OR OTHER RESPONSE ). INTERFERANCE THERAPY OFFERS THE POTENTIAL FOR THE PURIFICATION OF F/A/P'S ETC. WHICH CAN SAFELY NEUTRALIZE OTHERS WITH OR WITHOUT INVOLVEMENT OF THE HOST DEFENSE OR OTHER SYSTEMS . METHODS AND TECHNIQUES WILL BE DISCUSSED TO ENABLE THIS; HOWEVER THER EXISTS ANOTHER WAY OF UTILIZING THIS PHENOMENA WITH RELATIVE SAFETY, A DISCUSSION OF THIS WILL FOLLOW WITH AIDS BEING USED AS THE MEDICAL TREATMENT MODEL.

INTERFERANCE CLASSIFICATION AND USE

EARLY THIS CENTURY WORK WAS DONE INVESTIGATING THE INTERFERANCE NOTED BETWEEN SOME ORGANISMS. INVESTIGATION OF THIS PHENOMENON BETWEEN BACTERIA WITH OTHER BACTERIA OR WITH HIGHER ORGANISMS LED TO THE DEVELOPMENT OF SOME EARLY ANTIBIOTICS . THE OBSERVATION THAT SOME VIRUSES INTERFERE WITH OR INHIBIT THE DEVELOPMENT OF OTHER VIRAL INFECTIONS SIMULTANEOUSLY OR SOON AFTER IN ANIMAL OR TEST TUBE MODELS LED TO THE DEVELOPMENT OF INTERFERON NAMED BECAUSE OF THE INTERFERENCE PHENOMENON. IT IS THE INVENTOR'S CONTENTION THAT THE INTERFERENCE PHENOMENON IS FAR MORE COMPLICATED THAN THE SIMPLE PRODUCTION OF INTERFERON. INTERFERENCE PHENOMENA HAVE BEEN OBSERVED BY AUTHOR IN SYSTEMS WHERE INTERFERON GENERATION IS NOT POSSIBLE. LIVING ORGANISMS CAN INTERFERE DIRECTLY WITH OTHERS . AT THIS POINT ONE SHOULD OUTLINE A CLASSIFICATION SYSTEM FOR ALL ORGANISMS WITH INTERFERENCE PHENOMENON IN MIND.

INTERFERENCE CLASSIFICATION CAN BE; SYNERGISTIC

NEUTRAL INHIBITORY ALL ORGANISMS WILL FALL SOMEWHERE IN THIS CLASSIFICATION; IT IS IMPORTANT TO NOTE THAT CLASSIFICATION MAY VARY DEPENDING ON WHETHER THE ORGANISMS ARE TESTED ALONE, IN COMBINATION WITH OTHERS OR IN A LIVING SYSTEM.

IN A COMPLEX ENVIRONMENT THERE ARE MANY POSSIBILITIES;

SOME IMMEDIATE APPLICATION.

THE AIDS MODEL.

AN APPEAL OF INTERFERENCE THERAPY IN THE TREATMENT OF AIDS IS THAT LIVING SYSTEMS OF COMPATIBLE SURVIVAL SKILLS CAN BE USED TO HIV . CAUTION NEEDS TO BE TAKEN THAT SUCH AGENTS ARE PURELY

INHIBITORY AND HAVE NO PROPENSITY FOR SYNERGY WITH DISEASE OR HARM OF HOST. INHIBITORY OR INTERFERENCE -SPECIFIC FRACTIONS OR FRAGMENTS CAN BE PURIFIED OR EXTRACTED BY USE OF SUCH TECHNIQUES AS PRESENTED IN CLASSIFICATION PATENT. (SELECTIVE TESTING OF

FILTERED OR CENTRIFUGED FRAGMENTS CAN INDICATE BY TESTING, WHICH PROMOTES MAXIMAL INHIBITION)

STAPHYLOCOCCAL AND STREPTOCOCCAL INFECTIONS CAUSING SIGNIFICANT ERYSIPELAS WERE FOUND TO RAISE T CELL COUNTS IN SOME INSTANCES BUT TO CAUSE THEM TO DROP IN OTHERS. ANTIBIOTIC THERAPY FOR SUCH INFECTIONS OFTEN LESSENED THE DEGREE OF CHANGE INDUCED . WHERE DISAPPEARANCE OF BACTERIA WAS SPONTANEOUS, SOME MAJOR CHANGES WERE NOTED. THIS IS OF PARTICULAR IMPORTANCE LATER IN PATENT.

EVEN IN ADVANCED CASES OF AIDS IT IS LIKELY THAT MEMORY WILL EXIST FOR VIRAL INFECTION OF CHILDHOOD . THESE WOULD THEN BE REASONABLY SAFE TO USE TO INTERFERE WITH THE AIDS VIRUS. SUCH VIRAL AND BACTERIAL AGENTS MAY BE SELECTED AND MODIFIED TO HAVE MINIMAL AFFINITY FOR NORMAL HEALTHY TISSUE/CELLS BY TECHNIQUES WE WILL REVIEW AND WHICH ARE DISCUSSED IN THE CLASSIFICATION PATENT BY THE- SAME INVENTOR. IT IS ALSO PRUDENT TO HAVE ANTISERA

DEVELOPED AND PURIFIED FOR USE IF NEEDED.

A SIMPLE GUIDELINE TO MINIMISE RISK OF HARM TO PATIENT IS TO USE VIRUS OR INFECTION WHICH IS OF ANOTHER SPECIE AND WHICH WON'T OR RATHER CAN'T ACT ADVERSELY ON HEALTHY HUMAN CELLS AS HUMANS (OR WHATEVER SPECIE OF HOST TO BE TREATED) HAS NO TARGET ORGAN AND/OR NO SPECIFIC RECEPTORS FOR ORGANISM TO ATTATCH TO. FOR EXAMPLE , BACTERIAL PHAGES ARE VIRUSES WHICH SPECIFICALLY INFECT BACTERIA AND ARE LARGELY INCAPABLE OF CAUSING DISEASE IN HIGHER ORGANISMS

(UNLESS INDIRECTLY BY INFECTING SOME BENEFICIAL BACTERIA) .THESE WOULD THEREFORE FORM A SAFE EFFICIENT INTERFERANCE GROUP.

BACTERIAL PHAGES NEED TO BE TESTED TO HAVE NO OR MINIMAL DISRUPTION ON USEFUL BACTERIAL OR OTHER COMPONENTS OF THE HOST SYSTEM. A FURTHER CAUTION IS THAT THE PHAGE DOES NOT CARRY

INFORMATION WHICH CAN BE DAMAGING DIRECTLY OR FOLLOWING DONATION TO ANOTHER ORGANISM OR F/A/P'S ETC.

TO DEMONSTRATE THE ABOVE POINTS, THE INVENTOR HAS CARRIED OUT SOME PRELIMINARY TRIALS.

PHAGES WERE ISOLATED FROM THREE SOURCES AND TESTED IN LIMITED TRIALS FOR EFFICACY IN INTERFERANCE WITH GROWTH OF VARIOUS STRAINS OF CARCINOMA IN-VIVO ANIMAL MODELS , THESE WERE CHOSEN IN FAVOUR OF IN-VITRO MODELS AS THEY ALLOW STUDY OF COMPLEX

INTERPLAYS-INTERFERANCE BOTH DIRECT AND INDIRECT AS WELL AS

TAGGING AND OTHER PHENOMENON SUCH AS GENERAL AND SPECIFIC IMMUNOSTIMULATION. PHAGES ACTIVE AGAINST STRAINS OF STAPHYLOCOCCI WERE TESTED AS WERE PHAGES WITH ACTIVITY AGAINST LACTOBACILLI AND A THIRD GROUP HAD ACTIVITY AGAINST SERRATIA MARASCECENS . EACH DOSE WAS STANDARDISED TO 10 TO THE 12TH POWER PLAQUE FORMING UNITS PER ML.

IT APPEARED THAT IN THE ANIMAL MODEL,THE GENERAL DEGREE OF

IMMUNOSTIMULATION WAS COMPARABLE (AS ASSESSED BY BLOOD PARAMETERS AND AREA OF VISIBLE REACTION FOLLOWING INTRADERMAL INNOCULATION) EFFICACY IN RESTRICTION OF TUMOUR GROWTH,HOWEVER, DIFFERED GREATLY AS DID THIR ABILITY TO SUSTAIN IMMUNOSTIMULATION AND OTHER EFFECTS .

STAPHYLOCOCCAL PHAGES APPEARED FAR SUPERIOR TO SERRATIA PHAGES IN CARCINOMA INHIBITION (A LIMITED SERIES SHOWED GREATER SERRATIA PHAGE ACTIVITY AGAINST SOME SARCOMAS ), WHEREAS THE LACTOBACILLI PHAGES APPEARED TO ULTIMATELY INHIBIT EFFECTIVE IMMUNE RESPONSE AND STIMULATE OR ENCOURAGE CANCER GROWTH. SOME INSIGHT INTO REASONS FOR THESE PRELIMINARY OBSERVATIONS CAN BE GAINED FROM THE CLASSIFICATION PATENT WITH PARTICULAR REFERANCE TO DATA PRESENTED BY DR ALAN CANTWELL JUNIOR AND OTHERS. SIMPLY PUT, IF THE AGENT BEING TESTED INHIBITS OR OTHERWISE INTERFERES WITH F/A/P'S ETC. WHICH ARE USEFUL TO HOST IN GENERAL OR IMPORTANT IN MAINTANANCE OF INTEGRITY OF NORMAL F/A/P'S ETC. OR IMMUNE RESPONSE (SUCH ASD IN THE CASE OF LACTOBACILLI PHAGES TESTED PERHAPS) OR EVEN WHERE THE ANTI-HOST EFFECT IS MINIMAL OR ABSENT BUT THE ANTI-CANCER OR ANTIDISEASE F/A/P'S ETC. EFFECT IS NOT SIGNIFICANTLY PRESENT THEN EVEN A STRONG IMMUNOSTIMULATOR MAY END UP BEING DETRIMENTAL AS IT MAY INTERFERE WITH THE IMMUNE RESPONSE AGAINST THE DISEASE .IN OTHER WORDS, IN BALANCE, THE AGENT MUST CAUSE MORE OF A

DETRIMENTAL EFFECT AGAIST DISEASE CAUSATIVE OR SYNERGISTIC

F/A/P ' S ETC . THAN ON HEALTH RELATED F/A/P ' S ETC . OR MORE OF A BENEFICIAL ACTION ON HEALTH RELATED F/A/P'S ETC THAN ON DISEASE CAUSATIVE OR SYNERGISTIC F/A/P'S ETC. EVEN A NEUTRAL EFFECT MAY BE DAMAGING IF IMMUNE STIMULATION BY THE NEUTRAL F/A/P'S ETC.

DISTRACTS OR DEVIATES THE IMMUNE SYSTEM FROM THE MAIN THREAT. SUCH COMPEX INTERPLAYS MUST THEREFORE BE EVALUATED FOR DISEASE , HOST AND THERAPIES.SERRATIA PHAGES MAY PROVE TO BE USEFUL OR HARMFUL DEPENDING ON THE SITUATION. IT APPEARS THAT IN SOME CARCINOMATOUS CONDITIONS THEY MAY BENEFIT DISEASE OR SYNERGISTIC F/A/P'S ETC WHEREAS IN SOME SARCOMAS TESTED THE EFFECT WAS DIFFERENT,ElTHER INHIBITORY ON THE DRFAP'S ETC OR BENEFICIAL TO THE HRFAPS ETC. IT IS IMPORTANT TO RECALL ALSO THAT THESE RESULTS ARE OF A LIMITED SERIES AND ONLY SPEAK FOR THE PARTICULAR PHAGES USED , THERE ARE MANY RELATED TO EACH ORGANISM, THE INVENTOR DOES NOT RELATE THESE RESULTS AS REPRESENTATIVE OF THE GENRE BUT MORE AS GUIDELINES FOR EVALUATION AND EXPLANATION. IT IS ALSO IMPORTANT TO REALISE THAT TIME MAY BE A FACTOR IN THE USEFULNESS OF THE AGENT. MANY PHAGES MAY EXERT USEFUL ANTIDISEASE ACTIVITY IN PRELIMINARY USE BUT , AT LEAST IN THE CASE OF CANCER, THERE MAY SOON DEVELOP A TOLERANCE, RESISTANCE AND EVEN REVERSAL OF EFFICACY. AT LEAST NINE PHENOMENA DIRECTLY OR IN COMBINATION, MAY ACCOUNT FOR THIS.

1-MUTATION OF DISEASE OR DRF/TARGET SITE OF ACTION

2-SATURATION FOLLOWED BY THRESHOLD INHIBITION OF IMMUNE RESPONSE. 3-DEVELOPMENT OF SYNERGY BETWEEN DISEASE AND THERAPY- THIS WAS DEMONSTRATED BY AUTHOR IN USE OF PHAGES AS WELL AS OTHER THERAPIES INCLUDING IMMUNOLOGICAL ONES. ONE PARTICULARLY DRAMATIC EXAMPLE CAN BE DEMONSTRATED BY THE USE OF FELINE PANLEUKOPENIA VIRUS AND OR THE CANINE DISTEMPER VIRUS IN THE TREATMENT OF LEUKEMIA. INITIALLY CYTOPLASMIC AND NUCLEAR VACUOLATION PRECEDE LARGESCALE DESTRUCTION OF THE MALIGNANT CELLS.THE LEUKEMIA OFTEN RECURS . HOWEVER AND USUALLY WILL STILL DISPLAY

VACUOLATION , INDICATING THAT DESPITE PERSISTANT VIRAL ACTIVITY , THE VIRUS AND CANCER CELL NOW CO-EXIST IN SOME HARMONIOUS MANNER.

4-THE IMMUNE SYSTEM MAY DEVELOP A RESPONSE AGAINST THE TREATMENT AGENT AND DISABLE IT FROM TAGGING OR INTERFERING WITH THE DISEASE

5-MUTATION OF PHAGE OR OTHER INTERFERANCE ORGANISM TO SYNERGISE WITH DISEASE. WHEN LIVING ORGANISMS INTERFERE OR TAG, THEY ARE OFTEN DESTROYED AS WELL; EVENTUALLY THIS WILL CASUSE GENERATION AND OR SELECTION OF THOSE THAT WILL NOT HAVE THIS EFFECT.

6-DESTRUCTION OF TARGET. IF PHAGE TARGETS , FOR EXAMPLE, A

BACTERIA SYNERGISING WITH CANCER AND DESTROYS IT , THEN IT NO LONGER SERVES A PURPOSE AND REPEATED ADMINISTRATION MAY FURTHER DISTRACT A TAXED SYSTEM

LACTOBACILLI OFTEN SERVE A USEFUL FUNCTION IN THE BODY AND HAVE NOT BEEN DEMONSTRATED TO HAVE ANY MAJOR RELATED FACTOR IN CANCER

, HENCE IT IS NOT SURPRISING THAT PHAGES THAT DESTROY THEM MAY

CAUSE AGGRAVATION OF DISEASE CONDITION.

7- TAXATION OF OTHER SYSTEM EG KIDNEY/LIVER/OTHER ELIMINATION PATHWAY. 8-MUTATION OF INTERFERANCE AGENT TO INTERFERE WITH BENEFICIAL

F/A/P'S ETC.

9-ENTRANCE OF NEW F/A/P ETC. INTO SYSTEM .THIS MAY CAUSE STRAIN

OR MORE LETHAL CONSEQUENCES.

STRAIN COULD RESULT SIMPLY BY MAINTENANCE OF STRONG ANTICANCER

ACTIVITY IN THE FACE OF A MORE ACUTE THREAT EG. PNEUMONIA

REQUIRING IMMUNE ATTENTION MORE URGENTLY.

LETHAL CONSEQUENCES MAY FOLLOW EXTREME CONDITIONS SUCH AS THOSE

ABOVE OR MAY FOLLOW SOME INTERPLAY, AN EXAMPLE OF THE LATTER IS ;

SHOULD E COLI PHAGES EXERT GOOD ANTI-DISEASE ACTIVITY AND THE

BODY THEN ACQUIRE A STRAIN OF E.COLI WHOSE TOXIN PRODUCTION IS

INDUCED BY A PHAGE BEING USED CR A MUTANT THEREOF THEN THE RISK

CAN BE SEEN.

THE ABOVE POINTS STRESS THE IMPORTANCE OF KNOWING DETAILS OF THERAPY AND DISEASE(PARTICULARLY AS OUTLINED IN CLASSIFICATION PATENT BY SAME INVENTOR )AS WELL AS CONSTANTLY RE- EVALUATING, REASSESSING AND IF NECESSARY, MODIFYING OR RENEWING THERAPY .

INTERFERANCE DOES NOT EVEN NEED TO BE AT THE WHOLE ORGANISM LEVEL . USEFUL F/A/P'S ETC. NEED TO BE SCREENED FOR EFFECTS AGAINST TARGETED AGENT OR DISEASE, INTERACTION WITH HOST AND HOST

COMPONENTS, INTERPLAY OF ALL THREE WITH AND WITHOUT OTHER

VARIABLES SUCH AS OTHER THERAPY.

EVALUTING AND MODIFYING HOST RESPONSES TO THERAPY NOT ONLY ENABLES OPTIMISATION BUT ALSO RAISES NEW THERAPEUTIC INTERPLAY POSSIBILITIES AS OUTLINED IN PRECURSOR/INTERMEDIATE AND

ENDPRODUCT THERAPY PATENT BY SAME INVENTOR.

AN EXAMPLE OF THIS WILL BE MADE HERE AS RELATES TO ANTIBIOTICS/AND ANOTHER WILL BE MADE AS RELATEWS TO

CHEMOTHERAPY/RADIOTHERAPY AND IMMUNOTHERAPY.

INTERPLAY OF INTERFERANCE PHENOMENON, PRECURSOR/INTERMEDIATE/ENDPRODUCT

CONCEPTS AS APPLIED TO ANTIBIOTIC THERAPY.

PRECURSOR PHASE

COMMENCING AT PRECURSOR PHASE RAISES THERAPEUTIC POTENTIALS AND POSSIBILITIES UNUSED BY MODERN THERAPEUTIC TECHNIQUES. KNOWLEDGE OF TARGET ORGANISM AND THERAPEUTIC ORGANISM AND THEIR MODIFICATIONS CAN BE APPLIED AS FOLLOWS.

1 - IF THE ORIGINAL MATCH OF TARGET AND THERAPEUTIC ORGANISM IS

A GOOD ONE THEN IT IS IMPORTANT TO MAINTAIN SUCH A RELATIONSHIP UNTIL RESOLUTION OF DISEASE. THIS MAY BE ACCOMPLISHED BY ONE OF THREE METHODS;

1-MAINTENANCE OF DIRECT RELATIONSHIP; THIS INVOLVES THE USE OF TECHNOLOGY TO RESTRICT AND/OR MINIMISE THE RAISING OF MUTATIONS.

2-ALLOWING THERAPEUTIC ORGANISM(S) TQ REDEVELOP THERAPEUTIC POTENTIAL AGAINST THE MUTATED TARGET DISEASE.

3-ANTICIPATION OF RESISTANCE AND PREPARATION OF THERAPEUTIC ORGANISM OR OTHER MECHANISM FOR DEALING WITH DISEASE.

2 -IF PRFELIMINARY MATCH IS NOT A GOOD ONE THEN PRECURSOR

TECHNIQUES ENABLE THE DEVELOPMENT OF EFFICIENT MATCH OR THE RAISING OF EFFECTIVE RESPONSE FROM THE PREVIOUSLY INEFFECTIVE MATCH.

3 -PRECURSOR MATCHES CAN ALSO BE MADE FOR INTERFERANCE PHENOMENA

NOT RELATED NECESSARILY TO ANTIBIOTIC EFFECT AS WELL AS PRECURSOR THERAPY TO IMMUNISE AGAINST OR OTHERWISE TARGET THE EMERGENCE OF RESISTANCE, PRECURSOR CARRIER VACCINES AND PRECURSOR PREPARATIONS OR IMMUNISATION AGAINST F/A/P'S ETC. THAT INDUCE MUTATIONS OR CHANGES RESISTANT TO THERAPY . ALTERNATIVELY, THERAPIES CAN BE DEVELOPED AT THE OUTSET OR CO-TEMPORALLY WITH THERAPY TO DEAL WITH RESISTANCE. REASONABLY SAFE TO USE TO INTERFERE WITH THE AIDS VIRUS .SUCH VIRAL AND BACTERIAL AGENTS MAY BE SELECTED AND MODIFIED TO HAVE MINIMAL AFFINITY FOR NORMAL HEALTHY TISSUE/CELLS BY TECHNIQUES WE WILL REVIEW AND WHICH ARE DISCUSSED IN THE CLASSIFICATION PATENT BY THE SAME INVENTOR. IT IS ALSO PRUDENT TO HAVE ANTISERA

DEVELOPED AND PURIFIED FOR USE IF NEEDED.

PRECURSOR / INTERMEDIATE AND ENDPRODUCT THERAPY . TECHNOLOGY OF THERAPY

/PREVENTION OF RES I STANCE AND

COMPL ICATIONS AS WELL AS DIAGNOS I S , PROGNOS I S AS WELL AS OTHER CLINI CAL AND B I OLOG I CAL FEATURES .

I NTRODUCTION C URRENT TECHNOLOGY ADDRESSES A PARTICULAR FEATURE OF A SITUATION AND ALTHOUGH OCCASSIONALLY A DISEASE THERAPY MAY BE ADDRESSED BY ATTEMPTING TO EXPLOIT VARIUOS WEAKPOINTS, THE SCOPE OF CURRENT ENDEAVOUR IS SEVERELY RESTRICTED. PICTURE FOR EXAMPLE COMBINATION CHEMOTHERAPY; THE USE OF MULTIPLE POISONS WHEN TRYING TO KILL CANCER,AT ONE END OF THE SPECTRUM THE NARROWNESS OF THE FIELD IS BEEN AS ALL ATTEMPT TO POISON THE CANCER CELL, LARGELY BY

INTERFERACE WITH NUCLEIC ACID METABOLISM HENCE DESPITE YEARS OF FAILURE THE THERAPY AND ITS TARGET REMAIN LIMITED.ON THE

INCREASINGLY FREQUENT PRACTISE OF INCORPORATING 'IMMUNOTHERAPY' (EQUALLY INEFFECTIVE) TO IMPROVE EFFICACY OF THERAPY AND MINIMISE OR OFFSET IMMUNOSUPPRESSIVE ACTIVITY OF CHEMOTHERAPY BY CALLING ON AN ENTIRELY DIFFERENT SYSTEM LEANSA TOWARDS THE OTHER END OF THE SPECTRUM. THE INTERPLAY OF SUPPRESSION AND STIMULATION

EVENTUALLY MAY TOTALLY DEPLETE THE SYSTEM.UNDER THE GUIDELINES OF THIS PATENT THIS IMMUNOSUPPRESSION MAY BE ADDRESSED BY PRECURSOR/INTERMEDIATE OR ENDPRODUCT PATHWAYS AT THE COMPLICATED LEVEL THIS MAY ENTAIL INHIBITION/PROTECTION/NEUTRALIZATION OF NZYME PATHWAYS OR OTHER INTRICATE METHODS AT THE SIMPLE LEVEL THE AT-RISK SYSTEM MAY BE RAISED TO ABOVE NORMAL LEVELS TO

EXAMPLIFY ONE VEIN OF APPLICATION.

DEFINITION OF TERMS WILL BE FOLLOWED BY AN EXAMPLE AND DEMONSTRATION OF A NEW THERAPEUTIC TECHNOLOGY OUTLINING THE IMPROVEMENT OF EFFICACY OF THIS THERAPY IN MANAGEMENT OF INFECTIONS. PRIOR TO PROVIDING SOME DEFINITIONS , I NEED TO POINT OUT A FEW SHORTCOMINGS OF CURRENT THERAPY WHICH DIRECTLY STEM FROM LACK OF CONSIDERATION OF SUCH PARAMETERS IN THERAPY.

CHEMOTHERAPY INVOLVES THE APPLICATION OF TOXIC AGENTS FOR THE PURPOSE OF POISONING CANCER CELLS SYSTEMICALLY. ALTHOUGH IT IS ROUTINE PRACTISE TO CHECK INFECTIONS FOR ANTIBIOTIC SENSITIVITY REPEATEDLY IF UNRESOLVING AND TRACKING THEM AS THEIR SENSITIVITIES CHANGE SO THAT THE MOST EFFECTIVE AGENTS CAN BE USED, SOME INDICATION IS ALSO AVAILABLE OF DEGREE OF SENSITIVITY TO A PARTICULAR ANTIBIOTIC AND THEREFORE DOSEAGE MAY BE EVALUATED; THERE IS EVEN MONITORING OF BLOOD LEVELS TO ENSURE OPTIMAL THERAPEUTIC AND MINIMAL TOXIC EFFECTS (THIS IS ALSO TRUE OF OTHER MEDICATIONS SUCH AS DILANTIN, TEGRETOL , DIGOXIN ETC . ) . IN THE CASE OF GENTAMYCIN , AN ANTIBIOTIC WITH KIDNEY AS WELL AS AUDITORY TOXICITY, FOR EXAMPLE, THE SENSITIVITY OF A PARTICULAR ORGANISM TO IT AS DETERMINED BY LABORATORY CULTURE AND SENSITIVITY TESTING, CAN DETERMINE ITS DOSEAGE, (ALONG WITRH OTHER PARAMETERS SUCH AS KIDNEY FUNCTION, WEIGHT OF PATIENT, ETC. ) IN MANY CASES, COMBINATION ANTIBIOTIC THERAPY WILL BE INITIATED TO OBTAIN BETTER COVER AND DEAL WITH RESISTANT VARIANTS. IT IS NOT UNCOMMON., FOR EXAMPLE, TO COMBINE GENTAMYCIN WITH A PENICILLIN AND METRONIDAZOLE FOR DEALING WITH A STRONG INFECTION . ANTIBIOTIC AGENTS WHICH ARE TOXIC ARE MONITORED FOR LEVELS AND EFFECTS ON THE BODY AS WELL AS THE ORGANISM. (IT IS INTERESTING TO NOTE HERE THAT IT WOULD BE LOGICAL HERE TO TEST THE COMBINATIONS AGAINST THE ORGANISMS TO EVALUATE OPTIMAL COMBINATIONS AND DOSEAGE ; THIS IS NOT ROUTINELY DONE, IF AT ALL. AND IS INCLUDED IN THIS PATENT AS PART OF TESTING PRECURSOR/INTERMEDIATE /ENDPRODUCT THERAPY FOR SAFETY, EFFICACY AND TO DETERMINE IF OTHER

INTERMEDIATES/ENDPRODUCTS ARE GENERATED BY THESE

COMBINATIONS, ANIMAL MODELS MAY BE DESIGNED TO CARRY THE PATIENT'S DISEASE ALONG WITH DISEASED SAMPLE/RESPONSE ETC BY USE OF SUCH SYSTEMS AS NUDE MICE OR SKID RATS.)WHEN AN INFECTION FAILS TO RESOLVE, RETESTING OF SENSITIVITIES AND NEW COMBINATIONS/AGENTS ARE TRIED. THIS IS NOT OPTIMAL . IN THE OPINION OF THE

INVENTOR, INFECTIONS AND CULTURES SHOULD BE REPEATED

FREQUENTLY/DAILY OR MORE OFTEN IN VITRO/IN PATIENT OR IN VIVO IN ANIMAL MODELTO TEST FOR CHANGES/NEW STRAINS/INCREASED RESISTANCE TO OPTIMISE DOSEAGE AND DRUG COMBINATIONS.

EVEN IN CURRENT PRACTICE , ANTIBIOTIC CHOICE, DOSEAGE AND EVALUATION ARE DONE WITH MUCH GREATER LOGIC AND PRECISION THAN CHEMOTHERAPY PROTOCOLS . THE SITUATIONS CAN BE COMPARED AS MANY

CHEMK,OTHERAPEUTIC AGENTS CAN BE SEEN AS ANTIBIOTICS OF HIGH TOXICITY WHILE CANCER IS , IN THIS MODEL, A CHRONIC INFECTION WITH GREAT ABILITIES TO DEVELOP RESISTANCE TO THERAPIES. ALTHOUGH MANY CHEMOTHERAPEUTICAGENTS ARE INDEED ANTIBIOTICS OF HIGH TOXICITY , THE ANALOGY OF CANCER TO CHRONIC INFECTION IS ONLY DONE TO ILLUSTRATE AN IMPORTANT POINT. CURRENT TECHNIQUES AND PROTOCOLS ARE SIGNIFICANT ENDPOINT RESPONSES AS DETERMINED BY LABORATORY TESTING OF INVOVED PARAMETERS SUCH AS LIVER FUNCTION WHEN CANCER INVOLVES THE LIVER OR BY DIMENSIONAL EVALUATION AS WELL AS EVALUATION OF CONSISTENCY AS DETERMINED BY X-RAY AND OTHER

IMAGING MODALITIES AT INTERVALS OF WEEKS TO MONTHS . CANCER

THERAPY WOULD BE MUCH BETTER TITRATED AND WOULD YEILD BETTER RESULTS IF APPLIED BY THE FOLLOWING PROTOCOL OR SIMILAR GUIDELINES;

1-CHEMOTHERAPY(OR OTHER THERAPY) SCREENING PRIOR TO INITIATION OF THERAPY

2-CHOOSE A NORMAL CELL MODEL SUCH AS LIVING CELLS(EG BLOOD CELLS AND/OR OTHERS ISOLATED FROM BIOPSY)FROM PATIENT TO TEST AND BEST DOSE-TITRATE THERAPY . OTHER NORMAL CELLS CAN ALSO BE USED FROM LIBRARY /HUMAN /ANIMAL OR OTHER; ALTHOUGH THE PATIENT'S OWN CELLS WOULD MORE LIKELY FORM A MORE SPECIFIC SYSTEM.

3-ISOLATE PATIENT SERUM AND OR WHITE BLOOD CELLS TO USE IN MIXED CULTURES . THIS IS A VERY IMPORTANT OMITTED FACTOR IN ALL THERAPIES IT IS IMPORTANT NOT ONLY TO GAUGE EFFICACY AGAINST DISEASE, AND ESTIMATE DETRIMENTAL EFFECTS AGAINST HEALTHY CELLS/TISSUES

ETC. BUT ALSO TO GAUGE THE INTERACTION BETWEEN THERAPY AND

DISEASE, THERAPY AND NORMAL CELLS , THERAPY, NORMAL SYSTEMS AND HOST ' S ANTIDISEASE RESPONSE . THE INTERPLAY OF ALL THESE F/A/P ' S ETC. IS NECESSARY TO MONITOR AND ASESS FOR OPTIMAL EVALUATION. EVEN AS FAR AS ANTIBIOTIC THERAPY IS CONCERNED, AIDS HAS PROVEN HOW INEFFECTIVE 1

ARE SIGNIFICANT ENDPOINT RESPONSES AS DETERMINED BY LABORATORY TESTING OF INVOVED PARAMETERS SUCH AS LIVER FUNCTION WHEN CANCER INVOLVES THE LIVER OR BY DIMENSIONAL EVALUATION AS WELL AS EVALUATION OF CONSISTENCY AS DETERMINED BY X-RAY AND OTHER

IMAGING MODALITIES AT INTERVALS OF WEEKS TO MONTHS. CANCER

1-CHEMOTHERAPY(OR OTHER THERAPY) SCREENING PRIOR TO INITIATION OF THERAPY

2-CHOOSEΑ NORMAL CELL MODEL SUCH AS LIVING CELLS (EG BLOOD CELLS AND/OR OTHERS ISOLATED FROM BIOPSY)FROM PATIENT TO TEST AND BEST DOSE-TITRATE THERAPY. OTHER NORMAL CELLS CAN ALSO BE USED FROM LIBRARY /HUMAN /ANIMAL OR OTHER ; ALTHOUGH THE PATIENT ' S OWN CELLS WOULD MORE LIKELY FORM A MORE SPECIFIC SYSTEM.

3-ISOLATE PATIENT SERUM AND OR WHITE BLOOD CELLS TO USE IN MIXED CULTURES. THIS IS A VERY IMPORTANT OMITTED FACTOR IN ALL THERAPIES IT IS IMPORTANT NOT ONLY TO GAUGE EFFICACY AGAINST DISEASE, AND ESTIMATE DETRIMENTAL EFFECTS AGAINST HEALTHY CELLS/TISSUES

ETC . BUT ALSO TO GAUGE THE INTERACTION BETWEEN THERAPY AND

DISEASE, THERAPY AND NORMAL CELLS, THERAPY,NORMAL SYSTEMS AND HOST'S ANTIDISEASE RESPONSE. THE INTERPLAY OF ALL THESE F/A/P'S ETC. IS NECESSARY TO MONITOR AND ASESS FOR OPTIMAL EVALUATION. EVEN AS FAR AS ANTIBIOTIC THERAPY IS CONCERNED,AIDS HAS PROVEN HOW INEFFECTIVE STANDARD ANTIBIOTIC REGIMENS ARE IN THE ABSENCE OF A FUNCTIONAL IMMUNE RESPONSE. THIS WOULD SUGGEST THAT

OPTIMISATION OF THERAPY BY THE AFOREMENTIONED TECHNIQUES WOULD BE OF VITAL VALUE IN THIS DISEASE , IT ALSO SUGGESTS THAT USE OF SPECIFIC IMMUNE FRAGMENTS/MANIPULATIONS WHETHER SERUM/CELLULAR , DIRECT IMMUNE SUPPLEMENTATION/AUGMENTATION OR MANIPULATION SUCH AS WITH VACCINES GENERAL OR SPECIFIC. INVENTOR WILL DISCUSS

ANTICIPATION THERAPY WHERE IN-VITRO, IN-VIVO

PREPARATIONS(AUTOGENOUS OR OTHER) ARE MADE FOR ANTICIPATED

PATHOLOGY AND/OR RESISTANCE TO THERAPY.

1-MAINTENANCE OF EFFICACY.

1-MAINTENANCE OF DIRECT RELATIONSHIP USING TECHNOLOGY TO RESTRICT

AND/OR MINIMISE THE RAISING OF MUTATIONS.

THIS INVOLVES ;

A- MAINTENANCE OF ENVIRONMENTAL STABILITY EG PH ETC.

B- MAINTENANCE OF GENETIC/OTHER STABILITY . ONE SIMPLE WAY TO DO

THIS IS TO BATHE THE ORGANISM WITH ORIGINAL GENETIC/OTHER

EXTRACTS

C- VACCINE AGAINST RESISTANT FORMS / ORGANISMS THAT DONATE

RESISTANCE. VACCINE AGAINST FRACTION THAT DONATES RESISTANCE.

IT IS POSSIBLE TO VACCINATE ORIGINAL ORGANISM AS WELL AS AGAINST ITS RESISTANT FORM WHETHER SPONTANEOUS/GENERATED IN-VITRO OR IN- VIVO AS WELL AS AGAINST PLASMIDS ETC AS WELL AS OTHER GENETIC/OTHER MODALITIES OF IMMUNITY DEVELOPMENT.

TO FURTHER EXPLAIN THIS FURTHER; IT IS UNLIKELY THAT RESISTANT MUTATIONS OCCUR WITHOUT OTHER CHANGES TO THE ORGANISM SOME OF WHICH MAY YEILD IMMUNOLOGICAL TARGETS. IT HAS ALSO BEEN THE

INVENTOR'S EXPERIENCE THAT INTERNAL AS WELL AS EXTERNAL CELLULAR COMPONENTS MAY BE IMMUNOGENIC ; FUTRTHERMORE , IT IS POSSIBLE TO DIRECTLY EFFECT GENETIC FRAGMENTS/ENZYMES ETC. OR TO DO SO AFTER TAGGING. IT HAS BEEN DEMONSTRATED BY PRIOR RESEARCHERS THAT

GENETIC INFORMATION CAN BE DAMAGED BY IMMUNE RESPONSES. THE INVENTOR HAS DEMONSTRATED SPECIFIC IMMUNE

INACTIVATION/REMOVAL/INHIBITION OF INTRACELLULAR COMPONENTS. THIS NEW FIELD OF INTRACELLULAR IMMUNE MANIPULATION WILL BE DISCUSSED FURTHER BOTH DIRECTLY AND AS A CONSEQUENCE OF CARRIER VACCINE THERAPY.

IT HAS JUST BEEN STATED THAT IT IS UNLIKELY THAT GENETIC CHANGE WILL LEAD SOLELY TO SIMPLE UNDETECTABLE CHANGE. PLASMIDS CODE FOR SUBTLE CHANGES IN BACTERIAL METABOLISM AND OTHER CHANGES AND HAVE BEEN CREDITED WITH BEING AN IMPORTANT ELEMENT IN THE RISE IN ANTIBIOTIC RESISTANCE . IT APPEARS THAT BACTERIA WHICH POSESS RESISTANCE TO CERTAIN ANTIBIOTICS ARE NOT JUST CHOSEN FOR BY OVERUSE OF ANTIBIOTICS BUT ARE ACTUALLY ABLE TO SHARE THEIR RESISTANT ABILITIES WITH VULNEREABLE ORGANISMS .THIS IS

CLASSICALLY UNDERSTOOD TO HAPPEN BY PACKAGES OF GENETIC INFORMATION KNOWN AS PLASMIDS WHICH DONATE THIS INFORMATION FROM RESISTANT ORGANISMS TO THOSE WITH LOWER. ANTIBIOTIC RESISTANCE. THE INVENTOR HAS FOUND PHAGE AND OTHER MECHANISMS TO BE ACTIVE IN RESISTANCE ACQUISITION AND/OR AUGMENTATION AND EVEN HIGHER AND LOWER ORGANISM SPECIES MAY PARTICIPATE IN THIS PROCESS.

MUCH OF THIS IS DISCUSSED UNDER 'PLEOMORPHISM ' AND DEFINITION OF INTERACTIVE LIFECYCLES-A THEORY WHICH LINKS LIVING ENTITIES AND DEMONSTRATES THERAPIES FOR GENETIC CORRECTION IN CANCER AND GENETIC DISEASES AS BY MECHANISMS SIMILAR TO THOSE WHICH RID ACELL OF HIV. LET US NOW CONSIDER HOW THE AVAILABLE DATA ENABLES THE EMPLOY OF PRECURSOR/INTERMEDIATE/ENDPOINT PATENT TO YEILD EFFECTIVE

THERAPY.

LET US CONSIDER A CASE OF A STREPTOCOCCUS INFECTION WHICH IS SENSITIVE TO PENICILLIN. USE OF PENICILLIN MAY BE CUREATIVE

OR, DEPENDING IN PART ON THE IMMUNOLOGICAL COMPETENCY OF THE HOST, THE INFECTION MAY LINGER, ACQUIRING PENICILLIN RESISTANCE FROM OTHER ORGANISMS SAY VIA PLASMIDS (ONE SIMPLE TECHNIQUE DISCOVERED BY INVENTOR DOES NOT EVEN REQUIRE EVOLVED TRANSFER MECHANISMS SIMPLY REQUIRES ONE ORGANISM TO BE IN PROXIMITY OF GENETIC OR OTHER FRAGMENTS OF RESISTANT ORGANISM TO ACQUIRE A MEASURE OF RESISTANCE. IT IS ALSO POSSIBLE THAT BY MECHANISMS OF BIOLOGICAL ENHANCEMENT PATENT BY SAME INVENTOR THAT THE PROXIMITY OF THE RESISTANT ORGANISM TO THE SENSITIVE ONE MAY PROTECT OR SYNERGISE WITH IT. (MECHANISMS FOR GENERALISED OR SPECIFIC

BIOENHANCEMENT ARE OUTLINED IN THAT PATENT. WE HAVE A SITUATION THEREFORE THAT CAN BE SUMMARISED AS A SENSITIVE ORGANISM DEVELOPING RESISTANCE BY SOME PROCESS WHERE THE SENSITIVE ORGANISM AND SENSITIVE SYSTEM ALONG WITH INITIAL HOST CONDITION AND PRELIMINARY THERAPY COULD BE CLASSIFIED AS INITIAL OR PRECURSOR PHASE IF WE CHOOSE TO LABEL THE NEWLY RESISTANT BACTERIA AS WELL AS HOST STATUS AT THE TIME AND THE NOW INEFFECTIVE ANTIBIOTIC AS ENDPOINT/ENDPRODUCT PHASE THEN THE PROCESS IN AND DURING WHICH THE ORGANISM ACQUIRES RESISTANCE AND ALL RELATED F/A/P'S ETC.AS WELL AS HOST STATUS AT THE TIME WOULD BE TERMED INTERMEDIATE PHASE.ANY OF THESE F/A/P'S ETC. CAN ALSO BE IDENTIFIED, MAGNIFIED AND CLASSIFIED.

AN EXAMPLE OF IDENTIFICATION, MAGNIFICATION AND CLASSIFICATION IS DEPENDANT ON SOURCE OF REFERANCE; FOR EXAMPLE, ONE COULD LIMIT THE CLASSIFICATION TO THE ANTIBIOTIC ITSELF WHERE PENICILLIN WOULD BE THE PRECURSOR, THE DISASSEMBLED/DESTROYED/NEUTRALISED ANTIBIOTIC WOULD BE ENDPOINT/ENDPRODUCT AND F/A/P'S ETC. BETWEEN THE TWO WOUKLD BE CLASSIFIED AS INTERMEDIATE,

PRECURSOR INTERVENTION ANTIBIOTIC/CHEMOTHERAPY MODEL.

REFERRING TO THE ABOVE SITUATION,THE PRECURSOR SYSTEM PRECEDING ALL WOULD BE THE INTERPLAY OF THE DISEASE ORGANISM WITH THAT OF THE ANTIBIOTIC ORGANISM IE. TWO ABSOLUTE PRECURSORS WOULD BE THE BACTERIA CAUSING THE DISEASE AND THE PENICILLIUM FROM WHICH THE THERAPY IS ISOLATED. (IT IS IMPORTANT TO NOTE HERB THAT ONCE CELLS/TISSUES/ORGANS ETC. ARE INFECTED , DEPENDING ON POINT OF REFERANCE, THEY FORM INTERMEDIATE PHASES-LEADING TO SEPARATE THERAPY AS YET UNTAPPED BY MODERN MEDICINE ). PRECURSOR APPLICATION ENABLES FINE-TUNING, IMPROVING EFFICACY, SPECIFICITY; ANTICIPATION AND NEUTRALISATION /DEVELOPING COPING MECHANISMS TO RESISTANCE AS WELL AS CO-TEMPORAL PROCESS ING, AS WELL AS PREMATCHING AND PRECALIBRATING LIBRARIES OF PRECURSOR/INTERMEDIATE/ENDPRODUCT AND COPING

MECHANISMS/MODALITIES TO OVERCOME RESISTANCE.

CULTURE-ORGANISM- HOST INTERPLAY.

THE PENICILLIUM MOULD PLACED IN CULTURE MEDIUM WITH THE TARGET ORGANISM WILL KILL ALL SENSITIVE BACTERIA BY USE OF ITS PRODUCT ANTIBIOTIC , PENICILLIN. DEPENDING ON CULTURE CONDITIONS, RESISTANTR BACTERIAL STRAINS MAY ARISE , BE PROMOTED , INDUCED OR CAUSED

SPECIFICALLY. TO CLARIFY THIS POINT, A WELL BALANCED NUTRITIONAL MEDIUM FOR BACTERIA AND MOULD AS WELL AS IDEAL CONDITIONS OF TEMPERATURE ETC . MAY LEAD TO SPONTANEOUS GENERATION OF RESISTANT MUTATIONS. IF THE MEDIUM OR CULTURE CONDITIONS FAVOUR THE

BACTERIA AND ARE IN ANY WAY INHIBITORY TO THE MOULD OR TO PENICILLIN PRODUCTION; THE GREATER THE FAVOURING OF THE BACTERIAL SURVIVAL (TERMED MARGIN OF BIAS MOB) , THE MORE CHANCE OF PROMOTING THE DEVELOPMENT OF BACTERIAL RESISTANCE AS WELL AS THE POSSIBLE DEVELOPMENT OF F/A/P'S ETC. TO OPPOSE OR ATTACK THE MOULD.KNOWN RESISTANT ORGANISMS(WHOLE/PART/EXTRACT/PRODUCT/DERIVATIVE ETC.) AND/OR PLASMIDS AND /OR PHAGES CARRYING DATA CODING FOR

PENICILLIN RESISTANCE COULD BE ADDED TO THE CULTURE TO INDUCE RESISTANCE.

LEFT TO THEIR OWN DEVICES THE TWO ORGANISMS WILL OFTEN WAGE A BATTLE OF OFFENSIVE AND DEFENSIVE MOVES UNTIL ONE EMERGES TOTALLY TRIUMPHANT. THIS SEE-SAW CAN BE MANIPULATED BY IN-VITRO, IN-VIVO TECHNIQUES AND DEGREE OF BIAS.

SEPARATELY OR IN COMBINATION, THE BACTERIA AND MOULD CAN BE

CULTURED UNDER CONDITIONS OR IN THE PRESENCE OF F/A/P'S ETC.

WHICH PROMOTE MUTATION AND DIVERSITY (EG UV LIGHT, PLASMIDS ETC.). THIS ENABLES DEVELOPMENT OF A POPULATION OF WHICH SOME BACTERIA WILL BE RESISTANT TO PENICILLIN AND A VARIETY OF MOULD MUTATION, SOME OF WHICH MAY HAVE DEVELOPED CAPACITY TO DEAL WITH THE RESISTANT BACTERIA. MANIPULATION OF MEDIA , CULTURE CONDITIONS AND DEGREE OF BIAS CAN DEVELOP SUCH PROPERTIES FOR A LIBRARY OR COTEMPORALLY WITH THERAPY TO OVERCOME RESISTANCE DURING TREATMENT. THIS APPLIES TO BACTERIA AND ANTIBIOTICS AS WELL AS TO CANCER AND CHEMOTHERAPY AS WELL AS MANY OTHER SITUATIONS .

IN-VITRO AND IN-VIVO MODELS CAN ALSO BE ESTABLISHED TO MINIMISE AFFINITY OF THERAPY FOR HEALTHY TISSUE AND HENCE MINIMISE SIDE- EFFECTSBY THIS AS WELL AS BY OTHER METHODS . RAISING OF SELECTIVE AFFINITY NOT ONLY 'RAISES SPECIFICITY AND MINIMISES SIDE-EFFECTS BUT ALSO RAISES EFFICACY AND THERAPEUTIC INDEX.

MARGIN OF BIAS CAN ALSO BE USED IN-VITRO AND IN-VIVO TO RAISE EFFICIENT IMMUNE AND OTHER RESPONSES. MAINTENANCE OF EFFI CACY

1 -TARGET ORGANISM

IF THE TARGET ORGANISM IS SENSITIVE TOP THERAPY THEN IT IS OF THERAPEUTIC INTEREST TO MAINTAIN THE ORGANISM IN ITS SENSITIVE STATE/FORM AND PREVENT MUTATION AND/OR OTHER MODIFICATION LEADING TO RESISTANCE. IT IS POSSIBLE THAT THE SENSITIVE FORM OF THE ORGANISM IS BETTER EQUIPPED FOR SURVIVAL UNDER CERTAIN CONDITIONS THAN THE RESISTANT ONES. IT IS IMPORTANT THAT THESE BE

ESTABLISHED AND MAINTAINED. IT IS ALSO IMPORTANT THAT CELL OR ORGANISM DESTRUCTION/INHIBITION/NEUTRALISATION IS NOT ALLOWED TO GIVE MAXIMAL FEEDBACK TO SURVIVING ORGANISMS FOR THE NEED TO MUTATE, HENCE ELIMINATION OF BACTERIAL BREAKDOWN

PRODUCT/DENATURATION/OTHER INHIBITION OF FEEDBACK SYSTEM IS

DESIREABLE, .IT IS IMPORTANT TO SOMETIMES CONSIDER LIVING OR

BIOLOGICAL REACTIONS WITH THE SAME SIMPLICITY THAT WE VIEW CHEMICAL AND OTHER REACTIONS. EQUILIBRIUM IS REACHED BETWEEN

PRECURSOR(S) AND ENDPRODUCT(S), REMOVAL OF ENDPRODUCTS BY REMOVAL OF BREAKDOWN PRODUCTS , COUPLED WITH OPTIMAL BALANCING OF

PRECURSORS AND INTERMEDIATES WILL FAVOUR A REACTION FLOW BIAS

(RFB) THIS TERM AND PHENOMENON AS DESCRIBED BY AUTHOR CAN BE USED TO FAVOUR A USEFUL REACTION AND INHIBIT AN UNFAVOURABLE ONE. IT WILL LATER BE SHOWN HOW RFB AND OTHER TECHNIQUES CAN BE USED TO EFFECTIVELY INHIBIT HEALTHY CELL DAMAGE..

AS PROOF OF THE ABOVE TEACHING, INVENTOR HAS DEMONSTRATED

IMPROVED EFFICACY OF SEVERAL MODALITIES OF THERAPY WHEN A SIMPLE PROCEDURE SUCH AS DIALYSIS IS IMPLEMENTED. EFFICACY IMPROVES AS SPECIFICITY OF REMOVED FRACTION IS DEFINED . GREATER DETAIL WILL BE COVERED IN SECTION ON ENDPRODUCT/ENDPOINT THERAPY.

WHEN CONDITIONS ARE STABILISED, FEEDBACK REMOVED , IMMUNE AND OTHER

PATHWAYS ARE BROUGHT IN FOR FAST, EFFECTIVE RESPONSE ALONG WITH

THE CORRECT ANTIBIOTIC, WHAT THEN REMAINS IS TO EFFECTIVELY

ISOLATE THE ORGANISM FROM MUTATION, RESISTANT ORGANISMS AND DONOR

MECHANISMS , IT IS POSSIBLE TO IMMUNOLOGICALLY ;

1-TARGET ORGANISM

2-TARGET AND INHIBIT REPRODUCTIVE CYCLE

3-TARGET AND INHIBIT SPECIFIC RECEPTORS AND/OR F/A/P'S ETC.

INVOLVED IN THE ACQISITION OF RESISTANCE.

IMMUNOLOGICAL TARGETS CAN BE PREPARED BY SPECIFIC F/A/P'S ETC. GUIDELINES IN SPECIFI F/A/P'S ETC. PATENT BY SAME INVENTOR.

1-SPECIFIC TARGETING OF ORGANISM, FOR EXAMPLE, CAN BE DONE

CRUDELY AS IS THE CURRENT PRACTISE OF CULTURING AN ORGANISM, ATTENUATING, DISRUPTING OR OTHERWISE KILLING IT , OR REPRODUCING/DUPLICATING IMMUNOGENIC FRAGMENT BY PROCESSES

INCLUDING GENETIC ENGINEERING. DESPITE ALL CURRENT SOPHISTICATION IN PREPARATION OF VACCINE WHJICH ARE COVERED IN THIS USE BY THIS PATENT(CURRENT VACpINE USE IS IN PREVENTION OF INFECTION, CURRENT PATENT COVERS CONVENTIONAL AND NEW VACCINES IN THERAPEUITIC APPLICATION AS WELL AS IN USE TO PREVENT THE RISE OF RESISTANCE. MAINTENANCE OF EFFICACY

1 -TARGET ORGAN I SM

PRODUCT/DENATURATION/OTHER INHIBITION OF FEEDBACK SYSTEM IS

DESIREABLE, .IT IS IMPORTANT TO SOMETIMES CONSIDER LIVING OR

BIOLOGICAL REACTIONS WITH THE SAME SIMPLICITY THAT WE VIEW CHEMICAL AND OTHER REACTIONS.EQUILIBRIUM IS REACHED BETWEEN

PRECURSORS) AND ENDPRODUCT(S ), REMOVAL OF ENDPRODUCTS BY REMOVAL OF BREAKDOWN PRODUCTS, COUPLED WITH OPTIMAL BALANCING OF

PRECURSORS AND INTERMEDIATES WILL FAVOUR A REACTION FLOW BIAS

AS PROOF OF THE ABOVE TEACHING, INVENTOR HAS DEMONSTRATED

WHEN CONDITIONS ARE STABILISED, FEEDBACK REMOVED .IMMUNE AND OTHER

PATHWAYS ARE BROUGHT IN FOR FAST, EFFECTIVE RESPONSE ALONG WITH

THE CORRECT ANTIBIOTIC, WHAT THEN REMAINS IS TO EFFECTIVELY

ISOLATE THE ORGANISM FROM MUTATION, RESISTANT ORGANISMS AND DONOR

MECHANISMS.IT IS POSSIBLE TO IMMUNOLOGICALLY ;

1-TARGET ORGANISM

2-TARGET AND INHIBIT REPRODUCTIVE CYCLE

3-TARGET AND INHIBIT SPECIFIC RECEPTORS AND/OR F/A/P'S ETC.

INVOLVED IN THE ACQISITION OF RESISTANCE.

1 -SPECIFIC TARGETING OF ORGANISM, FOR EXAMPLE, CAN BE DONE

CRUDELY AS IS THE CURRENT PRACTISE OF CULTURING AN ORGANISM. ATTENUATING, DISRUPTING OR OTHERWISE KILLING IT , OR REPRODUCING/DUPLICATING IMMUNOGENIC FRAGMENT BY PROCESSES

VINCLUDING GENETIC ENGINEERING. DESPITE ALL CURRENT

SOPHISTICATION JN PREPARATION OF VACCINE WHJICH ARE COVERED IN THIS USE BY THIS PATENT(CURRENT VACCINE USE IS IN PREVENTION OF INFECTION, CURRENT PATENT COVERS CONVENTIONAL AND NEW VACCINES IN THERAPEUITIC APPLICATION AS WELL AS IN USE TO PREVENT THE RISE OF OF ALL CURRENT VACCINE, THE ONLY ONE THAT HAS BEEN USED FOLLOWING INFECTION BY A PARTICULAR AGENT, IN AN ATTEMPT TO OVERCOME AN INFECTION IN PROGRESS IS THE RABIES VACCINE. THIS IS DUE TO THE RELATIVELY LONG INCUBATION PERIOD AFTER INFECTION. THIS PATENT COVERS SUCH PROCEDURE FOR ALL OTHER INFECTIONS/DISEASES

/CONDITIONS/ AS WELL AS ALL (RABIES INCLUDED) ONCE DISEASE HAS

ALREADY MANIFESTED. BIOLOGICAL ENHANCEMENT AND PREVENTION PATENT WILL ALSO COVER OTHER ASPECTS AND SHOULD BE REFERRED TO.

I HAVE REFERRED TO ALL CURRENT VACCINE TECHNOLOGY AS PRIMITIVE IN THAT THERE IS LITTLE DONE TO PURIFY THE AGENT TO THE POINT WHERE IT DOES NOT BEAR ANY IMMUNOLOGICAL OR OTHER RELATIONSHIP TO HEALTHY HOST STRUCTURES AND/OR BENEFICIAL ORGANISMS ETC.

AN OVERVIEW OF DEFINING SPECIFIC FACTORS WILL NOW BE PRESENTED.

PHYSICAL/CHEMICAL AND BIOLOGICAL TECHNIQUES MAY BE USED TO DEFINE AND DELINEATE DIFFERENCES BETWEEN TARGET ORGANISMS(TO) AND OTHER TO BE PROTECTED ENTITIES(PE).

DIFFERENCES BETWEEN T.O. AND P.E. CAN BE DELINEATED IN WHOLE OR PART BY VARIOUS PHYSICAL/CHEMICAL AND BIOLOGICAL MEANS. ENTIRE ORGANISMS AND CELLS CAN BE COMPARED AND /OR LYSED OR DISASSEBLED COMPONENTS CAN BE COMPARED BY METHODS SUCH AS PHYSICAL;

ELECTROPHORESIS, GRADIENT FILTRATION, FOR EXAMPLE, CHEMICAL; SUCH AS ACID/BASE PRECIPITATION OR BIOLOGICAL SUCH AS ENZYMR DIGESTION OR IMMUNOLOGICAL SEPARATION. PATENT COVERS ALL SUCH METHODS AND PROPOSED USE.IMMUNNE METHODS WILL BE FURTHER

HIGHLIGHTED.

IMMUNE IDENTIFICATION OF SPECIFIC FACTORS MAY BE DONE IN-VITRO, IN-VIVO OR BY COMBINATION OF BOTH. HEALTHY CELLS/ORGANISMS CAN BE LYSED SONICALLY OR BY OTHER METHOD AND AN ANIMAL MAY BE VACCINED WITH ALL OR SPECIFICALLY DEFINED FRAGMENTS OF THE YEILD , AS

DEFINED,FOR EXAMPLE, BY P/C/B PARAMETERS . WATER SOLUBLE FRAGMENT WSF OF HEALTHY CELLS FOR EXAMPLE COULD BE COMPARED WITH WSF OF THE DISEASE ORGANISM LYSED IN THE SAME MANNER OR PARTICLES OF

T.O. CAN BE COMPARED WITH P.E. PARTICLES WHICH FALL IN THE SAME FILTRATION PARAMETERS. STUDY COULD BE CRUDE OR REFINED TO THE POINT WHERE ORGANELLE AND ORGANELLE FRAGMENTS OF T.O. AND P.E. ARE TESTED FOR DIFFERENCES.

CRUDE IMMUNOLOGICAL SEPARATION.EXAMPLE;

ANIMAL OR OTHER SYSTEM IS IMMUNISED AGAINST A BROAD SPECTRUM OR ALL OF P.E. FRAGMENTS THE ENTIRE P.E IS ALSO USED TO INDUCE AN IMMUNE RESPONSE IN THIS OR OTHER SYSTEM.THE IDENTICAL PROCESS IS NOW DONE TO THE T.O.

WHEN THE T.O. IS EXPOSED TO THE IMMUNE RESPONSE RAISED BY THE P.E., ALL IMMUNOLOGICALLY AND/OR ANTIGENICALLY COMMON FEATURES WILL BE REMOVED , ALL THAT WILL REMAIN IMMUNOLOGICALLY UNBOUND CAN BE TERMED TARGET ORGAN SPECIFIC. ALTERNATIVELY, ANTI T.O. IMMUNE RESPONSE WASHED AGAINST P.E. W/P/E F/A/P/ ETC. SO AS TO REMOVE ANTI-P.E. COMPONENTS COULD BE TERMED SPECIFIC ANTI-T.O. IMMUNE RESPONSE . SPECIFIC ANTI T.O. IMMUNE RESPONSE COULD BE ELLICITED BY VACCINATION USING ONLY THE T.O. SPECIFIC FRAGMENT.

IMPROVED PURITY AND SPECIFICITY CAN BE OBTAINED BY IMPROVING THE SPECIFICITY AND DEFINITION OF COMPARABLE ISOLATES E.G. -T.O MITOCHONDRIAL SPECIFIC OR P.E. SPECIFIC LIQUID SOLUBLE, MEMBRANE EXTRACTED PROTEIN BAND OF... FEATURES .

2ND AND 3RD ETC. GENERATIONS OF SUCH PURIFICATION TECHNIQUES MAY LEAD TO INCREASED SPECIFICITY. IT IS ALSO POSSIBLE TO GAUGE AND IMPROVE GENERATED EFFICACY AS WELL AS YEILD BY VACCINATING AN ANIMAL WITH THE SPECIFIC FRAGMENTS AND THEN CHALLANGING IT WITH THE ENTIRE ORGANISM OR USING AN ANIMAL OR SYSTEM WHICH HAS SUCCESSFULLY DEFENDED ITSELF AGAINST THE DISEASE TO GENERATE RESPONSE AFTER SPECIFIC T.O . CHALLANGE . OR TO REPEATEDLY IMMUNISE AN ORGANISM WITH SPECIFIC T.O. CHALLANGE UNTIL RAPID SUCCESSFUL RESPONSE REPELS T.O. CHALLANGE. ANY COMBINATION OF THIS

MANIPULATION COUPLED WITH THE DEMONSTRATION BEING NEUTRAL TO SPECIFIC P .E . CHALLANGE AS WELL AS ENTIRE P . E . CHALLANGE , WILL YEILD EFFICIENT SPECIFIC IMMUNE RESPONSES. IT IS ALSO POSSIBLE TO GENERATE SPECIFIC ANTI-T.O. RESPONSES USING HOST IMMUNE CELLS IN¬VITRO OR IN-VIVO, PERHAPS IN IMMUNOCOMPROMISED ANIMALS SUCH AS NUDE MICE OR SKID RATS . ANIMALS CAN BE MADE TOLERANT TO PE AND PE FAP'S ETC BY OVERLOADING WITH THE SAME TO ABOVE IMMUNE THRESHOLD LEVELS. A WIDE VARIETY OF OTHER MANIPULATIONS MAY BE DONE SUCH AS RAISING AN IMMUNE RESPONSE AGAINST THE ANTI-P.E. IMMUNE RESPONSE AND USING THAT TO FURTHER PURIFY THE ANTI-T.O. IMMUNE RESPONSE.

AN EFFECTIVE SPECIFIC RESPONSE E.S.R. IS THAT WHICH SPECIFICALLY AND EFFECTIVELY ELIMINATES DISEASE ORGANISM F/A/P'S ETC. WITHOUT SIGNIFICANT ANTI-P.E. ACTIVITY.

OTHER BIOLOGICAL METHODS FOR DEVELOPING P.E. SPECIFIC F/A/P'S ETC. INCLUDE DEVELOPING ORGANISMS OR ENZYME SYSTEMS WHICH ARE DEVELOPED SPECIFICALLY TO DIGEST/DENATURE/REMOVE T.O.SPECIFIC F/A/P ' S ETC. , AT VARIOUS TEMPERATURE AND OTHER VARIABLE FACTORS , THE TREATMENT OF IMMUNISING PREPARATION OF T.O. WITH THESE WOULD LEAVE ONLY T.O. SPECIFIC PREPARATION.

IT IS IMPORTANT THAT THESE AND OTHER TECHNIQUES OF EPECIFIC EXTRACTION AND SPECIFIC RESPONSE FORMATION IS DEFINED IN TIME, PHASE AND OTHER VARIABLES. SPECIFIC PREPARATIONS WILL VARY

DEPENDING, FOR EXAMPLE ON THE STAGE OF CELL DIVISION.

THIS , OF COURSE, MEANS THAT SPECIFIC PREPARATIONS AND RESPONSES SUCH AS ANTI-SERA TO THEM ARE PHASE/LIFE CYCLE SPECIFIC.

IT IS THEREFORE POSSIBLE TO IDENTIFY AND PREPARE SPECIFIC ANTISERA/IMMUNE AND/OR OTHER RESPONSES AGAINST ORGANISM

STRUCTURES WHICH ARE. SPECIFIC FOR ORGANISM MUTATION/ENTRY OF PLASMID ETC. TO BLOCK THESE RECEPTOR. AND OTHER STRUCTURES AND HENCE DISABLE ACQUISITION OF MUTATION. DEVELOPING MECHANISMS TO RESTRICT CR INHIBIT T.O. REPRODUCTION WILL SEVERELY LIMIT MUTATION ABILITY . FAP ' S ETC . SPECIFIC TO

REPRODUCTION CYCLE COULD BE DELINEATED BY ANY OF THE PCB METHODS MENTIONED PREVIOSLY, TECHNIQUES COULD BE USED TO TARGET A MATING APPENDAGE , FOR EXAMPLE OR TO CREATE A NUTRITIONALLY DEFICIENT ENVIRONMENT TO MINIMISE REPLICATION .ALTHOUGH MUCH OF THE DEBRIS FOLLOWING CELL DEATH MAY INHIBIT CUREATIVE PATHWAYS(EITHER BY CONSIDERING THE CHEMICAL REACTION FLOW MODEL WHERE CLEARANCE OF ENDPRODUCT MAINTAINS UNIDIRECTIONAL FLOW OF REACTION OR BY CONSIDERING THE HOST SYSTEMS FUNCTIONING BETTER IF NOT OVERLOADED WITH DIE-OFF DEBRIS AND POSSIBLE TOXINS), SOME OF THE CELL

BREAKDOWN PRODUCT MAY ACTUALLY STIMULATE/INITIATE/PROMOTE OR CODE FOR ORGANISM DESTRUCTION. ONE KNOWN MECHANISM IS THAT A

NUTRITIONALLY AND OTHERWISE CHALLANGING ENVIRONMENT WILL OFTEN LEAD TO BACTERIAL PHAGE ACTIVATION . THESE PHAGES MAY ACT AS

LYSOSOMES DO IN ANIMAL CELLS, INITIATING AUTODESTRUCTION WHEN CELL HAS RECIEVED MAJOR INSULT. PHAGES AND PLASMIDS MAY CODE FOR ORGANISM DESTRUCTION AND UPON THEIR ACTIVATION AND RELEASE CAUSE THE DESTRUCTION OF MORE BACTERIA, HOWEVER, THEY ALSO FORM

MECHANISMS FOR ENSURING SURVIVAL OF AT LEAST SOME OF THE PARENT BACTERIA'S GENETIC CODE AS IN NATURE A BACTERIA IS UNLIKELY TO EXIST ALONE AND AS OTHER BACTERIA IN THE VICINITY WILL ALSO SHARE WHATEVER HARDSHIP ; THE LARGESCALE RELEASE OF PHAGES , PLASMIDS AND OTHER MEANS OF SHARING GENETIC AND OTHER INFORMATION ENSURES EVOLUTION,DIVERSITY AND INCREASED POSSIBILITY OF SHARING SURVIVAL MECHANISMS SO THAT SOME MAY SURVIVE THE INSULT . EVEN IF THERE ARE NO BACTERIAL SURVIVORS , THE PLASMIDS AND PHAGES WILL FURTHER ENRICH THE GENE POOL.

IT IS IMPORTANT TO NOTE THAT PENICILLIN RESISTANCE HAS RISEN DRAMATICALLY OVER THE PAST FEW DECADES. SCIENTISTS AND DOCTORS ALIKE ACCREDIT THIS TO OVERUSE OF THE ANTIBIOTIC AND THEN TRY TO CHANGE ANTIBIOTICS OR DEVELOP ARTIFICIAL CHANGES IN PENICILLIN TO MAKE IT RESISTANT TO THE MUTATED BACTERIA.A FACT THAT SEEMS TO HAVE ESCAPED ALL THESE SCIENTISTS IS THAT THE PENICILLIUM MOULD HAS PREYED ON BACTERIA FOR UNTOLD MILLIONS OF YEARS PRIOR TO THE PURIFICATION OF PENICILLIN; THE SHARP RISE IN ANTIBIOTIC

RESISTANCE FOLLOWING PURIFICATION OF THE ANTIBIOTIC THEREFORE MUST INDICATE SIGNIFICANT DEVIATION FROM THE NATURAL PROCESS. WHEN A MOULD ENCROUCHES ON A BACTERIAL COLONY, IT IS NOT ONLY ITS ANTIBIOTIC THAT IT USES TO ATTACK, A COMPLEMENT OF OTHER FACTORS INCLUDING DIGESTIVE ENZYMES ARE ALSO USED. PLASMID AND PHAGE PHASES ARE ALLOWED TO OCCUR AND SHOULD RESISTANCE FORM, THE MOULD WILL OFTEN MODIFY ACCORDINGLY TO OVERCOME THE RESISTANCE.THIS PROCESS ENSURES THE SURVIVAL OF SOME BACTERIAL FRACTION AND THE CONTINIOUS EVOLUTION OF BOTH BACTERIA AND MOULD. IT IS UNLIKELY THAT ORGANISMS COULD DEVELOP RESISTANCE TO A CRUDE PENICILLIUM EXTRACT AS EASILY AS THEY CAN TO PURIFIED PENICILLIN-MUTATION TO OVERCOME ENZYMATIC AND OTHER CHANGES WOULD REQUIRE SEPARATE MUTATIONS TO ANTIBIOTIC RESISTANCE.

THIS PATENT COVERS THE USE OF CRUDE PENICILLIUM MOULD EXTRACT IN THE TREATMENT OF DISEASE. PATENT ACTUALLY COVERS THE USE OF CRUDE MOULD EXTRACTS IN THE TREATMENT OF DI SEASE . THESE MAY BE.

PREPARED BY DI SRUPTION AND FILTRATION PROCEDURES AND MAY BE FURTHER ENHANCED BY FEATURES OF THI S PATENT TO HAVE EFFECTIVE SPEC I FI C ANT ID I SEASE ACT IVI TY AND MI N IMAL S IDE EFFECTS .

CRUDE MOULD EXTRACTS MAY ACTUALLY HAVE LESS SIDE-EFFECTS THA PURIFIED COUNTERPARTS WHERE THEY MAY BE ,UNDER THE GUIDELINES OF THIS PATENT HAVE COMPONENTS RELATED TO ALLERGY OR OTHER SIDEEFFECTS BE TESTED(EVEN AGAINST PATIENT'S OWN CELLS) AND

REMOVED IN THE VARIOUS PHASES OF ACTIVITY AND SEQUALAE IN PRECURSOR/INTERMEDIATE/ENDPRODUCT CLASSIFICATION TO COVER ALL F/A/P'S ETC. AS THE COMPOUND CARRIES OUT THE DESIRED FUNCTION IN THE BODY .

IF WE NOW RETURN TO THE PREVIOUS RECOMMENDATION OF MAKING THE BACTERIA'S ENVIRONMENT NON-CODUSIVE TO REPLICATION; THIS APPEARS TO DIRECTLY CONTRADICT THE PREVIOUS RECOMMENDATION THAT MINIMAL CHANGE BE DONE TO THE BACTERIAL ENVIRONMENT SO AS NOT TO STIMULATE MUTATION , THESE TWO SEEMINGLY CONFLICTING REQUIREMENTS ONLY APPEAR TO BE SO AS THEY ARE BEING CONSIDERED IN THE SAME PHASE(PRECURSOR/INTERMEDIATE/ENDPRODUCT) IT IS A FEATURE OF THIS PATENT THAT WHEN SEEMINGLY CONFLICTING SITUATIONS ARE UNITED OUT OF PHASE THE UNITY CAN BE HARMONIOUS AND BENEFICIAL. CONSIDER FOR EXAMPLE, SOME FORCE CAUSING HEALTHY CELL DESTRUCTION. PRECURSOR PHASE INCLUDES THE DAMAGING AGENT , INTERMEDIATE PHASE INCLUDES THE DAMAGED CELL STRUCTURES , ENDSTAGE PHASE INCLUDES HEALTHY CELL DEBRIS. TO FASCILITATE HEALING, OPTIMAL CELL CONDITIONS SHOULD BE PROVIDED YET DIRECT ENDPRODUCTS OF THE HARMFUL INSULT MAY BE OF USE IN REVERSING THE DAMAGING AGENT AND ITS EFFECTS AS WOULD BREAKDOWN FRAGMENTS NOT RELATED TO THE INSULT. LET US CONSIDER THE EXAMPLE OF CHEMOTHERAPYCAUSING HEALTHY CELL BREAKDOWN ALONG WITH CANCER CELL DESTRUCTIONL; SLOWING THE ELIMINATION OF SOME DAMAGED HEALTHY CELLS MAY SLOW THE REACTION FLOW SUCH FRAGMENTS MAY ABSORB MORE OF THE TOXIC AGENT AND ALLOW HEALTHY CELL SURVIVAL ALTERNATIVELY, SLOWING THE REACTION FOR HEALTHY CELLS WILL ALSO ALLOW FOR MORE TIME SPENT IN INTERMEDIATE PHASE SO THAT DAMAGED HEALTHY CELLS CAN BE GIVEN A GREATER CHANCE TO ACQIBE RESISTANCE OR MUTATE . IDEALLY, BROKEN HEALTHY CELL FRAGMENTS FROM OTHER CAUSATIVE AGENTS (NON-TOXIC) SUCH AS LYSED BLOOD CELLS FROM PATIENT BROKEN SONICALLY OR HYPOTONICALLY OR CELLULAR STRUCTURE RELEASED AFTER HYPOOSMOTIC INTRAMUSCULAR INJECTION WITH OR WITHOUT PCR OR OTHER AMPLIFICATION PROVIDE FREE CELLULAR FRAGMENTS WHICH WOULD SLOW THE PRECURSOR TO ENDPOINT REACTION; FURTHERMORE SUCH FRAGMENTS MAY BIND THE TOXIC OR EVEN INFECTIVE OR OTHER AGENT CAUSING CELL DESTRUCTION AND LIMIT THAT EFFECT ON HEALTHY CELLS. IN THE CASE OF AIDS FO EXAMPLE, PROVIDING A LARGE AMOUNT OF CELLULAR RECEPTOR DECOUYS TO BIND IT MAY FREE MANY HEALTHY CELLS PARTICULARLY IF THE DECOYS HAD HIGHER AFFINITY(AGAIN RAISED BY FEATURES OF PATENT . )

IT CAN THEREFORE BE SEEN THAT ONE DOES NOT NEED TO ALTER THE ENVIRONMENT OF THE BACTERIA TO CAUSE IT TO BREAKDOWN BUT TO USE THE INTERMEDIATE AND ENDPRODUCT STAGES OF THE HOSTILE ENVIRONMENT EQUATION, I.E., TO SATURATE THE LARGELY FRIENDLY, STABLE ENVIRONMENT WITH PHAGES AND PLASMIDS CODING FOR BACTERIAL CELL LYSIS(THESE CAN EVEN BE USED TO TAG OR CAUSE TAGGING CHANGES IN THE ITERPLAY WITH THE IMMUNE SYSTEM.

IN PRECURSOR PHASE THEREFORE THE FOLLOWING ATTACKS ARE POSSIBLE.

SPEC IFI C ANT IB I OTI C/CHEMOTHERAPY

DEVELOPMENT OF L IBRARY PERSONAL I SED THERAPY

INTRODUCTION

THERE ARE CURRENTLY THREE MAJOR PROBLEMS WITH CHEMOTHERAPY AND ANTIBIOTIC THERAPIES. IMPROVEMENT ALONG THESE FIELDS WOULD

GREATLY ADVANCE MODERN MEDICINE.

1- LACK OF EFFICACY

2- LACK OF SPECIFICITY

3- SIDE-EFFECTS/ALLERGIES

SOME OF THESE ISSUES ARE ADDRESSED IN THE INVBNTOR'S PATENT ON PRECURSOR/INTERMEDIATE/ENDPRODUCT THERAPY AND SOME OF THESE ISSUES MAY BE BETTER ADDRESSED IN ONE OR OTHER OF THESE PHASES. THE OBJECT OF THIS PATENT IS TO OFFER GUIDELINES TO THE PREPARATION AND IMPROVEMENT OF CURRENT MODALITIES OF THERAPY AS WELL AS PRESENTING FORMAT FOR DEVELOPING NEW IMPROVED AGENTS.

FIELD OF PATENT

INVENTOR WILL DESCRIBE SEVERAL PROCESSES BY WHICH THERAPY MAY BE GIVEN INCREASED EFFICACY, SPECIFICITY AND DIMINISHED TOXICITY TO HEALTHY CELLS. INCLUDED WILL BE METHODS FOR DEVELOPMENT OF NEW IMPROVED THERAPIES FOR CONDITIONS BOTH CURRENTLY TREATABLE AND THOSE WITHOUT EFFECTIVE CURRENT THERAPY. IMPROVEMENTS WILL BE MADE ON CURRENT ANTIBIOTIC AND CHEMOTHERAPEUTIC AGENTS, AND A NEW CLASS OF MEDICATION WILL BE INTRODUCED, OVERLAPPING BUT DISTINCT FROM THERAPY INTRODUCED IN THE PRECURSOR/INTERMEDIATE. /ENDPRODUCT PATENT BY SAME INVENTOR. GUIDELINES OF THIS PATENT HAVE BROAD APPLICATIONS AND SHOULD NOT BE RESTRICTED BY THE EXAMPLES USED.

A- IMPROVING ON CURRENT THERAPY

1 -SPEC I F I CI TY-

THE HIGH TOXICITY OF CHEMOTHERAPEUTIC AGENTS HAS LED TO MAβTY ATTEMPTS TO BIND THIS TREATMENT TO 'MAGIC BULLETS', THE ONLY AVENUE PURSUED WHICH OFFERED EXCITING AND EAGERLY ANTICIPATED BUT ULTIMATELY DISAPPOINTING RESULTS WAS THE USE OF MONOCLONAL ANTIBODIES. THESE ANTIBODIES WERE OFTEN RAISED IN ANIMAL MODELS THEN THE CELLS GENERATING THEM WOULD BE SPLICED ONTO MYELOMA CELLS OR UNDERGO OTHER GENETIC OR OTHER MANIPULATION TO ENSURE CONSTANT SUPPLY OF ANTIBODY FROM A SINGLE CLONE OF CELLS WHICH WILL SPECIFICALLY ATTATCH TO THE CANCER BEING TREATED.

DIFFICULTIES IN THIS PROCESS INCLUDE FINDING SPECIFIC CANCER ANTIGENS TO RAISE THE ANTIBODY AGAINST,AS WELL AS FRQUENT

DISSOSCIATION OF THE ANTIBODY-CHEMOTHERAPY UNIT WHEN APPLIED IN THE LIVING SYSTEMS . RADIOACTIVE PARTICLES BOUND TO MONOCLONAL ANTIBODIES FACE SIMILAR PROBLEMS AND DESPITE FEW ANECDOTAL SUCCESSES, ALL LARGE TRIALS TO DATE HAVE BEEN DISAPPOINTING. EVEN IF THE MONOCLONAL ANTIBODY IS APPROPRIATE, IT ALONE IS INCAPABLE OF CAUSING CANCER DESTRUCTION IN THE MAJORITY OF CASES. THIS PATENT COVERS OPTIONS OF TARGETING THE ANTIBODIES AT OTHER SOURCES SUCH AS THOSE WHICH CAUSE OR SYNERGISE WITH DISEASE. IT ALSO COVERS METHODS OF INCREASING THERAPEUTIC EFFICACY OF MONOCLONAL OR OTHER ANTIBODIES BY ALSO RAISING COMPLEMENT AND OTHER NON-CELLULAR AND/OR CELLULAR IMMUNE RESPONSES TO THE

ANTIBODY-DISEASE COMPLEX AND/OR THE ANTIBODY ALONE BY TEMPORAL RELATION IE GENERATE AND STORE UNTIL TAGGING WITH ANTIBODY HAS TAKEN PLACE . FURTHER DISCUSSION OF THIS CAN BE FOUND AS PART OF

TAGGING THERAPY PATENT BY AUTHOR.

HENCE, SOME DIFFERENCES TO MONOCLONAL ANTIBODY THERAPY THAT HAS BEEN TESTED TO DATE INCLUDE;

TARGETING/DEVELOPMENT

ATTATCHMENT TO MEMBRANE/ANTIBODY/CLAS

USE OF PROTEIN AROUND CANCER/CELLMEMB TO TAG THERAPY

DEVELOPING MECHANISMS TO RESTRICT OR INHIBIT T.O.MUTATION AND/OR DEVELOPMENT OF RESISTANCE TO THERAPY AND/OR MECHANISMS TO

INCREASE SENSITIVITY OR DECREASE PATHOGENICITY IS POSSIBLE UNDER THE FOLLOWING CLASSIFICATIONS IN PRECURSOR STATE.

1- INHIBITION OF REPRODUCTION

2- INHIBITION OF INDUCTION OF RESISTANCE

3- STABILISATION OF GENETIC CODE.

4- INHIBITION/INTERFERANCE/PROTECTION AGAINST MUTATING AGENTS

5- DECREASING TIME OF EFFECTIVE THERAPY- INCREASED EFFICACY AND SPECIFICITY AS OUTLINED BY THIS PATENT ENABLES THE USE OF COMPOUNDS WITH GREATER EFFICACY AND GREATER THERAPEUTIC INDEX.

6- USE OF MULTIPLE MODALITIES WITH DIFFERENT TARGETS TO DECREASE THE POSSIBILITY OF MUTATION OR INDUCTION OF RESISTANCE,

THE CONCEPT OF COMBINATION THERAPY IS NOT NEW; COMBINATION

ANTIBIOTICS AND COMINATION CHEMOTHERAPY HAVE OFTEN BEEN USED IN THE HOPE OF EFFECTING IMPROVEMENT WHILE DECREASING THE CHANCE OF RISING RESISTANCE.WITHOUT AN UNDERSTANDING OF CLASSIFICATION PATENT,HOWEVER, THERE EXISTS A REAL DANGER OF DAMAGING HEALTH- RELATED F/A/P'S ETC AND OVERLOOKING DRFAP'S ETC.NONDESCRIMINANT USE OPF SUCH POWERFUL AGENTS ESSENTIALLY PUSHES ALL EXPOSED FACTORS TO ATTEMPT TO OVERCOME THE DANGER.ORGANISMS PREVIOUSLY ANTAGONISTIC, FOR EXAMPLE, MAY SHARE RESISTANCE PLASMIDS IN ORDER TO SURVIVE. THERAPY THAT DOES NOT TAKE THE

CLASSIFICATION. EFFICACY AND SPECIFICITY PATENTS INTO

CONSIDERATION WILL INVARIABLY BE EVENTUALLY OVERCOME BY MICROORGANISM AND OTHER ALLIES IT MAY CREATE.EVEN WHEN

CHEMOTHERAPY IS COMBINED WITH ANOTHER MODALITY SUCH AS RADIATION, THE PATHWAY OF EFFICACY IS A COOMON ONE IN THAT BOTH TECHNIQUES AIM TO CAUSE IRREPARABLE DAMAGE TO THE TARGET ORGAN OR CELL; THESE COMBINATION THERAPIES OFTEN SHARE 3 FEATURES;

1-LACK OF SPECIFICITY

EVEN WHERE A TREATMENT IS CLAIMED TO BE OF NARROW

SPECTRUM, FAILURE TO RECOGNISE

CAUSATIVE/ .SYNERGISTIC/INFECTIVE/NEUTRAL/ANTAGONISTIC F/A/P'S

ETC. WILL OFTEN ACTUALLY MEAN POOR SPECIFICITY.

SYSTEMS OFTEN WILL CHANGE CLASSIFICATION AND SYNERGISE IN THE

FACE OF A COMMON ENEMY.

A SIMPLE EXAMPLE CAN BE GIVEN WHERE TWO STRAINS OF STAPHYLOCOCCI

ARE GROWING IN THE SAME CULTURE MEDIUM; AS THEY ARE SHARING THE

SAME NUTRIENTS AND WHERE THERE IS NO DIRECT CONTACT BETWEEN THE

COLONIES SUCH AS WHERE THEY ARE BEING GROWN ON AGAR PLATES OR

WHERE THEY HAVE BEEN IMPLANTED AT SEPARATE SITES ON A LIVING

SYSTEM AGAIN, THEY MAY BE SEEN TO BE IN COMPETITION FOR

NUTRIENTS/SUBSTRATES ETC- DEGREE OF ANTAGONISM WILL DEPEND ON

FACTORS INCLUDING RESPECTIVE GROWTH RATES AS WELL AS SUPPLY OF

LIMITING ESSENTIAL FACTOR.

WHEN THE SYSTEM IS TREATED WITH AN ANTIBIOTIC TO WHICH CULTURE A

IS SENSITIVE BUT CULTURE B IS RESISTANT THERE WILL BE INITIAL

DIEOFF OF A BUT, OFTEN A WILL DEVELOP RESISTANCE TO THE

ANTIBIOTIC, BY THE SAME SYSTEM THAT PROTECTS B. APPARENTLY

CULTURE B CHANGES FROM ANTAGONISTIC TO SYNERGISTIC AND DONATES PLASMIDS, PHAGES AND OTHER SYSTEMS/FRACTIONS TO ITS FORMER

OPPONENT . SUCH DONATION MAY BE TRACED BY RADIOACTIVE LABELLING. AN THIS MODEL CAN ALSO APPLY TO UNRELATED SPECIES.

A SIMPLE MODEL THAT MAY BE EASIER TO PICTURE AND WHICH IS ALSO BIOLOGICALLY VALID IS ONE WHERE TWO ANTAGONISTIC BACTERIA OR ITHER ORGANISMS, NOT NECESSARILY RELATED NOR EVEN OF THE SAME SPECIES ARE OPPOSED BY COMPETITION FOR NUTRIENTS/SECRETION OF INHIBITORY FACTORS OR BY SOME COMPLEX INTERPLAY WITH HOST AND/OR OTHER FACTORS. LET US NOW CONSIDER A SITUATION WHERE ONE IS RESISTANT TO PENICILLIN AND THE OTHER IS PENICILLIN SENSITIVE; AS THE PENICILLIN IS INTRODUCED INTO THE SYSTEM, THE PENICILLIN RESISTANT COMPONENT OF THE RESISTANT ORGANISM WILL BE ACTIVATED OR INDUCED(AS PENICILLIN USE TODAY IS NOT TARGETED OR SPECIFIED TO ANY SIGNIFICANT DEGREE WHEN COMPARED WITH SPECIFIC LIBRARY AND TECHNIQUES PRESENTED IN THIS PATENT); IF THE RESISTANT MODALITY IS ONE OF PENICILLINASE ACTIVITY(AN ENZYME WHICH INACTIVATES

PENICILLIN) , ALTHOUGH THERE MAY BE DONATION OF THIS ABILITY FROM THE RESISTANT TO THE SENSITIVE ORGANISM, THIS IS NOT ESSENTIAL TO CAUSE ALTERATION IN THE CLASSIFICATION AND DYNAMICS OF THE ORGANISMS. CONSIDERING THAT A FINITE AMOUNT OF PENICILLIN WILL ENTER THE SYSTEM; AN ORGANISM CAPABLE OF BREAKING DOWN A QUANTITY OFG IT BY USE OF PENICILLINASE OR OTHER METHOD (EVEN IF SELFISH AND UNSHARED) IT WILL DECREASE THE TOTAL AMOUNT OF

ACTIVE, CIRCULATING PENICILLIN AND THEREFORE SYNERGISE WITH ALL PENICILLIN SENSITIVE ORGANISMS.

ORGANISMS NEED NOT EVEN BE POSESSED OF RESISTANT ABILITY TO CHANGE CLASSIFICATION.E.COLI AND LACTOBACILLI MAY BE IN

COMPETITION OVER BOWEL LIVING SPACE AND WILL ACTIVELY ATTEMPT TO DISPLACE EACH OTHER (PARTICULARLY IF E.COLI IS PATHOGENIC).

ALTHOUGH ALL ABOVE MODELS MAY APPLY IN THIS SITUATION AS WELL, IT IS NOT ESSENTIAL THAT EITHER ORGANISM SPECIE/COLONY BE RESISTANT TO THE ANTIBIOTIC TO SYNERGI SE . IF BOTH ARE SENSITIVE;THE PRESENCE OF ONE BEING KILLED BY THE ANTIBIOTIC EFFECTIVELY DECREASES THE FREE AVAILABLE CIRCULATING AMOUNT/CONCENTRATION OF THE

ANTIBIOTIC. THE LACK OF SPECIFICITY THEREFORE ENABLES SYNERGY AMONGST EVEN PREVIOUSLY OPPOSED ORGANISMS, F/A/P'S ETC. DEVELOPMENT OF BIOLOGICAL THERAPEUTIC AGENTS PATENT.

UTILIZATION AND INDUCTION OF PROPERTIES AND CHANGES OF THERAPEUTIC AND OTHER BENEFIT BOTH DIRECT AND UPON INTERACTION WITH HOST.

INTRODUCTION

THE FOLLOWING PATENT AIMS TO PRESENT METHODS AND GUIDELINES TO DEVELOP EFFECTIVE, SPECIFIC THERAPY, SUPERIOR TO AND/OR AS AN ADDITION TO THERAPIES AVAILABLE WIDELY TODAY; IT ALSO AIMS TO DEMONSTRATE TECHNOLOGY FOR THE DEVELOPMENT OF THERAPIES WHERE NOTHING EXISTS TODAY.

HISTORY

MUCH OF THE LIBRARY OF MODERN THERAPEUTIC AGENTS; PARTICULARLY THOSE OF THERAPEUTIC ORIGIN WERE STUMBLED UPON BY SERENDIPITY

(DIGITALIS, PENICILLIN ETC.) OR BY LARGESCALE SCREENING FOR

DESIRED QUALITIES (EG TOXICITY SCREENING HAS LED TO THE ISOLATION OF MANY CHEMOTHERAPEUTIC AGENTS ) .WHE SUCH AGENTS NO LONGER

DEMONSTATE EFFICACY (EG. RESISTANCE DEVELOPING TO CHEMOTHERAPY OR ANTIBIOTICS ) , OTHER AGENTS , OFTEN UNRELATED , ARE SOUGHT .

THE HAPHAZARD SEARCH FOR THERAPEUTIC AGENTS COUPLED WITH DISCARDING A FAMILY OF AGENTS WHEN THEY NO LONGER DEMONSTRATE EFFICACY, TOTALLY IGNORES (OR REPRESENTS AN APPARENT LACK OF KNOWLEDGE) OF A PROCESS THE INVENTOR HAS TERMED BIOLOGICAL

ADAPTATION.

BIOLOGICAL ADAPTATION.

THE ABOVE TERM REFERS TO THE ABILITY OF A LIVING SYSTEM TO ADJUST AND SURVIVE IN A VARIABLY CHALLANGING ENVIRONMENT. THE ABILITY OF ORGANISMS TO DO SO UNDER DEFINED CONDITIONS IS TERMED BY THE INVENTOR AS BIOLOGICAL ADAPTATION INDEX. THIS IS TAKEN INTO CONSIDERATION ALONG WITH THE MARGIN OF BIAS (DEGREE TO WHICH CULTURE OR OTHER ENVIRONMENTAL FACTORS FAVOUR THE ORGANISM'S GROWTH) IN THE GUIDELINES OF THIS PATENT. FIELD OF PATENT

PATENT COVERS THE USE OF BIOLOGICAL ADAPTATION COUPLED WITH MARGIN OF BIAS AND OTHER INNOVATIONS IN THE DEVELOPMENT OF NEW THERAPIES AND IN THE ENHANCEMENT OF PREEXISTING ONES.

DEMONSTRATIONS WILL BE MADE IN THE USE OF SUCH TECHNOLOGY IN THE FIELDS OF ANTIBIOTIC THERAPY AS WELL AS CHEMOTHERAPY; ALTHOUGH THIS PATENT IS BY NO MEANS RESTRICTED TO THESE EMBODYMENTS . THREE OTHER CONSEQUENCES OF THERAPEUTIC SIGNIFICANCE WHICH MAY RESULT FROM FEATURES OF THIS PATENT INCLUDING FORCED COHABITATION

/INDUCED, PROMOTED/PERMITTED INTERRELATIONSHIPS INCLUDE

1-CANNIBALISM

2-EXPRESSION

3-TAGGING

IT IS ALSO IMPORTANT TO NOTE THAT IN MANY OF THE SITUATIONS ILLUSTRATED IN THIS PATENT, WE WILL BE CONSIDERING THE INTERPLAY OF 2 OR MORE ORGANISMS. IN MANY CASES THIS WILL ALSO LEAD TO

EXPRESSION AND DEFINITION OF AN ORGANISMS REPRETOIRE OF

SURVIVAL MECHANISMS-THESE MAY BE CONSIDERED AS ;

1-OFFENSIVE

2-DEFBNSIVE

3-ELUSIVB-THIS INCLUDES EVOLUTIONARY, EVOLVING TO BYPASS OR

OVERCOME THE CONSTRAINTS OF THE SITUATION. EVOLUTION MAY INCLUDE

PROGRESSION OR REGRESSION; FEATURES WHICH MAY BE CONFUSED WITH

PLEOMORPHISM.

ALL THESE FACTORS MAY BE USEFUL ON THEIR OWN OR BY INTERPLAY WITH OTHER SYSTEMS.

TRACKING AN ORGANISM AS IT DEALS WITH SUCH

VARIABLES/STRESSES, MAY, FOR EXAMPLE , LEED TO THE EXPRESSION OR EXPOSURE OF PREVIOUSLY HIDDEN OR DISGUISED F/A/P'S ETC. SUCH AS ANTIBODIES WHICH MAY ALLOW FOR EASIER AND MORE EFFECTIVE THERAPY SUCH AS IMMUNOLOGICAL THERAPY TO BE DEVELOPED. SUCH THERAPY MAY BE INDUCED BY;

1-PRIMARY-ALTERATION/MODIFICATION OF ORGANISM W/P/E ETC.

2-SBCONDARY-ALTERATION/MODIFICATION OF IMMUNOLOGICAL RESPONSE. 3-TERTIARY-ALTERATION/MODIFICATION OF BOTH ORGANISM/HOST RESPONSE /OTHER VARIABLES.

IT IS ALSO IMPORTANT TO REALISE THAT THIS PATENT EXAMINES THESE RELATIONSHIPS AND DESIGNS SOLUTIONS BASED ON THE THREE VARIABLES _' OF ORGANISM/THERAPY HOST/ AS WELL AS OTHER RELEVANT FACTORS IN

WHAT THE INVENTOR TERMS DYNAMIC FLOW. DYNAMIC FLOW STUDIES ENABLE

1-PROPHYLAVCTIC

2-ANTICIPATORY AND

3-RESPONSIVE THERAPIES

FURTHER EXPLANATIONS AND DEFINITIONS ARE NOW REQUIRED.

DEFINITIONS AND CLARIFICATION

1- FORCED COHABITATION/INDUCED, PROMOTED, PERMITTED

INTERRELATIONSHIPS

THIS TERMINOLOGY REFERS TO THE CONDITIONS STUDIED IN-VITRO AND IN-VIVO, WHERE AT LEAST 2 ORGANISMS ARE FORCED TO EXIST FOR A TIME PERIOD UNDER CONDITIONS WITH VARIABLE DEFINED MARGINS OF BIAS. DURING THIS SET PERIOD, F/A/P'S ETC. MAY MANIFEST, BE

GENERATED , PROMOTED OR INDUCED WHICH MAY PROVE USEFUL.

2-CANNIBALISM

THIS TERM REFERS TO THE EVENT WHICH TAKES PLACE WHEN AN ORGANISM FEEDS ON ANOTHER OR OTHERWISE INCORPORATES THE OTHER WHOLE OR PART (W/P/E/FAP'S ETC.) INTO ITSELF OR INTO RELATED/ASSOSCIATED ORGANISM AND/OR F/A/P'S ETC.

3-EXPRESSION

EXPRESSION REFERS TO THE EXTERNAL OR INTERNAL CHANGES WHICH MANIFEST UNDER DEFINED CONDITIONS .EXPRESSION MAY FOLLOW

CANNIBALISM, VIRUSES ARE CAPABLE TO CANNIBALISE CELL CULTURE MEDIA AND EXPRESS ANTIGENS FROM THE CANNIBALISED CELLS FOR EXAMPLE.

EXPRESSION REFERS TO CHANGES WHICH MAY BE SUPERFICIAL SUCH AS THE UNCLOAKING OF PREVIOUSLY 'HIDDEN' ANTIGENS; AS WELL AS TO CHANGES THROUGHOUT ANY OR ALL THE ORGANISM AND PRECIPITATED BY INTRINSIC OR EXTRINSIC F/A/P'S ETC. EXPRESSION MAY REFER TO GENETIC

ACTIVATION AND SUBSEQUENT CHANGES. AT ONE LEVEL, THIS MAY COVER THE CHANGES TAKING PLACE IN AN ORGANISM EXPOSED TO PENICILLIN WHERE RESISTANCE MECHANISMS ENGAGED AT THE GENETIC LEVEL MAY LEED TO THE EXPRESSION OF DEFENSE SYSTEMS AND THEIR AUGMENTATION, ONE SUCH SYSTEM WOULD INVOLVE THE EXPRESSION OF ENZYMES SUCH AS PENICILLINASE. ALTERNATIVELY, IN AN ORGANISM WITHOUT ADEQUATE ANTIBIOTIC RESISTANCE , EXPOSURE TO AN ORGANISM GENERATING

ANTIBIOTIC(S), EXPRESSION OF THE GENETIC 'ESCAPE POD' OR PHAGE MAY BE INITIATED. LYTIC PHAGES CAN ALSO BE COMPARED TO CELLULAR

LYSOSOMES OR AUTO-DESTRUCT MECHANISMS.

ALTERNATIVELY, IF THE COHABITATING ORGANISMS CAN SYNERGISE OR INTERACT AT SOME INTIMATE LEVEL , WE MAY SEE EXPRESSION OF

REPRODUCTION TUBULES, PLASMIDS ETC. IF THE MARGIN OF BIAS IS RAISED BY ADDING PENICILLIN TO THE CULTURE AND IF ONE OF THE ORGANISMS IS RESISTANT TO PENICILLIN , WE MAY SEE PLASMID

GENERATION AND DONATION WHERE THE PLASMID MAY TRASNSFER PENICILLIN RESISTANCE TO THE SENSITIVE ORGANISM.

ALTHOUGH THE ABOVE EXAMPLES RELATE TO PENICILLIN, THIS IS ONLY BY EXAMPLE AND BY NO MEANS RESTRICTS THIS PATENT TO THIS AND OTHER ANTIBIOTICS. PATENT RELATES TO ANY RESPONSES TO DEFINED PARAMETERS AND SPECIFIC F/A/P'S ETC. WHICH MAY BE DEMONSTRATED BY PCB METHODS OF COMPARISON AND ISOLATION OF FACTIORS UNIQUE TO A

PARTICULAR SITUATION BY COMPARING TO BASELINE IN THE ABSENCE OF SITUATION OR FACTOR TO WHICH SPECIFIC FACTORS ARE BEING SOUGHT.

AGAIN, USING THE EXAMPLE OF PENICILLIN RESISTANCE TO EXPLAIN THIS PATENT'S VALUE; CURRENT TECHNIQUES TO OVERCOME PENICILLIN

RESISTANCE ARE TO ALTER ANTIBIOTIC PROTOCOL OR TO USE A PENICILLIN WHICH HAS BEEN STABILISED AGAINST PENICILLINASE. ISOLATION OF SPECIFIC FACTORS RELATED TO THE

ACQUISITION AND EXPRESSION OF RTESISTANCE INDICATES SEVERAL OTHER TARGETS FOR IMMUNOLOGICAL OR OTHER THERAPY . THESE INCLUDE

REPRODUCTIVE FEATURES , PLASMIDS , MEMBRANE AND OTHER CHANGES ETC .

EXPRESSION CAN ALSO BE CATEGORISED UNDER THE GUIDELINES OF PRECURSOR/INTERMEDIATE/ENDPRODUCT PATENT BY SAME INVENTOR.

IF THE HOST AND DISEASE CAUSING ORGANISM ARE CATEGORISED AS PRECURSORS AND FULL-BLOWN DISEASE AND ITS SEQUALAE ARE CONSIDERED AS ENDPOINT THEN SOMWHERE IN INTERMEDIATE PHASE WILL LIE THE ATTATCHMENT OR INVOLVEMENT OF CAUSATIVE ORGANISM F/A/P'S ETC. WITH HEALTHY ONES AND RESULTANT EXPRESSION OF F/A/P'S ETC . AS A CONSEQUENCE OF THE INTERACTION.

THIS PHASE/SITUATION HAS GREAT SIGNIFICANCE IN

DIAGNOSIS/EVALUATION/THERAPY/PROGNOSIS ETC.

AN EXAMPLE OF THIS CAN BE SEEN WITH AIDS.

H.I.V. WILL ENTER THE BODY, ATTATCH TO SPECIFIC SITES ON T4 LYMPHOCYTES AND INSERT ITS GENETIC CONTENT INTO THAT OF THE LYMPHOCYTE BY VIRTUE OF MECHANISMS INCLUDING THOSE OF ITS REVERSE TRANSCRIPTASE ENZYME. ONCE ENSINUATED IN THE CELL'S GENETICS, THE VIRUS AND ITS MESSAGES ARE EXPRESSED BOTH INTRACELLULARLY, ON THE CELL SURFACE AND EXTRACELLULARLY .

WHEN SEARCHING FOR CURES OR THERAPIES; THE RESEARCH HAS LARGELY CENTERED ON DISABLING THE VIRUS VOR OVERCOMING ITS ENDPOINT DAMAGING EFFECTS. THE CELL EXPRESSING THE VIRUS,HOWEVER, FORMS AN ENTITY WORTHY OF MAJOR CONSIDERATION IN DESIGNING THERAPY. THE INFECTED CELL, EXPRESSING DISEASE AND DISEASE F/A/P'S ETC. MAY ITSELF BE CONSIDERED TO BE A DISEASE ENTITY.

MANY MEDICAL MODELS APPEAR TO DOWNPLAY THE INTERMEDIATE PHASE OR MODIFICATIONS/ALTERED PRESENTATIONS/EMBODYMENTS OF THE DISEASE PROCESS WHICH MAY ALTER AS A CONSEQUENCE OF THERAPY OR OTHER

F/A/P'S. AND OF WHICH AT LEAST SOME MAY BE SEEN AS EXPRESSION RELATED.

USING CANCER, THERAPY TO CLARIFY THE

LATTER POINT.

THE BREAK IN LOGIC OF THERAPY RELATED TO CANCER OCCURS IN MANY STAGES OF THERAPY BUT CAN BE BEST EXAMPLIFIED BY ATTEMPTS TO COMBINE CHEMOTHERAPY/RADIOTHERAPY WITH IMMUNOTHERAPY. CANCER BIOPSIES ARE TAKE AND PROCESSED INTO SOME FORM FOR IMMUNISATION; THIS MAY INCLUDE CO-INCUBATION WITH MICRO-ORGANISMS OR OTHER PHYSICAL/CHEMICAL/BIOLOGICAL PROCESSES TO MODIFY PRESENTATION

AND/OR CAUSE EXPRESSION OF F/A/P'S ETC. WHICH MAY INCREASE

ANTIGENICITY OR OTHERWISE BE OF BENEFIT.

DURING THIS TIME THE PATIENT OFTEN UNDERGOES THERAPY .WHETHER THIS BE RADIOTHERAPY, CHEMOTHERAPY OR OTHER, EVEN SEEMINGLY

INNOCUOUS PRACTISES TO ALTER DIET/PH/VITAMIN AND OTHER

SUPPLEMENTS ETC. ALL THESE MAY BE ABLE TO CAUSE FURTHER CHANGES IN ORIGINAL CANCER CELLS. IT IS ALSO IMPORTANT TO NOTE THAT

CHASNGES AND VARIATIONS IN EXPRESSION OF ASPECTS OF THE DISEASE MAY BE FEATURES OF THE NATURAL HISTORY OF THE DISEASE AND NEED TO BE CONSIDERED IN THERAPY /EVALUATION ETC.

AS AN EXAMPLE ; VARIOUS TUMOURS INCLUDING THOSE OF THE BOWEL;

BREAST; OVARIES ETC. MAY SECRETE/EXPRESS PROTEINS/COMPLEXES SUCH AS CARCINOEMBRYONIC ANTIGEN (CEA) OR CA125 ETC. DURING SOME IF NOT ALL OF THE CYCLE OF MANY CANCER CELLS AND THEIR PROGENY .IT IS NOT UNCOMMON,HOWEVER, FOR THE DISEASE TO ALTER CHARACTERISTICS DURING ITS COURSE AS PART OF NATURAL PROGRESSION AND/OR OTHER FACTORS SUCH THERAPY ETC. CANCERS INITIALLY EXPRESSING CEA.CA125 AND/OR OTHER FACTORS MAY LOSE THE ABILITY TO EXPRESS THESE, OFTEN AS THEY UNDIFFERENTIATE TO A MORE AGGRESSIVE STAGE. THIS LEADS TO SOMETIMES CONFUSING SITUATION WHERE INCREASING LEVELS OF THESE CANCER 'MARKERS' INITIALLY INDICATE CANCER GROWTH AND DROPS IN THE LEVEL ARE USED TO INDICATE RESPONSE TO THERAPY , AS CELLS

BECOME MORE AGGRESSIVE AND LESS DIFFERENTIATED , THEY LOSE THE ABILITY TO PRODUCE THESE MARKERS. AND AS THE CANCER GROWS AND ENTERS POSSIBLY ITS MOST DANGEROUS , RAPID GROWTH

PHASE, CHARACTERISTICALLY REFRACTILE TO CONVENTIONAL

THERAPIES, BLOOD TESTS SHOW A DROP IN THE TUMOUR MARKER AND MAY BE FALSELY INTERPRETED AS IMPROVEMENT.

POINT TO BE ILLUSTRATED HERE IS THAT THERE APPEAR TO BE 2

MISCONCEPTIONS IN BOTH CONVENTIONAL MEDICAL AS WELL AS ALTERNATIVE AND LAY THOUGHTS THAT CANCER IS AN IMMORTAL CELL THAT PROLIFERATES UNCHECKED AND UNCHANGING TILL DEATH OF HOST.THE OTHER IS THAT THE MALIGNANT CHANGE IS IRREVERSIBLE.

THERE ARE MANY DEMONSTRABLE FEATURES F/A/P'S ETC. THAT WOULD DISPROVE THE CONTENTION THAT CANCER DOES NOT CHANGE SIGNIGFICANTLY THROUGH ITS COURSE; NOT THE LEAST OF THESE BEING THE LOSS OF CELL MARKERS; ANOTHER BEING DEVELOPMENT OF RESISTANCE TO THERAPY TO WHICH IT WAS PREVIOUSLY SENSITIVE.THE REASON I ACCUSE THE CONVENTIONAL MEDICAL PRACTITIONERS OF NOT APPRECIATING

/RECOGNISING/RESPONDING TO THE CHANGING CANCER CELL AS THERAPIES ARE USUALLY PLANNED AGAINST THE PRIMARY BIOPSY-AN EXAMPLE BEING THE PREPARATION OF VACCINES AGAINST TUMOUR CELLS THEN EXPOSING THE PATIENT TO RADIOTHERAPY/CHEMOTHERAPY ETC AND EXPECTING THE VACCINE TO EXERT SOME EFFICACY WHEN DISEASE PROGRESS AND THERAPY COULD HAVE ALTERED ITS ANTIGENS DRAMATICALLY. ( INVENTOR COVERS A MORE EFFECTIVE AND RELEVANT TECHNOLOGY IN THE

PRECURSOR/INTERMEDIATE/ENDPRODUCT PATENT AS WELL AS CO-TEMPORAL AND DYNAMIC SECTIONS OF HIS PATENTS). THE OTHER WIDELY BELIEVED FALLACY IS THAT THE MALIGNANT CHANGE IS IRREVERSIBLE AND THAT REDEFFERENTIATION IS NOT A VIABLE .

THERAPEUTIC OPTION. OTHER THAN SOME CASES OF SPONTANEOUS

REMISSION, NO DEMONSTRATION OF THIS PHENOMENON HAS EVER BEEN

REPRODUCED CLINICALLY AND THIS HAS ATTRACTED LITTLE INTEREST.

THERE ARE COMPOUNDS WHICH HAVE BEEN SHOWN UNDER LABORATORY EXPERIMENTAL CONDITIONS TO BE CAPABLE OF CAUSING CANCER CELL DIFFERENTIATION; THESE INCLUDE INSULIN , METHOTREXATE AND COPPER 3, 5,DIISOPROPYL SALICYLATE . THE INVENTOR HAS BEEN DOCUMENTING AND DEVELOPING IMMUNOLOGICAL AND OTHER MECHANISMS WHICH HAVE LED TO THE DIFFERENTIATION OF CANCER CELLS TO LESS MALIGNANT AND MORE NORMAL FORMS.

THIS HAS BEEN EXPRESSED IN CASES WHERE UNDIFFERENTIATED BOWEL CANCER HAS BEEN MADE TO PRODUCE TUMOUR MARKERS OR WHERE THERE WAS A TRANSIENT RISE IN TUMOUR MARKERS ASSOSCIATED WITH MEASUREABLE CANCER REGRESSION. LEUKEMIA CELLS HAVE BEEN MADE TO ACQUIRE MORE 'NORMAL 'APPEARANCE BY INVENTOR'S THERAPIES INCLUDING THOSE OF THIS PATENT . NORMALISATION OF APPEARANCE WAS ACCOMPANIED BY

INCREASE IN IMMUNE RESPONSIVENESS OF CELLS. IT IS A FEATURE OF LEUKEMIA THAT IT DOES NOT RESPOND TO EXTERNAL STIMULATION;

HOWEVER, IN TREATED PATIENTS THE ABNORMAL CELLS WILL POSE

EFFICIENT ANTI-DISEASE RESPONSES; RISING WITH ANTIGENIC CHALLENGE AND FALLING IN NUMBER AS THE CHALLENGE RESOLVES.

4-TAGGING

INVENTOR DESCRIBES THIS PHENOMENON AS THE ATTATCHMENT OF AN ORGANISM OR FRACTION OF (F/A/P'S ETC.) TO ANOTHER TO

ENABLE/ENHANCE THE LATTER ' S VISIBILITY AND VULNERABILITY TO HOST SYSTEMS .

THIS TECHNIQUE CAN BEST BE EXAMPLIFIED WHEN ADDRESSING CANCER CELLS .

CANCER CELLS BY INHERENT OR INDUCED MECHANISMS ARE ESSENTIALLY IMMUNOLOGICALLY INVISIBLE,THAT IS, THE IMMUNE SYSTEM APPEARS UNABLE TO SEE THEM AND/OR ADEQUATELY RESPOND TO THEM. IMMUNE CELLS THAT MAY SOMETIMES BE SEEN AND/OR INDUCED TO ATTACK CANCER CELLS ARE KNOWN AS NATURAL KILLER CELLS. THESE MAKE A VERY SMALL

PERCENTAGE OF THE IMMUNE SYSTEM AS A WHOLE.

BACTERIA,ON THE OTHER HAND, ATTRACT NEUTROPHILS AND OTHER CELLS WHICH MAY MAKE UP 60-80% OF CIRCULATING IMMUNE CELLS UNDER

BACTERIAL CHALLENGE. THE ANTIBACTETRIAL EFFECT IS USUALLY RAPID AND DRAMATICALLY EFFECTIVE.

ANTIVIRAL RESPONSE, MAY INVOLVE LYMPHOCYTES WHICH MAKE UP ANOTHER SIGNIFICANT PERCENTAGE OF THE CIRCULATING IMMUNE CELLS . AGAIN, RESPONSE AGAINST THE COMMON VIRAL AGENTS SUCH AS COLDS OR FLUS IS USUALLY RAPID AND DRAMATICALLY EFFECTIVE.

THE AUTHOR HAS DEMONSTRATED THAT CANCERS MAY INDUCE TOTALLY INEFFECTIVE OR EVEN PROTECTIVE RESPONSES FROM THE IMMUNE SYSTEM. THAT IS, RESPONSES WHICH PROTECT/FAVOUR/PROMOTE THE DISEASE.

CLEARLY, IF THE BODY COULD BE MADE TO RESPOND TO CANCER AS IT DOES TO BACTERIAL AND/OR VIRAL INFECTIONS THEN THE HOST COULD IMPACT MORE EFFECTIVELY AGAINST THE DISEASE.

THE IDEA OF TAGGING GIVES RISE TO THAT POSSIBILITY.

SPONTANEOUS REMISSIONS THAT OCCUR WITH CANCER FOLLOWING INFECTIONB MAY INDICATE ORGANISMS WITH AFFINITY FOR CANCER CELLS. AFFINITY MAY EXPRESS IN THE FORM OF SPECIFIC BINDING OF ORGANISM(W/P/E/ F/A/P'S ETC.) TO RECEPTORS ON THE SURFACE OF CANCER CELLS.

IN FACT, IT MAY BE POSSIBLE TO ATTATCH BIOLOGICAL OR OTHER

F/A/P'S TO SPECIFIC SITES ON AND/OR IN A CELL. SUCH A

PROCEDURE, PARTICULARLY WHERE IT LEADS TO RECOGNITION BY OR

TARGETING FOR ANOTHER SYSTEM IS TERMED TAGGING BY THE INVENTOR.

ORGANISMS MAY BE MADE TO DISPLAY AFFINITY AND SPECIFICITY TO OTHERS BY GUIDELINES OF THIS PATENT. SUCH PROPERTIES MAY BE

INHERENT OR REQUIRE DONATION OR INDUCTION BY THE GUIDELINES TO FOLLOW.

TAGGING THERAPY HAS PROVEN VERY EFFECTIVE AGAINST A BROAD RANGE OF DISEASES; BOTH CANCER AND AIDS RESPOND EXTREMELY WELL.THE

PHENOMENON OF IMMUNE AND OTHER RESPONSE MODIFICATION WHICH FOLLOWS TAGGING WHERE TAGGING COMPLEX INDUCES A WIDE RANGE OF MODIFIED RESPONSE TO DISEASE. THE IMPORTANCE OF IMMUNOLOGICAL MODIFICATION IN AIDS IS WORTH HIGHLIGHTING.

H.I.V. IS BELIEVED TO BE THE CAUSATIVE AGENT BEHIND AIDS. IT WILL ENTER THE BODY AND ATTATCH TO CD4 RECEPTORS ON T4 LYMPHOCYTES THEN INSINUATE ITSELF INTO THE CELL GENETICS AND FURTHER THE DISEASE.AS HIV TAGS THE INFECTED CELLS WITH VIRAL PARTICLES THROUGHOUT IT AND ON ITS MEMBRANE SURFACE, OTHER T4 CEKLLS WITH THE APPROPRIATE CD4 RECEPTORS WILL ATTATCH AND BE SUBSEQUENTLY INFECTED. IT APPEARS THAT THE HIV WILL INDUCE 'ATTACK' BY THE VERY CELLS IT CAN INFECT AND DESTROY.

CURRENT TECHNIQUES TO GENERALLY STIMULATE IMMUNE FUNCTION USING LYMPHOKINES SUCH AS INTERFERON/INTERLEUKIN AND OTHER METHODS ARE THEREFORE RIFE WITH THE INHERENT RISK OF FEEDING THE DISEASE PROCESS. MODIFICATION HERE IS MORE IMPORTANT AND AT LEAST A NECESSARY PRECURSOR/ADJUNCT TO IMMUNE STIMULATION.

THERE ARE MANY APPLICATIONS TO THE TAGGING THEORY WHICH MAY BE HIGHLIGHTED 'BY APPLICATION' IN AIDS.

THE PRECEDING DISCUSSION INDICATES THAT PATRT OF THE AIDS DISEASE PROCESS MAY INVOLVE THE EFFECTIVE TAGGING OF TARGET T4 CELLS BY THE HIV.THIS IMMEDIATELY SUGGESTS SEVERAL PATHWAYS OF DISRUPTING AT LEAST THIS PATHWAY OF DISEASE.

ATTEMPTS TO BLOCK CD4 RECEPTORS SUCH THAT HIV CANNOT 'DOCK' AND SUBSEQUENTLY ENTER T4 CELLS MAY BE ACCOMPLISHED IN A VARIETY OF WAYS.CAUTION IS NEEDED HERE AS BLOCKADING THAT RECEPTOR MAY ITSELF LEED TO SEQUALAE OF AIDS AND/OR OTHER UNDESIREABLE

CHANGES.A DEFINITIVE MULTI-PRONGED PROTOCOL SHOULD BE EMPLOYED AT THIS STAGE; IE, THIS PATENT SUPPORTS TYEMPORARY BLOCKADING OF CD4 RECEPTORS ONLY IF OTHER THERAPY IS SIMULTANEOUSLY INITIATED AGAINST AIDS. THIS ADJUNCTIVE TREATMENT MAY VARY FROM HYPERTHERMIA TO THE APPLICATION OF OTHER NATURAL OR STRUCTURED RECEPTORS FOR HIV TO 'SWEEP' THE BLOOD FOR VIRAL FRAGMENTS. ALTERNATIVELY THERAPY COULD BE INITIATED TO ALTER CD4 RECEPTOR STRUCTURE SO THAT IT NO LONGER EASILY BINDS HIV. SUCH THERAPY COULD BE AS BASIC AS HYPERTHERMIA OR AS COMLICATED AS GENETICALLY OR OTHERWISE MODIFY RECEPTORS TO BE SIMILAR TO THOSE OF RESISTANT ANIMALS AND/OR HUMANS. INVENTOR HAS DEMONSTRATED THAT SEVERAL BIOLOGICAL ORGANISMS MAY COMPETE FOR RECEPTOR SITES AND DISPLACE HIV. HYPERTHERMIA HAS ALSO BEEN SHOWN BY THE INVENTOR TO BE

CAPABLE OF INHIBITING BINDING OF HIV TO CD4 RECEPTORS AS WELL AS CAUSING DISASSOSCIATION.

CD4 'DECOYS' ALONE OR ATTATCHED TO SOME DEFINITIVE THETRAPY HAVE ALSO FUNCTIONED WELL. CD4 RECEPTORS ARE COVERED BY THIS PATENT AS PERFECT 'MAGIC BULLETS' OR HOMING MECHANISMS FOR BINDING TO AND/OR SELECTIVELY DELIVERING THERAPY TO HIV.PATENT COVERS THE USE OF CD4 RECEPTORS AS CARRIERS OR DIRECT DELIVERY MECHANISMS OF THERAPY , WHETHER STANDARD SUCH AS AZT OR NEW. SPECIFICITY OF DELIVERY WOULD ENSURE INCREASED CONCENTRATION AT SITE OF ACTION AS WELL AS DECREASED SIDE-EFFECTS.DESPITE HIV'S NOTORIOUS

PENCHANT FOR MUTATION, ATTATCHMENT TO CD4 APPEARS TO REMAIN A CONSTANT FEATURE WHICH CAN BE EXPLOITED.

A SIMPLE MODEL COVERED BY THIS PATENT WOULD BE TO RAISE ANTIBODIES THAT WOULD ATTATCH NOT TO CD4 RECEPTORS AND BLOCK THEM NOR SIMPLY TO H.I.V. WHICH MAY , IF EFFECTIVE,WORK AGAINST FREE VIRUS, BUT TO RAISE HUMAN OR ANIMAL IMMUNE RESPONSE, FOR EXAMPLE ANTIBODIES AGAINST THE BOUND HIV-CD4 COMPLEX. CD4 RECEPTORS ATTATCHED TO HUMAN/ANIMAL/BACTERIAL OR OTHER FRAGMENTS MAY ENABLE ATTATCHMENT TO HIV AND INITIATION OF EFFECTIVE IMMUNE RESPONSE AGAINST HIV-CD4 COMPLEX AND/OR AGAINST THE ATTATCHED FRAGMENT WHICH MAY BE IMMUNO-ATTRACTING/STIMULATING/MODULATING.EVEN WHERE THE CD4 AND CELLULAR FRAGMENTS ARE MADE FROM CULTURES OF THE PATIENT'S OWN CELLS, TARGETING THE CD4-HIV COMPLEX IMMUNOLOGICALLY BY ENDOGENOUS AND/OR EXOGENOUS TECHNIQUES ENABLES THE DESTRUCTION OF BOUND CD4 DECOYS AS WELL AS T4 CELLS WHICH HIV HAS BOUND TO AND/OR INFECTED,WHERE THE CD4-HIV COMPLEX EXISTS. IT MAY ALSO BE LOGOCAL TO VACCINATE AGAINST OTHER FRAGMENTS/WHOLE COMPLEXES OF INFECTED CELLS-THIS WOULD BE COVERED UNDER INTERMEDIATE STAGE VACCINATION BY INVENTORS OTHER PATENT.

VACCINATING AGAINST HIV-T4 OR OTHER INVOLVED CELLULAR COMPLEXES ENABLES BOTH THE USE OF DECOY FRAGMENTS TO ATTATCH TO FREE HIV AND THEN BE ATTACKED BY ENDOGENOUS OR EXOGENOUSLY RAISED IMMUNE MECHANISMS; IT WOULD ALSO ALLOW FOR THE SPECIFIC TARGETING OF INFECTED CELLS. TAGGING THERAPY CAN ALSO BE USED IN COMPETATIVE MANNER. AS THE BINDING OF HIV TO CD4 RECEPTORS HAS BEEN DESCRIBED AS A FORM OF TAGGING; COMPETITION FOR THAT RECEPTOR AND/OR ALTERATION OF ITS SHAPE AND/OR CHARACTERISTICS MAY INTERFERE WITH THE DISEASE

PROCESS .

CELLS WHICH HAVE BEEN TAGGED WITH HIV AND WHICH ARE INFECTED WITH THE VIRUS TEND TO BE MORE FRAGILE THAN THEIR HEALTHY COUNTERPARTS IN SEVERAL SITUATIONS. HYPERTHERMIA HAS BEEN DEMONSTRATED TO CAUSE INTERFERANCE WITH VIRAL BINDING TO CD4 RECEPTORS AS WELL AS LYSIS OF INFECTED CELLS WHICH APPEAR TO HAVE LOWER TOLERANCE TO PHYSICAL,CHEMICAL AND BIOLOGICAL AGENTS THAN THEIR HEALTH

COUNTERPARTS .

PH EXTREMES ALSO MAY CAUSE PREFERENTIAL DESTRUCTION OF DISEASED

CELLS.

CHEMOTHERAPY SUCH AS CYCLOSPORIN MAY ALSO CAUSE PREFERENTIAL

LYSIS OF DISEASED CELLS.

GENERAL ANTIHUMAN ANTISERA AND/OR ANTILYMPHOCYTE ANTISERA MAY BE RAISED IN ANIMALS AND EXERT PREFERENTIAL LYSIS TO DISEASED CELLS INVENTOR HAS OBSERVED GREATER SENSITIVITY OF THESE TO LOWER CONCENTRATIONS OF ANTISERA THAN ARE NECESSARY TO EFFECT HEALTHY CELL LYSIS.

EFFICACY AND SPECIFICITY ARE FAR ENHANCED WHEN THE IMMUNE RESPONSE IS RAISED AGAINST THE CD4-HIV COMPLEX. AUTOGENOUS

VACCINES COULD BE RAISED AND PURIFIED BY REMOVAL OF ANY FRACTION WHICH MAY ACT AGAINST NORMAL CELLS OF PATIENT.

A SUMMARY OF THE BENEFITS OF UNDERSTANDING THE ROLE OF TAGGING IN DISEASE COURSE AND THERAPY MAY BE BEST ILLUSTRATED BY THE RAISING OF EFFECTIVE AIDS IMMUNE THERAPY;

SEARCHING CASES OF SPONTANEOUS REMISSION (SR), UNUSUAL RESISTANCE OR HIGH RISK BUT HEALTHY INDIVIDUALS (HBH) OR SIMPLE BROAD SCREEN NORMAL/LABORATORY ENHANCED IMMUNE CELLS .SEARCHING HUMAN,ANIMAL AND/OR OTHER SYSTEMS FOR EFFECTIVE IMMUNE RESPONSES AGAINST THE DISEASE, 3 FORMATS CAN BE ENVISIONED.

ALTHOUGH PATENT REFERS TO ANY AND ALL FAP'S ETC.,WE SHALL BY VIRTUE OF EXAMPLE REFER TO ANTISERA WHILE UNDERSTANDING THAT PATENT COVERS ALL OTHER IMMUNOLOGICAL RESPONSES AS WELL AS OTHER FAP'S ETC.

1-EFFECTIVE, SPECIFIC HIV ANTISERA-

THESE MAY EXERT. ACTIVITY AGAINST FREE CIRCULATING HIV AND MAY BE

OF USE PROPHYLACTICALLY, IMMEDIATELY AFTER EXPOSURE OR OF LIMITED

EFFICACY IN THERAPY.

CELLS ALREADY 'INFECTED MAY NOT RESPOND AS WELL AS FREE VIRUS.

2-EFFECTIVE ANTISERA AGAINST THE CD4-HIV COMPLEX.THIS WOULD ATTACK/NEUTRALISE/DEMONSTRATE AFFINITY FOR INFECTED CELLS. IN COMBINATION WITH THE ABOVE ANTISERA BOTH CELLULAR AND EXTRACELLULAR PHASES OF THE VIRUS MAY BE EFFECTED..

3-DECOY-NATURALLY OR ARTIFICIALLY GENERATED CD4 RECEPTORS

OR ANALOGUES CAN BE USED TO BIND FREE HIV. PARTICULARLY WHERE THE DECOY CAN BE GIVEN HIGHER AFFINITY THAN PATIENT'S OWN RECEPTORS. DECOYS MAY BE THEMSELVES TAGGED BY IMMUNOSTIMULATING/IMMUNOMODULATING F/A/P'S ETC.

ANTI-DECOY-HIV COMPLEX RESPONSES MAY BE RAISED AND/OR

ANTICIPATED-ANTICIPATION IS COVERED IN INVENTOR'S PATENTS

ON CO-TEMPORAL THERAPY AND PRECURSOR/INTERMEDIATE/ENDPRODUCT THERAPY.

DECOYS MAY BE ADMINISTERED TO THE PATIENT AND FOLLOWED BY ANTI- DECOY-HIV ANTISERUM.

TAGGING INTERFERANCE IS ALSO A VIABLE THERAPY WHERE INACTIVE OR NON-PATHOGENIC COMPOUNDS /FRAGMENTS/ .ORGANISMS MAY INTERFERE WITH THE BINDING OF THE VIRUS.

TAGGING THERAPY, WHERE BACTERIAL OR OTHER ORGANISM W/P/E FAP'S ETC ARE MADE TO ATTATCH TO VIRUS OR TO VIRALLY-INFECTED CELLS,HAS STRONG THERAPEUTIC POTENTIAL AS IT NOT ONLY ALERTS AND ACTIVATES IMMUNOLOGICAL AND/OR OTHER SYSTEMS BUT ALSO CAN MODULATE SUCH RESPONSES. IF IN THE ORDINARY COURCE OF THE DISEASE, HIV ATTACKS AND DESTROYS T4 CELLS;AS THE BODY ATTEMPTS TO FIGHT THE INFECTION BY MORE T4 LYMPHOCYTES , THESE TOO MAY BE INFECTED. GENERAL NONSPECIFIC IMMUNOSTIMULATION THEREFORE MAY ACCELERATE THE PATIENT'S DETERIORATION. IF VIRUS AND INFECTED CELLS ARE TAGGED BY SAY BACTERIAL FRACTIONS, THE IMMUNE RESPONSE ATTRACTED TO THE COMPLEX IS LIKELY TO BE LARGELY NEUTROPHILIC,AS THESE CELLS APPEAR TO BE RESISTANT TO HIV INFECTION ;A SIGNIFICANT IMPROVEMENT IN THE HOST'S CHANCES OF BENEFICIAL RESPONSE MAY FOLLOW.

TAGGING MAY BE MADE SPECIFIC FOR DISEASE AND CAN TAGGING FAP ' SA ETC MAY BE RAISED IF NOT NATURALLKY OCCURING., TAGGING AND CARRIER MECHANISMS ARE LARGELY DIVIDED BY SIZE OF ATTATCHED FAP'S ETC. THESE TECHNIQUES COMBINED WITH RESPONSE LIBRARIES OF ANTISERA,OTHER IMMUNE AGENTS INCLUDING TRANSFER FACTOR,ANTICIPATORY AND OTHER GUIDELINES MAY REVOLUTIONISE VACCINES AND OTHER MEDICAL THERAPIES.; SURVIVAL MECHANI SMS

IT IS UNDERSTOOD THAT SOME ORGANISMS PLACED UNDER CERTAIN CONDITIONS MAY BEHAVE IN NEUTRAL MANNER TO EACH OTHER OR ACT TO SYNERGISE DIRECTLY OR INDIRECTLY.BY CLASSIFYING ORGANISMS

ACCORDING TO CLASSIFICATION PATENT, IDENTIFICATION OF

CAUSATIVE, SYNERGISTIC, INFECTIVE,NEUTRAL UNDER DEFINED CONDITIONS MAY INDICATE TARGETS FOR THERAPY.ORGANISMS THAT ASSIST DISEASE ORGANISMS UNDER CERTAIN CONDIOTIONS MAY NEED TO BE ADDRESSED OR NEUTRALISED IN THERAPY;ALTERNATIVELY, CONDITIONS MAY BE FOUND WHERE SYNERGY AND/OR OTHER ASSISTANCE DO NOT EXIST.SUCH

CONDITIONS SHOULD THEN BE DUPLICATED IF POSSIBLE IN THE PATIENT. WHEN TWO OR MORE ORGANISMS ARE PLACED IN A SETTING WHERE THERE IS A DEFINED MARGIN OF BIAS AND WHERE THEY ARE MADE TO COMPETE FOR OPTIMAL SURVIVAL EITHER BY NATURE OR BY DESIGNED CONDITIONS SEVERAL SURVIVAL MECHANISMS MAY DEVELOP THESE MAY BE CATAGORISED AS;

1-OFFENSIVE

WHEN ORGANISMS PRODUCE F/A/P'S ETC. SPECIFICALLY TO

DESTROY/INHIBIT/INJURE/DAMAGE/NEUTRALISE OTHERS THEY ARE SAID BY AUTHOR TO BE EXERTING OFFENSIVE BEHAVIOUR. ALTHOUGH THE OFFENSIVE MECHANISMS MAY BE PHYSICAL (EG HEAT GENERATION) /CHEMICAL (EG

ALTERING PH OR OXYGEN CONCENTRATION) BIOLOGICAL OR ANY

COMBINATION OF THESE, WE WILL CONSIDER BIOLOGICAL MECHANISM, S BY WAY OF EXAMPLE IN THIS PATENT.

ORGANISMS TO BE USED FOR CLARIFICATION OF CLASSIFICATION AND OTHER PARAMETERS WILL BE THE PENICILLIUM NOTATUM AND STAPHYLOCOCCUS AUREUS.

AN EXAMPLE OF OFFENSIVE MECHANISMS THEREFORE MAY BE SAID TO BE THE PRODUCTION OF PENICILLIN BY THE PENICILLIUM NOTATUM TO DESTROY THE STAPHYLOCOCCUS.

2-DEFENSIVE

CONTINUING WITH THE ABOVE MODEL, THE STAPHYLOCOCCUS MAY EMPLOY DEFENSIVE BEHAVIOUR BY PRODUCING PENICILLINASE,AN ENZYME THAT INACTIVATES PENICILLIN.

3-ELUSIVE/EVOLUTIONARY

THIS MECHANISM IS USUALLY MADE MORE POSSIBLE UNDER OPEN, IN-VIVO

CONDITIONS.BACTERIA MAY SURVIVE BY ELUDING THE PENICILLIN IN

AREAS OF THE BRAIN\FOR EXAMPLE, WHERE THE BLOOD-BRAIN BARRIER

MAY LIMIT THE ABILITY OF PENICILLIUM OR ITS PRODUCT(S) TO REACH

THE BACTERIA.

THE PENICILLIN-SENSITIVE BACTERIA MAY ACQUIRE GENETIC

INFORMATION, PERHAPS IN THE FORM OF PLASMID AND/OR PHAGE WHICH

WOULD CODE FOR SOME MECHANISM OF PENICILLIN RESISTANCE.

RADIOCELL TO NORMAL DYNAMIC FLOW

THE TERM DYNAMIC FLOW REFERS TO STUDIES OF INTERACTIONS AND THEIR CONSEQUENSES WITH STAGES DEFINED AS THEIR F/A/P'S ETC .RELATE ON SEQUENTIAL FLOW AND TEMPORAL RELATIONSHIPS.DYNAMIC FLOW STUDIES ALSO ENABLE CO-TEMPORAL INVESTIGATION AND THERAPEUTIC

APPLICATION.

EXAMPLES OF DYNAMIC FLOW STUDIES CAN BEST BE DEMONSTRATED BY INVITRO AND IN-VIVO APPLICATION IN THE TREATMENT OF CANCER.

DYNAMIC FLOW STUDIES (DFS) CAN BE MADE IN LIMITED OR NARROW

SPECTRUM IN ISOLATED OR IN OPEN SYSTEM. DFS CAN ALSO BE MADE IN BANDS OF VARYING WIDTH UP TO 'UNLIMITED' OR BROAD-SPECTRUM

SYSTEMS IN ISOLATED (CLOSED) OR OPEN SETTINGS. SETTINGS MAY BE VARIED FROM OPEN TO CLOSED

RADIOCELL TO NORMAL

RBC

WBC

INTERFERANCE

APHRODISIAC

DYNAMIC FLOW

THE TERM DYNAMIC FLOW REFERS TO STUDIES OF INTERACTIONS AND THEIR CONSEQUENSES WITH STAGES DEFINED AS THEIR F/A/P'S ETC .RELATE ON SEQUENTIAL FLOW AND TEMPORAL RELATIONSHIPS. DYNAMIC FLOW STUDIES ALSO ENABLE CO-TEMPORAL INVESTIGATION AND THERAPEUTIC

APPLICATION.

DYNAMIC FLOW STUDIES (DFS)CAN BE MADE IN LIMITED OR NARROW

SYSTEMS IN ISOLATED (CLOSED) OR OPEN SETTINGS. SETTINGS MAY BE VARIED FROM OPEN(TO VARIOUS EXTENTS) TO CLOSED.

IN HOST/INVITRO/IN-VIVO

SURVIVAL MECHANISMS

WHEN TWO OR MORE ORGANISMS ARE PLACED IN A SETTING WHERE THERE IS A DEFINED MARGIN OF BIAS AND WHERE THEY ARE MADE TO COMPETE FOR OPTIMAL SURVIVAL EITHER BY NATURE OR BY DESIGNED CONDITIONS SEVERAL SURVIVAL MECHANISMS MAY DEVELOP THESE MAY BE CATAGORISED AS;

RADIOCELL TO NORMAL

RBC

WBC

INTERFERANCE

APHRODISIAC

ITSELF LEED TO SEQUALAE OF AIDS AND/OR OTHER UNDESIREABLE

CHANGES. A DEFINITIVE MULTI-PRONGED PROTOCOL SHOULD BE EMPLOYED AT THIS STAGE; IE, THIS PATENT SUPPORTS TYEMPORARY BLOCKADING OF CD4 RECEPTORS ONLY IF OTHER THERAPY IS SIMULTANEOUSLY INITIATED AGAINST AIDS. THIS ADJUNCTIVE TREATMENT MAY VARY FROM HYPERTHERMIA TO THE APPLICATION OF OTHER NATURAL OR STRUCTURED RECEPTORS FOR HIV TO 'SWEEP' THE BLOOD FOR VIRAL FRAGMENTS. ALTERNATIVELY THERAPY COULD BE INITIATED TO ALTER CD4 RECEPTOR STRUCTURE SO THAT IT NO LONGER EASILY BINDS HIV. SUCH THERAPY COULD BE AS BASIC AS HYPERTHERMIA OR AS COMLICATED AS GENETICALLY OR OTHERWISE MODIFY RECEPTORS TO BE SIMILAR TO THOSE OF RESISTANT ANIMALS AND/OR HUMANS. INVENTOR HAS DEMONSTRATED THAT SEVERAL BIOLOGICAL ORGANISMS MAY COMPETE FOR RECEPTOR SITES AND DISPLACE HIV. HYPERTHERMIA HAS ALSO BEEN SHOWN BY THE INVENTOR TO BE

CD4 'DECOYS' ALONE OR ATTATCHED TO SOME DEFINITIVE THETRAPY HAVE ALSO FUNCTIONED WELL. CD4 RECEPTORS ARE COVERED BY THIS PATENT AS PERFECT 'MAGIC BULLETS' OR HOMING MECHANISMS FOR BINDING TO AND/OR SELECTIVELY DELIVERING THERAPY TO HIV.PATENT COVERS THE USE OF CD4 RECEPTORS AS CARRIERS OR DIRECT DELIVERY MECHANISMS OF THERAPY , WHETHER STANDARD SUCH AS AZT OR NEW. SPECIFICITY OF DELIVERY WOULD ENSURE INCREASED CONCENTRATION AT SITE OF ACTION AS WELL AS DECREASED SIDE-EFFECTS. DESPITE HIV'S NOTORIOUS

RADIOCELL TO NORMAL

RBC

WBC

INTERFERANCE

APHRODISIAC IN-VIVO TRIALS CAN INCLUDE MODELS SUCH AS NUDE MICE, SKID RATS AND OTHER IMMUNOLOGICALLY CHALLENGED AS WELL AS OTHER SYSTEMS.

THE REASONING BEHIND PART OF THE IMPORTANCE OF DYNAMIC FLOW/COTEMPORAL STUDIES IS TO GENERATE AND DEFINE F/A/P'S ETC. SEQUENTIALLY DEVELOPING IN THE INTERPLAY BETWEEN DISEASE, HOST AND THERAPY AS WELL AS OTHER RELEVANT FACTORS. BEING ABLE TO THEN IDENTIFY AND THEREFORE STAGE SUCH CHANGES ENABLES ENACTING OF MORE PRECISE AND RELEVANT DIAGNOSTIC AND THERAPEUTIC MEASURES.

VARIOUS PARAMETERS MAY BE DEFINED TO INDICATE POSITIONING OF SITUATION. AN EXAMPLE WOULD BE CHANGES IN A BACTERIUM AS IT

ACQUIRES PENICILLIN RESISTANCE STAGING DURING SUCH ACQUISITION COULD BE DEFINED BY DEGREE OF RESISTANCE AND/OR IMMUNOLOGICAL CHANGES DURING THAT TIME AND/OR METABOLIC CHANGES AS GROWTH RESUMES AND/OR LEVELS OF PENICILLINASE-DESTROYED PENICILLIN. THE LATTER FACTOR AND THOSE RELATED CAN NOT ONLY INDICATE STAGING BUT ALSO POSSIBILITY FOR DONATION OF RESISTANCE FROM AN OUTSIDE SOURCE OF RESISTANT ORGANISMS. IT MAY EE NECESSARY TO INTERPRET SEVERAL OF THESE FACTORS AND SYSTEMS(BOTH OPEN AND CLOSED)

TOGETHER TO INDICATE IF RISE IN DENATURED PENICILLIN IS FROM TARGETED ORGANISM DEVELOPING RESISTANCE OR FROM ANOTHER WHICH MAY DONATE RESISTANCE.

DYNAMIC FLOW AND CO-TEMPORAL MODELS ALSO CAN ESTIMATE/INDICATE AND GIVE REFERANCE VALUES UNDER CERTAIN CONDITIONS FOR SUCH IMPORTANT PARAMETERS AS THERAPEAUTIC TEMPORAL INDEX VALUES MAY BE GENERAL LIBRARY DATA FOR SPECIFIC SITUATIONS AND/OR PATIENT SPECIFIC.

IT IS POSSIBLE TO OUTLINE AND PREDICT DISEASE PATTERN FOR SPECIFIC PATIENT AS MANY DISEASES AS WELL AS NORMAL CELLS MAY BE ACCELERATED IN-VITRO OR IN CERTAIN ANIMAL MODELS. IT IS POSSIBLE THEREFORE TO DESIGN A PROTOCOL OF THERAPY AND TEST ITS EFFECTS ONSEVERAL GENERATIONS OF DISEASE AND NORMAL CELLS TO GAUGE EFFICACY, SPECIFICITY, TOXICITY AND TO OPTIMALLY DOSE-TITRATE.AGAIN STRESSING THAT FEATURES OF THIS PATENT ARE TO PROVIDE TIME AND BIOLOGICAL/OTHER MARKERS TO BEST INDICATE OPTIMAL DOSEAGE AND

PROVIDE INFORMATION FOR TEMPORAL DYNAMIC-FLOW

THERAPY . ( TDT )

TDT THERAPY INVOLVES 3 SUBDIVISIONS;

1-PROPHYLACTIC/PREVENTATIVE

2-ANTICIPATORY

3-RESPONSIVE

EACH STAGE MAY BE ACTIVATED AT ANY TIME DURING CLINICAL MANAGEMENT IE. IN TDT THERE WILL CONSTANTLY BE FAP'S ETC. WHOSE PRESENCE OR INTERACTION MAY BE PREVENTED,ANTICIPATED AND/OR

RESPONDED TO. TDT THERAPY-PROPHYLACTIC/PREVENTATIVE

POSSIBLE APPLICATIONS ARE VERY BROAD ,HOWEVER WE SHALL VARY

BETWEEN USE OF ANTIBIOTIC AND CANCER THERAPY MODELS, THIS IS NOT INTENDED TO RESTRICT PATENT APPLICATION.

IF TEMPORAL DYNAMIC FLOW STUDIES INDICATE THAT IN THE ENVIRONMENT WHERE THERAPY IS TAKING PLACE RESIATANCE WILL BE ACQUIRED BY DONATION FROM OTHER BACTERIA DURING REPRODUCTION THEN BACTERIOSTATIC AGENTS MAY BE INTRODUCED PRIOR TO THAT POINT TO PREVENT/INHIBIT/RESTRICT/NEUTRALISE ONE PATHWAY OF ACQUIRING RESISTANCE TO THERAPY.

TEMPORAL DYNAMIC FLOW STUDIES (TDFS) MAY ALSO INDICATE RELATIVE TOLERANCE TO THERAPY OF HOST AND DISEASE SUGGESTING PULSES OF ALTERED DOSEAGE;MAXIMISING IT WHEN HOST TOLERANCE IS HIGH FOR EXAMPLE.

KNOWLEDGE OF THE TDFS OF ACQUISITION OF RESISTANCE MAY INDICATE MULTI-OR COMBINATION THERAPY. TDFS IS USED TO INDICATE HOW THE TARGET WILL RESPOND OVER TIME IN THE HOST ENVIRONMENT IN WHICH IT RESIDES AS WELL AS HOST RESPONSES OVER THE TIME PERIOD.THIS

DIFFERS DRASTICALLY FROM CURRENT SCIENCE WHICH SIMPLY PLATES BACTERIA AND CHECKS FOR THEIR ANTIBIOTIC SENSITIVITY OVER A PERIOD OF DAYS AS THERAPY COMMENCES.TDFS WILL YEILD PERTINENT DATA OF THERAPY,HOST AS WELL AS DISEASE AND SUGGEST OPTIMAL

THERAPIES,DOSEAGES AND TIMING.

THE ABOVE STATEMENT CAN BE EXAMPLIFIED BY CONSIDERATION OF A STREPTOCOCCAL SKIN INFECTION IN SOMEONE OTHERWISE HEALTHY AND IN AN AIDS PATIENT. CURRENT ANTIBIOGRAM STUDIES WOULD INDICATE WHICH ANTIBIOTIC TO USE AND STANDARD DOSEAGES WOULD BE APPLIED.

FAVOURABLE RESULTS WOULD USUALLY FOLLOW WHERE THE IMMUNE SYSTEM IS RELATIVELY INTACT; IN ADVANCED IMMUNODEFICIENCY HOWEVER, INITIAL; RESPONSE WILL USUALLY BE SHORTLIVED. THIS WOULD BE

PREDICTED BY TDFS AND APPROPRIATE MANAGEMENT SUCH AS ADMINISTRATION OF GAMMAGLOBULINS ETC. WOULD BE INITIATED WHEN INDICATED RATHER THAN THE 'GUESSING' OR THE WAITING UNTIL FAILURE OF THERAPY AS IS THE PRACTISE TODAY.

ANTICIPATORY

THIS IS PERHAPS THE MOST EXCITING DIVERGENCE FROM CONVENTIONAL CONCEPTS OUTLINED IN THIS PATENT.

KNOWING AN EVENT AND ITS MECHANISM AS WELL AS THE EXPECTED TIMING OF ITS OCCURANCE ENABLES ANTICIPATORY STEPS TO BE TAKEN.

IF A PENICILLIN-SENSITIVE ORGANISM IS SHOWN AND/OR KNOWN BY TDFS TO BE LIKELY TO ACQUIRE PENICILLIN RESISTANCE BY PENICILLINASE MECHANISM ACQUIRED BY PLASMID DONATION FROM PENICILLIN RESISTANT,RELATED BACTERIA FOR EXAMPLE

(ELIMINATING/INHIBITING/NEUTRALISING THE RESISTANT BACTERIA BY WHATEVER MEANS WOULD BE CLASSIFIED AS PROPHYLACTIC, THIS HOWEVER WOULD INCREASE THE NUMBER OF TARGET ORGANISMS AND COMPLICATE THERAPY).TDFS WOULD INDICATE FACTORS ABOUT NEWLY RESISTANT

ORGANISMS WHICH MAY BE USED TO RAISE ANTICIPATORY IMMUNE RESPONSE IN PATIENT OR USE ONE FROM LIBRARY.ANTICIPATORY VACCINATION, PARTICULARLY WHERE THE CHANGE BEING VACCINED AGAINST IS SPECIFIC AND IN LOW TO NO CONCENTRATION AT TIME OF VACCINATION IS LIKELY TO BE MUCH MORE EFFECTIVE THAN VACCINES PREPARED FROM ANTIGENS ALREADY SATURATING THE BODY BECAUSE OF THE IMMUNE SUPPRESSION CAUSED BY ANTIGENS RISING ABOVE A CERTAIN THRESHHOLD.

ANT I CI PATORY THERAPY HAS THIS ADVANTAGE THAT ONE CAN

MANIPULATE A PARTICULAR SITUATION TO BRING ABOUT CHANGES WHICH CAN BE ANTICIPATED AND USED TO RESOLVE THE SITUATION.

USING CANCER AS AN EXAMPLE; VACCINES PREPARED AGAINST CANCER CELLS

USUALLY FAIL BECAUSE OF SEVERAL REASONS INCLUDING;

1-LACK OF IDENTIFIED, CANCER-SPECIFIC, IMMUNOSTIMULATING ANTIGENS.

2-CANCER MASS USUALLY GREATER THAN THAT REQUIRED FOR THRESHHOLD

INHIBITION OF IMMUNE SYSTEM.

3-LACK OF RELATIONSHIP BETWEEN VACCINE AND THE DISEASE

EMBODYMENT.

LET US CONSIDER ALL THESE POINTS IN TURN AND VIEW HOW PATENT OFFERS MEANS OF OVERCOMING THEM.

1-LACK OF IDENTIFIED EFFICIENT ANTIGENS.

THIS UNFORTUNATE SITUATION IS AT LEAST AS MUCH RELATED TO CURRENT TECHNIQUES AS IT IS TO THE PROWESS OF THE DISEASE PROCESS.

THERE HAVE BEEN ATTEMPTS TO MODIFY CANCER CELL STRUCTURE TO ATTATCH ANTIGENIC MARKERS AND/OR IMMUNE STIMULATORS, AND/OR TO PROCESS THE DISEASE IN A MANNER WHICH LEADS TO THE EXPRESSION OF HIDDEN OR SUPPRESSED COMPOUNDS OF ANTIGENIC AND/OR

IMMUNOSTIMULANT EFFECTS.

THE PROBLEM WITH ALL SUCH IMMUNOLOGIC MODALITIES IS THAT AFTER PREPARATION OF CANCER CELLS TO BE ANTIGENIC AND/OR

IMMUNOSTIMULANT, THE VACCINE USED WILL NOT MATCH CANCER CELLS EXISTING IN THE BODY. THE GENERAL HOPE IS THAT ENOUGH IMMUNE RESPONSE WILL BE GENERATED BY THE MODIFIED SECTION OF THE VACCINE THAT AN ANMGERED IMMUNE SYSTEM WILL ALSO ATTACK THE UNMODIFIED FRACTION WHICH IT SHARES WITH THE UNALTERED DISEASE. THE SHARED FRACTION WILL THEN INITIATE AN IMMUNE RESPONSE AGAINST THE CANCER. EVEN GENETICALLY ENGINEERING THE CANCER TO

SECRETE/PRODUCE IMMUNE ATTRACTING/STIMULATING/MODULATING AGENTS IS DONE WITH THE HOPE THAT FACTORS COMMON TO THE CANCER AND ITS ENGINEERED. COUNTERPART WILL CAUSE A VACCINE GENERATED REACTION TO INVOLVE THE DISEASE AS WELL.

THE USE OF ' SPECIFIC F/A/P'S ETC. , PARTICULARLY WHERE THESE ARE NOT IN ABUNDANT EXPRESSION BY THE DISEASE ENABLES THE FORMATION OF A VACCINE STRUCTURED OF MATTER WHICH IS NOT CAUSING THRESHOLD SUPPRESSION OF THE IMMUNE RESPONSE.WHERE SPECIFIC F/A/P'S ETC ARE HEAVILY EXPRESSED BY DISEASE THEN THE VACCINE IS LIKELY TO BE STRONGER AS A PREVENTATIVE THAN AS A THERAPY ONCE THE DISEASE IS ALREADY PRESENT.

ANTICIPATORY VACCINES MAY PROVIDE THE BEST OF BOTH WORLDS. DEFINED CONDITIONS WILL CAUSE CHANGES IN DISEASE. THESE CONDITIONS INCLUDE TEMPERATURE CHANGES, CHEMOTHERAPY, RADIOTHERAPY, FORCED COHABITATION ETC. CHANGES MAY INCLUDE THE EXPRESSION OF, UNMASKING OF, GENERATION OF NEW AND/OR ALTERATION OF INITIAL F/A/P'S ETC. TO POSSIBLY YEILD A DIFFERENT ANTIGENIC SIGNATURE AND/OR OTHER PROPERTIES. VACCINES PREPARED FROM INITIAL TISSUE BIOPSY OF CANCER OR THERAPY TAILORED AGAINST BACTERIA FROM INITIAL CULTURE MAY NO LONGER BE RELEVANT .HOWEVER , IF COTEMPORAL OR PRETEMPORAL MODELS (THOSE WHICH CAN PROCESS THE TARGET ORGANISM AND ALLOW IT TO EXPRESS ITS CHANGES PRIOR TEMPORALLY TO CHANGES OCCURRING IN PATIENT)COULD BE USED AND/OR IF THE CHANGES RESULTING CAN BE ANTICIPATED AND THERAPY OR VACCINES PREPARED AGAINST ANTICIPATED CHANGES THEN EFFECTIVE ANTICIPATORY THERAPY MAY BE USED TO GOOD EFFECT.

EXAMPLES OF APPLICATION IN VACCINE MANUFACTURE, CHEMOTHERAPY AND ANTIBIOTIC THERAPY-INCLUDING MULTIPHASIC THERAPY WILL FOLLOW IN LATE R SECTION OF PATENT.

TO CONCLUDE CLARIFICATION OF ANTICIPATORY BENEFITS AS OUTLINED;

2- CANCER MASS - IMMUNE THRESHOLD INHIBITION.

THE ABILITY TO ANTICIPATE A CHANGE AND IMMUNISE AGAINST IT BEFORE IT IS BROUGHT ABOUT ESSENTIALLY BYPASSES THIS PHENOMENON.

ANTICIPATION OF ANTIGENIC CHANGES BROUGHT ABOUT BY CHEMOTHERAPY AND/OR RADIOTHERAPY ALLOWS VACCINATION AGAINST THEM SO THAT THE CELLS MAY BE DESTROYED IMMUNOLOGICALLY AS THEY ARISE DURING CHEMOTHERAPY AND/OR RADIOTHERAPY. THE SPECIFIC CHANGES BEING VACCINATED AGAINST AND BEING CAUSED BY THE THERAPY DID NOT EXPRESS TO ANY SIGNIFICANT EXTENT PRIOR TO THERAPY HENCE VACCINATION IS NOT AGAINST ANTIGENS WHICH EXIST IN SUPPRESSIVE QUANTITIES AT TIME OF VACCINATION. IMMUNE THERAPY WHETHER INDUCED OR SUPPLEMENTED FROM EXOGENOUS CAUSE IS THEREFORE USED AGAINST A TARGET AS IT ARISES.

3- LACK OF RELATIONSHIP BETWEEN CONVENTIONAL VACCINES AND DISEASE EMBODYMENT. ARISES BECAUSE TUMOUR SPECIMENS USED TO GENERATE VACCINES ARE NOT THE SAME AS TUMOUR CELLS POST TREATMENT AND/OR THAT THE CHANGES TO THE SPECIMEN MADE TO INCREASE ITS ANTIGENICITY (EG PH ALTERATION, ENZYME DIGESTION, CO-INCUBATION WITH BIOLOGICAL AGENT ETC.) BEARS LITTLE RESEMBLANCE TO EXISTING DISEASE.

UNDER THE GUIDELINES OF THIS PATENT;

1- MATERIAL FROM WHICH VACCINE WILL BE GENERATED WILL BE

SUBJECTED TO CONDITIONS IDENTICAL OR ANALAGOUS TO THOSE THE DISEASE WILL EXPERIENCE DURING THERAPY SO AS TO ANTICIPATE ITS APPEARANCE AN CHARACTERISTICS. AND/OR;

2- DISEASE IS EXPOSED TO SAME OR ANALOGOUS CONDITIONS USED IN VACCINE PREPARATION. IF THE BODY IS VACCINED AGAINST SPECIFIC F/A/P'S ETC . RAISED BY INCUBATING TUMOUR CELLS WITH NEWCASTLE VIRUS; THE TUMOUR CELLS IN THE PATIENT SHOULD BE EXPOSED TO THE VIRUS AS WELL ONCE VACCINE STIMULATION IS AT SIGNIFICANT TITRE, AND/OR EXOGENOUS IMMUNE SYSTEMS ARE READY.

APPEARANCE AN CHARACTERISTICS. AND/OR;

2- DISEASE IS EXPOSED TO SAME OR ANALOGOUS CONDITIONS USED IN VACCINE PREPARATION. IF THE BODY IS VACCINED AGAINST SPECIFIC F/A/P'S ETC. RAISED BY INCUBATING TUMOUR CELLS WITH NEWCASTLE VIRUS;THE TUMOUR CELLS IN THE PATIENT SHOULD BE EXPOSED TO THE VIRUS AS WELL ONCE VACCINE STIMULATION IS AT SIGNIFICANT TITRE,AND/OR EXOGENOUS IMMUNE SYSTEMS ARE READY.

RESPONSIVE

IN DEALING WITH LIVING SYSTEMS THERE ARE ADVANTAGES OVER NONLIVING DRUGS. ONE SUCH ADVANTAGE IS THAT WHEN A TARGET DEVELOPS RESISTANCE TO A PARTICULAR THERAPY DERIVED FROM A LIVING BIOLOGICAL SOURCE, FORCED COHABITATION/MUTATION CULTURE AND OTHER TECHNIQUES MAY BE USED TO GENERATE A NEW RESPONSE FROM THE ORGANISM OF ORIGIN OF THERAPY; THIS NEW IMPROVED RESPONSE MAY

OVERCOME TARGET RESISTANCE- APPL ICA TION EXAMPLES

INCLUDE CHEMOTHERAPY, ANTIBIOTIC THERAPY AS WELL AS VACCINE THERAPY- CASES OF APPLICA TION WILL FOLLOW.

SURVIVAL MECHANISMS 1-OFFENSIVE

OFFENSIVE BEHAVIOUR MAY BE INHERENT /INDUCED/MUTATED /DONATED /DIRECT OR INDIRECT.

EXAMPLES OF THESE SUBDIVISIONS NOW FOLLOW;

INHERENT-AS WITH INHERENT ABILITY OF PENICILLIUM FOR PENICILLIN PRODUCTION.

INDUCED-EXAMPLES OF INDUCED OFFENSIVE SURVIVAL MECHANISMS INCLUDE THOSE DEMONSTRATED BY INVENTOR SUCH AS THE ABILITY OF PENICILLIUM TO GENERATE OTHER ANTIBIOTIC FAP'S ETC. WHEN COHABITING WITH ORGANISM RESISTANT TO ORDINARY PENICILLIN.

MUTATED-AS WITH ORDINARY SYMBIOTIC FLORA OF HOST MUTATING UNDER PHYSICAL, CHEMICAL OR BIOLOGIC AGENTS TO BE PATHOGENIC.

CANCER ITSELF MAY BE SEEN AS CELLULAR MUTATION TO DEVELOP SURVIVAL OFFENSIVE MECHANISM IN THE FACE OF PHYSICAL, CHEMICAL AND /OR BIOLOGICAL CHALLANGE.

DONATED-ESCHERCHIA COLI EXISTS IN ORDINARY BOWEL FLORA, CERTAIN STRAINS MAY ACQUIRE PATHOGENIC OR OFFENSIVE STATUS AFTER INFECTION WITH PHAGE CARRYING GENETIC INFORMATION WHICH IS

'DONATED' TO THE BACTERIA TO ENABLE IT TO MANUFACTURE TOXIN.

ALL ABOVE MECHANISMS AS WELL AS OTHERS INVOLVING FOR EXAMPLE, ENZYMES, ANTIBIOTICS, OTHER FAP'S ETC. MAY ACT DIRECTLY OR

INDIRECTLY. DIRECT ACTION IS AS SPECIFIED ABOVE; INDIRECT ACTION MAY INVOLVE OTHER FAP'S ETC. SUCH AS FOR EXAMPLE A HOST OR HOST SYSTEM ACTING AS A THIRD PARTY AND BEING INDUCED TO EXERT EFFECT AGAINST ONE ORGANISM BY THE OTHER.

IT APPEARS, FOR EXAMPLE, THAT CERTAIN INFECTIONS MAY LEAD TO CANCER REGRESSION IF NOT REMISSION IN DOCUMENTED CASES OF SPONTANEOUS REGRESSIONS AND REMISSIONS. IN THESE CASES, IT APPEARS THAT AT LEAST PART OF THE RESPONSE IS SECONDARY TO IMMUNOLOGICAL AND OTHER HOST INTERACTION.

DEFENSIVE

DEFENSIVE MECHANISMS MAY ALSO BE ALLOTED THE SAME SUBDIVISIONS OF-INHERENT/INDUCED/MUTATED/DONATED/DIRECT/INDIRECT, AS CAN ALL THREE DIVISIONS; AS WITH OFFENSIVE AND ELUSIVE, DEFENSIVE

MECHANISMS CAN INVOLVE ANY OF THE SUBDIVISIONS AS WELL AS ANY COMBINATION OR PERMUTATION OF THEM.

INHERENT-AS IN CASES OF BACTERIA WITH INHERENT PENICILLIN

RESISTANCE.

INDUCED-AS WITH ALL DIVISIONS .APPLICATION MAY BE MADE TO SIMPLE OR COMPLEX ORGANISMS . A SIMPLE EXAMPLE OF THIS CLASSIFICATION INVOLVES A COMPLEX ORGANISM WHERE IMMUNE CELLS MULTIPLY AND OFFER DEFENSE AGAINST AN INVADING ORGANISM, SUCH A RESPONSE BEING

INDUCED BY AN INTERPLAY OF INVADER AND HOST F/A/P'S ETC. ANOTHER SYSTEM WHICH MAY BE INDUCED INTO DEFENSIVE MODE IS OF LIVER ENZYME INDUCTION TO METABOLISE/NEUTRALISE/BREAK DOWN/ELIMINATE HARMFUL FAP'S ETC.

MUTATED-DEFENSE AGAINST A PARTICULAR CHEMOTHERAPY, FOR EXAMPLE MAY OCCUR BY CANCER CELL MUTATION.

DONATED-PLASMIDS CARRYING INFORMATION FOR THE MANUFACTURE OF PENICILLINASE MAY BE 'DONATED FROM PENICILLIN-RESISTANT ORGANISMS TO SENSITIVE ONES TO ENABLE THE LATTER TO RESIST PENICILLIN.

DIRECT-ALL OF THE ABOVE AND MANY OTHER DEFENSIVE F/A/P'S ETC. MAY BE DIRECT.

I NDIRECT- AN EXAMPLE OF INDIRECT DEFENSIVE MECHANISMS WOULD

INVOLVE A THIRD OR MORE PARTY; A COMPLEX EXAMPLE OF THIS IS

SUGGESTED BY THE LOW INCIDENCE OF 2 OR MORE PRIMARY TUMOURS IN THE ONE HOST. STUDIES HAVE SHOWN THAT THE PRESENCE OF ONE CANCER MAY CAUSE CHANGES IN THE HOST TO DEFEND AGAINST ANOTHER CANCER INVADING ITS TERRITORY. ELUSIVE.

I NHERENT-MANY BACTERIA/VIRUSES/CANCERS ETC. APPEAR TO HAVE AN INHERENT ABILITY TO HIDE/ELUDE/EVADE EFFECTIVE IMMUNOLOGICAL ATTACK AT LEAST FOR A TIME PERIOD.

I NDUCED-EXPERIMENTAL MODELS HAVE DEMONSTRATED THAT SOME VIRUSES IS WELL AS OTHER ORGANISMS ARE CAPABLE OF CANNIBALISING CELLS AND EXPRESSING THEIR ANTIGENS ON THEIR SURFACE . FORCED COHABITATION AND/OR IN THE PROGRESS OF AN ILLNESS SUCH A MECHANISM MAY ALLOW THE ORGANISM TO EVADE IMMUNOLOGICAL RESPONSE AS IT MAY BE RECOGNISED AS 'SAME' BY HOST BY VIRTUE OF CANNIBALISED ANTIGENS. MUTATION-MAY LEAD TO ONGOING ELUSIVENESS AS IS THOUGHT TO BE THE MECHANISM WITH THE rilV VIRUSE'S ABILITY.

DONATED-THESE FEATURES/MECHANISMS OF ELUSIVENESS MAY INCLUDE THOSE TRANSFERRED BY PHAGES/PLASMIDS.

D IRECT-ALL ABOVE AND OTHERS MAY BE INCLUDED HERE

I NDIRECT-CANCER CELLS MAY CAUSE INEFFICIENT IMMUNE RESPONSE YO PRODUCE BLOCKING/PROTECTING ANTIBODY WHICH MAY SHIELD/HIDE IT

SOME APPLICATIONS OF CURRENT PATENT

1-ANTIBIOTIC

2-CHEMOTHERAPEUTIC

3-IMMUNOLOGICAL

IMPROVEMENT IN THESE THERAPIES LIES IN INCREASING EFFICACY AND SPECIFICITY WHILST DECREASING TOXICITY. SOME

EXAMPLES OF HOW THIS CAN BE ACCOMPLISHED USING GUIDELINES OF THIS AND OTHER PATENTS BY INVENTOR WILL NOW BE DISCUSSED.

RELEVANT SUBCLASSIFICATIONS WILL

INCLUDE;

MODIFICATION

DE-NOVO GENERATION

PHASE THERAPY

INHIBITING THE GENERATION OF RESISTANCE

DEALING WITH RESISTANCE ONCE GENERATED

MULTIMODAL THERAPY.

ANTIBIOTIC W ITH THE UNDERSTANDING THAT PATENT MAY BE APPLIED TO ANY OF A NUMBER OF F/A/P'S ETC.WE WILL RESTRICT THIS DISCUSSION TO THE USE OF PENICILLIN IN THE TREATMENT OF STAPHYLOCOCCAL INFECTIONS.

TEMPORAL AND CONDITION MATCHED INDEX MAY BE DELINEATED FOR O RGANISMS AND CATALOGUED AS RESISTANCE POTENTIAL. ESISTANCE POTENTIAL WILL INDICATE HOW LIKELY AN ORGANISM/CELL

TC.IS TO PEVELOP RESISTANCE TO

PARTICULAR THERAPY UNDER DEFINED CONDITIONS AND OVER WHAT TIME PERIOD.

NDER THIS CLASSIFICATION WE WILL DISCUSS IT IS ALSO POSSIBLE TO DEFINE ABSOLUTE RESISTANCE POTENTIAL (ARP)AS WELL AS RESTRICTED RESISTANCE POTENTIAL JUST AS IT IS POSSIBLE TO DEFINE ABSOLUTE THERAPEUTIC POTENTIAL (ATP) AND

RESTRICTED THERAPEUTIC POTENTIAL (RTP) AS WELL AS F/A/P'S ETC. WHICH IMPACT FAVOURABLY OR UNFAVOURABLY UNDER THESE CLASSIFICATIONS.

INDEXING SUCH POTENTIALS WILL ENABLE REALISTIC, ENHANCED

MECHANISMS OF ANTICIPATION, THERAPY AS WELL AS THE ABILITY TO

OBSERVE BIOLOGICAL AND OTHER SHIFTS. INDEXED

POTENTIALS OFFER A NEW METHOD OF EVALUATION AND PLANNING;

THE TEMPORAL ELEMENT ADDS A NEW DIMENSION TO MEDICAL AND DIAGNOSTIC SKILLS (AGAIN REFERANCE TO THE MEDICAL MODEL IN NO WAY RESTRICTS THIS PATENT TO MEDICAL APPLICATION.)

AN EXAMPLE OF USE OF SUCH DATA WOULD BE THE DEFINITION OF PARAMETERS AND DOCUMENTATION OF RELATED FEATURES AGAINST A TEMPORAL AXIS. IF A TUMOUR IS KNOWN TO RESPOND IN A CERTASIN MANNER WHEN EXPRESSING CERTAIN CHARACTERISTICS AND IF TEMPORAL RESPONSE TO THERAPY AND/OR OTHER MARKER CAN BE USED TO CHART THE CELL STAGE THEN AN INDICATOR MAY BE OBTAINED AS TO THE STAGE THE CELL IS IN ASA RELATED TO ITS LIFECYCLE, GROWTH RATE, RES I STANCE TO THERAPY AND ANTICIPATED RESPONSE/RESISTANCE TO OTHER THERAPY.; HENCE MORE ACCURATE INDICATIONS CAN BE EVALUATED AS TO

CELLULAR STAGING, DIAGNOSIS, PROGNOSIS, ONSET OF

DISEASE, OPTIMAL THERAPY ETC. MANY OF THESE INDICATORS WOULD BE FURTHER REFINED BY POTENTIAL DATA RELATING TO THE HOST/HOST SYSTEMS AS WELL AS POTENTIAL DATA RELATING TO OTHER INTERACTING

F/A/P'S ETC.WHICH MAY INFLUENCE THE SITUATION INCLUDING THERAPY AND OTHER F/A/P'S ETC. WHICH MAY BENEFIT HOST AND/OR DISEASE.

CELLULAR STAGING IS. A PRIMITIVE ART IN ITS CURRENT

STATE WHERE ESTIMATION OF 'AGGRESSIVENESS' OF DISEASE IS MADE BY NUMBER OF MITOTIC FIGURES INDICATING CELL DIVISION ACTIVITY; IT IS LARGELY DISEASE STAGING THAT DETERMINES THERAPY AND PROGNOSIS TODAY. DISEASE STAGING IS CURRENTLY LARGELY DETERMINED BY LOCATION AND EXTENT OF SPREAD OF DISEASE. CELLULAR STAGING IS ALONE AND/OR IN COMBINATIONS MUCH MORE RELEVANT AND USEFUL PARAMETER. CANCER CELL ACTIVITY IS A MAJOR FACTOR IN STAGING .KNOWING THE DEGREE OF ACTIVITY/AGGRESSION AS EVALUATED BY CELL

CHARACTERISTICS IN DEFINED PARAMETERS AS INDEX RELATED TO DISEASE STAGING/DATA ON CELL ACTIVITY AND CHARACTERISTICS DURING THE COURSE OF DISEASE . FOR EXAMPLE; ADENOCARCINOMA OF THE BOWEL MAY GROW AT A CERTAIN RATE AND DEGREE OF INVASIVENESS, THESE WILL VARY THROUGHOUT THE COURSE OF THE DISEASE, CERTAIN FEATURES OF DIFFERENTIATION MAY ALTER, CANCER CELL MARKERS SUCH AS CEA AND CAI25 MAY BE LOST AS THE CELLS BECOME MORE UNDIFFERENTIATED CELL AND BIOPSY APPEARANCE MAY EVEN CHANGE (REPORTED FREQUENTLY WHEN LYMPHOMA RECURRS/BECOMES MORE AGGRESSIVE, AS A NEW

CLASSIFICATION/TYPE OF LYMPHOMA) .EVEN IN THE ABSENCE OF SUCH OVERTLY VISIBLE CHANGES; CHARACTERISTICS OF HOST AND DISEASE ALTER THROUGHOUT THE COURSE OF THE DISEASE. SUCH CHANGES MAY BE

DEPENDANT ON OR INDEPENDANT OF THERAPY. CELLULAR VSTAGING MAY BE ALONG NEW BASIC PARAMETERS SUCH GROWTH RATE IN VITRO/PERCENTAGE OF CELLS SURVIVING IN VITRO PLATING AND/OR SIMILAR PARAMETERS RELATING TO IN-VIVO TRANSPLANTATION .A CRUDE SUMMARY WOULD

DETERMINE THAT THE MORE CELLS SURVIVING AND THE GREATER THE GROWTH RATE IN CONDITIONS WITH GREATER MARGINS OF BIAS AGAINST THE TARGET CELL/ORGANISM, THE MORE RESISTANT, STURDY AND POSSIBLY MORE AGGRESSIVE/UNDIFFERENTIATED THEY ARE. CELLULAR AND ORGANISM STAGING AS SUGGESTED BY THIS PATENT ALSO OCCURS AT A MORE INTRICATE LEVEL. DATA BASE RELATING TO ACTIVITY/GROWTH/FUNCTION OF CELL /ORGANISM ETC UNDER INVESTIGATION UNDER CONDITIONS OF VARIOUS MARGINS OF BIAS .MEASURING SUCH VARIABLES AS GROWTH RATE, MUTATION RATE, RESISTANCE/SENSITIVITY TO VARIOUS F/A/P'S ETC INCLUDING THERAPY. ENABLES THE CHARTING OF CELL/ORGANISM ON

VARIOUS CURVES REPRESENTING A LARGE PERCENTAGE OF POSSIBLE BEHAVIOUR PATTERNS INCLUDING GROWTH RATE, EXPRESSION OF RESISTANCE AND CELLULAR MARKERS/CHANGES IN

COMPOSITION(ABSOLUTE/RATIO)/METABOLISM ETC . THIS DATA CAN THEN BE USED TO INDICATE STRENGTHS/WEAKNESSES .THERAPY LIKELY TO IMPACT FAVOURABLY AND HOW LONG IT WILL BE BEFORE RESISTANCE DEVELOPS ETC.INDICATYION OF HOST STATUS ALONG SIMILAR PARAMETERS CAN ALSO BE OBTAINED.

IN THE CASE OF AIDS, FOR EXAMPLE, IT HAS TO DATE BEEN VERY

DIFFICULT TO EVALUATE STAGING AND PROGNOSIS .TOTAL T CELL COUNTS AND OTHER PARAMETERS HAVE BEEN INDICATORS BUT BY NO MEANS HAS THERE BEEN AN EFFECTIVE WAY TO PREDICT WHEN A DROP WAS LIKELY TO OCCUR NOR ACCURATELY PROGNOSTICATE . CONTROVERSY HAS ALSO EXISTED AS TO OPTIMAL TIMING OF THERAPY. KNOWLEDGE OF DATA PERTAINING TO SUCH ISSUES AS IMMUNOLOGICAL RESPONSE TO VARIOUS STIMULI SUCH AS BACTERIAL/VIRAL/PARASITE/.FUNGAL/CANCER/OTHER CHALLENGE AND GRAPHING THESE PROPERTIES AS THEY CHANGE IN TIME WITH EVOLUTION OF DISEASE WILL ENABLE ACCURATE STAGING OF DISEASE . DATABANKS REPRESENTING DIFFERENT TIMES OF APPLICATION OF THERAPY AND RESPONSES MAY ALSO OPTIMISE TREATMENT.

SIMPLE IN-VITRO CULTURES TO DETERMINE CELL SURVIVAL PERCENTAGE AND TIME UNDER CONDITIONS OF VARIOUS MARGINS OF BIAS INCLUDING PH CHANGES ETC AS WELL AS ABILITY TO RESPOND AND EXTENT OF RESPONSE TO IMMUNOSTIMULATING AGENTS SUCH AS (BY WAY OF EXAMPLE, BUT NOT LIMITED TO) INTERFERON, INTERLEUKIN, LEVAMISOLE ETC. CAN ALL LEAD TO VALUABLE KNOWLEDGE.

IT IS IMPORTANT TO REALISE THAT THE INFORMATION OBTAINED WILL GIVE RELATIVELY RAPID INFORMATION AS TO STATE OF FACTORS BEING EVALUATED AS EVALUATION ONLY NEEDS TO PROCEED LONG ENOUGH TO PLACE TARGET ON PREEXISTING DATABASES BEFORE USEFUL INFORMATION IS AVAILABLE.

BUILDING THE DATABASE.

ALTHOUGH THE MEDICASL MODEL, PARTICULARLY WITH REFERANCE TO AIDS, CANCER AND INFECTIONS, WILL BE USED, THE PATENT IS NOT RESTRICTED TO THESE DISORDERS NOR IS IT RESTRICTED TO THE MEDICAL MODEL. IN

CONJUNCTION WITH THE CLAS S I F I CAT I ON PATENT . BY SAME

INVENTOR, BROADER APPLICATION CAN BE EASILY ENVISIONED BOTH WITHIN AN WITHOUT THE MEDICAL MODEL (EVEN WHERE CAUSE OF DISEASE IS UNKNOWN, FOR

EXAMPLE, SYNERGISTIC, INFECTIVE, NEUTRAL, ANTAGONISTIC, NEMESIS

F/A/P'S ETC. MAY EE KNOWN AND DATA OBTAINED FOR ANY/ALL OF THESE WOULD BE OF CLINICAL SIGNIFICANCE).

STRUCTURING OF DATABASE

1-TARGET DATA

2-INTERACTION DATA

3-HOST DATA

1-TARGET DATA.

TARGET HERE IS DEFINED AS ORGANISM/CELL/OTHER SUBJECT OF

INVESTIGATION.

TARGET DATA IS THAT UNIQUELY PERTAINING TO THE TARGET IN VARIOUS IN-VITRO/IN-VIVO SITUATIONS WITH VARIED MARGINS OF BIAS UNDER BOTH SET CONDITIONS AND THOSE WITH VARYING MARGINS OF BIAS (BOTH POSITIVE AND NEGATIVE BIAS ARE USED -IN THESE

SITUATIONS, SEPARATELY AND/OR, ALTERNATELY AND/OR IN VARIOUS

COMBINATIONS/PERMUTATIONS. IT IS POSSIBLE, FOR EXAMPLE, TO HAVE CONDITIONS FAVOURABLE TO TARGET(POSITIVE BIAS) COEXISTING WITH CONDITIONS UNFAVOURABLE TO TARGET(NEGATIVE BIAS). IF THE TARGET IS AN AEROBIC ORGANISM SENSITIVE TO PENICILLIN, IT MAY BE CULTURED IN A MEDIUM WHICH IS WELL AIRED(POSITIVE BIAS) BUT WHICH CONTAINS PENICILLIN(NEGATIVE BIAS).

MANY OF THE PARAMETERS TO BE DISCUSSED CAN BE MEASURED IN TERMS OF TIME/TARGET CYCLES AND/OR GENERATIONS .DATA CAN THEREFORE BE PRESENTED WITH REFERANCE TO DEFINED CONDITIONS/PARAMETERS AND TARGET RESPONSE PER UNITS OF TIME/CYCLE AND/OR GENERATIONS. OPTIMAL GENERATION

OF MAXIMUM EMBODYMENTS.

A-NEED

THE IMPORTANCE OF STRUCTURING DATA TO INCLUDE THIS PARAMETER MAY BE ILLUSTRATED IN MANY WAYS. ONE CURRENT SITUATION WHICH MAY BENEFIT CONSIDERABLY IS THE GENERATION OF A VACCINE FOR AIDS.

IMMUNISING AGAINST HIV. IS VEXED BY THE PROBLEM OF VIRAL MUTATION. IT APPEARS THAT THE VIRUS MUTATES IN A FASHION AND AT A RATE THAT RENDERS MANY VACCINES INEFFECTIVE BY ALTERATION OF ANTIGENIC

STRUCTURE AGAINST WHICH THE VACCINE WAS RAISED; IN OTHER WORDS, BY

ALTERING ITS APPEARANCE, IT ESCAPES VACCINE EFFECTS GENERATED AGAINST ITS 'OLD SKIN '. SIMILARLY, MUTATION ALLOWS OTHER SYSTEMS TO

ESCAPE THERAPY.

BY KNOWING A LARGE AMOUNT OF POSSIBLE MUTATION, COULD THERAPY NOT BE BETTER STRUCTURED?

FURTHERMORE ; VACCINES RAISED AGAINST MANY; IF NOT ALL MUTATIONS OF

VIRUS WOULD STAND A GREATER CHANCE OF SUCCESS THAN THOSE RAISED AGAINST ONE PRESENTATION AND WOULD SEEM TO BE EASIER TO PREPARE THAN SEARCHING FOR COMMON DENOMINATORS IN THE HIT AND MISS

TECHNIQUES CURRENTLY EMPLOYED. (COMMKON FACTOR DOES EXIST,SEE

PREVIOUS DISCUSSION RELATING TO CD4 RECEPTORS)

OBTAINING AN ADEQUATE POOL OF MULTIPLE EMBODYMENTS OF TARGET MAY BE DONE BY COLLECTING AND POOLING MULTIPLE SAMPLES FROM PATIENTS THESE MAY BE SUBDIVIDED BY OTHER FACTORS SUCH AS TREATMENT, TYPE

AND LENGTH OF, T CELLS AT START ; UNTREATED ETC. BUT THIS MAY NOT BE NECESSARY AS ULTIMATE GOAL IS THE COLLECTION OF AS LARGE A POOL OF VARIATIONS AS POSSIBLE . DIVISION OF POOL ACCORDING TO

DEFINED COLLECTION CRITERIA SUCH AS TREATED/UNTREATED AND/OR OTHER CLINICAL/LABORATORY PARAMETERS MAY BE USEFUL IN DEFINING WHICH GROUP APPLIES BEST IN A GIVEN PATIENT/SITUATION BOTH

CURRENT AND ANTICIPATORY. )

ABSOLUTE POTENTIAL MAY BE EVALUATED IN SEVERAL WAYS;LET US

CONSIDER SOME OF THESE;

1-ENRICHED MEDIUM,

N THIS SITUATION, THE TARGET IS PLACED IN SITUATION OF OPTIMAL GROWTH REQUIREMENT AND ALLOWED TO EXPRESS AS MANY EMBODYMENTS AS POSSIBLE OVER A PERIOD OF TIME. SOME ORGANISMS WILL MUTATE/DISPLAY COME OF THEIR OTHER FORMS, OTHERS WILL BE CONTENT TO REMAIN

U NCHANGED AS THEY ARE UNCHALLENGED.

2-RESTRICTED MEDIUM

TARGET IS PLACED IN MINIMAL MEDIUM, AND/OR OTHER SITUATION WHERE S URVIVAL AND GROWTH ARE BARELY SUPPORTED.RESPONSE TO THIS

SITUATIOJN HAS VARIED FROM ORGANISMS WHICH MUTATE TO A MORE HARDY/AGGRESSIVE FORM TO OTHERS THAT REMAIN THE SAME.GROWING W ITHIN THE CONFTNES PERMITTED ANDF EVENTUALLY DYING OFF.

IT MAY BE POSSIBLE TO INDUCE GENERATION OF DIFFERENT EMBODYMENTS OF TARGET BY CYCLING BETWEEN ENRICHED AND MINIMAL MEDIA.

3-INDUCTION/FASCILITATION OF CHANGE.

IF THERE ARE KNOWN TO BE MUTANTS/VARIANTS/INDUCEABLE CHANGES THAT ENABLE AN ORGANISM TO SURVIVE IN CONDITIONS THAT WOULD OTHERWISE BE INCOMPATIBLE WITH ITS SURVIVAL THEN THESE CHANGES MAY BE GRADUALLY INTRODUCED AND/OR PULSED WITH NORMAL/ENRICHED MEDIA TO ENCOURAGE THE EMERGANCE OF THE REQUIRED CHANGE(S).

CONDITIONS MAY BE CREATED IN BOTH ENRICHED AND MINIMAL MEDIA AND ANY VARIETY OF BIASED MEDIA, COMBINATIONS/PERMUTATIONS , PULSING OF MEDIA AND CONDITIONS OVER VARIED DEFINED TIME PERIODS IN ORDER TO GENERATE MULTIPLE CHANGES.

SOME F/A/P'S ETC. CAPABLE OF INDUCING CHANGE /MUTATION INCLUDE ; PHYSICAL/CHEMICAL AND BIOLOGICAL F/A/P'S ETC. CAPABLE OF CAUSING A CHANGE IN THE STRUCTURE/PRESENTATION/METABOLISM/FUNCTION AND/OR OTHER F/A/P/'S ETC. IN THE TARGET MAY DO SO DIRECTLY AND/OR INDIRECTLY.

DIRECT ACTION - THIS MAY BE BY DIRECT CAUSE - EXAMPLES OF THIS MAY BE PHYSICAL AGENTS SUCH AS HEAT/CHEMICAL CHANGES SUCH AS PH EXTREMES OR BIOLOGICAL AGENTS SUCH AS ENZYMES THAT CAN ACT DIRECTLY TO CAUSE INTERNAL AND OR EXTERNAL STRUCTURAL AND OR OTHER CHANGES IN THE TARGET ORGANISM. ENERGY AND CH

PHYSICAL-RADIATION- GAMMA, UV.ETC., TEMPERATURE

CHEMICAL-OZONE/PEROXIDE/OTHER CHEMICALS CAUSING STRESS INCLUDING PH ETC.

BIOLOGICAL-ANTIBIOTICS, PLASMIDS .

1-TEMPORAL STUDIES

2-ENRICHED MEDIUM/GROWTH CONDITIONS

3-RESTRICTED MEDIUM/GROWTH CONDITIONS

4-MUTATION FACTORS

5-ORDINARY MEDIUM/ANIMAL

6-CURRENT GROWTH MEDIUM

simple culture profileAND EVAL EFFICACY

CHECK GRAPH B4 DURING AND AFTER RX TO EVALUATE EFFICACY. DIRECT ACTION-THIS MAY BE BY DIRECT CAUSE -EXAMPLES OF THIS MAY BE PHYSICAL AGENTS SUCH AS HEAT, SOUND WAVES AND/OR OTHER

ENERGY/PHYSICAL AGENT WHICH CAUSES INTERNAL AND OR EXTERNAL CHANGES SUCH AS THE DENATURING/UNCOVERING/REMOVAL OF SUPERFICIAL STRUCTURES TO ALLOW PREVIOUSLY 'HIDDEN ' ONES TO PRESENT

THEMSELVES; VARIOUS CHEMICAL AGENTS INCLUDING THOSE THAT CAN CAUSE DRAMATIC PH CHANGES CAN ALSO DO THIS AS CAN BIOLOGICAL AGENTS SUCH AS DIGESTIVE ENZYMES . MANY CHANGES INDUCED OR BROUGHT ABOUT BY F/A/P'S ETC. IN THIS CATEGORY REQUIRE THE CONTINUED PRESENCE OF THE F/A/P'S ETC.

CHANGES WHICH LAST EVEN AFTER CAUSE IS REMOVED OFTEN NEED TO INVOLVE THE ALTERATION OF SOME INTERNAL F/A/P'S ETC. IN THE TARGET BY THE CAUSE. THIS WOULD INVOLVE PHYSICAL/CHEMICAL/BIOLOGICAL F/A/P'S ETC. CAPABLE OF DIRECTLY EFFECTING AND/OR DAMAGING TARGET STRUCTURE.RADIATION(U.V.,X-RAY,OTHER) CAPABLE OF DAMAGING NUCLEAR STRUCTURE MAY LEAD TO LASTING CHANGES IN TARGET AND ITS EFFECT MAY FOLLOW THROUGH SEVERAL GENERATIONS. CHEMICALS SUCH AS

CHEMOTHERAPEUTIC AGENTS AND OZONE ETC MAY ALSO BE CAPABLE OF THE AFOREMENTIONED. THERE ARE BIOLOGICAL AGENTS SUCH AS POISONS WHICH CAN ALSO ACT THIS WAY. IN THE FIELD OF BIOLOGICALS HOWEVER, IT IS ALSO POSSIBLE TO CAUSE A PERMANENT CHANGE BY DONATING IT.

BACTERIA, FOR EXAMPLE .MAY BE GIVEN GENETIC INFORMATION TO EXPRESS IN THE FORM OF PLASMIDS , PHAGES ETC.

PCB F/A/P'S ETC. MAY BE COMBINED IN ANY COMBINATIONS OR

PERMUTATIONS FOR DESIRED EFFECT.

PLASMIDS CODING FOR ANTIBIOTIC RESISTANCE MAY BE INSERTED INTO TARGET BACTERIAL GENOME, THEN THE ANTIBIOTIC MAY BE INTRODUCED INTO THE ORGANISM'S ENVIRONMENT TO CAUSE EXPRESSION OF INSERTED INFORMATION(OTHER PROPERTIES OF TARGET ORGANISM EXPRESSING THAT GENETIC INFORMATION MAY BE EVIDENT INCLUDING ANTIGENIC PROPERTY CHANGES . )

INDIRECT CHANGES INVOLVE INTERPLAY OF F/A/P'S ETC WITH THIRD PARTY BEFORE THE CONSEQUENCES CAN IMPACT ON TARGET CAUSING CHANGE.

ALL SUCH F/A/P'S ETC. MAY BE MADE TO ACT ON TARGET IN

AMPLE, ENRICHED/MINIMAL/RESTRICTED GROWTH ENVIRONMENT AND IN THOSE

OF VARIABLE BIAS; SINGLY AND OR IN VARIOUS COMBINATIONS OR

PERMUTATIONS.

MEDIA MAY BE CONSTANTLY STABILISED WITHIN DEFINED PARAMETERS OR ALLOWED TO DEPLETE ITSELF TO VARIOUS STAGES ± PCB F/A/P'S ETC TO CAUSE CHANGE(S)IN TARGET. DIRECT ACTION-THIS MAY BE BY DIRECT CAUSE -EXAMPLES OF THIS MAY BE PHYSICAL AGENTS SUCH AS HEAT, SOUND WAVES AND/OR OTHER

ENERGY/PHYSICAL AGENT WHICH CAUSES INTERNAL AND OR EXTERNAL CHANGES SUCH AS THE DENATURING/UNCOVERING/REMOVAL OF SUPERFICIAL STRUCTURES TO ALLOW PREVIOUSLY 'HIDDEN' ONES TO PRESENT

CHANGES WHICH LAST EVEN AFTER CAUSE IS REMOVED OFTEN NEED TO INVOLVE THE ALTERATION OF SOME INTERNAL F/A/P'S ETC. IN THE TARGET BY THE CAUSE. THIS WOULD INVOLVE PHYSICAL/CHEMICAL/BIOLOGICAL F/A/P'S ETC. CAPABLE OF DIRECTLY EFFECTING AND/OR DAMAGING TARGET STRUCTURE . RADIATION (U. V . , X-RAY , OTHER ) CAPABLE OF DAMAGING NUCLEAR STRUCTURE MAY LEAD TO LASTING CHANGES IN TARGET AND ITS EFFECT MAY FOLLOW THROUGH SEVERAL GENERATIONS. CHEMICALS SUCH AS

BACTERIA, FOR EXAMPLE ,MAY BE GIVEN GENETIC INFORMATION TO EXPRESS IN THE FORM OF PLASMIDS, PHAGES ETC.

PCB F/A/P'S ETC. MAY BE COMBINED IN ANY COMBINATIONS OR

PERMUTATIONS FOR DESIRED EFFECT.

PLASMIDS CODING FOR ANTIBIOTIC RESISTANCE MAY BE INSERTED INTO TARGET BACTERIAL GENOME, THEN THE ANTIBIOTIC MAY BE INTRODUCED INTO THE ORGANISM'S ENVIRONMENT TO CAUSE EXPRESSION OF INSERTED INFORMATION(OTHER PROPERTIES OF TARGET ORGANISM EXPRESSING THAT GENETIC INFORMATION MAY BE EVIDENT INCLUDING ANTIGENIC PROPERTY CHANGES.)

ALL SUCH F/A/P'S ETC. MAY BE MADE TO ACT ON TARGET IN

AMPLE,ENRICHED/MINIMAL/RESTRICTED GROWTH ENVIRONMENT AND IN THOSE

OF VARIABLE BIAS; SINGLY AND OR IN VARIOUS COMBINATIONS OR

PERMUTATIONS.

MEDIA MAY BE CONSTANTLY STABILISED WITHIN DEFINED PARAMETERS OR ALLOWED TO DEPLETE ITSELF TO VARIOUS STAGES ± PCB F/A/P'S ETC TO CAUSE CHANGE(S)IN TARGET.

AMPLIFICATION OF . DESIRED CHANGES MAY BE MADE BY ALLOWING SELECTED CHANGES TO GROW IN ENRICHED MEDIA,AND OR BY PCR OR OTHER METHOD TARGET DATA IN SUMMARY,THEREFORE AIMS TO IDENTIFY A LARGE AMOUNT OF POSSIBLE TARGET PRESENTATIONS BY PLACING IT IN A VARIETY OF CONDITIONS WHICHf, EITHER ALLOW IT TO PRESENT MULTIPLE EMBODYMENTS OR ACTUALLY CAUSE/INDUCE THE CHANGE. CHANGE/ALTERATION/MUTATION POTENTIAL MAY BE INDEXED AS ABSOLUTE IF UNRESTRICTED BY GROWTH CONDITIONS OR RESTRICTED IF WITHIN DEFINED GROWTH CONFINES. USE OF MULT I PHASED ANT IB I OTI C THERAPY WI TH B IOLOG I CAL COMB INAT I ON THERAPY .

D IRECT AND ANT I C I PATORY .

DEFINITIONS

MULT I PHAS I C ANT IB I OT I C THERAPY-

THIS TERM REFERS TO ANTIBIOTC(S) WHICH HAVE UNDERGONE ALTERATIONS IN ORDER TO RETAIN ACTIVITY AGAINST TARGET ORGANISM. THIS IS ACCOMPLISHED BY CULTURING THE ORGANISM OF ANTIBIOTIC ORIGIN(TO BE EXAMPLIFIED BY PENICILLIUM NOTATUM) ALONG WITH TARGET ORGANISM UNDER CONDITIONS OF VARIED BIAS AS WELL AS GENERATION AND ANTICIPATION OF RESISTANCE AND NEW COPING MODALITIES IN OPEN AND CLOSED SYSTEMS WHICH PROMOTE AND/OR INDUCE MAXIMUM VARIABILITY.

SIMPLY PUT, THE ANTIBIOTIC-GENERATING ORGANISM IS INCUBATED WITH TARGET ORGANISM.

PHASE ONE ANTIBIOTIC IS THAT GENERATED BY THE PENICILLIUM UPON PRIMARY EXPOSURE TO THE TARGET ORGANISM.

AS THE TARGET ORGANISM ACQUIRES RESISTANCE, THE PENICILLIUM WILL GENERATE COUNTERING MECHANISMS EITHER SPONTANEOUSLY OR UPON ASSISTANCE(VARIABLE BIAS/INDUCTION IN OPEN OR CLOSED SYSTEMS ETC. )ANTIBIOTICS GENERATED AT THIS STAGE WILL DEMONSTRATE

EFFICACY AGAINST ORGANISMS RESISTANT TO THE PREVIOUS ANTIBIOTIC. THIS NEW FORM IS CALLED PHASE 2 ANTIBIOTIC.

AS THE PROCESS REPEATS ONE GENERATES MULTIPLE PHASES OF ANTIBIOTIC COMPOUNDS AND COMPLEXES EACH LATTER PHASE ACTIVE AGAINST ORGANISMS PRIOR PHASES WERE NOT SUCCESSFUL AGAINST.

THIS, HOWEVER IS NOT TO SAY THAT EACH SUCCESSIVE PHASE NECESSARILY WILL BE ACTIVE AGAINST ALL OF THE PRECEDING PHASES. IT MAY BE AND OFTEN IS THE CASE THAT PHASE 2 ANTIBIOTIC IS MORE ACTIVE AGAINST PHASE 2 ORGANISM WHEREAS PHASE 3 ANTIBIOTIC IS MORE ACTIVE

AGAINST PHASE 3 BUT PERHAPS LESS ACTIVE THAN PHASE 2.

PATENT ALSO COVERS THE GENERATION OF AN ANTIBIOTIC/ANTIBIOTIC COMBINATION TO BE ACTIVE AGAINST A BROAD RANGE OF TARGET PHASES AS WELL AS THE USE OF THE PHASE LIBRARY(DATA ACCUMULATED ON TYPED ORGANISMS PERTAINING TO CHANGES IN

STRUCTURE/CONFIGURATION/FUNCTION WHEN EXPOSED IN OPEN AND CLOSED SYSTEMS TO CERTAIN ANTIBIOTICS AND ANTIBIOTIC COMBINATIONS ETC TO PREDICT LIKELY RESISTANCE PATTERN;. THERAPY PROGRAM DESIGNED TO NEUTRALISE THAT COULD THEN BE INSTITUTED EG. ANTIBIOTIC(S) WHICH CAN EFFECTIVELY DEAL WITH THE ANTICIPATED RESISTANT GROUP OF ORGANISMS COULD BE INSTITUTED EARLY IN THERAPY.

INVENTOR PREFERS THE APPLICATION OF MULTIPLE ANTICIPATORY PHASES OF THE ONE ANTIBIOTIC PERHAPS OVER 2 OR 3 PHASE GENERATIONS IN COMBINATION WITH OTHER PHASE MODALITIES SO AS NOT TO ACCELERATE THE DEVELOPMENT OF MORE ADVANCED RESISTANT TARGET STRAINS. DEMONSTRATION

A BASIC DEMONSTRATION INVOLVES E. COLI AND PENICILLIUM. STRAINS

WERE NOT IDENTIFIED FOR THIS TRIAL.

THE PENICILLIUM AND E. COLI WERE TESTED IN ANTIBIOTIC SENSITIVITY

ASSAY.

LESS THAN 10 PERCENT OF E. COLI COLONIES WERE RESISTANT TO THE

PHASE ONE PENICILLIN BEING GENERATED BY THE MOULD.

PENICILLIUM MOULD WAS PLACED INTO TRYPTICATED SOY BROTH AND

ALLOWED TO GROW FOR 3 WEEKS. AT THAT TIME TSB CONTAINED

SIGNIFICANT LEVELS OF PHASE ONE PENICILLIN, THIS WAS AGAIN TESTED

AND E. COLI CULTURES AGAIN DEMONSTRATED LESS THAN 10 PERCENT

RESISTANCE.

10 CC OF ECOLI ORGANISMS 10,000,000,000 ORGANISMS PER ML WERE

THEN INNOCULATED INTO THE BROTH.

WITHIN 3 DAYS THERE WAS CLOUDING OF THE MEDIUM, UPON

PLATING,E. COLI COLONIES WERE FOUND WITH 90% RESISTANCE TO PHASE

ONE PENICILLIN.

THIS CULTURE WAS THEN STORED

CULTURES WERE COLLECTED DAILY AND AT THE END OF THREE WEEKS , THE

BROTH CONTAINING THE MOULD HAD CLEARED. NO E. COLI REMAINED IN THE

MEDIUM.

TESTS ON THE TSB SHOWED INREASING ANTIBIOTIC EFFICACY WHICH

MAXIMISED AT ABOUT 2 WEEKS OF CO- INCUBATION.

PENICILLIUM MOULD REMOVED AT THAT TIME AND CULTURED ALONE

PRODUCED PHASE 2 PENICILLIN.

ATTEMPTS TO INCUBATE PHASE 2 E. COLI WITH PHASE 2 PENICILLIUM WERE

MET WITH SUCCESS 6 DAYS FOLLOWING INNOCULATION OF 10CC PHASE 2

E. COLI IN THE SAME MANNER AS WAS DONE IN PHASE 1 TRIALS.

AGAIN,REPEATING THE PROCESS GAVE RISE TO A PHASE 3 E COLI AND

PHASE 3 PENICILLIN.

MANY SUCH COMBINATIONS CAN BE TRIED E.G. INCUBATION OF MULTIPLE TARGET PHASES WITH MULTIPLE PENICILLIUM PHASES TO YEILD BROAD SPECTRUM THERAPY, PATENT COVERS THIS APPLICATION BUT DOES NOT ENCOURAGE IT AS IT MAY GREATLY MUTATE DISEASE.

THE TSB IN WHICH THE PENICILLIUM AND E.COLI WERE INCUBATED

DISPLAYED GRATER RESISTANCE TO E.COLI INFECTION THAN THE

DEVELOPED PHASE OF PENICILLIUM WHEN CULTURED ALONE .ALTHOUGH THE EFFICACY OF THE VARIOUS ANTIBIOTIC PHASES IS PROBABLY INFLUENCED BY FACTORS OTHER THAN ANTIBIOTIC MODIFICATION ITSELF;

PLAQUE FORMATION IN CULTURES CLOSE TO THE ANTIBIOTIC ZONE OF INHIBITION ON AGAR 'PLATE TESTING FOR ANTIBIOTIC SENSITIVITY WOULD SPREAD THROUGHOUT THE PLATE OVER A TWO DAY PERIOD, SUGGESTING THAT PHAGE LYSIS WAS ALSO PLAYING A ROLE.

WHEN CRUDE PENICILLIN(CP) WAS EXTRACTED FROM PURE CULTURES OF PHASE1,PHASE2 AND PHASE3 PENICILLIUM CULTURES; (CP WAS EXTRACTED BY 0.2 MICRON FILTRATION OF PURE CULTURE MEDIUM-TSB AFTER 3 WEEKS OF INCUBATION.) AND TESTED AGAINST THE ORIGINAL E.COLI

CULTURE; THERE WERE NO E. COLI SURVIVORS. IT APPEARS THAT FOR THIS PARTICULAR BACTERIA, A COMBINATION OF 3 PHASES OF RESISTANT THERAPY WAS ENOUGH TO RAPIDLY OVERCOME THE BACTERIA PRIOR TO DEVELOPMENT OF RESISTANCE. OTHER BACTERIA MAY NEED THE PROCESS EXTENDED TO FURTHER PHASES HENCE THE TERM MULTIPHASED ANTIBIOTIC THERAPY.

CLASSIFICATION BY PHASE LEVEL CAN NOW BE DONE. CHARTS

INDICATING PERCENTILES AND PHASE KILL PERCENTAGES MAY BE USED TO IDENTIFY CORRECT ANTIBIOTIC PROTOCOLS FOR PARTICULAR ORGANISMS AS INDICATED BY TYPING AND INITIAL CULTURE RESPONSE TO PHASED ANTIBIOTIC COMBINATIONS.

PHASE LEVEL CLASSIFICATION NEEDS TO BE RELATED

TO THE SYSTEM BEING EVALUATED E.G. PATIENT HOST AS MANY OTHER FACTORS INCLUDING IMMUNOLOGICAL STATUS MAY NEED CONDIDERATION. IMMUNOCOMPROMISED INDIVIDUALS MAY REQUIRE GREATER DOSEAGES AND MORE ADVANCED PHASE LEVELS, FOR EXAMPLE.

PHAGE /PLASMID INFLUENCE.

LYTIC PHAGES SYNERGISE WITH ANTIBIOTIC THERAPY TO CREATE GREATER BACTERIA CELL DESTRUCTION, PERMITTING LOWER ANTIBIOTIC DOSES AS WELL AS LOWER PHASE CLASSIFICATION TO ACHIEVE REASULTS .

IT IS POSSIBLE FOR EXAMPLE, FOR PHASE 1 PENICILLIN TO EFFECTIVELY DESTROY BACTERIA OF 2ND, 3RD OR EVEN MORE ADVANCED PHASES .IF COMBINED WITH LYTIC PHAGES. OF 1ST AND/OR MORE ADVANCED PHAGES.

IN A LIVING SYSTEM. PHAGES MAY BE USED ALONE, HOWEVER, PHASE

RESISTANCE CAN BE SEEN TO DEVELOP HERE TOO. USING MULTIPHASED PHAGE SYSTEMS PROVES MORE EFFECTIVE, BETTER YET IS COMBINATION WITH ANTIBIOTIC AND IMMUNE RESPONSES.

MULTIPHASED PHAGE SYSTEM.

IN MUCH THE SAME WAY AS ANTIBIOTICS ENCOUNTER RESISTANCE, SO CAN

LYTIC PHAGES. LYTIC PHAGES ARE THOUGHT TO EXIST IN BACTERIAL CELLS

IN MUCH THE SAME WAY THAT LYSOSOMES EXIST IN NORMAL CELLS; WITH

THE CAPACITY TO CODE FOR THAT CELL'S DESTRUCTION.

WORK IN THE 1920 'S UNTIL THE EARLY 1930 'S ATTEMPTED TO MAKE USE

OF THESE PHAGES IN THE TREATMENT OF INFECTIONS WITH VARIOUS , OFTEN

POOR RESULTS.

THE PHAGES USED WERE OFTEN ISOLATED FROM FLIES, SEWERAGE WATER

ETC.

THIS PATENT DIFFERS IN THAT PHAGES USED MAY BE GENERATED FROM

OTHER SOURCES OR FROM WITHIN THE TARGET BACTERIA ITSELF.

CULTURE AND PURIFICATION FASCILITIES/TECHNIQUES TODAY MAKE FOR

PURER PRODUCT

PATENT ALSO COVERS MULTIPHASED PHAGE DEVELOPMENT

PATENT COVERS USE OF PHAGES IN COMBINATION WITH ANTIBIOTICS AND

/OR IMMUNE RESPONSES THEMSELVES IN EITHER NORMAL AND/OR PHASED

APPLICATION. RAISING AND PROCESSING OF LYTIC PHAGES.

MANY BACTERIA WILL UNDERGO PHAGE LYSIS WHEN EXPOSED TO

TRAUMATIC/OTHER ENVIRONMENTAL CHANGES WHICH MAKE BACTERIAL

SURVIVAL DIFFICULT IF NOT IMPOSSIBLE.

SUCH CONDITIONS MAY INCLUDE MEDIA DEPLETED OF NUTRIENTS .CHANGES

IN OSMOLARITY, PH, ADDITION OF ANTIBIOTICS ETC.

PHAGE ACTIVATION MAY BE PRECIPITATED BY OZONE,UV RADIATION

AMONGST OTHER FACTORS OR AGENTS . PATENT COVERS ALL THESE

TECHNIQUES AS WELL AS THE USE OF PRE-EXISTING PHAGES

PHAGES EXTRACTED FROM TARGET ORGANISM

PHAGES CAN BE EXTRACTED FROM CULTURES OF TARGET ORGANISM BY CULTURING IN CLOSED OR IN OPEN SYSTEMS. SYSTEMS ARE CLASSIFIED AS OPEN OR CLOSED DEPENDING ON HOW ACCESSABLE THEY ARE TO OUTSIDE ORGANISMS/INFLUENCES; OPENNESS MAY EXIST IN VARIOUS DEGREES.

CONTINUOUS CULTURING OF BACTERIA WILL OFTEN LEED TO SPONTANEOUS

LYSIS FROM ACTIVATION OF INHERENT PHAGES.

OPEN SYSTEMS WHICH PERMIT INTERACTION WITH OTHER FORCES AND/OR

FACTORS MAY ACCELERATE THE PROCESS . AN EXAMPLE BEING EXPOSURE TO

U.V LIGHT, IONIZING RADIATION AND OR CHEMICAL STRAIN SUCH AS BY

OZONE OR PH EXTREMES OR BY BIOLOGICAL FACTORS SUCH AS

ENZYMES, ANTIBIOTICS ETC . AN OPPEN SYSTEM MAY THEREFORE BE ABLE TO

EXPOSE TARGET TO EXTRANEOUS SOURCES OF PHAGE AND/OR FACTORS WHICH

PRECIPITATE PHAGE ACTIVATION WITHIN THE TARGET ORGANISM

CULTURES OF LIMITED ACCESS ARE OF BENEFIT AS PRECISE CONTROL MAY

INDICATE CONDITIONS THAT CAN BE DUPLICATED IN-VIVO TO GENERATE

PHAGE ACTIVITY IN-SITU.

RAISING PHAGES FROM TARGET CAN OFTEN BE ACCOMPLISHED BY ALLOWING

BACTERIA TO GROW IN MEDIUM UNTIL FOOD/VITAL NUTRIENT SUPPLY IS

EXHAUSTED.

AN EXAMPLE OF CULTURE IN A LIMITED OPEN SYSTEM IS THE

INNOCULATION OF STAPHYLOCOCCUS AUREUS INTO 500CC OF TRYPTICATED

SOY BROTH. UPON EXPOSURE FOR 20 MINUTES TO ELECTRIC SPARKS

GENERATED BY 4 MILLION VOLTS OF ELECTRIC DISCHARGE ON DAY 3 OF

CULTURE , PHAGE ACTIVITY WAS APPARENTLY ACTIVATED BY THE UV, OZONE

AND ELECTROMAGNETIC FIELDS ASSOSCIATED WITH THE

DISCHARGE. CLEARING OF THE MEDIA OCCURRED ON DAY 4 INDICATING

PHAGE LYSIS. INNOCULATION OF MEDIA AFTER DASY 3 INTO OTHER

ESTABLISHED CULTURES CAUSED THEIR LYSIS ALSO.

ϊnfi TIME PERIOD FOR PHAGE GENERATION AND NUMBER AND AMOUNT OF

FACTORS INDUCTIVE OF PHAGE ACTIVATION REQUIRED IS VARIABLE.

RAISING OF PHAGE TITRE MAY BE ACCOMPLISHED BY

DIALYSIS, ULTRACENTRIFUGATION ETC. IT IS ALSO POSSIBLE TO RAISE

COUNTS BY ADDING FRESH BACTERIAL CULTURES REPEATEDLY TO PHAGE- RICH SOLUTION.

IF THIS PROCESS IS REPEATED IT WILL OFTEN BE FOUND THAT CLEARING FAILS TO OCCUR AFTER SEVERAL PASSAGES PARTICULARLY IF THE OTHER CONDITIONS OF CULTURE ARE CONDUSIVE TO BACTERIAL SURVIVAL; THIS MAY BE EITHER TO RESISTANCE DEVELOPING TO PHAGE ACTION, LOSS OF PHAGE EFFICACY, SYMBIOSIS DEVELOPING BETWEEN PHAGE AND BACTERIA AND/OR THE PRESENCE OF RESISTANT MUTANTS OF BACTERIA.

WHETHER ANY OF THE ABOVE ARE ACTIVE SINGLY OR IN ANY COMBINATION, IT RAISES THE IMPORTANT OBSERVATION THAT BACTERIA MAY ESCAPE PHAGE LYSIS DESPITE INITIAL RESPONSE.

EXPOSING THE RESISTANT BACTERIA TO AGENTS SUCH AS U.V., OZONE OR ANY OTHERS AS MENTIONED ABOVE,AND/OR OTHERS WILL OFTEN INDUCE

PHAGE ACTIVATION AND PHAGE LYSIS BY SECOND PHASE PHAGE.

IT IS POSSIBLE TO REPEAT THE PROCESS UNTIL SEVERAL PHASES OF LYTIC PHAGE ARE DEVELOPED . DEPENDING ON BACTERIA AND PHAGE

GENERATED, EACH PHAGE WILL BEAR GREATER ACTIVITY AGAINST ITS PHASE OF BACTERIAL CULTURE BUT MAY BE MORE OR LESS EFFECTIVE AGAINST LOWER PHASES. IT HAS ALSO BEEN OBSERVED WITH PHASED PHAGES AS WELL AS WITH PHASED ANTIBIOTICS THAT AS TARGET ORGANISM PASSES THROUGH SEVERAL PHASES, SENSITIVITY TO AN ANTIBIOYIC OR PHAGE OF EARLIER (BUT NOT PRIOR) PHASE MAY REVERT.

IT IS POSSIBLE ALSO TO EXPOSE THE MULTIPLE MUTATIONS AND OR PHASES OF TARGET ORGANISM TO PHAGE GENERATING FACTORS IN ORDER TO GENERATE BROAD-SPECTRUM PHAGE(S).

IT IS ALSO POSSIBLE TO EXPOSE THE TARGET REPEATEDLY TO MIXES OF VARIOUS PHASES OF PHAGES CONSECUTIVE OR OTHER IN ORDER TO ACCELERATE LATTER PHASE RESISTANCE OF ORGANISM.

IN CASE OF STAPHYLOCOCCI TESTED, TREATMENT WITH 3 OR MORE

COPNSECUTIVE PHASES OF PHAGE RESULTED IN IN-VIVO INFECTION

RESOLUTION COMPARABLE TO THAT OF ANTIBIOTIC USE. FURTHER PHASES MAY BE REQUIRED WITH DIFFERENT TARGET ORGANISMS AND EVEN DIFFERENT STRAINS OF THE SAME TARGET.

AS WITH PHASED ANTIBIOTIC THERAPY, IT MAY BE POSSIBLE TO

IMMUNOLOGICALLY NEUTRALISE/TARGET/PREVENT THE DEVELOPMENT OF RESISTANT TARGET PHASES BY TARGETING NEW FEATURES OF ANTIGENIC SIGNIFICANCE AND/OR RELATED TO THE RESISTANCE.THE WAY IN WHICH ANTIBIOTIC AND/OR PHAGE ARE NEUTRALISED MAY GIVE RISE TO

TARGETING MECHANISMS TO BE DISCUSSED LATER.

PHAGE/PLASMID USES/CAUTION

CULTURE TECHNIQUES AS THOSE SUGGESTED PREVIOUSLY AS WELL AS OTHERS GENERATE, PLASMIDS. PLASMIDS AS WELL AS PHAGES ARE CAPABLE OF CARRYING GENETIC INFORMATION INTO BACTERIAL STRUCTURES. IT IS POSSIBLE TO USE PLASMIDS FROM EARLY PHASE TO GIVE LATTER PHASES REGRESSED SENSITIVITY TO EARLIER PHASE AGENTS IE. PLASMIDS AND PHAGES OF EARLY PHASES MAY CARRY EARLY PHASE GENETIC INFORMATION IN-VITRO TRIALS

THESE WERE DESIGNED TO DEMONSTRATE THE EFFICACY AND APPLI CATION OF MULTIPHASED THERAPY .

METHOD

STAPHYLOCOCCUS AUREUS CULTURED FROM A SKIN LESION WAS INNOCULATED

INTO 300 CC OF TRYPTICATED SOY BROTH FOR THREE DAYS . AT THIS TIME

BROTH WAS CLOUDY WITH BACTERIAL GROWTH.

BROTH WAS SHAKEN AND 10CC DOSES WERE INNOCULATED INTO VARIOUS

TEST BROTH BOTTLES AS IDENTIFIED BELOW.THESE 10CC DOSES ARE

CALLED CHALLANGING DOSES OF TARGET ORGANISM (TO)

MULTIPHASED ANTIBIOTIC PREPARATION EFFICACY WAS DEMONSTRATED BY CRUDE PENICILLIN EXTRACTS (CPE), THEIR PHASE BEING NOTED BY

SUBSEQUENT NUMBERS.

MULTIPHASED ANTIBIOTIC PREPARATION EFFICACY WAS DEMONSTRATED BY ACTIVATED CRUDE PENICILLIN EXTRACT (ACPE)

DEFINITIONS AND PREPARATION

MULTIPHASED CRUDE PENICILLIN EXTRACT PREPARATION IS BY COINCUBATION OF PENICILLIUM WITH TARGET ORGANISM(S), THE NUMBEROF BACTERIAL STRAINS AND TYPES BEING CO-INCUBATED DETERMINE HOW BROAD OR RESTRICTED(SPECIFIC) THE CRUDE PENICILLIN EXTRACT IS. FURTHER SPECIFICITY CAN BE ATTAINED BY SELECTIVE CULTURE PROCESSES AS DEFINED PREVIOUSLY.

THE CRUDE PREPARATION OF CO-INCUBATION WITH PENICILLIUM, BACTERIAL CULTURE IN TRYPTICATED SOY BROTH, CELL DEBRIS, BYPRODUCTS ETC. FOR PURPOSES OF THIS TRIAL,THECRUDE PREPARATIONS WERE SIMPLE

FILTRATES OF CO-CULTURE. IT SHOULD BE UNDERSTOOD THAT CULTURE MEDIUM,TYPE, DURATION OF CO-INCUBATION AND OTHER FACTORS ARE VARIABLES ALTHOUGH DEFINED HERE.

THE TERM ACTIVATED FORM OF THE MULTIPHASED ANTIBIOTIC IS USED HERE TO REPRESENT CRUDE EXTRACT OF CULTURES OF ANTIBIOTIC ORGANISM(S) COINCUBATED WITH TARGET ORGANISM(S), PREPARED BY CO-CULTURING UNTIL THERE IS CLEARING OF THE TARGET ORGANISM(S )AT THIS POINT, THE TREATING ORGANISM(TO)OR ANTIBIOTIC ORGANISM IS CONSIDERED ACTIVATED. FILTRATION 0.2 MICRON OF THE BROTH AND CULTURES AT THIS STAGE IS CONSIDERED. ACVTIVATED CRUDE PREPARATION FOR THE PURPOSES OF THIS EXPERIMENT. IT SHOULD BE UNDERSTOOD THAT PATENT ALSO COVERS THE USEFULNESS OF ALL STAGES OF FILTRATION AND PURIFICATION OF PRODUCTS YEILDED BY THE MULTIPHASIC SYSTEM.

THE CRUDE ACTIVATED PRODUCT HERE IS RICH IN ENZYMES .NUCLEIC ACIDS AND MANY OTHER FRAGMENTS OF TREATMENT AND TARGET ORGANISMS .MANY OF THESE FRACTIONS WHEN PURIFIED RETAIN USEFUL FUNCTION BOTH DIRECTLY AND INDIRECTLY, LYSED TARGET FRAGMENTS CAN, FOR

INSTANCE, BE USED AS IMMUNOSTIMULATING AGENT. SOME BENEFICIAL PROPERTIES ARE RETAINED EVEN WHEN BOILED REPEATEDLY, THESE ARE NOT RESTRICTED TO IMMUNOSTIMULANT ACTIVITY.

PATENT COVERS MULT I PHASE ASPECT OF THRAPY GENERATION

AND APPLICATION , IT IS DEMONSTRATED BY BUT NOT RESTRICTED TO THE FURITY AND/OR PRECISE FORMULATIONS OF PODUCTS GIVEN.

WHEN THE ACTIVATED ANTIBIOTIC ORGANISM IS SEPARATED FROM THE CO-INCUBATION AND CULTURED SEPARATELY,AND/OR IS ISOLATED IN NEUTRAL LIQUID SUCH AS SALINE, IT MAY BE ALLOWED TO CONTINUE PRODUCING ITS ANTIBIOTIC PRODUCT(S). THE CONCENTRATION OF THESE WILL DEPENE ON MEDIUM, TIME SINCE CO-INCUBATICN AND TIME SPENT IN THE ISOLATION MEDIUM.

ONCE ISOLATED, A CONCERNTRATE OF THE FUNGUS OR OTHER THERAPEUTIC ORGANISM MAY BE MADE BY SONICATION AND/OR PRESSURE DISRUPTION AND OR OTHER PHYSICAL /CHEMICAL/BIOLOGICAL METHOD OF DISRUPTING THE LIVING ORGANISDM FOLLOWED BY FILTRATION.

AGAIN, IT IS NOT THE PREPARATION TECHNIQUE THAT IS VITAL IN THIS PATENT BUT RATHER THE FACT THAT USEFUL CHANGES OCCUR BY PHASING THE THERAPEUTIC ORGANISMS AND THAT CULTURTES OF VARIOUS DEGREES OF BIAS ALONGST WITH CULTURES OF SPECIFIC TARGET FRAGMENTS CAN EE USED TO INCREASE SPECIFICITY, DECREASE SIDE-EFFECTS AS WELL AS ALLOW A THERAPEUTIC ORGANISM TO MODIFY ITS ACTIVITY AND PRODUCT TO RESTORE ITS EFFICACY OR TO ACQUIRE EFFICACY AGAINST RESISTANT TARGETS.

IN THIS EXPERIMENTAL PROTOCOL, PENICILLIUM MOULD IS TESTED VBOTH IN ACTIVATED FORM AS WELL AS BEING REMOVED FROM CO-INCUBATION AND ALLOWED TO CULTURE SEPARATELY FOR 6 WEEKS IN TRYPTICATED SOY BROTH-500CC. EXTRACTS OF THIS PREPARATION(FITERED THROUGH 0.2 MICRONS) IS TERMED CRUDE PENICILLIN EXTRACT (CPE).

EXPERIMENT 1

OF TRYPTICATED SOY BROTH IN WHICH STAPHYLOCOCCUS HAS BEEN CULTURED FOR 3 DAYS.

GROUP B- 5 ANIMALS WERE INJECTED WITH 5CC OF TRYPTICATED SOY BROTH IN WHICH STAPHYLOCOCCUS WAS CULTURED FOR 3 DAYS

ALONG WITH 10 MILLION UNITS OF PROCAINE PENICILLIN.

GROUP C- 5 ANIMALS WERE INJECTED WITH PHASE 1 AND PHASE 2 CRUDE PENICILLIN EXTRACT (CPE)5cc OF EACH ALONG WITH 5CC OF

STAPHYLOCOCCUS CHALLANGE

GROUP D.

CPE PREPARATIO, SURPRISING PRE ALSO HELPED, LYSATES INC BACT

PRODUCT. FURITY AND/OR PRECISE FORMULATIONS OF PODUCTS GIVEN.

WHEN THE ACTIVATED ANTIBIOTIC ORGANISM IS SEPARATED FROM THE CO-INCUBATION AND CULTURED SEPARATELY , AND/OR I S ISOLATED IN NEUTRAL LIQUID SUCH AS SALINE, IT MAY BE ALLOWED TO CONTINUE PRODUCING ITS ANTIBIOTIC PRODUCT(S).THE CONCENTRATION OF THESE WILL DEPENE ON MEDIUM, TIME SINCE CO-INCUBATION AND TIME SPENT IN THE ISOLATION MEDIUM.

AGAIN, IT IS NOT THE PREPARATION TECHNIQUE THAT IS VITAL IN THIS PATENT BUT RATHER THE FACT THAT USEFUL CHANGES OCCUR BY PHASING THE THERAPEUTIC ORGANISMS AND THAT CULTURTES OF VARIOUS DEGREES OF BIAS ALONGST WITH CULTURES OF SPECIFIC TARGET FRAGMENTS CAN BE USED TO INCREASE SPECIFICITY, DECREASE SIDE-EFFECTS AS WELL AS ALLOW A THERAPEUTIC ORGANISM TO MODIFY ITS ACTIVITY AND PRODUCT TO RESTORE ITS EFFICACY OR TO ACQUIRE EFFICACY AGAINST RESISTANT TARGETS.

IN THIS EXPERIMENTAL PROTOCOL, PENICILLIUM MOULD IS TESTED VBOTH IN ACTIVATED FORM AS WELL AS BEING REMOVED FROM CO-INCUBATION AND ALLOWED TO CULTURE SEPARATELY FOR 6 WEEKS IN TRYPTICATED SOY BROTH-500CC . EXTRACTS OF THIS PREPARATION ( FITERED THROUGH 0. 2 MICRONS) IS TERMED CRUDE PENICILLIN EXTRACT (CPE).

BOTTLE 4-CRUDE PENICILLIN EXTRACT PHASE 1 5CC AND PHASE 2 5CC WERE' ADDED. CLEARING OCCURRED IN 24 HOURS BUT RETURNED TO A LESSER EXTENT WITHIN 48 HOURS.

CULTURE SHOWED PURE STAPHYLOCOCCUS AUREUS, PENICILLIN RESISTANT.

BOTTLE 5-ACTIVATED PENICILLIN EXTRACT PHASE 1,2,- 3.33 CC OF EACH

WERE ADDED.

TOTAL CLEARANCE WITHIN 24 HOURS . NO RETURN OF CLOUDINESS

CULTURE NEGATIVE.

BOTTLE 6-CRUDE PENICILLIN EXTRACT PHASES 1,2 AND 3 WERE ADDED. TOTAL CLEARING WITHIN 24 HOURS. NO RECURRENCE

CULTURE NEGATIVE.

EACH TEST WAS REPEATED 3 TIMES WITH IDENTICAL RESULTS.

I DROP OF BOTTLES 3 OR 5 OR SEVEN WERE CAPABLE OF CAUSING PLAQUE FORMATION IN STAPHYLOCOCCAL CULTURES AS DID A DROP OF ACTIVATED PENICILLIN OF ANY PHASE. THIS SUGGESTS THAT AT LEAST PART OF THE EFFICACY OF SUCH PREPARATIONS IS DUE TO PRESENCE OF PHAGES IN THE PREPARATIONS.

PENICILLIN-RESISTANT STRAINS RAISED IN BOTTLES1.2 AND4 WERE ELIMINATED BY ANY OF THE FOLLOWING; CPE123 , ACPE1.2 ACPE123.

ALONG WITH 10 MILLION UNITS OF PROCAINE PENICILLIN.

STAPHYLOCOCCUS CHALLANGE

GROUP D.

CPE PREPARATIO, SURPRISING PRE ALSO HELPED, LYSATES INC BACT

PRODUCT. INTO LATTER PHASES AND RETURN , AMONGST OTHER THINGS, THEIR

SENSITIVITY. PLASMIDS OF LATTER PHASES CAN ALSO BE IMMUNOLOGICALLY

TARGETED AS WILL BE D I SCUSSED IN IMMUNOLOGI CAL PHASED THERAPY .

MRD IN BIOL ENHANCEMENT

INHIBITION OF PLASMIDS/ENZYMES ETC.

CHANGES SUGGESTED BY OTHER MECHANISMS

INTERESTINGLY, WHEN THE CO-CULTURED MEDIUM WAS CHALLANGED-FASTER

THAN PURE PEN MORE IN 2 DAYS.

ALSO PHAGE/PLASMID RESISTANCE TRANSFER

ALSO ON LEUK/AIDS

PEN/PHAGE/ANTISERA TO R PLASMID/PHAGE/OTHER CHANGE USE OF HYPERTHERMIA IN COMBINATION WITH VACCINE THERAPY INDIVIDUALLY/AS PART OF PRECURSOR/INTERMEDIATE/ENDPRODUCT

THERAPY.

INTRODUCTION

IN PREPARING AN ANTIEACTERIAL VACCINE, FOR EXAMPLE, IT MAY BE

POSSIBLE TO DECREASE THE POSSIBILITY OF FUTURE INFECTION BY RAISING SOME DEGREE OF PROTECTIVE IMMUNITY, WHERE THIS FAILS IT MAY BE BECAUSE OF INSUFFICIENT OVERLAP BETWEEN ANTIGENICITY OF VACCINE AND OF DISEASE., IT MAY BE THAT THE ALTERATIONS TO

TO OVERCOME THIS ONE OR ALL OF THREE MODIFICATIONS NEED TO TAKE PLACE

1-MAKING THE VACCINE RESEMBLE THE

DISEASE MORE CLOSELY.

2-MAKING THE DISEASE RESEMBLE THE

VACCINE MORE CLOSELY.

3-MAKING THE HOST SYSTEM/IMMUNE SYSTEM

RECOGNISE VACCINE/DISEASE WITH

IDENTICAL, EFFECTIVE RESPONSES.

ANOTHER SHORTCOMING OF VACCINES AND RELATED IMMUNOTHERAPlES IS THAT WHEREAS SUCH MEASURES MAY BE OF BENEFIT IN PREVENTION OR IN DEALING WITH A SMALL AMOUNT OF DISEASE; PROCESSES SUCH AS THE WELL DEFINED THRESHHOLD INHIBITION PHENOMENON RESTRICT IMMUNOLOGICAL RESPONSE WHEN THE CHALLANGING LOAD IS OVERWHELMING.

1-MAKING THE VACCINE RESEMBLE THE

DISEASE MORE CLOSELY.

1-RAISING VIRUS IN TARGET AND/OR OTHER CELLS OF HOST TO BE

VACCINATED-THIS ENABLES SCREENING FOR AND REJECTION OF ANY

VARIANTS WHICH MAY BE GROSSLY PATHOLOGICAL TO THE RECIPIENT.

USE OF TEMPORAL EXTRAPOLATION PATENT CAN ALSO TEST

FOR SPECIFIC SYSTEMS/SITUATIONS/INTERACTIONS IN

NORMAL/REDUCED/ACCELERATED TIME FORMATS TO PREDICT FUTURE

EFFECTS. (CELL DIVISION MAY BE ACCELERATED IN VITRO/OTHER ANIMAL SYSTEMS TO STUDY FURTHER GENERATION IMPACT, SLOWED DOWN TO STUDY CELLULAR IMPACT; SIMILAR PROCEDURES WITH DISEASE PROCESS CAN

ACCELERATE OR RETARD ITS GROWTH SO ITS INTERPLAY MAY BE STUDIED WITH OTHER FACTORS, CELLS, DISEASES ETC.)

VARIABLES BUT IN-VITRO AND DEDICATYED ANIMAL

2-MAKING THE DISEASE RESEMBLE THE

VACCINE MORE CLOSELY.

THIS IS THE MAIN POINT TO BE DEMONSTRATED AND EXPLOITED BY THIS

PATENT.

MAKING THE DISEASE RESEMBLE THE VACCINE MORE CLOSELY AT A GRADUAL

PACE CAN BE AVCCOMPLISHED IN SEVERAL WAYS, ONE WILL BE OUTLINED

BELOW;

THE CONCEPT IS Tp TREAT THE DISEASE IN THE SAME MANNER USERD TO

GENERATE THE .VACCINE AND THEN TO ALLOW AN IMMUNE SYSTEM HONED BY

PRIOR ADMINISTRATION OF VACCINE TO ATTACK THE DISEASE.

VACCINES PREPARED BY HEAT INACTIVATION WILL BE USED TO

DEMONSTRATE THE APPLICATION OF THESE GUIDELINES BUT ARE NOT

INTENDED TO LIMIT PATENT APPLICATION. PATENT APPLIES TO ANY METHODOLOGY WHICH AIMS TO TREAT THE DISEASE CONDITION IN A MANNER WHICH ALTERS IT TO A FORM THAT CAN BE BETTER DEALT WITH BY THE BODY; PARTICULARLY A BODY PREPARED TO DEAL WITH SUCH CHANGES, FOR EXAMPLE , BY PRIOR VACCINATION.

STEP ONE

PREPARE VACCINE BY CULTURING ORGANISM/TARGET THEN HEAT

INACTIVATION.

STEP2

USE VACCINE PREPARATION TO RAISE IMMUNE RESPONSE

STEP 3

USE HYPERTHERMIA TO EXPOSE /ALTER DISEASE STRUCTURE TO FORMAT

CONFORMING TO THAT OF THE VACCINE USED TO GENERATE IMMUNE

RESPONSE.

AS THE HEAT CAUSES STRUCTURES TO ALTER AND THE EXPOSURE OF

PREVIOUSLY COATED AND/OR OTHERWISE DISGUISED; THE IMMUNE SYSTEM

ALREADY STIMULATED AGAINST THEM BY THE VACCINE WOULD BE ACTIVATED

DEVASTATINGLY.

EASILY SEEN APPLICATIONS THAT FOLLOW FROM THESE GUIDELINES IS THAT IN THE TREATMENT OF CANCER, FOR EXAMPLE; BIOPSIES SHOULD BE TREATED WITH WHATEVER RADIOTHERAPEUTIC OR CHEMOTHERAPEUTIC PROTOCOL ARE TO BE IMPLEMENTED UPON THE PATIENT; THE RESULTANT SURVIVING AND ALTERED CELL STRUCTURES SHOULD THEN BE USED IN THE PREPARATION OF A VACCINE. THIS COULD BE USED AS A SUPERIOR IMMUNE PROTOCOL AND/OR AS AN ADJUNCT TO VACCINES PREPARED FROM INITIAL BIOPSY. FURTHER INACTIVATION PROCEDURE SUCH AS HEAT KILLING OF CELLS MAY ALSO BE USED ON THE DISEASE IN ORDER TO CLOSER M,ATCH THE VACCINE.

WHAT THEN FOLLOWS IS THAT BY USING THIS NEW PATENT FIELD OF

ANTICIPATORY IMMUNOLOGY THE BODY WILL BE

1-ABLE TO MOUNT AN EFFICIENT IMMUNE RESPONSE WITHOUT RESTRICTION BY THRESHOLD INHIBITION. AS IT IS BEING TARGETED AGAINST ANTIGENS AND OTHER COMPLEXES NOT NORMALLY EXPOSED TO ANY GREAT EXTENT BY THE DISEASE.

2-MATCHING OF DISEASE TO VACCINE-THIS HAS NEVER BEFORE BEEN ATTEMPTED IN THIS MANNER.

PATIENT N.B. PRESENTED WITH PRIMARY HEPATOMA WHICH HAD PERFORATED IS DIAPHRAGM AND ENCIRCLED HIS RIGHT LUNG . CANCER ADVANCED

DESPITE CHEMOTHERAPY, RADIOTHERAPY AND IMMUNOTHERAPY.

THE VACCINE WAS MANUFACTURED FROM BIOPSY TISSUE WHICH HAD BEEN FRAGMENTED PHYSICALLY AND BOILED FOR 15 MINUTES EVERY DAY FOR 3 DAYS.

HYPERTHERMIA USING RADIOFREQUENCY 'MAGNETRODE' EQUIPMENT WAS PPLIED FOR 3 SESSIONS OF 20 MINUTES EACH. ON CONSECUTIVE DAYS.

WHAT FOLLOWED WAS AS PREDICTED BY THEORY.

I N EACH OF THE HYPERTHERMIA SESSIONS THE BODY WAS HEATED TO 102 DEGREES .

THE FOLLOWING DAY AND FOR 1 WEEK SUBSEQUENTLY PATIENT

S PONTANEOUSLY DEVELOPED A CONTINUEOS FEVER RANGING FROM 100-104 DEGREES. PAIN RAPIDLY SUBSIDED . THERE WAS A MEASUREABLE

LYMPHOCYTOSIS AND LEUKOCUTOSIS BUT NO INFECTIVE FOCUS WAS FOUND A ND REPEATED BLOOD CULTURES WERE NEGATIVE. IT WAS AS PREDICTED THAT HYPERTHERMIA EXPOSED STRUCTURES ON THE DISEASE MASS TO WHICH THE BODY HAD BEEN PREVIOUSLY IMMUNISED AND MASSIVE IMMUNE

EJECTION THEN RESULTED.

F ILMS TAKEN SIX WEEKS APART INDICATE THE DRAMATIC TUMOUR REDUCTION FOLLOWING THIS PROCESS.

INDUCED REMISSION THERAPY WAS PREVIOUSLY DISCUSSED UNDER

INDUCED REMISSION THERAPY PATENT BY SAME

INVENTOR. TO BRIEFLY RECAP AND ILLUSTRATE THE APPLICATION OF SUCH PATENT UNDER THESE GUIDELINES; IT APPEARS THAT THERE ARE

BIOLOGICAL ORGANISMS-VIRUSES , BACTERIA, FUNGI, YEASTS ETC. WHICH CAN BE CLASSIFIED AS EITHER SYNERGISTIC OR ANTAGONISTIC TO THE DISEASE PROCESS.

WHEN VACCINATING AGAINST THE SYNERGISTIC ORGANISMS, INVENTOR HAS USED PHYSICAL(SUCH AS SONICATION), CHEMICAL(CHLORINE/PHENOL/OTHER) AND BIOLOGICAL MEANS (SUCH AS ENZYMATIC DEGRADATION) TO PREPARE VACCINES. LET US CONSIDER BY EXAMPLE ALTHOUGH IT SHOULD BE

LET US CONSIDER THE DISEASE CANCER.

CANCER BIOPSIES CAN BE SHOWN TO DEMONSTRATE ORGANISMS OF VARIABLE MORPHOLOGY. (CANTWELL ET AL) IT IS INTERESTING THAT ORGANISMS HAVE LONG BEEN REPORTED IN ASSOSCIATION WITH CANCERS BUT HAVE BEEN IGNORED AS INFECTION AND/OR CONTAMINATION . YET SUCH ORGANISMS CAN BE DEMONSTRATED IN EVEN THE MOST STERILE OF BIOPSIES AND ARE NOT ASSOSACIATED WITH ANY LOCAL INFLAMMATORY PROCESS AS WOULD BE EXPECTED OF INFECTIONS.

SUCH ORGANISMS APPEAR INTEGRAL IN THE DISEASE PROCESS . AS

WHEN THE SAMPLES ARE DISRUPTED BY PHYSICAL, CHEMICAL, BIOLOGICAL AND OR EVEN IMMUNOLOGICAL PATHWAYS SUCH AS BY SPECIFIC OR POOLED ANIMAL/HUMAN/OTHER SERUM, STAPHYLOCOCCAL -LIKE CULTURES MAY

FOLLOW . ACTUALLY , A VARIETY OF ORGANISMS INCLUDING E . COLI AND

AS THESE ORGANISMS DO NOT APPEAR TO ATTRACT A SIGNIFICANT IMMUNOLOGICAL RESPONSE FROM THE PATIENTS. PREPARATION OF VACCINE IS BENEFITED BY ALTERATION OF PRESENTATION SUCH AS BY PHYSICAL AND/OR CHEMICAL AND/OR BIOLOGICAL TREATMENT AS PREVIOUSLY

DISCUSSED.

ORGANISM. CULTURE IS GROWN FOR 2-3 DAYS THEN BOILED FOR 15 MINUTES ON 3 CONSECUTIVE DAYS . PREPARATRION IS THEN REPLATED ON BLOOD AGAR AND REINNOCULATED IN TSB TO ENSURE NO GROWTH.

ANIMALS VACCINATED WITH THE HEAT-KILLED VERSION OF THE ORGANISMS WILL GENERATE BOTH LOCAL AND SYSTEMIC REACTIONS WHICH ARE DOSE-DEPENDANT. IN TESTING LIVING ORGANISM INNOCULATIONS INTO IDENTICAL ANIMALS, IT IS FOUND THAT THEY RARELY CAUSE AN ACUTE RESPONSE AT LOW DOSEAGE. SIMILAR LOW DOSEAGE OF THE HEAT-KILLED PREPARATIONS YEILDS

SIGNIFICANT LOCAL REDNESS AS WELL AS SYSTEMIC SIDE-EFFECTS SUCH AS HIGH TEMPERATURES . OBVIOUSLY , THEREFORE THE VACCINE DIFFERS IN IMMUNOLOGIC PROPERTIES TO THE ORGANISM. THE PROTECTIVE FACTORS AND/OR AGENTS APPEAR TO BE REMOVED AND/OR NEUTRALISED BY HEAT ,STRONGLY IMMUNOGENIC FACTORS APPEAR TO BE GENERATED/EXPOSED BY HEAT . AS THESE ORGANISMS APPEAR RELATED TO THE CANCER

PROCESS; WHETHER BELIEVED TO BE CAUSATIVE, SYNERGISTIC OR INFECTIVE OR NEUTRAL,THEY OBVIOUSLY DISPLAY AFFINITY FOR THE DISEASE

SEVERAL CASES HAVE DEMONSTRATED TEMPORARY BENEFICIAL TUMOUR SHRINKAGE FOLLOWING ADMINISTRATION OF HEAT-KILLED VACCINES .AGENTS USED TO GENERATE SYSTEMIC HEAT WHICH WOULD PREVIOUSLY ONLY LAST FOR LIMITED DURATION( PHYSICAL/CHEMICAL/BIOLOGICAL)WILL OFTEN GIVE RISE TO LONG LASTING AND GREATER TEMPERATURE RISES ONCE THE VACCINES HAVE GENERATED SIGNIFICANT IMMUNE RESPONSE; AT THAT POINT HYPEDRTHERMIA, EVEN FROM A HIGH DOSE VACCINE OR FROM

HYPERTHERMIA ALONE IS KNOWN TO SOMETIMES CAUSE EXCELLENT RESPONSES, OTHER THAN HEAT'S DESTRUCTIVE ABILITY, THIS EXPLANATION ALSO GIVES ANOTHER MECHANISM OF ALTERATION OF IMMUNOLOGICAL PRESENTATION OF TARGET ; UNFORTUNATELY , USE OF HYPERTHERMIA WITH VACCINE THERAPY IS VERY LIMITED.

HYPERTHERMIA IS USUALLY USED ALONE AND/OR IN COMBINATION WITH RADIOTHERAPY AND/OR CHEMOTHERAPY . UNDER THESE CIRCUMSTANCES IT IS VERY LIKELY THAT THE IMMUNE SYSTEM WILL BE FLOODED WITH ANTIGENIC MATERIAL AND MAY SUCCUMB TO THRESHOLD INHIBITION (AT WORST IF HYPERTHERMIA IS USED ALONE). IT IS THEORETICALLY MORE DAMAGING IMMUNOLOGICALLY IF THE HYPERTHERMIA IS USED SIMULTANEOUSLY WITH CHEMOTHERAPY AND/OR RADIOTHERAPY THEN ALTHOUGH SUCH SYSTEMS MAY SYNERGISE IN THEIR TUMOUR-DESTRUCTIVE ABILITY THE IMMUNE SYSTEM WILL ALSO BE WEAKENED BY THE COMBINATION THERAPY AND OVERWHELMED BY THE NEW ANTIGENIC INFORMATION. IT APPEARS PREFERABLE, THEREFORE

TO PRECEDE SUCH PROCEDURES WITH 2 WEEKS OF ANTICIPATORY

IMMUNOTHERAPY WHERE THE BODY IS STIMULATED AGAINST

DISEASE PRESENTATION AFTER IT HAS BEEN TREATED OUTSIDE THE BODY BY SUGGESTED PROTOCOLS TO BE INSTITUTED 2 WEEKS LATER . THE 2 WEEK LAG PERIOD IS SELECTED TO ALLOW THE BODY TO GENERATE SIGNIFICANT SERUM IMMUNITY TO THE CHANGES ABOUT TO OCCUR. SOME DEMONSTRATIVE CASES NOW FOLLOW; MULT I PHASED PHAGE THERAPY

TRYPTICATED SOY BROTH 3000CC WAS INNOCULATED WITH STAPHYLOCOCCUS AUREUS AND ALLOWED TO CULTURE FOR THREE DAYS.

BROTH WAS THEN DIVIDED INTO 100 CC BOTTLES

PHAGES WERE RAISED BY ALLOWING BACTERIAL CULTURE IN TSB TILL NUTRIENT DEPLETION AND LYSIS. BROTH WAS THEN CHECKED FOR PLAQUE- FORMING ABILITY IE PRESENCE OF PHAGES.THE INITIAL BROTH IS

CONSIDERED CRUDE PHAGE PREPARATION WAS PURIFIED BY DIALYSIS AND CONCENTRATED BY ELECTROPHORESIS TO 10 TO THE NINTH POWER PFU'S PER CC OF SALINE IN WHICH THEY WERE RESUSPENDED.THIS WAS THEN CALLED PURIFIED PHAGE EXTRACT.THE BACTERIAL; DEBRIS WAS LABELLED CRUDE EACTERIAL LYSATE CBL AND PROVED EFFECTIVE IN

IMMUNOSTIMULATION PARTICULARLY IN ANTICIPATORY

IMMUNOTHERAPY .

BOTTLE 1

PHASE ONE CRUDE PHAGE PREPARATION WAS ADDED AT DOSE OF 1CC PFU'S

WERE ABOUT 10 TO TH 5TH POWER.

CLEARING OF CLOUDINESS OCCURRED IN 48 HOURS

CULTURE NEGATIVE.

AN IMPORTANT DIFFERENCE SHOULD BE POINTED OUT HERE BETWEEN ANTIBIOTIC AND PHAGE THERAPY .

ANTIBIOTICS ARE ESSENTIALLY NON-LIVING PRODUCTS AND HENCE WILL NOT SIGNIFICANTLY ALTER IN BEHAVIOUR. PHAGES, ON THE OTHER HAND ARE LIVING AND MAY DO SO .TO DEMONSTRATE THIS ,BOTTLES THAT WERE TREATED WITH MULTIPHASED ANTIBIOTIC THERAPY THAT HAD REMAINED CLEAR IN PREVIOUS SECTION AND NOT CULTURED ANY ORGANISMS SUBSEQUENT TO TREATMENT WERE RECHALLANGED.BY 10CC OF ORIGINAL STAPHYLOCOCCAL CULTURE.

TREATED CULTURES RESISTED AT LEAST 3 SUCH CHALLENGES.

PHASE 1 CRUDE PHAGE PREPARATION PHASE 1 CLEARED PRELIMINARY CULTURE BUT DID NOT REMAIN ACTIVE AFTER 2 OR SOMETIMES EVEN ONE RECHALLANGE .

BOTTLE-2

PURIFIED PHAGE PREPARATION-PHASE 1 ADDED ICC

CLEARING OF BROTH WITHIN 24 HOURS.

SURVIVED 3 RECHALLANGES BUT THEN APPEARED TO LOSE ACTIVITY.

BOTTLE THREE

CRUDE PHAGE PREPARATION PHASE 1 AND 2 ADDED 0.5CC OF EACH

CLEARING OF BROTH WITHIN 24 HOURS .CULTURE NEGATIVE

SURVIVED 4 RECHALLANGES BUT THEN APPEARED TO LOSE ACTIVITY

WITH NEW GROWTH

BOTTLE 4

PURIFIED PHAGE PREPARATION PHASES 1 AND 2 0.5CC OF EACH

CLEARING OF BOTTLE WITHIN 24 HOURS

SURVIVED 6 RECHALLANGES THEN REGROWTH. BOTTLE 5-

CRUDE PHAGE PREPARATION PHASE 1, 2 AND 3

CLEARING OF BOTTLE WITHIN 24 HOURS CULTURE NEGATIVE

SURVIVED OVER 6 RECHALLANGES.

EOTTLE 6-

PURIFIED PHAGE PREPARATION PHASES1,2 AND 3

CLEARING OF BOTTLE WITHIN 24 HOURS CULTURE NEGATIVE.

SURVIVED OVER 6 RECHALLANGES.

IT SHOULD BE NOTED THAT THE EFFECTS SHOWN ON SUCCESSFUL

RECHALLANGE MAY NOT BE SIMPLY DUE TO DECREASE IN THERAPEUTIC

DOSEAGE .

THE PHENOMENON OF ADAPTATION AND CO-SYNERGY MAY BE BEST

DEMONSTRATED BY PLEURIPOTENT PHAGES.

IT IS LIKELY THAT PHAGES DEVELOP SYNERGY WITH THEIR BACTERIAL

HOST.

IF SUCCESSFUL RECHALLANGE IS DUE TO WEAKENING DOSEAGE OF PHAGE

MIX THEN IT SHOULD ONLY BE A MATTER OF REESTABLISHING THE

DOSE, HOWEVER, PHAGE WHICH PREVIOUSLY CAUSED CLEARING OF BROTH

WOULD ONLY CAUSE PARTIAL IF ANY CLEARING AS PREDICTED FROM

REPEATED PASSAGE WORK IN ESTABLISHING PHAGE PHASE.

THIS WOULD HAPPEN WITH ORIGINAL BACTERIAL CULTURE AS WELL AS WITH

LATTER PHASE CULTURES INDICATING THAT THE ADAPTATION IS NOT ONLY

BACTERIAL BUT ALSO OF PHAGE.

THIS SHOULD NOT BE SURPRISING AS WE ARE DEALING WITH TWO LIVING PRODUCTS. IT VDOES HOWEVER SUGGEST COMBINING THIS THERAPY WITH ONE THAT WILL NOT DEVELOP SYNERGY WITH INITIAL CULTURE, SUCH AS PHASED ANTIBIOTIC THERAPY AND/OR PHASED IMMUNE THERAPY.

PHASED IMMUNE THERAPY.

DIRECT/INDIRECT.

DIRECT

DIRECT IMMUNOTHERAPY INVOLVES THE RAISING OF AN IMMUNE RESPONSE

IN-VITRO OR IN-VIVO BY USE OF HUMAN AND/OR OTHER SYSTEM . DIRECT

RELATES TO RAISING OF A SYSTEM CELLULAR, HUMORAL, OR OTHER AGAINST

TARGET ORGANISMS.

ALLOWING THE TWO SYSTEMS TO INTERACT IN AN OPEN OR CLOSED SYSTEM

AND/OR INDUCING MULTIPLE MUTATIONS/PRESENTATIONS OF TARGET

ORGANISM(S) (AS DISCUSSED PREVIOUSLY) .

AS RESISTANT/ELUSIVE STRAINS EMERGE. NEW IMMUNE RESPONSES ARE RAISED TO COPE WITH THE CHANGES OF TARGET HENCE PHASED IMMUNE REPONSE IS ALSO POSSIBLE.

THE PHASED IMMUNE RESPONSE IN THIS DEMONSTRATION WILL BE SERUM RESPONSE AS INDUCED AND PURIFIED FROM HORSES.

PREPARATION OF HORSE SERUM

FOR PURPOSE OF THIS DEMONSTRATION, A HORSE WAS INJECTED WITH BACTERIAL PELLETS OF 3X 10 TO THE 8TH POWER

INTRADERMALLY. INJECTION OF BACTERIAL FRAGMENTS AFTER BREAKDOWN BY OTHER MODALITY AND/OR IMMUNISATION CAN HELP GENERATE ANTICIPATORY IMMUNE RESPONSES WHICH CAN HELP COPE WITH ELIMINATION OF DISEASE BREAKDOWN PRODUCT.

INDIRECT

INDIRECT IMMUNE RESPONSE IS TERM GIVEN BY AUTHOR TO USE OF IMMUNE RESPONSE TO SUPPORT ANTIBIOTIC AND/OR PHAGE THERAPY.

IT IS ALSO POSSIBLE TO USE ANTISERUM TO TARGET RESISTANCE-SPECIFIC FACTORS SUCH AS PLASMIDS CARRYING GENETIC MESSAGE FOR PENICILLIN RESISTANCE.

RAISING OF ANTISERUM -AFTER INJECTION WITH IMMUNISING DOSE 3TIMES A WEEK FOR THREE WEEKS INTRADERMALLY(DOSE .MANNER AND AREA OF

INJECTION ARE ALL VARIABLE FACTORS)

PURIFICATION OF SERUM FOR THE IN-VITRO TESTING WAS SIMPLY BY CENTRIFUGATION TO SEPARATE CELLULAR FROM HUMORAL CONTENT.

IT SHOULD BE NOTED HERE THAT PURIFICATION MAY NOT BE A VERY CRUCIAL FACTOR AS DOSEAGE TO PREVENT RESISTANT PHASE MAY NOT BE VERY HIGH AS SAID PHASE IS NOT ALREADY IN EXISTANCE.

IN-VITRO TEST

STAPHYLOCOCCUS AUREUS CULTURE WITH PENICILLIN SENSITIVITY WAS CULTURED IN 3000 CC OF TRYPTICATED SOY BROTH FOR THREE DAYS.

BROTH WAS DIVIDED INTO 100 CC BOTTLES.

THE FOLLOWING EXPERIMENTS WERE THEN DONE AND REPEATED; BOTTLE ONE;

PROCAINE PENICILLIN 500,000 U WAS ADDED TO STAPHYLOCOCCUS

CULTURE.

SOME CLEARING OCCURRED WITH REGROWTH WITHIN 6 DAYS.

CULTURE THEN YEILDED PENICILLIN-RESISTANT STAPHYLOCOCCUC AUREUS.

THE BROTH WITH REGROWTH WAS INNOCULATED INTO A HORSE(5OCCS WERE

SPUN DOWN AND BACTERIAL PELLET WAS IMPLANTED INTRACUTANEOUSLY

INTO A HORSE, 5 CCS OF SAME BROTH WAS INJECTED INTRADERMALLY

EVERY 3 DAYS FOR 3 WEEKS

50CC OF HORSE BLOOD WAS THEN COLLECTED ,SPUN DOWN YEILDING SERUM.

AS THE HORSE WAS VACCINATED WITH BACTERIA AS WELL AS THE BROTH IN

WHICH RESISTANCE OCCURRED , IT IS LIKELY THAT THE HORSE WAS ALSO

INNOCULATED AGAINST PLASMIDS AND ENZYMES SUCH AS

PENICILLINASE (SUBSEQUENT TESTS IN WHICH BACTERIA WERE SONICALLY

LYSED PRIOR TO IMMUNISATION APPEARED TO INCREASE EFFICACY OF THIS

STEP.

BOTTLE2

ANTI-PHASE 2 BACTERIA ANTISERUM WAS ADDED 1CC DOSE TO 500,000

UNITS OF PENICILLIN.

BOTTLE CLEARED AND REMAINED CLEAR.UP TO I WEEK LATER, CUTURE

NEGATIVE.

BOTTLE THREE- ANTI-PHASE 2 ANTISERUM WAS ADDED ICC DOSE. -NO

RESPONSE CULTURE-STAPH AUREUS -PENICILLIN SENSITIVE.

IT THEREFORE APPEARS THAT AT THIS DOSEAGE, THE MAJOR EFFECT OF ANIMAL SERUM IS TO PREVENT THE RISE OF RESISTANCE.

AT HIGHER DOSEAGES SOME DIRECT ANTIBACTERIAL EFFECTS WERE OBSERVED; THESE WERE EVEN MORE MARKED IF WHOLE BLOOD WAS USED. IN VIVO-CRUDE TO REFINED IMMUNE RESPONSES ELLICITED EXCELLENT RESPONSE.

ANIMAL SERUM ADDED TO PHAGES IN THE TREATMENT OF BACTERIAL CULTURES INHIBITED RISE OF RESISTANCE BOTH AS PHASE ONE (IN WHICH CASE PHASE ONE PHAGE AND PHASE ONE ANTISERUM HAVE ADDITIVE MULTIMODAL EFFECT) AND AS ANTISERUM TO PHAGE RESISTANT PHASE.

IT IS ALSO INTERESTING TO NOTE THAT INITIAL WORK INDICATES THAT EVEN WHEN PHAGE LOSES LYTIC ABILITY OVER PARTICULAR BACTERIA IT MAY STILL RETAIN AFFINITY TO IT IN WHICH CASE RAISING AN IMMUNE RESPONSE AGAINST THE PHAGE MAY SERVE AS A TAG AND ATTACK THERAPY. WHERE BACTERIA WERE ALLOWED TO BE TAGGED BY PHAGE THEN ANTISERUM OF ANIMAL IMMUNISED AGAINST PHAGE APPLIED,BACTERIAL LYSIS

FOLLOWED.

SUPPORT OF PHAGE AND ANTIBIOTIC MULTIPHASE THERAPY BY MULTIPHASE IMMUNE SUPPORT CAN BE ACCOMPLISHED BY SERUM AND/OR CELLULAR

COMPONENTS OF IMMUNISED ANTMAL'S BLOOD.

NEW MECHANISMS WILL BE PRESENTED FOR IMMUNE ACTIVITY. EFFICACY OF MULTIMODAL/MULTIPHASED

THERAPY AS PERTAINING TO CANCER.

DEVELOPMENT OF ANTICANCER ANTIBIOTICS/MULTIPHASIC CHEMOTHERAPY

INTRODUCTION

A LIMITING FEATURE OF CURRENT CHEMOTHERAPEUTIC THERAPY IS THE COMMON DEVELOPMENT OF RESISTANCE BY THE TARGET DISEASE. THE

STANDARD RESPONSE AT THIS POINT IS TO EITHER INCREASE DOSEAGE AND/OR ADD TO OR TOTALLY ALTER THERAPEUTIC REGIMEN. IN MOST CASES OF CANCER IT IS LIKELY THAT CHEMOTHERAPEUTIC OPTIONS WILL BE EXHAUSTED PRIOR TO ELIMINATION OF DISEASE,THE CANCER WILL THEN PROGRESS TO DEATH OF PATIENT.

AS MANY CHEMOTHERAPEUTIC AGENTS ARISE FROM LIVING ORGANISMS. IT IS POSSIBLE TO ALLOW CO-INCUBATION METHODS AS PREVIOUSLY DISCUSSED TO YEILD NEW THERAPEUTIC PRODUCTS. IT IS ALSO LIKELY THAT SUCH MULTIPHASIC THERAPEUTICS MAY BE ACTIVE BOTH DIRECTLY AND INDIRECTLY AGAINST AGENTS DETERMINED BY CLASSIFICATION PATENT..

DEMONSTRATION OF CLASSIFICATION PATENT AS APPLIES TO MULTIPHASIC THERAPY.

INTRODUCTION

THE CLASSIFICATION PATENT STATES THAT FOR EVERY CONDITION ORGANISMS, FACTORS AND AGENTS CAN BE SUBDIVIDED INTO THOSE THAT PROMOTE, INHIBIT OR ARE NEUTRAL TO THE CONDITION. SOME MAY BE CAUSATIVE WHEREAS OTHERS ARE NEMESES OR CUREATIVE.

EPIDEMIOLOGY

THE SUGGESTION THAT INFECTIONS MAY BE ANTAGONISTIC TO DISEASES SUCH AS CANCER IS BORNE OF OBSERVATIONS THAT WHERE CERTAIN INFECTIONS DOMINATE ANN ATREA OR AN ERA, CANCER WAS SCARCE. CASES CAN BE MADE FOR TUBERCULOSIS .MALARIA AND SYPHILLIS BEING SUCH AGENTS. IT IS ALSO TRUE THAT MANY OF THESE CONDITIONS WHICH

INHIBIT CANCER GROWTH IN ACUTE STATE MAY CAUSE OR PROMOTE IT IN CHRONIC STATE.

IT IS KNOWN ,FOR EXAMPLE, THAT CHRONIC TUBERCULOUS FOCI MAY LEAD TO DEVELOPMENT OF LUNG CANCER, CHRONIC MALARIA TO LYMPHOMA AND

CHRONIC SYPHILLIS TO OTHER TYPES OF CANCER.

OTHER INFECTIONS SUCH AS SCHISTOMYCETES HAVE BEEN LINKED DIRECTLY TO BLADDER CANCER.

INTERESTINGLY AN OFTEN CITED INFECTION ASSOSCIATED WITH SPONTANEOUS REMISSION IS THAT OF ERYSIPELAS .THIS IS OFTEN CAUSED BY STAPHYLOCOCCAL OR STREPTOCOCCAL INFECTION.AS THESE INFECTIONS IN ACUTE FORM CAN ACT TO ELIMINATE DISEASE, IT IS PROBABLY MORE THAN COINCIDENCE THAT TUMOUR BIOPSIES APPEAR TO INDICATE AT TIMES SIMILAR INFECTIONS COEXISTING IN CHRONIC MANNER WITH THE . IN CHRONIC INFECTIONS,THERE IS USUALLY AN IMMUNE RESPONSE INCAPABLE OF ELIMINATING THE INFECTION. IN BACTERIAL AND OTHER INFECTIONS INTIMATELY ASSOSCIATED WITH CANCER THERE MAY BE ALMOST TOTAL ABSENCE OF VISIBLE IMMUNE RESPONSE-SEE PHOTOGRAPHS WITH

CONSPICIOUS ABSENCE OF LOCAL INFLAMMATORY CELLS IN AREAS OF BACTERIA OR OTHER ORGANISMS IN CLOSE PROXIMITY TO CANCER CELLS. THIS MAY SUGGEST THAT THESE ORGANISMS ARE EITHER INHERENTLYT ELUSIVE/RESISTANT TO IMMUNOLOGICAL RESPONSES AND/OR ARE USING THE CANCER MASS TO ELUDE SAID RESPONSE. IT IS ALSO LIKELY THAT THE SAME MECHANISM BY WHICH CANCER ELUDES SAID RESPONSE AS THE ORGANISMS ARE OFTEN CULTUREABLE FROM BLOOD AS WELL AS FROM MANY TISSUES IN PATIENTS WITH DISEASE. (THE PRESENCE OF

CAUSATIVE , SYNERGISTIC , NEUTRAL , INFECTIVE, ANTAGONISTIC AND NEMESIS ORGANISMS IS NOT RESTRICTED TO CANCER BUT VIRTUALLY TO ALL DISEASE AND OTHER CONDITIONS ) SEE PHOTOS OF CANCER, AIDS , TISSUES ETC.

MANY OF THESE BACTERIA APPEAR STAPHYLOCOCCAL OR STREPTOCOCCAL IN ORIGIN.

ALTHOUGH CONVENTIONAL; MEDICAL THINKING DOES NOT CREDIT THESE ORGANISMS WITH ANYTHING MORE THAN NEUSANCE CONTAMINANT VALUE, IT WAS NOT ALWAYS THE CASE.AT THE TURN OF THE CENTURY, ORGAN I SMS ISOLATED FROM CANCER PATIENTS WERE THOUGHT DIRECTLY LINKED AND CAUSATIVE TO THE DISEASE PROCESS.THE WORK OF GLOVER, SCOTT, GREGORY AND LIVINGSTON LED TO THE IDENTIFICATION OF MANY ORGANISMS ASSOSCIATED WITH CANCER.LIVINGSTON AND OTHERS DESCRIBED AN

APPARENT PLEOMORPHIC ABILITY TO THESE ORGANISMS.VARIOUS VACCINES AND ANTIBIOTIC THERAPIES PROVED TO HAVE A VARIABLE DEGREE OF EFFICACY. IT IS NOT SURPRISING,THEREFORE, THAT MANY EFFECTIVE CHEMOTHERAPEUTIC REGIMENS ACTUALLY HAVE ANTIBACTERIAL ACTIVITY-IT IS POSSIBLE TO EVALUATE CHEMOTHERAPEUTIC EFFECTIVENESS BY TESTING IT AGAINST BACTERIAL AND OTHER ORGANISM CULTURES-BY SYSTEMS INTRODUCED BY INVENTOR.- KNOWING A LIBRARY OF ASSOSCIATED

ORGANISMS ALSO ENABLES PREDICTION OF SUSCEPTIBILITY AS WELL AS INCREASE ACCURACY OF DIAGNOSIS AND ESTIMATE DISEASE ACTIVITY. AS WELL AS DEVELOPING A RANGE OF NOVEL THERAPY.

IT IS ALSO KNOWN THAT ANTIBIOTIC THERAPY MAY CAUSE TEMPORARY IMPROVEMENT IN CANCER AND OTHER PATIENTS-MORE RECENTLY ALSO IN ARTHRITIS AND ULCERS .DISEASES UNTIL RECENTLY NOT THOUGHT RELATED TO BACTERIAL DISEASE.WHILE TEMPORARY IMPROVEMENT MAY BE DUE TO THE CLEARING OF A SUPERADDED INFECTION, IT IS HARD TO EXPLAIN THE OCCASSIONAL REMISSION OF CANCER FOLLOWING ANTIBIOTIC THERAPY BY THIS REASONING.IT IS HOWEVER ALSO LIKELY THAT THE INFECTION BEING TREATED WAS ITSELF THE CAUSE OF THE REMISSION.

IT IS ALSO CONVENTIONALLY RECOGNISED THAT MANY VIRUSES MAY BE IDENTIFIED IN CANCER CELLS.THESE HAVE BEEN NOTED AS OF DUBIOUS SIGNIFICANCE ALTHOUGH ANIMAL CANCERS MAY OFTEN BE CAUSED IN A LABORATORY BY VIRUSES.BACTERIA,FUNGII ETC WERE ALSO AT SOME TIME THOUGHT TO BE RELATED TO CANCER.MUCH WORK NOW SUGGESTS LINKS BETWEEN VIRUSES SUCH AS HEPATITIS,POLYOMA AND CANCER;FUNGII SUCH AS ASPERGILLUS FLAVUS, PARASITES SUCH AS BCHISTOCOMYCETES,ETC. IT IS NOT THE OPBJECT OF THIS PATENT TO CLAIM CAUSATIVE FUNCTION OF MICROORGANISMS IN DISEASES OF UNKNOWN AETIOLOGY;BUT TO

DEMONSTRATE AFFINITY AND USE OF MICROORGANISM RELATIONSHIP TO DISEASE IN THERAPY.

MULTIPLE PHOTOS OF DR.CANTWELL DEMONSTRATING ORGANISMS SHOULD BE

INSERTED HERE.

IT SHOULD BE NOTED THAT THERE IS MUCH EVIDENCE LINKING THESE

ORGANISMS TO CANCER AND OTHER DISEASES;THEY ARE FREQUENTLY

ISOLATED FROM BIOPSIES, BLOOD,OTHER SPECIMENS; THEY CAN BE

IDENTIFIED IN DISEASE FRAGMENTS; INJECTED INTO ANIMAL MODELS THEY

CAN CAUSE DISEASE AND THEN BE ISOLATED AGAIN FROM INDUCED

DISEASE. (LIVINGSTON AND ALEXANDER 1950-1970)

MORE RECENTLY,THE INVENTOR HAS FOUND THAT A WIDE RANGE OF

ORGANISMS RANGING FROM STREPTOCOCCAL-LIKE, STAPHYLOCOCCAL-LIKE

ORGANISMS.YEASTS,FUNGII ETC.CAN BE ISOLATED FROM TUMOUR SAMPLES

AND FROM BLOOD AND OTHER PATIENT SAMPLES WHEN INJECTED INTO A

TUMOUR- BEARING ANIMAL,WILL SELECTIVELY LODGE IN TUMOUR

MASSES.THIS MAY BE SECONDARY TO MANY MECHANISMS BUT APPEARS TO

INDICATE AT LEAST AFFINITY FOR THE ORGANISMS AND CANCER.

THE INVENTOR HAS ALSO DEMONSTRATED THAT ANTISERA RAISED AGAINST

ORGANISMS ISOLATED FROM VARIOUS CANCERS WILL EXERT ACTIVITY

AGAINST THE CANCER CELLS THEMSELVES.THIS CAN BE DEMONSTRATED BOTH

WITH ORGANISMS ISOLATED FROM THE CANCER CELLS AND/OR FROM

ORGANISM LIBRARY OF SIMILAR/RELATED CANCERS EVEN AS BROAD A MATCH

AS CARCINOMAS AND SARCOMAS.

SEVERAL ORGANISM AND ORGANISM TYPES HAVE BEEN DEFINED BY AUTHOR

AS RELATE TO CANCER AETIOLOGY, SYNERGY AND THERAPY.THE OBSERVATION

OF SEVERAL ORGANISMS HAS LED MANY TO BELIEVE THAT THE CANCER

ORGANISM IS PLEOMORPHIC; IT HAS BEEN USED BY MORE TO SUPPORT THE

CONTENTION THAT THESE ORGANISMS ARE CONTAMINANTS.ALTHOUGH ABOVE

EVIDENCE TENDS TO SUGGEST OTHERWISE ,THE INVENTOR WISHES TO

INDICATE THAT EVEN IF SUCH INFECTIONS ARE CONTAMINANTS THAT ALONE

MAY INDICATE AFFINITY OF ORGANISMS FOR TUMOUR MASSES.

MULTIPHASIC THERAPY CAN BE APPLIED IN TERMS OF

CHEMOTHERAPY, IMMUNOTHERAPY,RADIOTHERAPY AND INTERPLAY OF THESE

AND OTHER THERAPIES.

ISOLATION OF ORGANISMS

THE MULTIPHASIC APPROACH IN TISSUE ANALYSIS AND TREATMENT YEILDS INTERESTING RESULTS .CONDIDERATION OF CANCER AS A SYSTEMIC DISEASE AS OPPOSED TO CANCER AS A BALL OF DISEASED CELLS,OBSERVATIONS CAN YEILD AN INTERESTING THEORY.

IN-VITRO THERAPIES MAY BE CAPABLE OF 100% CANCER CELL KILL

WHETHER BY CHEMICALS,RADIATION, IMMUNOMOLOGICAL AGENTS AND YET WOULD BE UNABLE TO ACHIEVE IN-VIVO REMISSION;MORE

IMPORTANTLY,EVEN AFTER SUCH IN-VITRO 'INACTIVATION' INJECTION OF IN-VITRO'KILLED' PREPARATION OF CANCER TISSUE WHERE CELLS HAVE BEEN DISRUPTED SONICALLY,CHEMICALLY, IMMUNOLOGICALLY ,OTHER

PHYSICAL MANNER THEN FILTERED SO THAT NO LIVING CELLS PASS THROUGH THE FILTER,FILTRATE INJECTED INTO AN ANIMAL SYSTEM WOULD OFTEN RESULT IN ANIMAL DISEASE OR DEATH.THIS STRONGLY SUGGESTS THAT THE LIVING CANCER CELL IS NOT NECESSARY TO PREPETUATE/INITIATE DISEASE CONDITION.

THIS POINT IS ALSO OF RELEVANCE WHEN ONE CONSIDERS THE NUMBER OF VACCINES CULTURED ON CONTINUEOS CELL-LINES.

IT IS CURRENTLY STANDARD PRACTICE TO CULTURE VIRAL VACCINES ON

CONTINUEOUS CELL LINES .

CONTINUEOUS CELL LINES ARE IMMORTAL CELL LINES .ESSENTIALLY CANCER

CELLS . RESEARCH WORK BY INVENTOR INDICATES THAT DAMAGED/DEGRADED

CANCER CELL PREPARATIONS, EVEN WHEN FILTERED TO REMOVE LIVING

CELLS, STILL MAY CONTAIN FACTORS/AGENTS/ORGANISMS WHICH MAY

INITIATE /AGGRAVATE DISEASE CONDITION.

THIS POINT IS STRESSED TO STATE LINK AND RELEVANCE WITH NEW

VACCINE MANUFACTURE PATENT.

OTHER PROBLEMS WITH CURRENT VACCINE MANUFACTURE PRACTICES RELATES TO THE LONGTERM SEQUALEA OF SUCH LIVING VACCINES INCLUDING SUBACUTE SCLEROSING PAN-ENCEPHALITIS DUE TO ASSUMED SLOW VIRUS ACTIVITY.

MULT I PHAS IC SYSTEM APPROACH WOULD THEN AIM TO

ATTEMPT TO DEFINE OTHER LIVING SYSTEMS THAT MAY BE ACTIVE IN THE

DISEASE PROCESS.

THE SEARCH FOR LIVING SYSTEMS WAS CONDUCTED ON THE FOLLOWING

BASIS;

1-EVIDENCE FOR LIVING SYSTEMS BEING PRESENT WITH PROXIMITY TO

DISEASE AND DISSEMINATED THROUGH DISEASED BODY ON BIOPSY.

2-ABILITY TO REPEATEDLY CULTURE ORGANISMS FROM

BLOOD, SERUM,URINE,BIOPSIES AND OTHER SAMPLES FROM HOSTS OF CANCER

AND/OR OTHER DISEASES.

3-WORK BY DR.LIEDA MATTMAN DEMONSTRATING PRESENCE OF CELL-WALL - DEFICIENT ORGANISMS IN DISEASES SUCH AS CANCER, AIDS, ARTHRITIS

ETC.

4-WORK BY INVENTOR DEMONSTRATING THE ABILITY TO CULTURE ORGANISMS

FROM PATIENT SAMPLES

5-PREVIOUS WORK BY LIVINGSTON,ALEXANDER, SCOTT AMONGST MANY OTHERS

INDICATING THAT A VARIETY OF ORGANISMS ISOLATED FROM DISEASES

SUCH AS CANCER CAN GENERATE DISEASE OFTEN SIMILAR IF NOT

IDENTICAL TO THE ORIGINAL AND FROM WHICH ORGANISMS MAY OFTEN BE

RECOVERED.

6-WORK BY INVENTOR DEMONSTRATING THE ABILITY OF ORGANISMS TO

CAUSE/INDUCE/ASSIST/ACCELERATE/AGGRAVATE DISEASES SUCH AS CANCER

AND THAT IMMUNOLOGICAL AS WELL AS OTHER THERAPIES TARGETING THESE

ORGANISMS WOULD OFTEN REFLECT WITH IMPROVEMENT IN DISEASE

CONDITION.

FOR THE PURPOSE OF ILLUSTRATION WE WILL CENTRE ON THE DISEASE

CANCER,ALTHOUGH THIS IS BY NO MEANS INTENDED TO RESTRICT PATENT

OR APPLICATIONS AS THE CLASSIFICATION PATENT AND EMERGENT

THERAPIES ASPPKLY TO ALL DISEASE AND OTHER CONDITIONS.

THE MULTIPHASIC APPROACH WOULD ALLOW FOR THE FOLLOWING LOGIC

DISEASE A IS RESPONSIVE TO DISEASE THERAPY ANTI-A,AS THE DISEASE DEVELOPS RESISTANCE TO AND/OR RECURRS AFTER TREATMENT IT IS LIKELY TO HAVE CHANGED IN SOME FORM OR TO HAVE ACTIVATED INTRINSIC/EXTRINSIC METHODS FOR COPING WITH THERTAPY. EXTRINSIC METHODS MAY INCLUDE ACTIVATION OF SOME DEFENSIVE RELATIONSHIP WITH CAUSATIVE AND/OR SYNERGISTIC ORGANISM.

THE MULTIPHASIC APPROACH AS APPLIED TO CANCER CAN BE SUMMARISED SIMPLY; AS MANY CHEMOTHERAPEUTIC AGENTS ORIGINATE FROM LIVING ORGANISMS, (THESE MAY BE CLASSIFIED AS ANTAGONISTIC OR NEMESES DEPENDING ON EFFICACY)AND AS CERTAIN ORGANISMS APPEAR CAPABLE OF CO-EXISTING WITH CANCER AND SOMEHOW EXERT AN EFFECT FAVPOURABLR TO THE DISEASE; THESE MAY BE CATAGORISED AS CAUSATIVE OR

SYNERGISTIVC, THESE MAY ALSO HAVE DEFINED ANTAGONISTS AND

NEMESES, IN FACT,THEY MAY ALSO BE USEFUL TO PROVIDE AND/OR TEST PHAGES/PLASMIDS/OTHER GENETIC MANIPULATION TO EFFECT CHANGE OF CLASSIFICATION STATUS.

AS CANCER CELLS DEVELOP RESISTANCE TO A PARTICULAR THERAPY; CO- INCUBATION AND BIASSED CULTURES ALLOW DEVELOPMENT OF MORE EFFECTIVE THERAPY.

CO-INCUBATION MAY BE USED TO DEVELOP THERAPY DE-NOVO.

THE OBJECT OF THIS PATENT IS TO DEMONSTRATE

1-GENERATION OF THERAPY

2-MINIMISATION OF SIDE-EFFECTS

3-CRUDE/PURIFIED USE

4-CO-TEMPORAL UPGRADING OFD THERAPY

5-USE AS MULTIPHASIC THERAPY

6-INTERACTION WITH OTHER MULTIPHASIC THERAPIES

7-INTERACTION WITH OTHER MODALITIES IN INDUCED REMISSION THERAPY 8-NEWLY-DEFINED MECHANISMS

9-LINK WITH MACHINE THERAPY.

IMMUNOLOGICAL INC ASCITES

OPP REGENERATION

ORGAN

ORGANISM BUG

RE INFORCE NORMAL FUNCTION

PEN AND OTHER UDSED DIRECT/VS Asssd inf

INDUCED REMISSION THERAPY

INTRODUCTION

INDUCED REMISSION THERAPY COMBINES SEVERAL TREATMENT PROTOCOLS AS

INVENTED AND IMPLEMENTED BY DR. SAM CHACHOUA.

THIS THERAPY IS BASED ON OBSERVATIONS ON

1-SPONTANEOUS REMISSION

2-ORGAN RESISTANCE

3-ORGANISM RESISTANCE

WHEN SUCH DATA IS INCORPORATED WITH

1-CATEGORISATION PATENT

2-PRECURSOR/INTERMEDIATE/ENDPRODUCT THERAPY

3-MULTIPHASIC THERAPY

4-BIOLOGICAL ENHANCEMENT PATENT

5-EXTERNAL MACHINE/OTHER INTERVENTION

6-APPLICATION AND INDUCTION OF NEW WHITE AND RED BLOOD CELL

MECHANISMS.

INTERMEDIATE SUPPLEMENTS

SPONTANEOUS REMISSION OBSERVATIONS UNIQUE TO PATENT.

OBSERVATIONS OF SPONTANEOUS REMISSIONS FROM CANCER AND OTHER

DISEASES HAVE INDICATED THAT THESE HAVE OFTEN FOLLOWED AND/OR

BEEN CONCURRENT WITH INFECTIONS.

IT IS UNIQUE TO PATENT THAT THESE OBSERVATIONS HAVE BEEN COMPARED

AND CONTRASTED WITH CASES OF CANCER DETERIORATION AND/OR SUDDEN

AGGRAVATION/DETERIORATION IN CANCER CONDITION. IT WAS FOUND THAT

THERE WERE REPORTS OF THIS PHENOMENON ALSO OCCURING CONCURRENTLY

OR SUBSEQUENT TO INFECTIONS.

INFECTIONS REPORTED IN CASES OF IMPROVEMENT HAVE FALLEN UNDER A

WIDE CLASSIFICATION OF

MICROORGANISMS,-VIRAL,BACTERIAL, FUNGAL,,YEAST, PARASITE ETC.

INTERESTINGLY, CASES OF DETERIORATION ALSO OFTEN OCCURRED AFTER

EXPOSURE TO ORGANISMS THAT MAY FALL ANYWHERE WITHIN SUCH A BROAD

SPECTRUM.

IT APPEARS THEREFORE THAT ORGANISMS MAY EXERT DIRECT OR INDIRECT

EFFECTS THAT MAY;

1-BENEFIT THE HOST(BIOLOGICAL ENHANCEMENT).

2-BENEFIT THE DISEASE

3-INHIBIT THE DISEASE

BENEFIT/INHIBITION OF DISEASE MAY BE ON DIRECT ACTIVITY ON

DISEASE/DISEASE-RELATED FACTORS,AND/OR INDIRECTLY SUCH AS BY

INHIBITION OR AUGMENTATION OF ANTI-DISEASE RESPONSE OF HOST.

PATENT DIFFERS FROM PRIOR ART IN THE USE OF MICROBIAL ORGANISMS

IN DEVELOPMENT OF CANCER THERAPIES IN THAT THIS PATENT SEEKS TO

DEFINE A FORMAT AND RELATIONSHIPS BETWEEN ORGANISMS AND DISEASE

IN ORDER TO ACHIEVE A LOGICAL BASIS FOR IMPROVED

DIAGNOSTIC, THERAPEUTIC AND PROGNOSTIC MEASURE DEVELOPMENT. FOLLOWING THE RULES OF THE CLASSIFICATION/CATAGORISATION PATENT

NATURAL ORGANISMS MAY BE SELECTED , OTHERS MAY BE

MODIFIED, CREATED, BRED , ENGINEERED TO FULF I L , POTENT I ATE , MIMIC

AMPLIFY OR COPY BENEFICIAL CHARACTERISTICS AND

OPPOSE, NEUTRALISE , ELIMINATE HARMFUL FACTORS THAT ASSIST DISEASE . .

TO DATE THE USE OF MICROORGANISMS IN THE TREATMENT OF CANCER HAS BEEN RESTRICTED TO HAPHAZARD ATTEMPTS TO IMMUNOSTIMULATE AND/OR CAUSE DAMAGE TO THE DISEASE DIRECTLY OR BY GENERATION OF CHEMOTHERAPEUTIC AGENTS .TECHIQUES TO BE DEMONSTRATED WHICH

OUTLINE THE CLASSIFICATION,DEVELOPMENT AND PURIFICATION OF

MICROBIOLOGICAL AGENTS AS WELL AS THE MULTIPLE PHASE CONCEPT DEFINE MANY OF THE SUPERIOR CONCEPTS OUTLINED BY THIS PATENT.

PRECURSOR /INTERMEDIATE/ ENDPRODUCT

THERAPY .

AS WITH THE CLASSIFICATION PATENT,A MORE EXTENSIVE DISCUSSION IS

INCLUDED, THE AIM OF THE FOLLOWING IS TO INDICATE PRACTICAL

APPLICATION.

LIVING BIOLOGICAL SYSTEMS ARE DISCUSSED IN THE 2MEA-CU DIPSAL-

BHT-PATENT.AS MENTIONED THIS PATENT REFERS TO IMMUNE-MODULATING

FUNCTION AS WELL AS CELL-PROTECTIVE EFFECTS OF THE COMBINED

FURMULA.

LIVING BIOLOGICAL SYSTEMS REFERS TO A COMBINATION OF

BACTERIA.VIRUSES,YEASTS AND FUNGII WHICH AS AWHOLE AND/OR IN PART

CAPABLE OF CONFERRING HEALTH BENEFITS TO HIGHER ORGANISMS.

BENEFITS MAY BE DIRECT OR INDIRECT.BY SUPPLEMENTATION,BIOLOGICAL

ENHANCEMENT AND/OR ANTIDISEASE THE FOLLOWING MECHANISMS ARE

PROVIDED AS EXAMPLES AND ARE NOT RESTRICTIVE OF PATENT.

EXAMPLES OF LIVING BIOLOGICAL SYSTEM EFFICACY SOLELY AND AS PART

OF OTHER THERAPY ARE INCLUDED AS WELL AS EXAMPLES OF THEIR USE IN

PRECURSOR/INTERMEDIATE / 'ENDPRODUCT THERAPY AND APPLICATIONS AS

THERAPY , PREVENTION , AND BIOLOGICALLY ENHANCED FOODS, CELLS OF

TARGET OR OTHER SPECIE(S) MAY ALSO BE INCLUDED IN THE LIVING

BIOLOGICAL SYSTEM.

SUPPLEMENTATION

BACTERIA SUCH AS LACTOBACILLI CAN PROVIDE MANY USEFUL NUTRIENTS AS WELL AS SUPPLEMENTS.THE CONCEPT OF LIVING BIOLOGICAL SYSTEMS DIFFERS FROM ORDINARY SUPPLEMENTATION IN THAT LIVING BIOLOGICAL SYSTEMS ARE LIVING IN WHOLE ORGASNISM SENSE OR IN REPLICATING UNIT SENSE.

EXAMPLES OF LIVING BIOLOGICAL SYSTEMS(LBS)ACTING AS REPLICATING SUPPLEMENTATION INCLUDE LACTOBACILLI THAT GENERATE FOLIC ACID, VITAMIN B12-SUCH AS LACTOBACILLUS LACTIS,MANY ORGANISMS CAPABLE OF GENERATING THESE AND OTHER ESSENTIAL AND NON-ESSENTIAL BUT BENEFICIAL SUPPLEMENTS AND NUTRIENTS,WHEN PRESENTED TO THE BODY IN THE FORM\OF LIVING BIOLOGICAL SYSTEMS,DESIGNED TO

GROW/REPLICATE IN HARMONY WITH THE BODY'S INTESTINAL OR OTHER FLORA(LBS HAVE SO FAR BEEN DEVELOPED FOR FOOD, SUPPLEMENT,TOPICAL AND COSMETIC APPLICATIONS AS WELL AS INHALATION BOTH AS SIMPLE AND MULTIPHASED .

A BASIC LBS CONSISTS OF FOOD-DERIVED ORGANISMS SUCH AS

LACTOBACILLI, YEASTS, FUNGII ETC. SELECTED FOR THEIR INHERENT SAFETY AND BENEFICIAL PRODUCTS/EFFECTS-IF A SUPPLEMENT SUCH AS B12 IS TAKEN, IT WILL ONLY LAST THE DURATION OF ABSORPTION AND

ELIMINATION FROM THE SYSTEM; IF A LIVING BIOLOGICAL SYSTEM CAPABLE OF MANUFACTURING THE NUTRIENT IS GIVEN, THEN THE NUTRIENT WILL BE GENERATED DE-NOVO FOR THE DURATION THET THE LBS OR AT LEAST THAT COMPONENT OF THE LBS REMAINS VIABLE. NUTRITION IS THEREFORE ALSO PROVIDED MORE CONTINUEOSLY THAN INERT BOLUS SUPPLEMENTATION.

ANOTHER EXAMPLE WOULD BE THE ADMINISTRATION OF ANTIBIOTICS TO PREVENT INFECTION(SUCH AS IS OFTEN DONE IN IMMUNOLOGICAL AND/OR STRUCTURAL DISORDERS WHICH PREDISPOSE TO INFECTIONS)

SUPPLEMENTATION WITH A LIVING BIOLOGICAL SYSTEM CAPABLE OF PRODUCING REQUIRED ANTIBIOTIC WILL CONSTANTLY DELIVER SMALL DOSES INTO THE SYSTEM AFTER INITIAL APPLICATION/ADMINISTRATION,A

SPECIFICALLY DESIGNED AND/OR

MULTIPHASIC SYSTEM WILL CONFER HIGHER PROTECTIVE EFFICACY.

LBS MAY THEREFORE PROVIDE USEFUL SUPPLEMENTARY

FUNCTIONS,ANTIBIOTIC

ABILITY,ENZYMES (ASPERGILLI, YEASTS, LACTOBACILLI CAN CONTRIBUTE

DIGESTIVE AS WELL AS MANY OTHER ENZYMES ), PROTECTION TO HOST

ORGANISM MAY BE DIRECTLY OR INDIRECTLY GIVEN

A PROPOSED FORMULA FOR LIVING BIOLOGICAL SYSTEMS-PRESENTED AS EXAMPLE BUT NOT TO RESTRICT PATENT.

LACTOBACILLI- ACIDOPHILUS

THERMOPHILUS

CREMORIS

LACTIS

BIFIDUS

BULGARICUS ( INCLUDING LACTOBACILLUS BULGARICUS 51 )

PLANTARUM

FAECIUM

KEFIR CULTURE

RHIZOPI I

ASPERGILLUS ORYZAE

BACILLUS SUBTILIS

FORMULA CONTAINS APPROX 300 MILLION ORGANISMS PER GRAM OF EACH

STRAIN AND SPECIE.

THESE ARE BASIC FOOD EXTRACTS AND CAPABLE OF BROAD SPECTRUM

NUTRITIONAL,ANTIBIOTIC, IMMUNOSTIMULATING,DIGESTIVE AND OTHER

FUNCTIONS .

IT IS POSSIBLE TO ADJUST FORMULATION FOR SPECIFIC FUNCTION, TO

PASS IT THROUGH MULTIPHASIC SYSTEM AND TO ADD SPECIFIC OTHER

ORGANISMS SUCH AS SACCAROMYCES CEREVISEAE

TORULA YEASTS ASPERGILLUS ORYZAE PENICILLIUM NOTATUM

CAUTION IS NEEDED WITH SPECIFIC FORMULATIONS WITH ACTIVE PENICILLIUM/YEAST/ASPERGILLI ETC BECAUSE OF PROBLEMS OF

ALLERGY, FERMENTATION, GAS ETC.

LIVING BIOLOGICAL SYSTEMS MAY BE PHASED-THIS COULD BE IN THE FORM OF RESAISTANT FLORA REPLACEMENT AFTER BEING PASSAGED WITH THE ANTIBIOTIC TO BE USED FOR DISEASE TREATMENT .HENCE A SUPPLEMENT OF LBS PHASE ONE OR MORE POST PENICILLIN PASSAGE WOULD FORM A MORE EFFICIENT BOWEL REPLACEMENT THAN UNPHASED ORGANISM SUPPLEMENT.

LBS AND TS (TARGET SYSTEM) AS WELL AS

NTS ( NON-TARGET SYSTEMS ) ARE ESSENTIAL IN

PRECURSOR/INTERMEDIATE/ENDPRODUCT THERAPY. IN INCREASING

SPECIFICITY, EFFICACY AND DECREASING SIDE-EFFECTS.

DEFINING THESE SYSTEMS IS ALSO ESSENTIAL IN BIOLOGICAL ENHANCEMENT PATENT.

MULTIPHASIC THERAPY-CONTINUED

ALTHOUGH DEMONSTRATED CASES SPEAK OF MULTIPHASIC THERAPIES BEING DEVELOPED IN LINEAR SEQUENCE; IT IS ALSO POSSIBLE TO DEVELOP MULTIPHASIC THERAPY NON-SEQUENTIALLY AND BY CLONAL OR OTHER CELL/TARGET POPULATION EXPANSION, IN WHICH CASE TARGET MAY BE EXPOSED TO VARIOUS MUTATING AGENTS AND CONDITIONS,WHICH MAY INCLUDE THERAPEUTIC ORGANISM EXTRACT IN DOSES AND CONDITIONS WHICH ENABLE DEVELOPMENT OF RESISTANCE.THERAPEUTIC

ORGANISM/EXTRACTS MAY EVEN BE PROVIDED IN MULTIPLE PHASES SUCH THAT THE THERAPY TO BE DEVELOPED BY CO-CULTURING OF MULTIPLE-RESISTANCE TARGET WITH THERAPEUTIC ORGANISM WILL BE HIGHLY EFFECTIVE AND SUPERIOR TO SINGLE AND/OR LIMITED COMBINATIONS OF MULTI-PHASED THERAPY. PRELIMINARY CULTURE EXPERIMENTS HAVE

INDICATED THIS.

BY THE THIRD OR FOURTH, OCCASSIONALLY EVEN SECOND PHASE SHIFT IN THERAPEUTIC ORGANISM, TARGET MAY REGRESS TO ORIGINAL

SENSITIVITY, THIS MAY NOT BE COVERED BY LATTER PHASE THERAPY.

THERE ATRE THEORETICAL DANGERS IN THIS APPROACH;

1-CREATING RESISTANCE IN TARGET ORGANISMS COULD NOT ONLY POSE SERIOUS RISK IF IT EVER ESCAPED THE TEST TUBE SCENARIO BUT ALSO IT OPENS THE BASIC PHASE ONE POOL SO THAT EACH VARIATION NOW HAS THE POTENTIAL OF NECESSITATING NEW .DIFFERENT PHASE THERAPY. 2-IT APPEARS TO BE MORE LOGICAL TO ALLOW PHASE THERAPY TO MIMIC OR DUPLICATE BODY HOST CHANGES SO THAT SUBSEQUENT PHASES BEAR RELATIONSHIP TO WHAT WILL ARISE IN THE BODY IN THE FORM OF RESISTANCE. CO-CULTURING THE ORGANISMS IN FRESH BLOOD AND/OR OTHER RELEVANT PATIENT SAMPLE. BY PRODUCING CHANGES AS WILL OCCUR IN THE BODY AND/OR REFERRING TO A LIBRARY WITH PREDICTED CHANGE IN TARGET AND REQUIRED COMPENSATION BY THERAPY AS INDICATED BY PRELIMINARY TESTING THAT PLACES TARGET ON ANTICIPATED CHANGE CURVES.

3-USING BLOOD, TISSUE,OTHER PATIENT SAMPLES DUPLICATION OF

HORMONAL AND OTHER CONDITIONS AS WELL AS THE ABILITY TO EXPOSE STOCK OF ORGANISMS CLASSIFIED AS CAUSATIVE/SYNERGISTIC TO

IDENTICAL CONDITIONS PREVIOUSLY EXPERIENCED BY PATIENT.

FOR EXAMPLE,LIBRARY MAY INDICATE A STAPHYLOCOCCAL-LIKE ORGANISM TO BE RELATED TO THE DISEASE PRESENTED.

WHILE AWAITING SPECIFIC CULTURE TO BE IDENTIFIED AND PURIFIED FROM PATIENT, ORGANISMS SUCH AS THE STAPHYLOCCOCUS-LIKE ONE

DESCRIBED MAY BE TREATED ACCORDING TO PATIENT HISTORY OF FEATURES SUCH AS PRIOR TREATMENT WITH

ANTIBIOTICS,CHEMOTHERAPY,RADIOTHERAPY ETC. IN COMBINATION PERHAPS WITH A CULTURE MEDIUM WHICH CONTAINS PATIENT BLOOD AND/OR OTHER PATIENT-SPECIFIC FACTORS.

LIMITED OR CLOSED CULTURE PROCESSING ALONG WITH RELEVANT OPEN- CULTURE AS RELATES TO PATIENT.

OPEN-CULTURE TECHNIQUES ARE MADE TO EXPOSE TARGET ORGANISM TO MECHANISMS AND FACTORS WHICH MAY BENEFIT IT IN-VIVO.

AN EXAMPLE OF AN OPEN-CULTURE TECHNIQUE THAT MAY BE OF BENEFIT INCLUDES THE CO-CULTURING OF TARGET ORGANISM WITH THERAPEUTIC ANTIBIOTIC ALONG WITH ANTIBIOTIC-RESISTANT ORGANISMS ISOLATED FROM PATIENT (STOOL, SKIN,MOUTH, SPUTUM ETC.)SUCH THAT DONATION OF RESISTANCE(FOR EXAMPLE BY PHAGE OR PLASMID)MAY BE ANTICIPATED AND THERAPY DEVELOPED ACCORDINGLY. DEFINING LIVING BIOLOGICAL SYSTEMS

LBS MAY BE DEFINED FOR VARIOUS SITUATIONS AND CONDITIONS.

USE OF LBS MAY BE ACTIVE(EG IN DEVELOPMENT OF THERAPY)OR PASSIVE

EG. IN EXPRESSION OF INTERMEDIATE AND ENDPRODUCT. LBS MAY BE A

CONGLOMERATE OF THERAPEUTIC ORGANISMS OF SIMILAR OR DIFFERENT

SPECIES OR MAY BE TARGET ORGANISM CONGLOMERATE.

AN EXAMPLE OF THERAPEUTIC ORGANISMS OF THE SAME SPECIES BEING

COMBINED IN A LIVING BIOLOGICAL SYSTEM WOULD BE A MIXTURE OF

PENICILLIA BEING COMBINED AS THERAPEUTIC LBS;EVEN THE SAME

PENICILLIUM MAY BE DEFINED AS A LBS IF COMBINED WITH OTHER

PHASES.LBS CAN BE DEFINED BY ORGANISMS CO-EXISTING IN CERTAIN

SAMPLES EG STOOL, SOIL EACTERIA ETC., IN DEFINED ENTITIES EG.KEFIR

CULTURE. SUCH LBS POOLS MAY BE TAPPED IN WIDE SEARCH FOR THERAPY

OR OTHER FACTOR.

LBS THERAPEUTIC MAY REPRESENT NATURALLY OCURRING ENTITIES AND/OR

THOSE ARTIFICIALLY OR OTHERWISE COMBINED OR MODIFIED.AN EXAMPLE

WOULD BE THE COMBINATION OF ANTIBIOTIC SYSTEM WITH PHAGE SYSTEM

AND/OR IMMUNE SYSTEM AS A MULTIFACTORIAL LBS THERAPEUTIC ENTITY.

LBS AS A THERAPEUTIC ENTITY MAY ALSO BE DEFINED AS A MIXTURE OF

ANTAGONISTIC AND NEMESIS FACTORS AS DEFINED IN CLASSIFICATION

PATENT.

TARGETED LIVING BIOLOGICAL SYSTEMS MAY INCLUDE DISEASE CAUSATIVE

ORGANISM ALONG WITH DISEASE SYNERGISTIC ORGANISM ALONG WITH

DISEASE -MODIFIED TISSUE-AN EXAMPLE IN AIDS WOULD BE A LBS

COMBINING HIV, PNEUMOCYSTIS CARINNI AND INFECTED T CELLS.

COMBINED THERAPEUTIC LBS MAY BE DRAMATICALLY MORE EFFECTIVE THAN

ANY SINGLE COMPONENT.

TARGET MAY BE CO-INCUBATED WITH LBS EMPIRICALLY,EG STAPHYLOCOCCUS

AUREUS MAY BE INCUBATED WITH PENICILLIUM. STAPHYLOCOCCUS PHAGE AND

ANTI-STAPHYLOCOICCUS AUREUS ANTISERUM .

THE IDEA OF SUCH EMPIRICAL METHOD IS THAT ANY ORGANISM MUTATION

RESISTANT TO ONE MODALITY MAY SUCCUMB TO ANOTHER ORGANISM IN THE

LBS, THIS TECHNIQUE MAY BE USEFUL IN REACHING FAST THERAPIES BUT

IS NOT ONLY INEFFICIENT-EG IT MAY BE IMPOSSIBLE TO RAISE PHAGE

SPECIFICALLY FOR ORGANISM IF ANTIBIOTIC OR ANTISERUM RAPIDLY

DESTROYS IT. IT IS ALSO POSSIBLE THAT THE VARIOUS INGREDIENTS OF

THE LBS MAY INTERFERE WITH EACH OTHER AND THEIR

ACTIVITY, PARTICULARLY IF THE LBS IS AN ARTIFICIAL ONE. IT IS

POSSIBLE, FOR EXAMPLE THAT THE ANTISERUM CAUSES BACTERIAL CLUMPING

AND THAT ANTIBIOTICS CANNOT THEN ADEQUATELY PERMEATE THE MASS. IT

IS ALSO POSSIBLE THAT CONDITIONS FOR OPTIMAL SURVIVAL AND

FUNCTION OF THE VARIOUS LBS COMPONENTS MAY DIFFER PARTICULARLY

WHERE THE LBS IS COMPRISED OF DIFFERENT SPECIES ARTIFICIALLY

COMBINED.

MUTATIONS RESISTANT TO L;BS,ALTHOUGH LESS LIKELY TO OCCUR THAN

AGAINST ANY SINGLE MODALITY OF LBS SEPARATELY. MAY BE HARDER TO

DEAL WITH.EXPANDING THE RESISTANCE POOL TO MULTIPLE MODALITIES

MAY NOT BE AS, PRUDENT AS EXPOSING THE TARGET TO SINGULAR

MODALITIES IN ISOLATION OPTIMISING THEM AND THEN USING THEM AS

MULTIMODAL/MULTIPHASIC THERAPY.

USING A LIVING SYSTEM/PATIENT TO DEVELOP MULTIPHASIC/MULTIMODAL

THERAPY IS PROBABLY THE OPTIMUM METHOD OF SPECIFYING THERAPY AND BUILDING RELEVANT LIBRARY.

PATIENT TREATED WITH PARTICULAR PHAGE OR ANTIBIOTIC FOR EXAMPLE MAY DEVELOP RESISTANCE TO THAT THERAPY; REISOLATING THE TARGET ORGANISM THEN COINCUBATING IT WITH THE THERAPEUTIC ORGANISM ALLOWS FOR DEVELOPMENT OF SPECIFIC PHASE TWO THERAPY ETC.

THIS DATA ALLOWS FOR ACCUMULATION OF IN-VIVO MULTIPHASIC LIBRARY DATA WHICH MAY BE EFFECTIVELY APPLIED TO SUBSEQUENT PATIENTS. IT IS ALSO NOT NECESSARY TOWAIT FOR PHASE ONE FAILURE IN-VIVO TO SEARCH FOR PHASE TWO AS WITHIN HOURS TO DAYS OF PRELIMINARY APPLICATION OF THERAPY,RESISTANT TARGET FORMS MAY BE ISOLATED FROM PATIENT BEFORE BECOMING CLINICALLY SIGNIFICANT. IT MAY

THEREFORE BE POSSIBLE TO REMAIN AHEAD OF THE OVERALL DISEASE PROCESS BY RAISING THERAPEUTIC COUNTERMEASURES AGAINST RESISTANCE BEFORE SAID RESISTANCE CAN BECOME CLINICALLY MANIFESTED.

LIVING BIOLOGICAL SYSTEMS CAN ALSO BE SELECTED TO AMPLIFY/EXPRESS SPECIFIC THERAPEUTIC MODALITY. LET AUS CONSIDER, FOR EXAMPLE THE SUPPLERMENT GLUTATHIONE; IT IS USEFUL IN THE GENERATION OF

GLUTATHIONE PEROXIDASE AS WELL AS CARRYING OUT SYSTEMIC ANTI-OXIDANT FUNCTIONS.CELLS SUCH AS HEPATIC CELLS AND OTHERS WHICH MAY BE TARGETED FOR OPTIMAL PRODUCTION OF ACTIVE INTERMEDIATES AND ENDPRODUCTS. IF HEPATIC CELLS AND/OR BLOOD CELLS FROM PATIENT OR OTHER CELLS FROM PATIENT OR FROM OTHER COMPATIBLE SOURCE INCLUDING ANIMAL CELLS AND/OR ORGANISMS/SYSTEMS CAPABLE OF

PRODUCING COMPATABLE INTERMEDIATES/ENDPRODUCTS/CO-FACTORS FOR EASY UTILIZATION/ASSSIMILATION BY HOST/PATIENT.

THE MOST VALID INGREDIENT IN A LIVING BIOLOGICAL THEREFORE WOULD BE CELL TYPE OF THE SAME AS TARGET CELL TYPE PREFERABLY FROM PATIENT PROVIDED THAT THE DESIRED ENDPOINT AND INTERMEDIATE PRODUCTS ARE BEST MANUFACTURED BY TARGET CELLS . WE WILL NOW EXPAND ON ALL THESE POINTS.

DESIGNING LBS AS PROCESSING INTERMEDIATES.

1-AMPLIFICATION OF INTRINSIC SYSTEM

WHERE INTRINSIC ANTIOXIDANT SYSTEM SUCH AS SOD IS STIMULATED.

2-AMPLIFICATION OF THERAPY

3-INHIBITION OF TOXICITY

BY PRODUCTION OF DESIRED ENDPOINTS AND CO-FACTORS,THESE MAY BE

SEPARATED PRIOR TO ADMINISTRATION.

THERAPIES/AGENTS MAY BE PROCESSED THROUGH LBS SIMPLY TO BE

PASSAGED THROUGH LIVING SYSTEMS THAT MAY NEUTRALISE SIDE-EFFECTS.

OR TOXIC FRAGMENTS INHERENT OR RELEASED DURING SOME PATHWAY OF

METABOLISM OF AGENT.

A SIMPLE EXAMPLE OF LIVING BIOLOGICAL SYSTEMS BEING USED TO PRE-PROCESS FACTORS WHICH MAY COMPROMISE A RECIPIENT INCLUDES THE USE OF LACTOBACILLI,AND RELEVANT ASPERGILLI AND OTHER SAFE ORGANISMS CONTAINING LACTASE ENZYMES TO PROCESS MILK PRODUCTS FOR LACTOSE INTOLERANT INDIVIDUALS.NEW INVENTION DIFFERS FROM PRIOR ART IS THAT PRIOR ART NECESSITATES ADMINISTRATION OF PURIFIED LACTASE ENZYME ALONG WITH LACTOSE CONTAINING FOODS IN ORDER TO ADEQUATELY DIGEST THE FOOD. THIS PATENT AIMS TO INTRODUCE LACTOSE-DIGESTING ORGANISMS INTO BOWEL FLORA AS A LONGLASTING SOLUTION, IT IS ALSO POSSIBLE TO MODIFY AND ENHANCE INTRINSIC BOWEL ORGANISMS SO THAT THEY DEVELOP LACTASE ABILITY BY SIMPLE CO-INCUBATION WITH ORGANISMS WITH THAT ABILITY,WITH COMPLICATED GENETIC MANIPULATION TECHNIQUES OR BY SIMPLE ADDITION OF APPROPRIATE LBS INTO BOWEL FLORA.

LET US NOW CONSIDER A SPECIFIC EXAMPLE OF LBS USE WITH

SUPPLEMENTS AS RELATED TO 2-MEA, COPPER2

3,5DIISOPROPYL SALICYLATE PATENT.

LIVING BIOLOGICAL SYSTEM TESTED WAS COMPOSED OF;

LACTOBACILLI-STRAINS OF THE FOLLOWING;

ACIDOPHILUS

BIFIDUS

THERMOPHILUS

BULGARICUS

LACTIS

CREMORIS

FAECIUM

PLANTARUM

KEFIR

RHIZOPII

SACCHROMYCES CERVESEAE

EACH ORGANISM CONCENTRATION-50 MILLION VIABLE UNITS PER GRAM

MANY PAPERS HAVE BEEN WRITTEN REPORTING IMMIUNOSTIMULATING

PROPERTIES AS WELL AS ANTIBIOTIC, ANTIFUNGAL, ANTICANCER, AS WELL AS

A PLETHORA OF OTHER ATTRIBUTES.

ALL SUCH BENEFITS ARE OF USE , HOWEVER IN APPLICATION AS

INTERMEDIATE AND ENDPRODUCT GENERATION, THIS SAMPLE FORMULA AS

WELL AS OTHERS CONTAINING ORGANISMS WITH ABILITIES RANGING FROM

ANTIOXIDANT TO ANTIBIOTIC AND ANTIVIRAL WAS ADDED TO THE

FORMULATION OF THE 2-MEA AND CU DIPSAL.

IT WAS FOUND THAT PATIENTS TREATED NOTED A MORE RAPID INCREASE

AND VITALITY THAN WITH THE CHEMICAL FORMULATION ALONE.

AN EXPLANATION FOR THIS MAY RELATE TO THE LBS ABILITY TO GENERATE

SUPEROXIDE DISMUTASE AS WELL AS HAVING ITS OWN BENEFICIAL

INHERENT PROPERTIES. THE CHEMICAL PART OF THE FORMULATION WAS

THEREFORE ABLE TO INTERACT WITH MICROBIAL MECHANISMS TO BOOST AND

ENHANCE LBS ANTIOXIDANT ENZYME GENERATION.THE LBS WOULD IN TURN

PROVIDE INCREASED ENDPRODUCT LEVELS OF THE ANTIOXIDANT ENZYMES TO

THE BODY AS WELL AS XOMPLEMENTS OF CO-FACTORS AND INTERMEDIATES

REQUIRED IN THE PATHWAYS OF GENERATION OF ENDPOINT.

PRELIMINARY TRIALS HAVE INDICATED THAT PHASE 2 LBS , IE . THAT WHICH

HAS BEEN PREVIOUSLY CULTURED WITH 2-MEA AND CUDIPSAL PROVIDED

GREATER ANTIOXIDANT ABILITY WHEN COMPARED WITH PHASE 1 LBS. MULTIPHASIC THERAPY MAY BE USED IN SYNERGISTIC MULTIMODAL

APPROACH.

THAT IS TO SAY THAT VARIOUS MODES MAY BE USED TO AUGMENT EACH OTHER'S FUNCTION.

PHAGES RAISED AGAINST OR WITH ACTIVITY AGAINST PENICILLIN RESISTANT ORGANISMS WILL AUGMENT THE FUNCTION OF SAID ANTIBIOTIC. FUNCTION IS EVEN AUGMENTED AGAINST PENICILLIN SENSITIVE ORGANISMS

AN EXAMPLE OF THIS IS THE PLATING ON BLOOD AGAR OF STREPTOCOCCAL

CULTURE WITH PENICILLIN SENSITIVITY.

STREPTOCOCCUS WAS ISOLATED FROM SKIN SAMPLE AND POSESSED

PENICILLIN SENSITIVITY (TEST WAS REPEATED ON SEVERAL OCCASSIONS

USING PENICILLIN AS WELL AS OTHER TYPES OF ANTIBIOTICS AND

STREPTOCOCCAL, STAPHYLOCOCCAL AND OTHER HOST ORGANISMS AS WELL AS

THEIR PHAGES AS SUPPLIED BY ATCC AND/OR RAISED INDEPENDANTLY,WITH

SIMILAR RESULTS)AFTER PLATING AND CULTURING FOR 3 DAYS AT ROOM

TEMPERATURE, THE PLATE WAS COVERED WITH MANY PURELY STREPTOCOCCAL

COLONIES . ON THE THIRD DAY, A DISC SATURATED WITH PROCAINE

PENICILLIN WAS PLACED IN THE CENTRE OF THE AGAR PLATE.WITHIN 24

HOURS A ZONE OF CLEARANCE WAS EVIDENT AROUND THE DISK AS A HALO

MEASURING 2MM IN DEPTH. THE FOLLOWING DAY THE ZONE MEASURED

3MM, THERE WAS NO FURTHER ENLAGEMENT OF ZONE WITH FURTHER

INCUBATION.

SREPTOCOCCAL PHAGE WAS ADDED TO THE PENICILLIN-SATURATED

DISC. PHAGE WAS EITHER ONE OBTAINED FROM ATCC WHICH HAD

DEMONSTRATED EFFICACY IN LYSIS OF THIS PARTICULAR STREPTOCOCCUS

OR ONE RAISED FROM THE BACTERIA BY TECHNIQUES PREVIOUSLY NOTED.

SOLUTION OF PHAGE ESTIMATED AT 10 TO THE NINTH POWER OF PLAQUE

FORMING UNITS 0.5CC OF PHAGE TSB SUSPENSION WAS ADDED TO DISC

SATURATED WITH PROCAINE PENICILLIN.

ZONE OF CLEARANCE FORMED AS IN PREVIOUS TEST; ZONE OF CLEARANCE

WAS MARGINALLY LARGER 0.5 MM,MORE IMPORTANTLY,WITHIN 24 HOURS

PLAQUE FORMATION WAS EVIDENT THROUGHOUT MANY OF THE COLONIES-AGAR

PLATE CONTAINED NO VIABLE COLONIES WITHIN 48 HOURS.

IN OTHER TEST SYSTEMS WHERE TOTAL COLONY CLEARANCE DID NOT

OCCUR,MULTIPHASED(USUALLY NO MORE THAN 3)WERE REQUIRED TO ACHIEVE

TOTAL BACTERIAL LYSIS.

THIS IN-VITRO DATA DOES NOT EASILY TRANSLATE IN IN-VIVO DATA AS

PHAGE OF SINGLE PHASE IS USUALLY UNABLE TO ERADICATE INFECTION

FROM A LIVING BODY;NOT ONLY IS A LIVING OPEN SYSTEM CONDUSIVE TO

THE BACTERIAL TARGET'S DEVELOPMENT OF RESISTANCE BUT THERE IS

ALSO THE PROBLEM OF THERAPY REACHING TARGET,MUCH OF THE PHAGE

LOAD MAY BE INTERCEPTED BY THE HOST'S IMMUNE RESPONSE AND

ELIMINATED PRIOR TO REACHING THE BACTERIA.PRIOR MECHANISMS AND

EXAMPLES DESCRIBED SHOW THE ABILITY OF MULTIPHASED PHAGES AND

IMMUNE RESPONSES TO AUGMENT EACH OTHERS ABILITY AS WELL AS OTHER

PATHWAYS OF THERAPY SUCH AS ANTIBIOTIC THERAPY..

MULTIPHASIC THERAPY IN MULTIPLE MODES CAN ENHANCE EACH OTHERS

FUNCTION AS WELL AS OFFER PREVENTION AGAINST THE DEVELOPMENT OF

RESISTANCE

PHAGES CAN BE RAISED SPECIFICALLY AGAINST ANTIBIOTIC -RESISTANT

STRAINS OF TARGET ORGANISM.

IMMUNE RESPONSE SUCH AS ANTISERUM MAY BE RAISED AGAINST ORGANISMS RESISTANT TO ANTIBIOTIC AND/OR PHAGE. THESE MODALITIES, INTERTWINED MAY BE PASSAGED THROUGH SEVERAL PHASES.

USE OF INTERTWINED MODALITIES

PATENT COVERS THE USE OF MULTIPHASIC THERAPY AS WELL AS THE USE

OF PHAGES AND/OR ANTISERA AS ADJUNCTS TO ANTIBIOTIC

THERAPY, ANTICANCER AND ANTI-AIDS THERAPY.

IT IS ALSO TO BE STRESSED THAT ALTHOUGH CURRENT APPLICATIONS MAY

APPEAR CRUDE, PATENT COVERS THE APPLICATION OF MORE REFINED

TARGETING OF THE VARIOUS MODALITIES SUCH AS THE RAISING OF

SPECIFIC IMMUNE RESPONSES AGAINST PLASMIDS WHICH MAY CODE FOR

ANTIBIOTIC RESISTANCE

EXAMPLES OF ANTIBIOTIC ENHANCEMENT.

STAPHYLOCOCCAL TONSILITIS USUALLY REQUIRES 7-10 DAYS OF

ANTIBIOTIC THERAPY FOR ADEQUATE RESOLUTION.

3 PATIENTS AGE 15-19 SUFFERING FROM RECURRING BOUTS OF

TONSILLITIS HAD PREVIOUSLY BEEN TREATED WITH AMOXIL 250 MG TDS

FOR 10 DAYS ON THREE OCCASSIONS .EACH PRESENTATION YIELDED

STAPHYLOCOCCUS AUREUS CULTURE.WITH SENSITIVITY TO AMOXIL BUT NOT

TO PENICILLIN PHAGE WAS RAISED AGAINST THE CULTURE BY CULTURING

THE ISOLATED STAPHYLOCOCCUS IN 500CC OF TRYPTICATED SOY BROTH 0.05CC OF 1%HYDROGEN PEROXIDE SOLUTION WERE ADDED ON THE THIRD

DAY OF CULTURE WHEN BACTERIAL GROWTH WAS RICH.BACTERIAL LYSIS

OCCURRED 2DAYS LATER. 0.1CC OF BROTH WAS THEN DRAWN FOR TESTING.

AND CAUSED LYSIS OF ESTABLISHED COLONIES OF THE BACTERIA ON AGAR

PLATE INDICATED PHAGE PRESENCE

BROTH WAS AGITATED AND FILTERED THROUGH 0.2 MICRONS.

HORSE ANTISERUM WAS RAISED BY INTRADERMAL INJECTION OF 0.5CC OF

TSB CONTAINING ONE MILLION ORGANISMS PER ML.

INTRADERMAL INNOCULATION WAS REPEATED EVERY THREE DAYS FOR 2

WEEKS.

3 CC OF BACTERIAL CULTURE WERE THEN TREATED WITH 100,000 U OF

PROCAINE PENICILLIN(CULTURE OT THIS SAMPLE INDICATED BACTERIAL

SURVIVAL)CULTURE WAS CONTINUED FOR A 12 HOUR PERIOD;ORGANISMS

WERE THEN LYSED BY 15 MINUTES OF SONICATION.

THE THEORY HERE IS THAT CHANGES IN BACTERIAL STRUCTURE AND

CONTENT WILL ALTER AS PENICILLIN-RESISTANCE SYSTEMS VARE

INDUCED,HORSE IMMUNE RESPONSE WILL THEN BE ABLE TO TARGET THESE

AS WELL AS BACTERIAL STRUCTURE IN UNCHALLANGED STATE.

IT SHOULD BE NOTED HERE THAT COMPARISON OF SERUM ELECTROPHORESIS

FROM ANIMALS VACCINATED WITH BACTERIA/BACTERIAL FRAGMENTS IN

UNCHALLANGED STATE AND THOSE CHALLANGED WITH THE ANTIBIOTICS

ENABLES DEFINITION OF IMMUNE RESPONSE RAISED AGAINST INDUCEABLE

RESISTANCE FACTORS.

100 CC OF HORSE BLOOD IS DRAINED TWO WEEKS FOLLOWING THE FINAL HORSE IMMUNISATION. AND CENTRIFUGED TO YEILD SERUM, SERUM IS STORED AT 3 DEGREES CELSIUS FOR 9 MONTHS.THIS IS AN OLD TECHNIQUE THAT REMOVES MUCH OF ALLERGIC COMPONENT OF SERUM. IT IS WITHIN THIS PATENT PARAMETERS TO .INCLUDE ANY MORE SOPHISTICATED PURIFICATION TECHNOLOGY INCLUDING 'WASHING' OF SERUM AGAINST HUMAN/AND/OR PATIENT'S OWN RED BLOOD OR OTHER CELLS/CELL FRAGMENTS AS WELL AS OTHER TECHNIQUES INCLUDING SELECTIVE FILTRATION,ELECTROPHORESIS AND OTHER TECHNOLOGIES INCLUDING ISOLATION AND GENETIC AMPLIFICATION TECHNOLOGY INCLUDING MONOCLONAL ANTIBODY PRODUCTION AND OTHER MECHANISMS INVOLVING HYBRID AND OTHER CELL LINES.

THE PATENT COVERS THE USE OF ANTISERA/WHITE BLOOD CELL

EXTRACT/IMMUNOSTIMULATION AS ADJUNCT TO ANTIBIOTIC THERAPY BOTH DIRECTLY AND BY RAISING RESPONSE AGAINST TARGET PREVIOUSLY TREATED WITH ANTIBIOTIC SO THAT THERE IS A PASSIVE AS WELL AS A LATTER ACTIVE IMMUNE RESPONSE AGAINST THERAPY RESISTANT ORGANISMS. IT IS POSSIBLE TO INCUBATE PATIENT CELLS WITH TRANSFER FACTOR FROM IMMUNISED CELLS OF OTHER SOURCE, TO INDUCE THEIR ACTIVITY AGAINS TARGET ORGANISM,TO RECOGNISE ISOLATE AND AMPLIFY USING INTERFERON, INTERLEUKIN AND/OR OTHER MODALITIES PATIENT CELLS WITH ACTIVITY AGAINST TARGET.

FOLLOWING SEVERAL MONTHS OF COLD STOREAGE PRECIPITATES FORM IN THE SERUM WHICH ARE FILTERED OUT. SERUM IS THEN FILTERED THROUGH 0.2 MICRONS.

0.3CC OF SERUM IS INJECTED INTRADERMALLY.DOSES UP TO 5CC HAVE BEEN USED INTRADERMALLY/SUBCUTANEOUSLY/INTRAMUSCULARLY WITHOUT HARMFUL RESULTS.THE LOW DOSE IS USED AS IN THEORY,THE TARGET RESISTANT POPULATION EXISTS IN EITHER LOW DOSE OR HAVE NOT YET BEEN GENERATED.FURTHERMORE WE CAN USE THE ANTISERA TO INHIBIT DONASTION OF PLASMIDS OR OTHER RESISTANCE-DONATING FACTORS.

EVEN WHERE RESISTANT STRAINS EXIST IN SIGNIFICANT AMOUNTS; IT IS UNLIKELY THAT THEY WILL SURVIVE BOTH ANTIBIOTIC AND PHAGE ATTACK,AGAIN LEAVING RELATIVELY LITTLE FOR THE ANTISERA TO

OVERCOME.

THERAPY

1 MILLION UNITS OF PROCAINE PENICILLIN

0.6CC OF PHAGE LYSATE (10 TO THE NINETH POWER PLAQUE FORMING

UNITS)

0.3CC HORSE SERUM. (ANECDOTAL CASES HAVE SUGGESTED THAT HUMAN AND

OR ANIMAL IMMUNOGLOBULINS INCLUDING THE COMMONLY AVAILABLE FORMS

SUCH AS POOLED IMMUNOGLOBULINS EVEN IF NOT SPECIFICALLY RAISED

AGAINST TARGET MAY BE OF BENEFIT BUT TEND TO NOT BE AS EFFECTIVE;

CURRENT RISK OF HEPATITIS AND AIDS CONTAMINATION OF HUMAN STOCK

MAY MAKE ANIMAL SERA MORE APPEALING.

TECHNIQUE

1 MILLION UNITS OF PROCAINE PENICILLIN WERE INJECTED

INTRAMUSCULARLY.

0.6CC OF PHAGE LYSATE WAS INJECTED INTRADERMALLY AT THE SAME

TIME.

0.3CC OF ANTISERUM WAS INJECTED INTRADERMALLY 6 HOURS LATER.THE

REASON FOR THE DELAY IS THE THEORETICAL POSSIBILITY THAT

ANTISERUM MAY,BIND AND NEUTRALISE PHAGE LYSATE PRIOR TO ITS

CIRCULATION AND REACHING TARGETS.

THE PHAGE INJECTION IN ALL THREE PATIENTS GAVE RED MARKS 1-4 INCHES IN DIAMETER AND WAS ITCHY FOR SEVERAL MINUTES.ONE REPORTED A MILD HEADACHE AND TEMPERATURE OF 100 DEGREES CELSIUS THAT

LASTED FOR 6 HOURS.

TONSILLITIS RESOLVED IN ALL PATIENTS WITHIN 48 HOURS OF TREATMENT FOLLOWUP FOR 1 YEAR REVEALED NO RECURRENCE OF TONSILLITIS IN ANY OF THE THREE. THIS WAS QUITE UNUSUAL IN VIEW OF PREVIOUIS HISTORY OF AT LEAST TWO YEARLY BOUTS AMONGST THEM.

THERE EXIST OTHER IN-VITRO AND THERAPEUTIC DATA SUGGESTING THE EFFICACY OF MULTIMODAL THERAPY COMBINED WITH CURRENT STANDARD THERAPY AS WELL AS MULTIPHASED MULTIMODAL THERAPY ALONE AND/OR IN COMBINATION WITH STANDARD THERAPY.

INDUCED REMISSION THERAPY.

USE OF MULTIPHASED MULTIMODAL THERAPY IN COMBINATION WITH CHEMOTHERAPY

OVERCOMING CHEMOTHERAPY RESISTANCE.

AS MENTIONED IN CLASSIFICATION PATENT, THERE EXIST ORGANISMS CAPABLE OF INTERACTING WITH CANCER CELLS IN EITHER CAUSATIVE OR SYNERGISTIC FASHION. INHIBITION OR ELIMINATION OF THESE ORGANISMS CAN BENEFIT THE PATIENT.

IT HAS ALSO PREVIOUSLY BEEN MENTIONED THAT THE FAILING OF MODERN ADJUVANT IMMUNOTHERAPY IS THAT THE PATIENT'S IMMUNE RESPONSE IS FAULTY AS IN THEORY FURTHER STIMULATION MAY AUGMENT A SYSTEM WITH DISEASE BIAS; FURTHERMORE, WHEN

INDUCE IF/IL2 ETC.

PHAGE CARRYING ANTIGEN OR OTHER TARGETED CHEMO ANTIBIOTIC ANTISERUM WELLS TARGET AND IMMUNISE-

CHOLESTEROL

EXPRESSION LBS CANCER WILL BE USED HERE AS AN EXAMPLE TO DEMONSTRATE APPLICATION OF TECHNOLOGY; IT IS NOT TO RESTRICT THIS PATENT WHICH APPLIES TO MANY, IF NOT ALL DISEASE AND OTHER CONDITIONS.

1-RAISING OF REPONSE AGAINST CANCER-SPECIFIC FACTORS.

THIS INVOLVES PREPARATION OF SUCH ENTITIES AND/OR REFERRING TO LIBRARY SAMPLES . CANCER TISSUE, IN CERTAIN CASES OF NATURE OR AFTER SPECIFIC CULTURE/PREPARATION TECHNIQUES .OCCURS IN HIGHLY

UNDIFFERENTIATED (OFTEN ASSOSCIATED WITH CLINICAL AGGRESSIVENESS) FORM. INTERESTINGLY, THE GREATER THE DIFFERENTIATION, THE LESS AGGRESSIVE THE DISEASE, SUGGESTING THAT REDIFFERENTIATIN EVEN PARTIAL OF TARGET CANCER CELLS MAY PROMOTE GREATER

SURVIVAL.(SEE REDIFFERENTIATION SECTION OF BIOLOGICAL ENHANCEMENT-ALSO TIE IN OF LBS WITH INTERFERANCE PHENOMENON IN CANCER, ULCERS ETC.)

INJECTION OF AN ANIMAL SUCH AS A HORSE WITH NORMAL HUMAN CELLS WHOLE AND/OR FRAGMENTED PREFERRABLY FROM THE SAME CELL TYPE AS DISEASE FROM EITHER PATIENT OR GENETICALLY RELATED DONOR

(ACTUALLY SYSTEM ALSO WORKS WELL WITH GENERAL POOLED ANTIHUMAN

ANTISERA(CONTRAST WITH MULTIPHASIC

IMMUNOLOGICAL THERAPY TO BE DISCUSSED LATER INCLUDING NEUTRALISATION OF FAULTY ANTISERUM AND USING IT AS MARKER FOR SECONDARY IMMUNE RESPONSE)

HORSE IS VACCINATED WITH NORMAL HUMAN BLOOD CELLS WHICH HAVE BEEN

EXPOSED TO 10,000DB FOR 1 MINUTE.BLOOD FROM POOL IS INJECTED INTO

THE ANIMAL INTRADERMALLY AT 0.5 CC EVERY 3 DAYS FOR 3

WEEKS.ANIMAL SERUM AT THAT TIME CONTAINED SIGNIFICANT AMOUNTS OF

ANTI-HUMAN ANTISERUM.

LEUKEMIA CELLS WERE SUSPENDED IN SALINE(CML 150,000 X 10 TO THE

NINETH POWER PER CC FROM PATIENT MENTIONED PREVIOUSLY)AND TREATED

WITH ANTI-HUMAN ANTISERUM.

ICC OF LEUKEMIA SALINE SUSPENSION WAS ADDED TO 0.5CC OF ANTISERUM

AND INCUBATED FOR 6 HOURS.WHOLE CELLS WERE THEN SPUN DOWN AND

WASHED 3 TIMES WITH SALINE THEN RESUSPENDED IN 2CC OF

SALINE.AGAIN ALTHOUGH PATENT DETAILS USE OF ANTIHUMAN

ANTISERUM,ANY ANTI-HUMAN IMMUNOLOGICAL RESPONSE INCLUDING CELL

MEDIATED, ENZYMATIC, ORGANISM , CHEMICAL, PHYSICAL OR BIOLOGICAQL

AND/OR COMBINATIONS MAY BE USED THE PATENTED CONCEPT OF THIS

PATENT IS TO RAISE AN ANTI-NORMAL RESPONSE TO EFFECTIVELY TREAT

DISEASE AND REMOVE FROM IT ANY NORMAL FACTORS, HENCE FASCILITATING

THE AIMING OF THERAPY WITH HIGH PRECISION AT THE RESIDUAL

FASCTORS WHICH WE WILL TERM CANCER-SPECIFIC OR DISEASE-SPECIFIC

FRACTION(DSF)

SIMILARLY TECHNIQUES PHYSICAL, CHEMICAL/BIOLOGICAL( INCLUDING THAT

OUTLINED ABOVE )CAN BE USED TO RAISE AN ANTI-DSE RESPONSE,UPON

TREATING HEALTHY CELLS WITH THE ANTI-DSE WE ARE LEFT WITH HEALTHY-CELL SPECIFIC EXTRACT(HCSE).. IT IS A VALID ASSUMPTION THAT

HCSE MAY BE AUGMENTED WITHOUT ENHANCING DISEASE PROCESS(SEE

BIOLOGICAL ENHANCEMENT SECTION)

ANOTHER CRUDE BUT USEFUL PROCEDURE IS THE IMPLANTING OF TUMOUR

BIOPSIES INTO ANIMAL VACCINED AGAINST NORMAL HUMAN FACTORS AND

RECOVERING IMPLANT 3-6 DAYS LATER WHEN ANIMAL SYSTEMS WOULD HAVE

ATTACKED, RE MOVED OR DENATURED MUCH OF THE NORMAL HUMAN

COMPONENTS OF THE BIOPSY. EVEN NORMAL ANIMAL IMPLANTATION WITHOUT

ANY PRIOR ANTIHUMAN IMMUNISATION WOULD STILL REMOVE MUCH OF THE

NORMAL HUMAN COMPONENT OF DISEASED HUMAN CELLS BUT PERHAPS NOT AS

EFFICIENTLY.

THERAPEUTIC ORGANISM CAN THEN BE CULTURED WITH VARIBLE DEGREES OF

BIAS WITH THE SPECIFIC DISEASE FRACTIONS AS WELL AS WHOLE CVELLS

WHICH HAVE BEEN 'DEHUMANISED'.

SEVERAL STRAINS OF PENICILLIUM WERE INCUBATED WITH LEUKEMIA CELLS

THAT HAD SURVIVED THE 'DEHUMANISING' PROCEDURE FOR THREE WEEKS.

OTHER TECHNIQUES

AS PREVIOUSLY MENTIONED, IT IS POSSIBLE TO DEFINE LIVING

BIOLOGICAL SYSTEMS TO CERTAIN PROCEDURES; BY EXPOSING TARGET TO

LIVING BIOLOGICAL SYSTEMS TO TARGETS IT IS POSSIBLE TO ISOLATE

ORGANISMS WITH SPECIFIC AFFINITY

LIVING BIOLOGICAL SYSTEM MAY BE BROAD(SUCH AS SOIL ORGANISMS)

NARROW (WITH VARIOUS DEGREES OF DEFINITION EG BY

SPECIE/SUBSPECIE)

DEFINED FOR FUNCTION/OTHER;EXAMPLE -CHEMOTHERAPY GENERATING

ORGANISMS.

EXPANDED; NATURALLY BY ADDITION OF LIVING/NON-LIVING COMPONENTS.

EXPANDED ARTIFICIALLY BY EXPOSURE OF LBS TO MUTATING AGENTS.

A NARROW,DEFINED LBS WAS CHOSEN WHERE THE COMPOSITION WAS

PENICILLIUM SPECIES ISOLATED FROM VARIOUS FOOD SOURCES;

GRAPE JUICE,MOULDY BREAD, PENICILLIUM NOTATUM STOCK ATCC

CULTURES;ALL WERE CO-INCUBATED WITH CANCER CELLS AND CELL

FRAGMENTS THAT WERE 'HUMANISED' FOR A PERIOD OF THREE WEEKS

TERMEDADAPTAT I ON PHASE .

THE SECOND PHASE OF THE PROCESS IS THE SELE CT I VE

I SOLAT ION PHASE DURING THIS PHASE THE LBS OF POOLED

PENICILLIUM ORGANISMS,HAVING BEEN CO-INCUBATED IN 500CC OF

TRYPTICATED SOY BROTH WITH DEHUMANISED LEUKEMIA CELLS (10CC OF SALINE SUSPENSION AT 150,000 CELLSX 10 TO THE NINETH POWER)FOR THREE WEEKS IN THE ADAPTATION PHASE;ARE NOW 'CHALLANGED WITH THREE LYMPH NODE BIOPSIES,EACH MEASURING ICMM DIAMETER

APPROXIMATELY WITH ATTATCHED PIN MARKERS OF DIFFERENT COLOURS. RED-NORMAL -HISTOLOGICALLY DISEASE-FREE LYMPH-KODE FROM LEUKEMIA PATIENT.

BLUE-DISEASED LYMPH NODE FROM SAME PATIENT HISTOLOGICALLY SHOWING ALMOST TOTAL DISPLACEMENT BY LEUKEMIA CELLS.

GREEN-NORMAL LYMPH NODE REMOVED FROM HEALTHY VOLUNTEER AXILLA. (IN OTHER CASES THE THIRD CONTROL LYMPH NODE WAS REMOVED FROM AUTOPSIES AND/OR ANIMAL LYMPH NODES) EACH OF THE THREE BIOPSY TYPES ARE REPRESENTED BY THREE BIOPSIES OF 1CM DIAMETER WERE PLACED INTO THE BROTH CONTAINING THE

PENICILLIUM LBS AFTER THE ADAPTATION PHASE OF 3 WEEKS.

SAMPLES ARE IMMERSED IN BROTH FOR THREE DAYS, 6 DAYS AND THREE WEEKS . AT EACH TIME ONE OF THE BIOPSY SAMPLES WAS WITHDRAWN HALF WAS INSERTED INTO 200CC OF TRYPTIC SOY BROTH, THE OTHER HALF WAS RINSED WITH 30 CC OF SALINE AND THEN PLACED INTO 200CC OF TSB HALF IS RINSED TO DIMINISH THE CHANCE OF CULTURING

SUPERFICIAL,NON-SPECIFIC ORGANISMS FLOATING IN THE TSB AND SIMPLY WERE REMOVED ALONG WITH THE BIOPSIES WITHOUT HAVING ANY REAL AFFINITY FOR THEM .

(THIS MODEL IS AN EXAMPLE MODEL AIMED TO INDICATE HOW TO CREATE AND EXTRACT EFFICIENT,UNI AND/OR MULTIPHASIC THERAPY ,ENHANCING CURRENT CHEMOTHERAPY PROTOCOLS, THE TIME PERIODS ARE DEPENDANT ON ORGANISM ACTIVITY, IF DEALING WITH FAST VIRUSES OR BACTERIA, THE IUMMERSION OF BIOPSIES MAY BE MEASURED IN MINUTES OR HOURS, FOR EXAMPLE, SLOWER ORGANISMS MAY REQUIRE MORE TIME.TUMOUR BIOPSIES ARE ABLE TO REMAIN STRUCTURALLY COHESIVE UP TO SEVERAL WEEKS, ORGANISM WITH THE HIGHEST AFFINITY MAY BE SLOWER THAN OTHERS IN THE LBS AND TAKE TIME TO ESTABLISH ITSELF AND DISPLACE OTHER ORGANISMS FROM THE BIOPSY. THE BEST LIVING MATCH WILL BE OBTAINED IF CANCER CELLS ARE STILL VIABLE AT THE TIME OF ORGANISM INVASION AND/OR IF THE BIOPSY SPECIMEN IS REPRESENTATIVE OF THE DISEASE AS IT EXISTS IN-VIVO.PATENT ALSO COVERS IN-VIVO MATCHING TECHNIQUES USING ANIMAL MODELS THAT CAN SUSTAIN LIVING CANCER CELLS AND LIVING LBS CULTURES OVER A DEFINED PERIOD AND ALTHOUGH SUCH A SYSTEM WAS TESTED OUT IN SHEEP. ONE WOULD REQUIRE EITHER ABSENCE OF IMMUNOLOGICAL RESPONSE OR ANIMAL MODEL WITH ITS OWN 'HUMAN EQUIVALENT' CANCER IN ORDER TO MAINTAIN CANCER EXPOSURE OVER A TIME PERIOD OF SEVERAL WEEKS. THERE ARE DIFFICULTIES IN FACTORING FOR ANIMAL-SPECIFIC CONDITIONS AND ALTHOUGH THE RESULTS CAN BE DRAMATIC(ANIMAL IMPLANTED WITH SOLID TUMOUR ON ONE

BUTTOCK. INJECTED WITH LBS IN OTHER BUTTOCK WILL WITHIN DAYS TO WEEKS DEVELOP PUS COLLECTION AT BOTH SITES, CULTURE OF THE LBS SITE WILL REVEAL MIXED ORGANISMS DOMINATED THE MOST HARDY/IMMUNE RESISTANT,THE CULTURE OF ABSCESS WHERE TUMOUR WAS INJECTED WILL OFTEN YEILD A PURE CULTURE OF ORGANISM,EITHER FROM THE LBS(IF SHORT TIME PERIOD, INDICATING THAT WITH HIGHEST AFFINITY, BUT OCCASSIONALLY OTHER ORGANISMS WOULD BE CULTURED AS WELL;THESE WERE ASSUMED TO BE FROM OTHER LBS IN THE ANIMAL MODEL BUT MAY HAVE BEEN OTHER DISEASE-RELATED ORGANISMS FROM WITHIN THE

BIOPSY.),ANIMAL MODELS WERE NOT EXTENSIVELY USED FOR THIS TESTING AS A CLOSED SYSTEM SEEMED EASIER,MORE PRACTICAL AND MORE HUMANE).

THE BIOPSY FRAGMENT WERE THEN CULTURED INDIVIDUALLY IN SEPARATE

STERTILE MEDIA,MANY TYPES OF MEDIA COULD BE USED ,TSB IS CHOSEN

TO ILLUSTRATE PATENT.

WITHIN 2 WEEKS PURE CULTURES OF PENICILLIUM COULD BE ISOLATED

FROM FROM THE SIX DAY AND 3 WEEK SPECIMENS,MACROSCOPIC AND

MICROSCOPIC EXAMINATION REVEALED INFILTRATION OF BIOPSIES BY

PENICILLIUM MOULD.

EARLIER SAMPLES WERE VARIABLY POSITIVE BUT AT THREE WEEKS, GROWTH

EVEN IN THE SALINE-WASHED BIOPSY WAS DEFINITE. EACH OF THE BIOPSY PREPARATIONS SERVES A PURPOSE, SAMPLES REMOVED EARLY WILL CONTAIN ORGANISMS AND ORGANISM PRODUCTS CAPABLE OF FAST ATTATCHMENT AND SUPERFICIAL COATING.OPTIMAL DATA MAY BE OBTAINED IF CULTURE MEDIUM INCLUDES FRACTIONS OF OR IS LARGELY COMPRISED OF PATIENT'S BLOOD,ALTERNATIVELY,BIOPSY SAMPLES MAY BE TESTED ON SELECTED CULTURES GROWN ON HUMAN AND/OR PATIENT'S BLOOD AS A SECOND CHECK.USE OF BLOOD AND/OR OTHER SAMPLES OF HUMAN AND/OR ANIMAL ORIGIN DEPEND LARGELY ON LOCATION OF CANCER AND THERAPY TYPE BEING DEVELOPED.

ORGANISMS/AGENTS THAT ADHERE TO NORMAL TISSUE BIOPSY MAY BE USED TO IMMUNISE ANIMALS SO THAT ANTISERA OR OTHER IMMUNE RESPONSE COULD BE DEVELOPED TO INHIBIT THE DEVELOPMENT OF SUCH CHARACTERISTICS IN FURTHER CULTURES.

ORGANISMS THAT ATTATCH TO CANCER CELL/CANCER MASS SELECTIVELY MAY

BE USED TO DEVELOP TAGG I NG AND TARGET I NG

THERAP IES . TO BE COVERED LATER .

IN COMPLICATED LBS ' S ORGANISMS/PRODUCTES AND OTHER FACTORS WILL BE FOUND THAT WILL PENETRATE TO VARIOUS DEPTHS AND ACT AT VARIOUS LEVEL(EG BACTERIALO COMPONENTS OF LBS MAY ATTATCH TO NECROTIC CENTRE OF MASS WHEREAS VIRAL COMPONENT OF LBS MAY ACT ON CELLULAR LEVEL.

THE ORGANISM ISOLATED FROM THE BIOPSY WHICH WAS RINSED AFTER 3 WEEK EXPOSURE WILL BE CULTURED IN TSB(USED AS EXAMPLE ALTHOUGH MANY OTHERS COULD BE SUBSTITUTED IN PATENT) A BIOPSY OF CANCEROUS LYMPH NODE AND ONE OF HEALTHY LYMPH NODE WILL BE CO-INCUBATED WITH PENICILLIUM AS DONE IN PREVIOUS PHASE.

AS WITH PREVIOUS PHASE .ORGANISMS FROM WASHED DISEASE BIOPSIES WILL BE PLACED ALONG WITH NORMAL AND PATHOLOGIC TISSUE UNTIL GROWTH ON PATHOLOGIC TISSUE IS FASTER AND MORE LUXURIOUS ON THE DISEASED AS OPPOSED TO THE NORMAL BIOPSY.

ORGANISMS CAN BE ISOLATED AND REINCUBATED REPEATEDLY UNTIL OBVIOUS AFFINITY FOR DISEASED TISSUE IS EXPRESSED, THIS MAY BE AIDED BY THE ANTISERA RAISED AGAINST ORGANISMS WITH AFFINITY FOR HEALTHY TISSUE AND/OR OTHER MECHANISMS AND FACTORS RAISING

CULTURE BIAS AGAINST THEM(ONCE THESE STRAINS ANDF TYPES ARE DEFINED AS EXPRESSING PREFERANCE TO HEALTHY OR DISEASED TISSUE;THE HEALTH-PREFERRED ORGANISM TYPES MAY BE

INHIBITED, REMOVED OR NEUTRALISED AND THOSE WITH DISEASE

PREFERANCE PROMOTED.

FOLLOWING THREE SUCH PASSAGES, THE PENICILLIUM ISOLATED FROM THE LEUKEMIC LYMPH NODE WAS PLACED INTO 500CC TSB AND CULTURED FOR THREE WEEKS THE MEDIUM WAS THEN PASSED THROUGH A 0.2 MICRON FILTER. 0.1CC OF THIS PRODUCT WAS ADDED TO PATIENT'S BLOOD, SAME PATIENT WHO HAD, DONATED THE DISEASED NODE BIOPSIES.WHITE CELLS WERE CENTRIFUGED DOWN AND RESUSPENDED IN SALINE LEUKEMIA COUNT AT THIS TIME WAS 220,000 × 10 TO THE NINETH POWER PER CC. ICC OF SALINE SUSPENSION WAS USED.

WITHIN 2 HOURS OF SITTING AT ROOM TEMPERATURE, LEUKEMIA COUNT WAS 118,000. 0.1 CC OF CRUDE SPECIFIC PENICILLIN EXTRACT(FILTRATE AS DEFINED ABOVE) WAS ALSO ADDED TO POOLED NORMAL WHITE BLOOD CELLS

RESUSPENDED IN SALINE AT 210,000 CELLS PER CC.

2 HOURS LATER COUNT WAS 200,000.

TESTS PREVIOUSLY DONE WITH CRUDE PENICILLIUM EXTRACT INDICATE MOUSE LD50 LEVEL GREATER THAN ICC PER KG

ORAL/INTRAMUSCULAR/INTRADERMAL/SUBCUTANEOUS DOSING ROUTES.

PATIENT WAS INJECTED WITH 3CC OF SCPE{SPECIFIC CRUDE PENICILLIN EXTRACT) INTRAMUSCULARLY. W3C COUNT BASELINE 220,000,24 HOURS LATER COUNT 180,000 REPEATED DOSE OF SCPE DROPPED COUNT TO

150,000 24 HOURS LATER. REPEATED DOSEAGE DROPPED LEVEL TO 120,000 THE WHITE BLOOD CELL COUNT REMAINED AT THAT LEVEL WITH VARIATIONS OF NO MORE THAN 20,000 FOR 6 WEEKS WITH DAILY DOSEAGE OF 3CC SCPE INTRAMUSCULAR THERE WAS NO FURTHER DROP DESPITE CONTINUED DOSEAGE. IN VITRO TESTING DEMONSTRATED LOSS OF EFFICACY OF SCPE. IN LEUKEMIA CELL KILL.

THIS SITUATION WOULD BE ANALAGOUS TO THE DEVELOPMENT OF

CHEMOTHERAPY RESISTANCE.

TO GENERATE NEW,EFFECTIVE THERAPY FROM THE SAME INITIAL

SOURCE,ANY NUMBER OF COINCUBATION METHODS WITH VARIOUS DEGREES OF

BIAS FOR THE PURPOSE OF THIS DEMONSTRATION, THE FOLLOWING WAS

DONE '

WHITE BLOOD CELLS FROM PATIENT WERE SPUN DOWN,RESUSPENDED IN

SALINE THEN SPUN DOWN AGAIN(IN THEORY,THIS PROCESS ALLOWS REMOVAL

OF OTHER BLOOD CELLS AND OTHER NORMAL BLOOD COMPONENT SO THAT

THESE ARE NOT ALSO TARGETED BY THE PENICILLIUM OR OTHER

THERAPEUTIC ORGANISM) .WHITS BLOOD CELLS ARE SPUN DOWN INTO A

PASTE AND THE ORGANISM IS INNOCULATED INTO THIS

PASTE.ESSENTIALLY,THEREFORE, THE LEUKEMIC CELLS FORM ALL OF THE

SOURCES OF NUTRITION FOR THE FUNGUS.THE PENICILLIUM MOULD GREW

RAPIDLY AND WITHIN 3 WEEKS THE 10 CM BY ONE CM CANCER PASTE WAS

TOTALLY REPLACED BY MOULD KACROSCOPICALLY.THIS MOULD WAS THE

INNOCULATED INTO 500CC OF TSB AND FOLLOWING 3 WEEKS OF CULTURE,

SCPE WAS AGAIN PREPARED AND TESTED AGAINST LEUKEMIA CELLS FROM

THE PATIENT.THIS SECOND GENERATION OF SCPE PROVED HIGHLY

EFFECTIVE. SALINE LEUKEMIA SUSPENSIONS OF 200,000 COUNT PER CC

WERE REDUCED TO 80,000 WITHIN THREE HOURS OF INCUBATION OF 1CC OF

SUSPENSION WITH 0.1CC OF SCPE SECOND GENERATION.

THIS PROCESS CAN AGAIN BE REPEATED WHEN RESISTANCE DEVELOPS TO

SECOND GENERATION SCPE.THE COMBINATION OF MULTIPLE

PHASES/GENERATIONS OF SCPE PROVES MORE EFFECTIVE AND LONGLASTING

THAN SINGLE PHASES; TECHNIQUES PREVIOUSLY MENTIONED TO INCREASE

SPECIFICITY SUCH AS TESTING AGAINST NORMAL TISSUE,RAISING

ANTISERA TO FEATURES WITH ANTI-NORMAL EFFECTS AS WELL AS USING

BROAD OR EXPANDED LBS TO HAVE A LARGE SAMPLE GROUP FROM WHICH TO

CHOOSE.

PATET ALSO INCLUDES DESIGNING OF LBS FOR SELECTIVE TARGETING OF

CONDITIONS AS WELL AS CELL TYPES IT IS POSSIBLE TO CULTURE LBS

WITH ANAEROBIC OR MICROAEROPHILIC CHARACTERISTICS FOR EXAMPLE

WHICH THEY MAY ENCOUNTER IN THE ANAEROBIC CENTRE OF TUMOUR MASSES

THE OBJECTIVE OF THIS AREA OF THE PATENT,HOWEVER , IS TO TEACH A PRINCIPLE THAT PRODUCTS OF ORGANISM A MAY BE MADE SPECIFIC FOR TARGET B AND SHOULD THAT TARGET DEVELOP RESISTANCE THEN CO- INCUBATION MAY ENABLE THE MODIFICATION OR EXPANSION OF THE ORGANISM'S ABILITY SO THAT IT IS AGAIN EFFECTIVELY ANTAGONISTIC TO TARGET.

SIMILAR EXPERIMENTS WERE CONDUCTED WITH ACTINOMYCETE AND STREPTOMYCETE SPECIES WHICH WERE ISOLATED BY LEAVING CANCER BIOPSIES OPEN TO AIRBORNE CONTAMINATION.AGAIN,AS RESISTANCE

DEVELOPED, RE-COINCUEATION PRODUCED NEW EFFECTIVE PATHWAYS.

THIS PATENT APPLIED TO MODERN CANCER THERAPY ESSENTIALLY PRESENTS THE ABILITY TO CONSTANTLY DEVELOP NEW SAFE THERAPIES AND AS PREVIOUSLY SEEN,MULTIPHASIC THERAPY PROVES MORE EFFECTIVE THAN SINGLE GENERATION.COMPOUND MULTIPHASIC(WHERE 2 OR MORE

GENERATIONS OF THERAPY ARE PRESENTED AS PHASE ONE)COVER MANY RESISTANT GROUPS OF CELLS PRIOR TO THEIR EXPRESSION IN SIGNIFICANT NUMBERS.

AT ITS SIMPLEST APPLlCATION,WHERE THERAPEUTIC ORGANISMS ARE

CULTURED IN MEDIUM PURELY OF TARGET AS IT EXISTS IN PATIENT OR IN EXPANDED FORM(EXPOSED TO PRIOR THERAPY OR MUTATING AGENTS TO EXPAND CELL CLONE NUMBER TO ANTICIPATE MUTATION) THERAPEUTIC PRODUCTS WHICH ARE HIGHLY EFFECTIVE MAY BE OBTAINED.WHEN THE ORGANISM EXTRACT AND DISEASE ARE CO-INCUBATED WHERE THE DISEASE MAY DEVELOP RESISTANCE; INCUBATION OF THERAPEUTIC ORGANISM ON CULTURE MEDIUM COMPOSED WHOLLY OF RESISTANT CELLS WILL ALLOW FOR THE DEVELOPMENT OF NEW AGENTS FROM THE THERAPEUTIC ORGANISM TO DEAL WITH RESISTANT CELLS.

PATENT GENERATION OF THERAPY BY INCUBATION OF MI CROORGANI SMS IN CULTURE MED IA MOSTLY I F NOT WHOLLY COMPRI SED OF TARGET .

THIS TECHNOLOGY THEREFORE PROVIDES FOR CONSTANT GENERATION OF THERAPY(WHEN ORGANISM USES ARE EXHAUSTED RELATED OR OTHER

ORGANISM CAN BE SIMILARLY PROCESSED TO YEILD NEW THERAPIES) CULTURE MEDIA WHOLLY OR MOSTLY COMPRISED OF TARGET TEND TO CONFER STRONG ACTIVITY AND SPECIFICITY TO THE THERAPEUTIC ORGANISM, OTHER TECHNIQUES SUCH AS DE-HUMANISING THE CANCER CELLS OR WHATEVER TARGET AS MAY ALLOW FOR DISEASE-SPECIFIC MEDIA WHICH WOULD, IN TURN FURTHER INCREASE SPECIFICITY AND EFFICACY. IN PRACTISE,WITH CANCER, THIS OFTEN LEADS TO MICROBIOLOGICAL COMPLICATIONS AS DEHUMANISING THE CELLS OFTEN STIMULATES THE EXPRESSION OF SYNERGISTIC OR CAUSATIVE ORGANISMS.

THE PRECEDING ARM OF INDUCED REMISSION THERAPY EXPLAINED THE USE PATENT TECHNOLOGY TO IMPROVE AND EXPAND CHEMOTHERAPY TO THE POINT WHERE AN ENDLESS ARMY OF SAFE, SPECIFIC CHEMOTHERAPEUTIC AGENTS COULD BE GENERATED.

IT ALSO HAS BEEN PROVEN THAT MANY ORGANISMS SUCH AS PENICILLIUM MOULD CAN EXERT POWERFUL ANTICANCER PROPERTIES.THIS PATENT COVERS THE USE OF CRUDE AND PURIFIED SPECIFIC EXTRACTS OF PENICILLIN IN THE TREATMENT OF CANCER AND AIDS

(WHERE HIV-INFECTED T CELLS WERE MADE TARGET AS PER THE ABOVE GUIDELINES, PENICILLIN EXTRACTS WITH ANTI-AIDS ACTIVITY WERE GENERATED. PENICILLIUM EXTRACTS RAISED AGAINST LEUKEMIA CELLS ALSO APPEARED TO EXERT ANTI-AIDS ACTIVITY)

TESTS FOR BOTH CANCER AND AIDS WERE CONDUCTED WITH PENICILLIUM , STREPTOMYCETES ,KAMBUCHA , ACTINOMYCETES ,ASPERGILLI AS WELL AS OTHER UNIDENTIFIED MOULDS, IN EACH CASE,EVEN WHERE THERE WAS NO PREVIOUS ANTIDISEAE ACTIVITY OR SPECIFICITY, THESE WERE ENABLED BY THE PRECEDING TECHNOLOGY.

THE ABOVE SECTION RELATED TO TARGETING OF DISEASED CELLS AND CANCER MASSES BY FUNGII AND WAS DESIGNED TO ILLUSTRATE HOW STANDARD CHEMOTHERAPY TECHNIQUES COULD BE IMPROVED, TAILORED AND EXTENDED.

USE OF VIRAL/BACTERIAL AND OTHER

BIOLOGICAL AGENTS TO ATTACK DISEASED

CELLS- (THIS IS DIFFERENT TO TAGGING AND TARGETING THERAPY ALTHOUGH OVERLAPPING MECHANISMS MAY EXIST)

VIRUSES AND BACTERIA MAY BE PROCESSED IN MUCH THE SAME WAY AS THE PENICILLIUM WAS PROCESSED, HOWEVER, THERE ARE DISTINCTIVE FACTORS ALSO IN BIOLOGICAL MECHANISMS AS WELL AS SPEED OF CO-CULTURE.

VIRAL USE

CHOOSING AND DEVELOPING SPECIFICITY

EPIDEMIOLOGICAL, LOGICAL AND OTHER SEARCH TECHNIQUES WERE

PREVIOUSLY COVERED.

DIRECT INFECTION-VIRAL

VIRUSES TO BE USED AS EXAMPLES IN DEMONSTRATION OF USE OF VIRUSES

AS THERAPEUTIC AGENTS ARE LISTED BELOW BUT NOT INTENDED TO

RESTRICT PATENT, THESE AND ALL OTHERS ARE COVERED UNDER THE

GUIDELINES OF THIS PATENT.

FELINE PANLEUKOPENIA VIRUS

CANINE DISTEMPER VIRUS

NEWCASTLE VIRUS

PIDGEON POX

MEASLES VIRUS

MUMPS VIRUS

THESE WERE USED BECAUSE OF READY AVAILABILITY AND BECAUSE OF

RELATIVE HUMAN SAFETY.

FELINE PANLEUKOPENIA VIRUS AND CANINE DISTEMPER VIRUS WERE CHOSEN

FOR THE LEUKEMIA MODEL .

BLOOD WAS COLLECTED FROM PATIENT WITH CHRONIC LYMPHOCYTIC

LEUKEMIA COUNT 88,000.

FELINE PANLEUKOPENIA VIRUS WAS CHOSEN AS IT LOGICALLY APPEARED A

GOOD AGENT FOR INFECTING ROGUE WHITE BLOOD CELLS.

PREVIOUS STUDIES CIRCA THE MID 50'S DEMONSTRATED THE ABILITY OF

VACCINATION WITH FELINE PANLEUKOPENIA VIRUS TO CAUSE TEMPORARY

REMISSIONS OF LEUKEMIA, LASTING SEVERAL WEEKS AFTER SINGLE DOSE. THERE ARE SEVERAL MODIFICATIONS PRESENTED BY THIS PATENT.FPLV WAS PREVIOUSLY ADMINISTERED IN SINGLE DOSE AND OCCASSIONALLY CORTICOSTEROIDS TO ALLOW MAXIMUM TIME FOR INFECTION TO ATTACK TARGET BEFORE IMMUNE REJECTION TAKES PLACE .SUCH TECHNIQUES

SELDOM IMPACTED FAVOURABLY ON THE DISEASE, LEUKEMIA INVARIABLY RECURRED WITH RAPID DEATH WITHIN WEEKS TO MONTHS.

IT SEEMED THAT AS A UNIMODAL THERAPY VIRAL INFECTION OF LEUKEMIA CELLS WAS INEFFECTIVE LONGTERM,YET,OBVIOUSLY THE THERAPY WAS EFFECTIVE IN THE SHORTERM, POSSIBLE HYPOTHESES FROR THIS

OBSERVATION FOLLOW;

1-DISEASE MUTATES TO RESIST VIRUS

2-IMMUNE RESPONSE NEUTRALISES VIRUS AFTER INITIAL EFFECT SO THAT IT IS ELIMINATED.

3-VIRUS CHANGES IN SOME WAY SO THAT IT IS NO LONGER DAMAGING TO DISEASE, IN MANY CASES REPORTED, THE RECURRENCE OF DISEASE AFTER INITIAL RESPONSE WAS EVEN MORE AGGRESSIVE THAN BEFORE, IT IS POSSIBLE THAT THE VIRUS EITHER STRENGTHENS THE DISEASE OR WEAKENS THE HOST IN THE LONGTERM.

THE ANSWER APPPEARS TO LIE IN A MIXTURE OF 1 AND THREE

LARGELY;ALTHOUGH IMMUNE ELIMINATION OF VIRUS MAY BE A FACTOR IT DOES NOT APPEAR TO BE MAJOR. THIS IS STATED FOLLOWING OBSERVATIONS THAT CORTICOSTEROID AND OTHER INHIBITION OF IMMUNE RESPONSE DOES NOT SEEM TO FAVOURABLY EFFECT OUTCOME; FURTHERMORE, IF THE IMMUNE RESPONSE DOES ATTACK THE VIRUS IT SHOULD ALSO ATTACK THE VIRALLY

-INFECTED CANCER CELLS.

VIRAL MUTATION TO LESS AGGRESSIVE FORM ALSO DOES NOT SEEM TO BE A MAJOR FACTOR AS INFECTED CELLS ,WHEN REMOVED FROM PATIENT SEVERAL WEEKS INTO THERAPY WILL EXHIBIT INFECTION AND RAPID LYSIS OF LEUKEMIA CELLS WHICH HAVE NOT BEEN PREVIOUSLY EXPOSED TO IT.

IT APPEARS THAT THE MAJOR FACTOR AT PLAY IS THE ADAPTION AND/OR MUTATION OF CANCER CELLS TO SURVIVE AND FUNCTION WHILE COEXISTING WITH VIRAL INFECTION( ANOTHER FEATURE WHICH APPEARS TO INDICATE THAT VIRUS MAINTAINS ACTIVITY AND THAT IMMUNE RESPONSE DOES NOT PROTECT CANCER CELLS FROM THE VIRUS IN THE LONGTERM IS THAT THE CYTOPLASMIC VACUOLATION WHICH MARKS VIRAL ACTIVITY CASN BE SEEN IN THE MAJORITY OF CANCER CELLS EVEN AFTER RECURRENCE OF DISEASE.THESE CELLS ARE CAPABLE OF INFECTING OTHERS THAT HAVE NEVER BEEN EXPOSED TO THE VIRUS. )ATTEMPTS TO DEVELOP VIRUSES WITH GREATER ANTICANCER VIRULENCE HAVE INVOLVED REPEATED PASSAGES OF VIRUS THRUGH CANCER CELL GENERATIONS;AS SEEN FROM THE ABOVE, IT APPEARS THAT VIRUS AND CANCER DEVELOP A SYNERGISTIC RELATIONSHIP AFTER THE INITIAL THERAPEUTIC RESPONSE HENCE ATTEMPTS TO DEVELOP GREATER VIRULENCE THROUGH REPEATED PASSAGING WAS,NOT

SURPRISINGLY,OFTEN MET WITH FAILURE.

A CASE DESCRIBING THESE FEATURES WILL NOW BE DESCRIBED.

FEMALE 50,WITH 6 YEAR HISTORY OF CHRONIC LYMPHOCYTIC LEUKEMIA PRESENTS WITH RISSNG WHITE -BLOOD CELL COUNT -30,000 AT

PRESENTATION AND 87% LYMPHOCYTES.PATIENT WAS UNRESPONSIVE TO CHEMOTHERAPY.IT WAS DECIDED TO ATTEMPT RAPID LEUKEMIA SATURATION WITH VIRUS AND RAISE MINIMAL IMMUNE RESPONSE WITHOUT USING IMMUNOSUPPRESSIVE TECHNIQUES (AS NOTED STEROIDS HAD PROVEN OF NO USE IN PRIOR EXPERIMENTS.)WHITE BLOOD CELLS.OF PATIENT WERE SPUN DOWN AND SEPARATED,THEY WERE THEN RESUSPENDED AT 100,000 × 10 TO THE NINETH POWER PER CC IN 5CC OF SALINE.FELINE PANLEUKOPENIA VIRUS 1 CC AS PRESENTED FOR VETERINARY USE WAS INCUBATED WITH THE LEUKEMIA CELLS FOR 24 HOURS THE CELLS WERE THEN WASHED WITH 10 CC OF SALINE THREE TIMES (CELLS WERE SPUN DOWN THEN RESUSPENDED IN 10CC OF SALINE THREE TIKES).THE POINT OF THIS PROCEDURE IS TO INTRODUCE AS MUCH OF THE VIRUS INTRACELLULARLY AS

P0SSI3LE,MINIMISING FREE VIRUS INJECTION AND INCREASING DELIVERY DOSE. PATIENT'S INFECTED CELLS DEMONSTRATED CYTOPLASMIC

INCLUSIONS.THEY WERE PLACED INTO 500CC OF SALINE AND INJECTED INTRAVENOUSLY INTO THE PATIENT (APPROXIMATELY 500,000 X 10 TO THE NINETH POWER INFECTED CELLS) INTRAVENOUS DRIP INJECTED OVER A SIX HOUR PERIOD.PATIENT WAS OBSERVED FOR SIGNS OF A REACTION,NONE WAS NOTED .

PROCEDURE WAS REPEATED DAILY FOR SIX DAYS. SLIGHT TEMPERATURE (ICO DEGREES CELSIUS)WAS NOTED BUT ONLY LASTED FOR A FEW HOURS ON DAY THREE.NO OTHER SIDE EFFECTS WERE NOTED.BY THE SECOND DAY WBC COUNT HAD DROPPED TO 25,000;AND PERHAPS MORE SIGNIFICANTLY, LYMPHOCYTE PERCENTAGE DROPPED TO 65% OVER 24 HOURS,BLOOD SMEAR SHOWED 30% OF WHITE BLOOD CELLS WITH CYTOPLASMIC INCLUSIONS .BY THE SECOND TEST(48 HOURS AFTER FIRST INJECTION) WBC COUNT HAD DROPPED TO 15,000 AND 80% OF WBC DEMONSTRATED CYTOPLASMIC

INCLUSIONS. LYMPHOCYTE PERCENTAGE DROPPED TO 50%. IT IS NOTED HERE THAT,ALTHOUGH THE PRACTISE OF INJECTING INFECTED CANCER CELLS INTO THE PATIENT IS AN ADVANCED FORM OF GENE THERAPY. SUPERIOR SEPARATION TECHNIQUES,WHERE LEUKEMIC CELLS CAN BE SEPARATED FROM NORMAL WHITE BLOOD CELLS AND OTHER NORMAL CELLS VIRUS MAY BE

RESTRICTED TO INFECTION OF LEUKEMIA CELLS SEE ALSO

SPECIFICATION TECHNOLOGY TO BE D I SCUSSED LATER .

IMPROVEMENT CONTINUED. THE NIGHT SWEATS WHICH HAD PLAGUED THE PATIENT FOR THREE YEARS STOPPED AFTER THIRD TREATMENT .WBC AND PERCENTAGE LYMPHOCYTES WILL NOW BE DISPLAYED FOR SUBSEQUENT DAYS DAY3-11,000 - 50%

DAY4- 9,800- 54%

DAY5- 7,200- 48%

DAY 6- 5,600- 34%

PATIENT WAS IN REMISSION WITHIN DAYS OF STARTING THERAPY. IT APPEARS THAT INJECTION OF INFECTED CELLS IS A MUCH MORE EFFICIENT MANNER OF ADMINISTRATION THAN INJECTION OF VIRUS.

AT THE END OF 1 WEEK.ALL WBCS STILL DISPLAYED CYTOPLASMIC

VACUOLATION,DAY 12 PATIENT SPIKED A FEVE OF 104 CELSIUS WHICH LASTED FOR THREE HOURS.WBC COUNT 3,200-20%LYMPHOCYTES .DAY 15 SHOWED A DROP IN PERCENTAGE OF WBCS WITH INCLUSION BODIES;NEUTROPHILS AND OTHER NORMAL CELLS REGAINED NORMAL

MORPHOLOGY.A PERCENTAGE OF LYMPHOCYTES (15%)CONTINUED TO DISPLAY INCLUSION BODIES ALTHOUGH NO DIZARRE NUCLEAR CHANGES OR HEAVY CHROMATIN STAINING SUGGESTIVE OF MALIGNANCY WERE PRESENT.

PATIENT REMAINED IN REMISSION FOR 6 WEEKS,FOLLOWING WHICH THE COUNTS OF WBC AS WELL AS % OF LYMPHOCYTES BEGAN TO RISE.BY WEEK 8 COUTS WERE 20,000-84%.ALMOST ALL LEUKEMIC CELLS DEMONSTRATED CYTOPLASMIC INCLUSION BODIES SUGGESTIVE OF CONTINUED VIRAL ACTIVITY IN THE LEUKEMIC CELLS.CO-INCUBATING THESE CELLS WITH NORMAL AND/OR LEUKEMIC WBC FROM ANOTHER SOURCE RESULTED IN

INCLUSION BODIES AND CELL LYSIS OF THE NEW CELLS HENCE PROVING THAT VIRUS WAS STILL ACTIVE.ELEVATION OF INTERFERON AND

INTERLEUKIN LEVELS WAS NOTED AT START OF THERAPY.THESE REMAINED ELEVATED; THE IMMUNE SYSTEM WAS,HOWEVER,APPARENTLY AS BLIND TO THE VIRUS AS IT WAS TO THE CANCER CELLS.

STAGE 2 VIRAL THERAPY

THE SECOND STAGE OF VIRAL THERAPY ATTEMPTED INVOLVED THE INTRODUCTION OF ANOTHER VIRUS WITH AFFINITY FOR LEUKEMIA IN ITS MODE OF APPLICATION. CANINE DISTEMPER VIRUS WAS NOTED IN IN-VITRO STUDIES TO CAUSE NUCLEAR VACUOLATION AND CELL DESTRUCTION IN LEUKEMIA CELLS (OTHER STUDIES ALSO DEMONSTRATED THAT CULTURING MANY FORMS OF VIRUSES IN LEUKEMIA CELLS THEN INJECTING INFECTED LEUKEMIA CELLS INTO THE BODY WOULD LEAD TO THE

PREFERRENTIAL,ACCELERATED INFECTION OF OTHER LEUKEMIA CELLS.EVEN IN CASE DISCUSSED ABOVE IT CAN BE SEEN THAT MASSIVE IMPROVEMENT OCCURRED BEFORE MAXIMUM VIRAEMIA ON DAY 12, PRIOR USE OF VIRAL; VACCINES WOULD NECESSITATE DAYS TO WEEKS PRIOR TO MARKED IMPROVEMENT BEING EVIDENT ; IT IS AS IF LEUKEMIC CELLS/CELL

FRAGMENTS FORM OPTIMAL VECTORS FOR THE DELIVERY OF VIRAL AGENT TO OTHER LEUKEMIC CELLS. THE INTRACELLULAR VIRAL REPLICATION AND HENCE AMPLIFICATION OF ADMINISTERED DOSEAGE IS ALSO A FEATURE OF THIS PATENT

CANINE DISTEMPER VIRUS WAS INCUBATED WITH THE RECURRED LEUKEMIA CELLS FOR 24 HOURS AS PER PREVIOUS TECHNIQUE DESCRIBED FOR FELNE PANLEUKOPENIA VIRUS .NUCLEAR VACUOLATION WAS APPARENT WITHIN 24 HOURS. PROTOCOL DESCRIBED ABOVE WAS REPEATED.

IT APPEARED THAT THE SAME PROCESS TOOK PLACE WHEREBY THE LEUKEMIA CELLS BECAME RAPIDLY INFECTED AND WBC DROPPED INTO NORMAL RANGE WITHIN 10 DAYS.LEUKEMIA CELLS ONLY APPEARED TO BE INFECTED IN THIS SECOND STAGE OF VIRAL; INFECTION AND DISPLAYED BOTH THE CYTOPLASMIC INCLUSIONS OF THE FPLV AND NUCLEAR VACUOLATION OF THE CDTV.PRESUMABLY,THE VIRAL INTERFERANCE PHENOMENON PROTECTED NORMAL CELLS BUT WAS NOT AS PROTECTIVE FOR LEUKEMIA CELLS.COUNTS REMAINED WITHIN NORMAL RANGE FOR A PERIOD OF 4 WEEKS THE DISEASE RECURRED;DEMONSTRATING BOTH NUCLEAR VACUOLATION AND CYTOPLASMIC INCLUSIONS. CELLS RETAINED INFECTIVE CAPACITY FOR CDTV AND FPLV. OTHER IN-VITRO;ANIMAL AND HUMAN STUDIES WERRE CONDUCTED WHERE A THIRD STAGE THERAPY WITH FOWL POX VIRUS WAS ADDED AS WELL AS THE USE OF 2 OR MORE VIRUSES TOGETHER IN INFECTING AND DESTROYING LEUKEMIA CELLS. IT APPEARED THAT THE COMBINATION OF CDTV AND FPLV DESTROYED MORE LEUKLEMIA CELLS IN-VITRO THAN EITHER ONE ALONE;YET IN THE LIVING SYSTEM,ALTHOUGH BOTH INFECTED THE LEUKEMIC CELL AND CAUSED REMISSION, THAT WAS AS SHORT LASTING AS USING ONLY ONE AGENT. IN THESE LIMITED TRIALS, THE SEQUENTIAL USE OF VIRAL AGENTS COULD REPEATEDLY CAUSE

TAG WITH INHERENT VIRUSES TOO CANCERE IMPLANTS INFECTED ADRIAMYCIN/STREPTOMYCETE

CARRY HUMAN ANTIGENS ON V

TARGETING OF CAUSATIVE AND SYNERGISTIC

ORGANISMS.

ASCITESD/EFFUSIONS HAVE ORGS

IDENTIFY,ANTIBIOTIC, TAG, PHAGE, INTERFERANCE, CARRIER OF CRGS/TARGET CELLS

INDUCED REMISSION THERAPY INCLUDING LBS ROLE IN MINIMISING SUPRADDED INF, OTHER DISEASE, PHAGE. /PLASMID DONORS.

GENETIC/OTHER IMBALANCE EVIDENT BY ATTACK

;IF THE SEARCH FOR AGENTS AND ORGANISMS THAT 'STICK' TO CANCER CELLS AND/OR CELL MASSES IS MADE WITH THE PURPOSE OF TAGGING SUCH TARGETS

TO SURFACE LIGHT AMPLIFYING X-RAYS.

BROAD,DEFINED, SPECIFIC,EXPANDED NATURAL, /ARTIFICIAL

LBS VS ULCERS THE DISEASE TO GO INTO REMISSION YET THE LEUKEMIA'S ADAPTATION MECHANISM IS SUCH THAT EVEN THREE VIRAL VECTORS COMBINED TOGETHER

(FPLV, CDV. FOWL POX VIRUS) DID NOT EXTEND REMISSION TIME ACHIEVED BY FPLV ALONE(UNLESS THEY WERE APPLIED IN SEQUENCE RATHER THAN SIMULTANEOUSLY).

IT APPEARS THAT ANTIVIRAL IMMUNOLOGICAL RESPONSE IS HAMPERED WHEN THE VIRUS IS INTRACELLULAR IN LEUKEMIA CELLS. TWO OBERVATIONS ARE IMPORTANT, THE LEUKEMIA CELLS DISPLAY VIRAL ACTIVITY YET THERE ARE NO SYSTEMIC MANIFESTATIONS OF THE VIRUS UPON LEUKEMIA RECURRENCE; FURTHERMORE, RE-ACTIVATION OF VIRUS APPEARS RESTRICTED AND LIMITED, THE LONGER IT IS ASSOSCIATED WITH THE LEUKEMIA; IT IS AS IF THE VIRUS INCORPORATES AND SYNERGISES WITH THE LEUKEMIC CELL MECHANISM,VIRAL RECOVERY AND INFECTION OF OTHER CELLS

DECREASES .

VIRAL INFECTION, HOWEVER, HAS BEEN NOTED TO CAUSE SPONTANEOUS REMISSION IN THE PAST (EG NEWCASTLE VIRUS INFECTION LINK WITH REMISSION FROM STOMACH CANCER REPORTED IN LANCET)

VIRAL SOURCE SHOULD ALSO BE CONSIDERED.MOST VACCINES ARE CULTURED ON EMBRYONIC CELLS OR ON CONTINUOUS CELL LINES(CANCER CELLS) A CHANCE OF VIRAL ADAPTATION ALREADY THEREFORE MAY HAVE TAKEN PLACE. MANY VIRUSES ARE ABLE TO CANNIBALISE FRACTIONS OF CELLS IN WHICH THEY ARE CULTURED AND EXPRESS THEM.SPONTANEOUS REMISSION FOLLOWING VIRAL INFECTION AND/OR TRIALS USING VIRUSES TO INFECT CANCER CELLS HAVE DEMONSTRATED MAXIMAL EFFECTS AFTER INITIAL INCUBATION PERIOD OF SEVERAL DAYS. TO THREE WEEKS; THIS TIME PERIOD ALLOWS FOR MAXIMUM VIRAL CELL LYSIS AS WELL AS ANTIVIRAL IMMUNOLOGICAL RESPONSE.

AS SPONTANEOUSLY CONTRACTED VIRUSES ARE LIKELY TO BE MORE VIRULENT AS WELL AS CARRY OTHER ANTIGENS RELATED TO THE PERSON OR SPECIE FROM WHICH THEY ORIGINATED,BOTH THE VIRAL DESTRUCTIVE EFFECT AS WELL AS ANTIVIRAL IMMUNE RESPONSE ARE LIKELY TO BE STRONGER THAN RESPONSE AND EFFECT CAUSED BY THE ATTENUATED FORMS AVAILABLE FOR VACCINES WHICH BY CULTURE IN CANCER CELL LINES NOT ONLY RISK CARRYING HARMFUL FACTORS,BUT ALSO ARE THUS ATTENHUATED IN THEIR ANTICANCER ABILITY AS WELL..

THE RECURRENCE OF CANCER FOLLOWING VIRAL-INDUCED REMISSION IS OFTEN MOPRE AGGRESSIVE THAN PREVIOUS CANCER ACTIVITY;THIS MAY BE DUE TO HOST FACTOR DEPLETION BY VIRAL INFECTION, E. G.BY DIRECT VIRAL ACTIVITY, BY ALLOWING SUPERADDED INFECTION OR OPPURTUNISTIC INFECTION TO ENTER THE SYSTEM,OR BY THRESHOLD INHIBITION OF IMMUNE RESPONSE; IF VIRUS REACHES ADEQUATE LEVELS ,AND EXPRESSES ITSELF ON THE CANCER CELL SURFACE IT MAY BY THRESHOLD EFFECT LEAD TO FURTHER IMMUNE RESISTANCE OF CANCER CELLS.

WHEREAS CANCER CELLS ARE ABLE TO ADAPT TO AND INCORPORATE THEIR VIRAL INVADERS TO A POINT WHERE DIRECT VIRAL ACTIVITY IS NO LONGER A VIABLE PROBLEM FOR THE DISEASE,WHEREAS SOME OF THE ANTIDISEASE PROPERTIES OF THE VIRUS MAY BE

NEUTRALISED,MAINTENANCE OF CELL INTEGRITY IN THE FACE OF FURTHER CHALLANGE MAY BE COMPROhlSED, INITIAL STUDIES APPEAR TO INDICATE THAT SENSITIVITY TO OTHER CHEMICAL OR PHYSICAL THERAPIES RISES DEPENDING ON THE NUMBER OF VIRAL STAGES USED.

THE AGGRESSIVENESS OF THE TUMOUR UPON ITS RECURRENCE MAY BE DUE TO A PROCESS OF CLONE SELECTION; WHERE THE CANCER CELLS SURVIVING ARE THOSE THAT DIVIDE RAPIDLY,PRIOR TO VIRUS REACHING DEADLY LOAD, THE DIVISION TIME OF CELL AND VIRUS MAY EVEN SYNCHRONISE IN

SOME WAY; THE PRESENCE OF THE VIRUS MAY EVEN CHOOSE FOR OR CAUSE

THE REVERSION OF CELLS TO MORE PRIMITIVE,UNDIFFERENTIATED

LEVELS (THIS RAISES THE INTERESTING HYPOTHESIS THAT AS CANCER CELL

DIVIUSION RATES MAY SYNCHRONISE WITH INVADING VIRUS THAT SLOW

VIRUSES OR VIRUSES INSERTED THEN INHIBITED IN SOME WAY MAY SLOW

CANCER REPLICATION.

THERE APPEARS TO BE A LIMIT IN CANCER CELL'S COPING ABILITY WITH

SUPERADDED INFECTIONS TO THE POINT WHERE A SPECIFIC OR MULTIPLE

INFECTIONS CAN TAX THE CANCER CELLS ABILITY TO COPE WITH FURTHER

INSULTS, EVEN WHERE SUCH INSULTS WERE PREVIOUSLY INEFFECTIVE.

THERE APPEAR TO BE THREE TIMES AT WHICH FURTHER INTERVENTION MAY

OPTIMISE RESULTS;

1-INITIAL VIRAL SATURATION

2-POINT OF OPTIMAL EXPRESSION

3-TIME OF ADAPTATION/RECURRENCE

INITIAL VIRAL SATURATION

OPTIMAL, RAPID TUMOUR LOAD DECREASE CAN BE ACCOMPLISHED BY THE

GUIDELINES OF THIS PATENT WHEREBY TARGET CELLS ARE INCUBATED WITH

VIRUS PRIOR TO REINSERTION INTO THE SYSTEM. SLOW INTRAVENOUS

INSERTION OF VIRUS AND VIRALLY TAGGED CELLS SEEK TO SATURATE

DISEASED CELLS .USE OF CORTISONE TO FASCILITATE DISEASED CE4LL

SATURATION(IE EXTEND UNOPPOSED PERIOD OF VIRAEMIA), THIS IS NOT

RECOMMENDED AS NORMAL CELLS THEN ALSO BECOME AT INCREASED RISK OF

VIRAL INFECTION.

IF MULTIPLE VIRUSES ARE TO BE USED SIMULTANEOUSLY, THEIR

COMPATIBILITRY IN CULTURE AND MECHANISMS SHOULD FIRST BE

DEMONSTRASTED SO THAT INTERFERANCE DOES NOT OCCUR BETWEEN

THEM. OPTIMISING THE VIRAL VECTOR CAN BE ACCOMPLISHED BY SEVERAL

PROCESSES .

1-INCREASING AFFINITY OF VIRUS FOR CANCER CELLS.

SELECTIVE CULTURE AND 'WASHING' PROCEDURES MAY BE DONE TO ISOLATE

MOST SPECIFIC STRAINS.AS WITH THE PENICILLIUM EXAMPLE PREVIOUSLY

DESCRIBED LBS OF THE VARIOUS CLASSIFICATIONS MAY BE INCLUDED IN

SALINE,WASHING RELATES TO THE REPEATED ADDITION OF NORMAL CELLS

TO THE SOLUTION AND,ALLOWING 30 MINUTES FOR ADSORPTION AND THEN

SPINNING DOWN AND REMOVING CELLS SEVERAL TIMES UNTIL THE FINAL

BATCH OF SPUN DOWN CELLS SHOW MINIMAL TO NO VIRAL INFECTION AFTER

24 HOUR CULTURE.THE REMAINING PORTION OF THE LBS IS LIKELY TO

THEREFORE HAVE LITTLE AFFINITY FOR THE HEALTHY CELLS TESTED.

IN SELECTING FRACTIONS OF LBS WITH PARTICULAR AFFINITY FOR CANCER

CELLS, THEY CAN BE ADDED ALONG WITH COMPLIMENTARY NORMAL CELLS TO

THE SOLUTION AND ADSORPTION ALLOWED TO OCCUR OVER, SAY 30

MINUTES,SUBSEQUENT SEPARATION AND INCUBATION OF CANCER CELLS ONLY

WILL IN THEORY YEILD VIRUS WITH PREFERRED AFFINITY FOR CANCER

CELLS.THESE CELLS ARE CULTURED TO LYSIS,VIRUS RESUSPENDED AND

EXPOSURE TO NORMAL AND HEALTHY CELLS AGAIN

UNDERTAKEN.ADSORPTION, CULTURE, SEPARATION PROCEDURE IS REPEATED

UNTIL ONLY CANCER CELLS APPEAR INFECTED,VIRUS THEN MAY BE SAID TOHAVE PARTICULAR AFFINITY FOR TUMOUR CELLS.

MANY VIRUSES WILL DEVERLOP TUMOUR CELL AFFINITY; CANCER CELLS HAVE

OFTEN BEEN REPORTED TO HAVE VIRAL STRUCTURES AND IT IS BELIEVED

THAT CANCER CELLS HAVE RESTRICTED RESISTANCE TO VIRAL INFECTION

AS COMPARED TO NORMAL CELLS.AS THESE CELLS ARE ABLE TO SURVIVE WITH MULTIPLE INFECTIONS IT CAN BE SEEN WHY SUCH CELLS APPEAR TO SUIRVIVE IN A CHAOS DEADLY TO NORMAL CELLS,HENCE DO NOT NEED OTHER DEFENSE MECHANISMS AS ADVANCED AS THOSE OF NORMAL CELLS..

IN-VITRO TESTING. HOWEVER SHOWS TOTAL CELL LYSIS OF PERIPHERAL CIRCULATING LEUKEMIA CELLS, IT IS LIKELY THAT RESISTANCE BEGINS IN THE BONE MARROW OR WHERBVER STEM CELLS MAY BE. INCUBATION OF BONE MARROW LEUKEMIA CELLS WITH VIRUS , SEARCHING FOR OPTIMAL LYTIC FRACTION.

DURING THIS TIME IT HAS BEEN SHOWN THAT ANIMAL OR HUMAN ANTISERA TO THE

WITH MULTIPLE INFECTIONS IT CAN BE SEEN WHY SUCH CELLS APPEAR TO SUIRVIVE IN A CHAOS DEADLY TO NORMAL CELLS,HENCE DO NOT NEED OTHER DEFENSE MECHANISMS AS ADVANCED AS THOSE OF NORMAL CELLS..

IN-VITRO TESTING,HOWEVER SHOWS TOTAL CELL LYSIS OF PERIPHERAL CIRCULATING LEUKEMIA CELLS, IT IS LIKELY THAT RESISTANCE BEGINS IN THE BONE MARROW OR WHEREVER STEM CELLS MAY BE. INCUBATION OF BONE MARROW LEUKEMIA CELLS WITH VIRUS, SEARCHING FOR OPTIMAL LYTIC FRACTION.

OPTIMISING VIRAL SATURATION INVOLVES IDENTIFICATION OF TARGET IN WHATEVER MANIFESTATION (STEM CELL , CIRCULATING PERIPHERAL CELL ETC. ), INCUBATING ALL CELL FORMS POSSIBLE WITH VIRUS, USE OF VIRUS CULTURED FOR SPECIFICITY IN FREE FORM AS WELL TO SATURATE ALL TARGET CELLS.

VIRUS AS CARRIER

MANY SPONTANEOUS REMISSIONS HAVE BEEN REPORTED SUBSEQUENT TO INFECTION WITH ANIMAL VIRUS OR VIRUS FROM OTHER HUMKAN CARRIER, IN BOTH CASES IT IS LIKELY THAT VIRUS MAY HAVE CANNIBALISED CELLULAR STRUCTURES FROM PREVIOUS HOST WHICH MAY SIGNIFICANTLY FIGURE ANTIGENICALLY.

IT IS KNOWN THAT MOST HUMAN CANCERS WILL BE DESTROYED WHEN IMPLANTED INTO ANIMALS, THIS IS DUE TO THE ANIMAL'S RECOGNITION OF FOREIGN SPECIE ANTIGENS AND MOUNTING AN IMMUNOLOGICAL RESPONSE AGAINST THEM.

IT IS THEREFORE A FEATURE OF THIS PATENT THAT VIRUSES TO BE USED IN THE THERAPY OF CANCER SHOULD BE INITIALLY CULTURED ON IMMUNOGENIC MEDIA ,SUCH AS ADULT, PERHAPS EVEN NON-HUMAN SOURCES. IN THEORY,ALLOWING THE VIRUS TO CANNIBALISE ANTIGENIC STRUCTURES .AND/OR GENETICS THAT EXPRESS ANTIGENIC STRUCTURES ,ENABLES THEIR EXPRESSION TO MARK CANCER CELLS MORE STRONGLY, IE TO GIVE NON-SELF ANTIGENS AS WELL AS VIRAL ANTIGENS FOR THE IMMUNE SYSTEM TO

RESPOND AGAINST.

IT APPEARS THAT THE ABILITY OF CANCER TO MUTATE SO READILY IS AT

LEAST IN PART DUE TO ITS EXISTANCE IN AN OPEN SYSTEM WHERE IT CAN

READILY ABSORB AND INCORPORATE OTHER ORGANISMS;THESE ORGANISMS

MAY, IN TURN,ABSORB AND INCORPORATE CANCER-REL;ATED INFORMATION

WHICH MAY ALLOW THEM TO BE USED AS A VECTOR IN ITS PREPETUATION

AND/OR SPREAD.NUMEROUS STUDIES HAVE SHOWN THAT ORGANISMS ISOLATED

FROM CANCERS,WHEN INJECTED INTO ANIMALS,CAUSE GENERATION OF

CANCER IN ANIMAL(ALEXANDER, LIVINGSTON, SCOTT)

IN RESPONSE TO MANY INFECTIONS AT LEAST ONE AND USUALLY ALL THREE

OF THE FOLLOWING PHASES WILL BE DESCRIBED;

1-CANCER SHRINKAGE/LOSS OF DENSITY

2-CANCER SPREAD/ACCELLERATION OF GROWTH (ORGANISM OF INFECTION

STILL IDENTIFIABLE/CULTUREABLE)

3-AGGRAVATION OF ^DISEASE CONDITION/FAILURE OF HOST SYSTEM/DEATH.

FOR EVERY INFECTIOUS/OTHER ORGANISM TIME AND POTENTIALS MAY BE

ESTIMATED FOR ANTIDISEASE ACTIVITY/DISEASE SYNERGY.

INTERNAL OR EXTERNAL INTERVENTION ALONG ANY OF THESE PHASES MAY

DRASTICALLY EFFECT OUTCOME.

S PREVIOUSLY DEFINED,THERE IS AN INITIAL PERIOD OF VIRAL SATURATION WHERE THE THERAPEUTIC OBJECTIVE IS TO ACCOMPLISH AS COMPLETE A SATURATION OF DISEASE AS POSSIBLE;HOPEFULLY WITH .AN ORGANISM WHICH HAS BEEN MADE HIGHLY SPECIFIC AND AGGRESSIVE.

THE POINT OF OPTIMAL EXPRESSION OCCURS WHERE ORGANISMS SATURATING THE DISEASED CELL HAVE CONVERTED IT INTO A VIRAL REPLICATION FACTORY AND ARE EXPRESSING ON THE CELL SURFACE AS WELL AS WITHIN CELL STRUCTURE. THIS PHASE OFFERS AN EXCELLENT WINDOW FOR

IMMUNOLOGICAL OR OTHER THERAPY.

TIME OF ADAPTATION/RECURRENCE MAY OR MAY NOT SIGNAL THE RETURN OF THE CANCER WITH EXPRESSION OF THE VIRUS/OTHER ORGANISM; IT WILL

HOWEVER,USUALLY BE A MORE AGGRESSIVE DISEASE UPON ITS RECURRENCE.

DEPENDING ON WHETHER OR NOT THE ORGANISM HAS SURVIVED IN ACTIVE FORM, THE CANCER CELL MAY STILL PROVE TO BE SENSITIVE TO OTHER THERAPY (IF ORGANISM/S ARE STILL ACTIVE, THEY MAY BE TAXING THE CANCER CELL'S ABILITY TO COMPENSATE FOR FURTHER INSULTS SUCH AS CHEMOTHERAPY OR RADIOTHERAPY.

AT THE START OF THIS PHASE AS IN THE END OF THE PREVIOUS TWO PHASES, THE TOTAL CANCER LOAD IS AT A LOW.

USING VIRUSES AS ADJUNCTS TO

CONVENT I ONAL THERAPY .

FOWL POX/PIDGEON POX VIRUSES AS WELL AS THE NEWCASTLE VIRUS HAVE PROVEN EFFECTIVE TO THIS INVENTOR IN REDUCING TUMOUR MASS.

ADMINISTRATION CAN BE DIRECT (DOSE OF RECONSTITUTED PELLET AS USED FOR ANIMAL VACCINATION INJECTED DIRECTLY INTO TUMOUR, IN THE VICINITY OF THE TUMOUR AND/OR AT A DISTANT

SITE. INTRAMUSCULAR/INTRADERMAL AND SUBCUTANEOUS ROUTES WERE ALL TRIED.

PATENT COVERS THE USE OF THIS FAMILY OF VIRUSES IN THE TREATMENT OF CANCER ALONE,AND/OR IN COMBINATION WITH OTHER THERAPY.

VIRUSES MAY BE PASSAGED THROUGH TUMOUR CELLS AND TESTED FOR EFFICACY AND SPECIFICITY AS WELL AS AUGMENTING THESE CHARACTERISTICS.

FOR DEMONSTRATION PURPOSES,WE WILL DISCUSS THE USE OF PIGEON POX VIRUS.VIRUS WAS RECONSTITUTED FRO STERILE VETERINARY PELLET WITH 1CC OF SALINE.

PATIENT, 38 PRESENTED WITH GRAPEFRUIT SIZED BREAST CANCER WITH ATTATCHMENT TO PECTORAL MUSCLES SDIMPLE SURGERY WAS NOT POSSIBLE AND CANCER HAD GROWN DESPITE CHEMOTHERAPY AND LOCALISED RADIATION. FOR THREE DAYS, DAILY INTRATUMOURAL APPLICATION OF THE PIGEON-POX VIRUS WAS DONE AT 3 SEPARATE SITES SURROUNDING THE TUMOUR PATIENT DEVELOPE AN AREA OF ERYTHEMA ABOUT 2CC DIAMETER AT SITE OF EACH INJECTION (MADE AT 3 CM DEPTH INTO TUMOUR WHICH WAS ATTATCHED TO SKIN)THE END OF THE THIRD DAY OF APPLICATION COULD BE NOTED AS OPTIMAL EXOGENOES SATURATION AS DEFINED IN THIS EXPERIMENT.12 ON DAY 12 PATIENT DEMONSTRATED A GENERAL REDDENING OF DISEASED BREAST AND A TEMPEKATURE OF 104,THESE FEATURES MARK THE PERIOD OF OPTIMAL EXPRESSION;AT THIS TIME TUMOUR WAS

RADIOGRAPHICALLY PROVEN TO HAVE SHRUNK BY 35% AND WAS NO LONGER

ATTATCHED TO MUSCLE OR TO SKIN. IT WAS EASILY REMOVED SURGICALLY. VIRUSES CAN THEREFORE BE USED AS DIRECT KILLING/NEUTRALISING AGENTS WHICH .APPEAR USEFUL IN CAUSING AT LEAST A TEMPORARY

REDUCTION IN TUMOUR BULK. IT ALSO APPEARS THAT EVEN UPON

RECURRENCE ,CANCER CELLS WOULD OFTEN BE MORE SENSITIVE TO

THERAPIES THAT THEY WERE INITIALLY RESISTANT TO.

USE OF VIRUS AS THERAPY MAY BE DIRECT AND IN THREE PHASES

1-MAXIMUM SATURATION WHERE ACTION IS LARGELY BY DIRECT VIRAL

LYSIS THIS OCCURS WITHIN A FEW DAYS OF INFECTION

2-MAXIMUM EXPRESSION -THIS OCCURS WITHIN 1-3 WEEKS OF INFECTION

WITH THE VIRUSES MENTIONED AND VARIES WITH INCUBATION

PERIOD.MAXIMUM EXPRESSION OCCURS WHEN VIRUS EXPRESSES BEYOND

SATURATION AND OFTEN INVOLVES SIGNIFICANT VIRAEMIA.

THIS STAGE INVOLVES BOTH DIRECT VIRAL ACTIVITY AS WELL AS MAJOR

IMMUNOLOGICAL INVOLVEMENT;BY THIS TIME NOT ONLY ARE CELLULAR

IMMUNE MECHANISMS ALERTED BUT ANTIVIRAL ANTISERUM SHOULD ALSO BE

AT HIGH TITRE.ALL IMMUNOSTIMULATING AND/OR IMMUNE AUGMENTING

MECHANISMS CAN COME HEAVILY INTO PLAY HERE . PATENT THEREFORE

COVERS PRIOR VACCINATIONS , INTERFERON, INTERLEUKIN AND OTHER

LYMPHOKINES.IMMUNOSTIMULANTS AS WELL AS PASSIVE IMMUNISATION OF

HUMAN OR NON-HUMAN ORIGIN.

THIS RAISES THE TWO FIELDS OF TAGGING AND TASRGETIONG WHICH WILL

BE DISCUSSED LATER.

IT SHOULD BE NOTED THAT THE VIRUSES MENTIONED WILL CAUSE MARKED

RISE IN INTERFERON/INTERLEUKIN LEVELS.

3-REGRESSION/DEVELOPMENT OF SYNERGY /COEXISTANCE BETWEEN CANCER

AND VIRUS.

THESE CELLS ARE OFTEN MORE VULNEREABLE TO

CHEMOTHERAPY/RADIOTHERAPY THAN THEIR PREDECESSORS AND ARE

PROBABLY BEING DEPLETED IN THEIR ABILITY TO COPE WITH FURTHER

INSULT BY THE PRESENCE OF VIRAL LOAD.

FEATURES OF PATENT AS RELATE TO ABOVE CLASS IFI CATION .

1-MAXIMUM SATURATION.

IN THEORY,THE MORE RAPID AND COMPLETE THE SATURATION, THE LESS THE

CHANCE OF DEVELOPING OF RESISTANCE AND THE GREATER THE

POSSIBILITY OF LONGTERM REMISSION.

PATENT FEATURES IN DEVELOPMENT OF THERAPY;

1-DEVELOPMENT OF VIRAL VECTOR/VECTORS

A UNIQUE FEATURE OF THE PATENT IS THE DEVELOPMENT OF A VIRAL

THERAPY PROTOCOL INVOLVING MORE THAN ONE VIRUS; IN-VITRO DATA CAN

INDICATE WHICH VIRUS IS BEST SUITED IN WHICH ORDER;GENERALLY IT

IS THE VIRUS CAPABLE OF CAUSING THE GREATEST TUMOUR CELL

DESTRUCTION AS WELL AS CAPABLE OF SYNERGISING WITH SUBSEQUENT

VIRAL INFECTIONS IT WOULD NOT BE WISE. FOR EXAMPLE.TO FIRST INFECT WITH AN ORGANISM WHICH WILL IMMUNISE OR INTERFERE WITH SUBSEQUENT

THERAPEUTIC ORGANISMS.

IT IS A FEATURE OF THE PATENT TO SELECT FOR AND BREAD VIRUSES TO

BE HIGHLY ACTIVE AS WELL AS HIGHLY SPECIFIC FOR CANCER CELLS.THIS

CAN BE ACCOMPLISHED BY CO-CULTURE AND SELECTIVE WASHING.SOME SUCH MECHANISMS WILL NOW BE OUTLINED;

1-INCREASING VIRAL POOL-THIS MAY REFER TO SINGLE VIRUS AND/OR

VIRAL MIXTURE.

VIRUS IS PASSAGED THROUGH VARIOUS CELL TYPES IN ORDER TO CREATE A

LIBRARY.

THE FELINE PANLEUKOPENIA VIRUS,FOR EXAMPLE COULD BE INCUBATED IN

VARIOUS CANCER CELL LINES AS WELL AS NORMAL CELL LINES AS WELL AS

VARIOUS FRESH TISSUE AND CELL BIOPSIES.THIS WOULD THEN INDICATE

NOT ONLY WHICH TISSUES FORM TARGETS FOR THE VIRUS BUT ALSO THE

AGGRESSIVENESS AND RATE OF GROWTH IN EACH. TESTING CANCER CELL

LINES AND BIOPSIES IS IMPORTANT AS REGARDLESS OF WHAT IS KNOWN OF VIRAL BEHAVIOUR AND FAVOURED TARGET CELL TYPE; IT IS LIKELY THAT CANCER CELLS OF VASTLY DIFFERENT TYPES MAY ALSO BE VULNEREABLE .

TESTING THE AFFINITY OF THESE FOR THE CANCER TO BE TARGETED MAY BE ACHIEVED IN VITRO OR IN-VIVO. IN-VIVO TESTING MAY BE

ACCOMPLISHED IN MUCH THE SAME WAY AS THERAPEUTIC ORGANISM SCREEN IN PREVIOUS EXAMPLE OF PENICILLIUM LBS.

A VIRUS WHICH IS MADE INTO AN EXPANDED TEST LBS EITHER BY PASSAGING THROUGH VARIOUS CELL TYPES OR BY

PHYSICAL/CHEMICAL/BIOLOGICAL MANIPULATION , ALONE OR AS PART OF LBS CONTAINING OTHER VIRUSES(THESE ALSO PERHAPS EXPANDED)CAN BE

INJECTED OR OTHERWISE ADMINISTERED TO ANIMALS BEARING AN IMPLANT OF THE TARGET TISSUE TO BE ASESSED.ANIMAL CHOSEN WOULD BE TESTED TO DEMONSTRATE NO PRIOR EXPOSURE/INHERENT RESISTANCE TO VIRUSES BEING TESTED(AS WITH PENICILLIUM LBS);SAMPLES OF THE TUMOUR

IMPLANT ARE REMOVED AT VARIOUS INTERVALS OVER A TWO WEEK PERIOD

(IT IS POSSIBLE TO USE NUDE MICE AND/OR SKID RATS FOR TESTING WITHOUT THE INCUMBERENCE OF THE IMMUNE SYSTEM, THIS

WILL. HOWEVER,OFTEN RESULT IN ANIMAL DEATH.)

A PROTOCOL WOULD BE AT 6 HOURS, 12 HOURS THEN DAILY FOLLOWING ORAL, RECTAL, SUBLINGUAL , INTRADERMAL, SUBCUTASNEOUS, INTRAMUSCULAR ADMINISTRATION. FOLLOWING INTRAVENOUS APPLICATION. SAMPLES MAY BE TAKEN EARLIER, PERHAPS AT 30 MINUTES THEN AT DAILY INTERVALS.

INFORMATION GAINEDBY CULTURING THESE BIOPSIES IN VIRAL CULTURE WILL INDICATE WHICH VIRUSES HAVE HIGH INHERENT ABILITY TO ATTATCH TO CANCER.CULTURES OF THE EARLY BIOPSIES WILL SHOW WHICH OF THE VIRAL LBS HAS THE GREATEST EARLY AFFINITY FOR THE

CANCER.SUBSEQUENT BIOPSIES WILL INDICATE WHICH OF THE LBS ATTATCH TO AND INFECT THE CANCER CELLS IN THE LONGTERM.THIS IS ALSO A SYSTEM FOR INDICATING WHICH OF THE VIRUSES CAN COMBINE WELL AS MIXED THERAPY.

THE TEST CAN BE REPEATED FOR EACH STAGE OF VIRAL INFECTION;AS IN FOLLOWING FPLV INFECTION .OTHER VIRUSES CAN THEN BE TESTED IN THE SAME AS ABOVE MANNER AGAINST THE INFECTED CANCER CELLS TO INDICATE OPTIMAL SECOND STAGE VIRUS TO BE USED.TEST CELLS COULD BE FROM IN-VITRO OR IN-VIVO CULTURES,FROM PATIENT SAMPLES POST TREATMENT.

IN VITRO TESTING FOR AFFINITY COULD BE ACCOMPLISHED BY IMMERSING TARGET CELLS/TISSUES INTO SOLUTIONS CONTAINING VIRAL LBS'S OF VARIABLE CONCENTRATIONS.

VIRAL AFFINITY CAN BE DELINEATED IN TERMS OF TIME NEEDED TO INFECT A SAMPLE WITH RELATION TO CONCENTRATION,ALONE OR WHEN IN LBS OF COMPARABLE OR OTHER CONCENTRATIONS.

VIRAL AFFINITY FOR TARGET TISSUE MAY BE GIVEN AND/OR

AMPLIFIED/AUGMENTED BY REPEATED PASSAGE THROUGH A TARGET . PASSAGE OF VIRUS THROUGH TARGET CELLS IS A COMMONLY USED METHOD IN VIRAL RESEARCH;EXPANDING THE VIRAL LBS AND THE USE OF MULTIPLE VIRUSES IN THERAPY ARE UNIQUE IN THIS PATENT.A FURTHER PROBLEM WITH ATTEMPTS TO REPEATEDLY PASSAGE VIRUS THROUGH CANCER CELLS INVOLVES THE PREVIOUSLY DESCRIBED PHENOMENON OF VIRAL/CANCER ADAPTATION WHERE FOLLOWING A SHORT REMISSION, LEUKEMIA CELLS RECURRED WITH VACUOLATION SUGGESTING VIRAL ACTIVITY PRESENT;VIRUS COULD BE RECOVERED FROM LKEUKEMIA CELLS RECURRING AFTER INITIAL REMISSION.THIS SUGGESTS THAT REPEATED PASSAGING IN-VITRO MAY ALSO RESULT IN LOSS OF VIRULENCE AND EFFECTIVENESS.

IT IS ALSO TRUE THAT TWO UNIQUE PHENOMENON HAVE BEEN OBSERVED BY THE INVENTOR; VIRUS(S) CO-EXISTING IN CANCER CELLS MAY BE

REACTIVATED INTO VIRULENT STATE AND CELLS MAY BE REINFECTED BY THE SAME VIRUS. FPLV,UPON REPEAT CHALLANGE OF LEUKEMIA CELLS CARRYING FPLV MAY REINFECT THE CANCER,ALTERNATIVELY,REACTIVATION MAY OCCUR.REACTIVATION OF VIRAL VIRULANCE MAY ALSO BE

ACCOMPLISHED BY HEAT-KILLED VACCINE PREPARATIONS OF THE SAME VIRUS. FOLLOWING THE PHASE OF TUMOUR RECURRENCE THEREFORE,AT LEAST PARTIAL INHIBITION OF DISEASE MAY BE ACCOMPLISHED BY REACTIVATION OF VIRAL AGENT INFECTING THE CELL.

ANOTHER UNIQUE FEATURE OF THIS PATENT THEREFORE IS THE REACTIVATION OF VIRAL AGENT. A CASE OF CHRONIC MYELOID LEUKEMIA IN A 38 YEAR OLD MAN WAS PUT INTO REMISSION BY IDENTICAL PROTOCOL TO THAT USED IN THE CASE OF CHRONIC LYMPHOCYTIC LEUKEMIA PREVIOUSLY DESCRIBED, PATIENT HAD BEEN SUFFERING FROM THE DISEASE FOR THREE YEARS AND WAS NO LONGER RESPONDING TO CHEMOTHERAPY.WBC COUNT 53,000 AT BASELINE, -FOLLOWING FPLV INNOCULATION, PATIENT WAS IN REMISSION THREE WEEKS LATER, LEUKEMIA RECURRED WITHIN TWO

MONTHS.CYTOPLASMIC INCLUSION BODIES CHARACTERISTIC OF FPLV COULD BE SEEN IN ALL LEUKEMIA CELLS UPON RECURRENCE OF DISEASE;COINCUBATION OF RECURRED LEUKEMIA CELL LYSATES WITH OTHER LEUKEMIA CELLS/WHITE BLOOD CELLS SHOWED LITTLE TO NO VIRAL ACTIVITY.ADMINISTRATION DAILY BY INTRADERMAL INJECTION OF HEAT- KILLED FPLV,CAUSED REACTIVATION OF VIRUS AND MARKED DROP IN LEUKEMIC CELL COUNT. (COUNT PRIOR TO THERAPY BY HEAT-KILLED

PREPARATION;38,000, COUNT DROPPED WITHIN 24 HOURS TO 35,000,THEN 28,000 WITHIN 48 HOURS;AT THE END OF 1 WEEK OF INJECTING 1CC OF HEAT-KILLED FPLV, COUNT DROPPED TO 18, 000. IT REMAINED STABLE FOR SEVERAL DAYS BUT THEN BEGAN TO RISE AGAIN FOLLOWING TWO WEEKS OF THERAPY WITH HEAT KILLED FPLV- (PREPARATION WAS VETERINARY AND INJECTED AS ICC AMPOULE).

RECHALLANGE AT THIS POINT WITH FPLV LIVE VIRUS ASGAIN CAUSED DROP IN COUNT. IN VITRO ASSAY DEMONSTRATED THAT FPLV LYTIC ACTIVITY COULD STILL BE DETECTED DESPITE SYNERGY ARISING WITH PRIOR VACCINATION.AGAIN THERAPEUTIC EFFECT WAS SHORT-LIVED.AT A CUNT OF 60.000WBC 4 MONTHS AFTER COMMENCING THERAPY;HYDROXYUREA WAS ADMINISTERED(PRIOR DOSEAGE OF 6 TABLETS DAILY FOR THREE DAYS A WEEK WAS INEFFECTIVE AT PRESENTATION BUT NOW DISPLAYED SOME ACTIVITY); COUNT WAS STABLE AT 45,000 6 WEEKS LATER;HYDROXYUREA WAS DISCONTINUED FOR A WEEK(TO ALLOW FOR SOME AUGMENTATION OF IMMUNOLOGICAL RESPONSE. PATIENT WAS THEN TREATED WITH CANINE DISTEMPER VIRUS AS PER PRIOR PROTOCOL;REMISSION FOLLOWED WITHIN TWO WEEKS AND LASTED FOR EIGHT WEEKS. AT THE TIME OF

RECURRANCE, LEUKEMIA CELLS DISPLAYED BOTH THE CYTOPLASMIC

INCLUSION BODIES CHARACTERISTIC OF FPLV AS WELL AS INTRANUCLEAR VACUOLATION CHARACTERISTIC OF CDTV. CELL LYSATES SHOWED LITTLE TO NO ACTIVITY OF VIRAL PARTICLES WHEN TESTED AGAINST UNINFECTED LEUKEMIA CELLS.THE RECURRENCE OF LEUKEMIA WAS MARKED BY GREATER LEUKEMIA GROWTH RATE.WBC COUNT ROSE FROM 50,000 TO 145,000 WITHIN TWO WEEKS. INTERESTINGLY, HEAT KILLED FPLV VACCINE ADMINISTERED AS PREVIOUSLY WAS CAPABLE OF RESTORING BOTH FPLV AND CDTV VIRULENCE AND FOLLOWING A WEEK OF VACCINATION, COUNT DROPPED TO 80,000.

PATIENT REFUSED CHEMOTHERAPY OFFERS AT THIS STAGE AND WISHED TO CONTINUE VIRAL THERAPY. THIRD STAGE VIRAL THERAPY INVOLVED THE USE OF THE FOWL POX VACCINE.VACCINE WAS APPLIED AS PER PREVIOUS

PROTOCOLS;THERE WAS NO FURTHER DROP IN WHITE CELL COUNTS.

COUNT REMAINED 80-90,000 FOR 4 WEEKS

HYDROXYUREA COMMENCED AT ITABLET DAILY HAD A DRAMATIC EFFECT AT THIS STAGE WITH WBC COUNT DROPPING TO 20,000 OVER A 1 WEEK

PERIOD.FOLLOWUP FOR A FURTHER 4 MONTHS SHOWED GOOD DISEASE

CONTROL AT THIS DOSE.

THIS CASE CARRIED OUT AT AN EXPERIMENTAL RESEARCH INSTITUTE WITH FULL PATIENT AUTHORISATION,DEMONSTRATED A THREE STAGE THRESHOLD PRIOR TO DRAMATIC RETURN TO LEUKEMIA SENSITIVITY TO THERAPY. IT ALSO DEMONSTRATED THE ABILITY TO REACTIVATE TWO UNRELATED VIRUSES WITH HEAT-KILLED FRACTIONS OF ONE .-THIS SUGGESTS A COMMON

MECHANISM OF TUMOUR SYNERGY WHICH MAY BE REVERSED BY A HEAT- KILLED FRACTION OF ONE.

IT SHOULD BE NOTED THAT THESE OBSERVATIONS ARE ON LIMITED VIRAL TYPES; OTHERS MAY BE CAPABLE OF MORE EFFECTIVE ANTI-CANCER

ABILITIES.

IT SHOULD ALSO BE NOTED THAT IMMUNE RESPONSES WHICH PROTECT NORMAL CELLS FROM VIRAL INFECTION(PARTICULARLY,MULTIPLE VIRAL INFECTIONS )DO NOT SEEM TO FUNCTION IN CANCER CELLS. THIS IS USEFUL KNOWLEDGE AS IT MAY BE POSSIBLE TO CHOOSE SPECIFICITY BY USING A VIRUS TO WHICH THE BODY IS ALREADY IMMUNE; SUCH AS MEASLES OR MUMPS.ANTISERA AS WELL AS OTHER SYSTEMS WOULD PREVENT NORMAL CELLS FROM BEING REINFECTED,WHEREAS CANCER CELLS WOULD BE EASIER TO INFECT.

80 YEAR OLD PATIENT SUFFERING FROM CHRONIC LYMPHOCYTIC LEUKEMIA WAS VACCINATED WITH THE MUMPS VACCINE AFTER IT HAD BEEN INCUBATED WITH HIS CELLS IN THE MANNER PREVIOUSLY DESCRIBED.WBC COUNT AT START OF THERAPY WAS 86,000; PATIENT ACHIEVED REMISSION WITHIN 2 WEEKS, STILL DISEASE-FREE AT 2 YEAR FOLLOWUP.

INJECTION OF MEASLES VACCINES AND MUMPS VACCINES INTO PATIENTS SUFFERING FROM VARIOUS CANCERS RANGING FROM BTRAIN,BREAST AND BOWEL TO LEUKEMIA,LYMPHOMA AND OTHERS RESAULKTED IN MINIMAL TO NO EFFICACY. IT IS UNLIKELY THAT MAXIMUM SATURATION WAS EVER ACHIEVED AS IMMUNE RESPONSE MEMORY WOULD ELIMINATE VIRUS PRIOR TO REACHING ITS TARGET.EVEN DIRECT INTRATUMOUR INJECTION MET WITH LITTLE EFFICACY.THIS COULD ALSO HAVE BEEN DUE TO THE ATTENUATED FORM OF VIRUS AVAILABLE IN COMMERCIAL VACCINES (PRIOR STUDIES IN THE EARLY SEVENTIES SHOWED MARKED SOLID TUMOUR,SHRINKAGE FOLLOWING

INNOCULATION OF VIRULENT FORM OF MUMPS INTO THE TUMOURS.

IN THE CASES TESTED BY INVENTOR,THERE NEVER APPEARED TO BE A STAGE OF MAXIMUM EXPRESSION FOLLOWING DIRECT INNOCULATION OF VACCINE.THE LEUKEMIA CASE, HOWEVER,WAS TREATED WITH PATIENTS LEUKEMIA CELLS WHICH HAD ABSORBED THE VIRUS VAS PER THE TEACHINGS OF THIS PATENT.VIRAL LOAD WAS THEREFORE AMPLIFIED; THIS PROCESS ALSO APPEARS TO BE MORE EFFICIENT IN SPREADING THERAPY AMONGST DISEASED CELLS THAN SIMPLE APPLICATION OF VIRUS.

2-MAXIMAL EXPRESSION.

ADMIN-TAGGED CELLS ETC

PROTECT OTHER , NORMAL CELLS BYVACCINE/OTHER V, ANTISERA

TAILOR FOR PATIENT BLOOD AND IMMUNITY

I T SHOULD BE NOTED HERE THAT SOME VIRAL AGENTS MAY NOT EVEN NEED SUCH CONS IDERAT I ON AS

REACTIVATION USING DEAD V

ANOTHER CASE OF LOCALISED BREAST CANCER DISPLAYED RESISTANCE TO BOTH HORMONE AND CHEMOTHERAPY RADIOTHERAPY WAS NOT ATTEMPTED AS

MASS WAS 12 INCHES IN DIAMETER,WITH MARKED SKIN ATTACHMENT AIDS PATIENTS REVIEWED CNTINUED THERAPY OVER SEVERAL MONTHS(6 MONTHS MIN

AS CARRIER

AS INHIB/DIRECT ATTACK

AS TAG

TARGET1

STAGE OF MAXIMUM EXPRESSION FOLLOWING DIRECT INNOCULATION OF VACCINE.THE LEUKEMIA CASE,HOWEVER,WAS TREATED WITH PATIENTS LEUKEMIA CELLS WHICH HAD ABSORBED THE VIRUS VAS PER THE TEACHINGS OF THIS PATENT.VIRAL LOAD WAS THEREFORE AMPLIFIED;THIS PROCESS ALSO APPEARS TO BE MORE EFFICIENT IN 6PREADING THERAPY AMONGST DISEASED CELLS THAN SIMPLE APPLICATION OF VIRUS.

PATENT TEACHINGS FOR MAXIMAL SATURATION

1-SELECT VIRUS/GROUP OF VIRUSES WITH HIGH AFFINITY FOR TARGET CELL.

2-CULTURE TO DEVELOP AFFINITY BUT NOT ADAPTATION.

IN MULTIPHASIC THERAPY INVENTOR SPEAKS OF REPEATED CHALLANGE OF THERAPEUTIC ORGANISM WITH RESISTANT TARGET.WE HAVE SPOKEN HERE OF THERAPY WITH VARIOUS STAGES CORRESPONDING TO THE USE OF VARIOUS VIRAL AGENTS .THE PROBLEM WITH USING MULTIPHASIC THERAPY HERE IS THAT THE TARGET HAS NOT REALLY DEVELOPED RESISTANCE BUT, RATHER, SYNERGY WITH THERAPEUTIC AGENT.THERE IS THE FURTHER RISK THAT CO-INCUBATION WILL MORE LIKELY RESULT IN ATTENUATION AND ADAPTATION OF VIRUS.

IN CASES WHERE THE CANCER RECURRS WITHOUT PRESENCE OF VIRUS, PHASE THERAPY IS EASY AS ONE WOULD THEN SEARCH FOR VIRAL MUTATION OR OTHER VARIATION OF THE SAME VIRUS WHICH COULD RE-INFECT THE TARGET CELL,ALTERNATIVELY ONE CAN TRY TO TRIGGER REACTIVATION OF ATTENUATED VIRUS OR SEARCH FOR VIRAL VARIANT WHICH CAN REINFECT OR INFECT RESISTANT CELL CLONES.DIFFICULTY HERE ARISES AS,UNLIKE WITH MANY HIGHER ORGANISMS SUCH AS BACTERIA AND FUNGII,VIRAL CO-INCUBATION WITH CANCER CELLS TENDS TO RESULT IN ATTENUATION AND ADAPTATION OF VIRUS AND TARGET CELLS

CROSS BREEDING OF VIRUSES MAY RE-ESTABLISH VIRULENCE AS MAY PASSAGE OF VIRUS THROUGH ORIGINAL TARGET(IN THIS CASE

ANIMAL)TISSUE. THEREFORE WE HAVE TWO SEPARATE SITUATIONS IN DEVELOPMENT OF MULTIPHASED THERAPY;ONE INVOLVES EXPOSING CANCER CELLS TO A VIRUS WHERE THE VIRUS DOES NOT ACHIEVE TOTAL CELL DESTRUCTION, IE WHERE RESISTANT CELLS ARE PRESENT AND/OR WHERE DI

KILL VIRUS THEN REINFECT 2-MAXIMAL EXPRESSION.

ADMIN-TAGGED CELLS ETC LEUKEMIA CELLS UPON RECURRENCE, IF VIRAL ACTIVITY IS STILL EVIDENT WILL BE SENSITIVE TO CHEMOTHERAPY EVEN IF THE SAME WAS NOT PREVIOUSLY EFFECTIVE.

THE PREVIOUSLY DISCUSSED CASE OF CLL , FOR EXAMPLE HAS BEEN

CONTROLLED ON VERY LOW DOSES OF HYDROXYUREA SINCE ITS RECURRENCE ALTHOUGH SUCH AND HIGHER DOSEAGES WERE PREVIOUSLY INACTIVE..

TOTAL CANCER CELL DESTRUCTION OCCURS IN VITRO USING ONLY THESE VIRAL AGENTS, IT APPEARS THAT A MECHANISM OTHER THAN CELLULAR REGENERATION IS RESPONSIBLE FOR CANCER CELL RECURRENCE.

AS WITH THE PREPARATION OF MULTIMODAL CHEMOTHERAPY,ATTEMPTS TO DEVELOP MULTIMODAL VIRAL THERAPY IN SITUATIONS WHERE VIRUS WAS INCUBATED WITH CANCER CELLS IN TSB;DESPITE STRICT STERILE

PRECAUTIONS IN COLLECTION OF SAMPLE AND INCUBATION BACTERIAL GROWTH OFTEN WAS EVIDENT.

MULTIPLE BIOPSY WORK BY DR.ALAN CANTWELL AND OTHERS DEMONSTRATE SIMILAR COCCAL ORGANISMS IN THE VICINITY OF TUMOUR MASSES.THESE MAY BE CLASSIFIED BY CLASSIFICATION PATENT AND DEALT WITH ACCORDINGLY.

AS CANCER CELLS PASS THROUGH THE VARIOUS PHASES OF THERAPY,THEY ARE VACCINATED INTPO ANIMALS

DISEASE RECURS WITHOUT PRESENCE OF VIRUS, THE OTHER SITUATION NIS WHERE THE VIRUS HAS DEVELOPED ACCOMODATION OR SYNERGY WITH CANCER CELLS AND THE TWO APPEAR TO CO-EXIST.

DEVELOPMENT OF MULT I PHAS I C THERAPY

1 -WHERE RES I STANT CELLS ARE

PRESENT/VIRUS-FREE CELLS RECCUR .

THIS SITUATION MAY BE ADDRESSED BY MULTIPHASE TECHNIQUES PREVIOUSLY DESCRIBED. INVENTOR HAS FOUND HUMAN VIRUSES LESS LIKELY TO DEVELOP ADAPTATION.

IT IS IMPORTANT TO DEVELOP AFFINITY IF CELL DESTRUCTION DOES NOT OCCUR, THEN PASSAGE OF VIRUS THROUGH" NATURAL TARGET CELLS IS LIKELY TO RESTORE VIRULENCE .VIRUS CAN THEN BE RETURED FOR

THERAPEUTIC APPLICATION.

ALTHOUGH VIRUS IS MORE LIKELY TO MAINTAIN ITS VIRULENCE BY PASSAGE THROUGH ITS FAVOURED SPECIE AND FAVOURED TARGET TISSUE; CO-INCUBATION WITH OTHER VIRAL AGENT MAY RESTORE ITS VIRULENCE AND/OR ENABLE ACTIVITY EVEN AGAINST CELLS WHICH HAVE DEVELOPED RESISTANCE TO INITIAL VIRAL AGENT.

ENABLING DEVELOPMENT OF SECOND PHASE THERAPY MAY INVOLVE ANY OR A COMBINATION OF THE FOLLOWING;

1-EXPOSURE OF VIRUS TO UNINFECTED CELLS BY SEPARATING OUT THE CELL DEBRIS FROM LIVING, UNAFFECTED CELLS AFTER FIRST PHASE

PASSAGE. THIS CAN BE ACCOMPLISHED BY PLATING THE CANCER CELLS AND ADDING TO THEM VIRAL CONCENTRATES FROM VIRAL CULTURES SAME AS ORIGINAL AND/OR FROM OTHER CULTURES OF SAME VIRUS FROM DIFFERENT TARGET CELLS/TISSUES.

2-EXPOSURE OF UNINFECTED CELLS TO VIRUS FROM PHASE 1 AFTER

RESTORING/REINFORCING VIRULENCE BY METHODS INCLUDING CO- INCUBATION WITH RELATED AND/OR UNRELATED VIRUSES WHICH CAN

REACTIVATE VIRAL VIRULENCE

3-PASSAGE OF PHASE ONE VIRUS THROUGH NORMAL TARGET TISSUE TO ACQUIRE VIRULANCE RESISTANT CANCER CELLS CAN BE COINCUBATED SO THAT THEY ARE EXPOSED TO THE VIRULENT FORM OF THE VIRUS.

WHERE VIRUS AND CANCER CELLS ADAPT TO EACH OTHER AND SYNERG I SE .

1-BREAKING OF SYNERGY MAY BE ACCOMPLISHED BY THE ABOVE

MECHANISMS;

2-INDUCTION OF VIRULENCE OR REACTIVATION OF VIRAL AGGRESSION MAY

BE ACCOMPLISHED BY EXPOSURE OF ADAPTED CELLS TO PHYSICAL/CHEMICAL

AGENTS SUCH AS UV.AND/OR PEROXIDE ETC.SOME CHEMOTHERAPEUTIC

AGENTS MAY BE CAPABLE OF INDUCING VIRAL AGGRESSION.

3-AN INTERESTING MECHANISM USEFUL BOTH IN THIS AND THE ABOVE

SITUATION INVOLVES THE USE OF KILLED VIRAL PREPARATIONS TO

RESTIMULATE ACTIVITY AS WITH EXAMPLES GIVEN PREVIOUSLY.

THE ABOVE MECHANISMS AIM TO ACHIEVE MAXIMUM SATURATION,EXPRESSION AND ANTI-DISEASED CELL ACTIVITY.MECHANISMS OF ANTIDISEASE

ACTIVITY ARE NOT RESTRICTED TO DIRECT VIRAL ACTIVITY.

AS THE VIRUS EXPRESSES ITSELF AND VIRAL ANTIGENS EMERGE ON THE CANCER CELL'S MEMBRANE, THE IMMUNE SYSTEM OF HOST MAY BE ANTIGENICALLY ATTRACTED TO THESE AND HENCE ATTACK THE CANCER

CELL.

THE ABILITY OF THESE ANTIGENS TO HIGHLIGHT PREVIOUSLY NON-IMMUNE

ATTRACTING SYSTEMS AND/OR SYSTEMS SUCH AS CANCER OR AIDS INFECTED

CELLS WHICH ATTRACT INAPPROPRIATE AND/OR INSUFFICIENT IMMUNE

RESPONSE.THIS PHENOMENON IS CALLED TAGGING BY THE INVENTOR.

VIRAL ANTIGENS ATTATCHED TO CANCER CELLS MAY MAKE THEM MORE

ANTIGENIC'VIRAL EXPRESSION MAY CARRY EVEN GREATER ANTIGENIC

POTENTIAL; IF VIRUS IS DERIVED FROM ANIMAL SOURCE, OR HUMAN OR

OTHER SOURCE WHERE IT IS ABLE TO TRANSFER AND EXPRESS ANTIGENS

RELATED TO PRIOR CULTURE HOST/MEDIUM. I . E . IT IS KNOWN THAT

CANCERS TRANSPLANTED FROM ONE SPECIE INTO ANOTHER,ARE OFTEN

DESTROYED DUE REJECTION OF ANTIGENS OF OTHER SPECIE.VIRAL TAGGING

MAY BE ACCENTUATED BY THE CANNIBALIUSATION AND SUBSEQUENT

EXPRESSION OF ANTIGENS FROM ANOTHER SPECIE/ANTIGENICALLY

DIFFERENT SOURCE.

TARGETING INVOLVES THE FURTHER STEP OF RAISING AN IMMUNE RESPONSE

TO THE EXPRESSED ANTIGENS AND/OR CATERING FOR PRE-EXISTING IMMUNE

RESPONSE.

TAGGING AND TARGETING WILL BE DISCUSSED IN GREATER DETAIL.

UNDER THEIR OWN TITLE AND CAN BE APPLIED TO

VIRUSES, BACTERIA, FUNGII AS WELL AS ANTIBODIES AS WILL BE

DISCUSSED LATER.

BACTERIA

THGERE ARE BACTERIA WHICH CAN BE USED IN THE DEVELOPMENT OF

SPECIFIC DIRECT THERAPY AND/OR VACCINES AGAINST CANCER AND OTHER

DISEASES.

BY USE OF THE PREVIOUSLY DESCRIBED TECHNIQUES OF CO-INCUBATION

WITH VARIABLE BIAS , BACTERIA CAN BE SELECTED AND GROEN TO

SPECIFICALLY ATTATCK TARGET.

THERE ARE , AS WITH ALL LIVING THERAPIES TO BE CONSIDERED, THREE

FACTORS TO BE CONSIDERED;

1-AFFINITY

2-EFFECACY

3-ANTIGENICITY.

SEARCH FOR AFFINITY/DEVELOPMENT OF

AFFINITY.

THE OBJECTIVE HERE IS TO DEMONSTRATE, ISOLATE AND UTILISE

ORGANISMS AND ORGANISM FRACTIONS WITH AFFINITY FOR DISEASE.AS DESCRIBED IN CLASSIFICATION PATENT, ORGANISMS MAY BE SEEN AND ISOLATED FROM DISEASED HOST SAMPLES AND/OR DIRECTLY FROM DISEASE

BIOPSY.THESE WILL BE COVERED LATER UNDER INDUCED

REMI SS ION THERAPY SUMMARY , WE WILL NOW DESCRIBE

HOW BACTERIA MAY BE ISOLATED/SEPARATED/DEFINED BY OR GRANTED

AFFINITY.THE MECHANISM IS SIMILAR TO THAT USED FOR VIRUSES AND

FUNGII AS PREVIOUSLY DESCRIBED.

STEP1-DEFINE A LIVING BIOLOGICAL SYSTEM FOR TESTING

STEP2-DEFINE MEDIUM

STEP3-DEFINE TARGET STEP 1-DEFINING THE LIVING BIOLOGICAL SYSTEM.

THE SCOPE HERE MAY BE NARROW, AS IN TESTING 2 OR 3 STRAINS OF A SINGLE ORGANISM OR MAY BE AS EXPANDED AS A LARGE RANGE OF STRAINS, ORGANISMS, SPECIES AS THEY EXIST IN A NATURAL CONDITION (AN EXAMPLE BEING KEFIR, KAMBUCHA MUSHROOM,VARIOUS FERMENTED FOODS) OR ANY COMBINATION OF THESE, LBS MAY BE EXPANDED BY

ADDITION OF OTHER ORGANISMS .EXPOSURE OF MUTATING AGENTS TO EXPAND

POOL. ETC.

DEFINING MEDIUM

IT IS UNLIKELY THAT ANY SINGLE MEDIUM WOULD BE NEUTRAL/NOT

FAVOURING THERAPEUTIC OR TARGET ORGANISM UNLESS THEY ARE BOTH RELATED-(CANCER VS CANCER-TO BE DISCUSSED LATER).TRYPTICATED SOY BROTH IS USED IN MOST EXAMPLES, THIS PATENT IS,HOWEVER NOT

RESTRICTED TO IT; IF IT IS INTENDED TO BIAS FOR THERAPEUTIC

BACTERIA EXEMPLIFIED HERE BY HAEMOLYTIC STAPHYLOCOCCI VS.TARGET CANCER CELLS, BLOOD AGAR PLATE WOULD FAVOUR THE BACTERIA. IF ONE WISHED TO FAVOUR THE TARGET TO ALLOW IT TO EXPRESS SOME RESISTANC MECHANISMS; CELL NUTRIENT BROTH FORTIFIED WITH ANTIBIOTICS WOULD FORM THE OTHER END OF THE SPECTRUM, DECREASING ANTIBIOTIC DOSE TO SUBLETHAL LEVELS FOR TARGET BACTERIA DECREASES THE DEGREE OF BIAS, INTERMEDIATE FORMULATIONS ALLOW FOR THE VARYING DEGREES OF BIAS.

DEFINING TARGET

TARGET TO BE USED AS EXAMPLE HERE IS A CANCER CELL.THIS TARGET MAY BE RESTRICTED OR PURE (AS SIMPLE CELL-LINE,FOR EXAMPLE) OR MORE COMPLEX SUCH AS BY MULTIPLE PHASES FOLLOWING TREATMENT/OTHER MUTATION OR MODIFICATION, RESTRICTED TO SINGLE LINE OR TO SINGLE BIOPSY OR REPRESENTED BY POOLED BIOPSY OF PARTICULAR CANCER TYPE. AS ULTIMATELY CANCER THE DISEASE IS WHAT IS BEING ATTACKED, OTHER TARGETS NEED TO BE ASSOSCIATED ORGANISMS; CAUSATIVE, SYNERGISTIC ETC.

EVEN NEUTRAL OR ANTAGONISTIC ORGANISMS MAY BE

TARGETED(PARTICULARLY IMMUNOLOGICALLY AS THIS ALLOWS FOR A 1-2 SYSTEM-DISCUSSION OF THIS WILL FOLLOW TAGGING/TARGETING THERAPY, SUCH IMMUNE RESPONSES ARE NOT ONLY EFFECTIVE BUT CAN ALSO DECREASE DEBRIS SO AS NOT TO TAX IMMUNE RESPONSE.)

AN EXAMPLE WILL NOW BE MADE OF LEUKEMIA CELL8/SOLID TUMOURS- AND BACTERIAL THERAPEUTIC ORGANISMS.

1-CUSTOMISING PRE-EXISTING THERAPY

THE COLEY VACCINES, DEVELOPED FROM STREPTOCOCCUS PYOGENES AND SERRATIA MARASCESENS AS A HEAT-KILLED PREPARATION WAS PUBLISHED TO HAVE SHOWN GOOD PROMISE IN THE THERAPY OF CANCER, PARTICULARLY SARCOMA.WITH FIGURES EXCEEDING 30% REMISSION RATE IN SOME TRIALS. THE COLEY VACCINES WERE ASSOSCIATED WITH INTENSE TEMPERATURES AS WELL AS WITH SEVERE SHAKING,HYPOTENSION AND OTHER FEATURES OF ANAPHYLAXIS.

THIS SHOCK REACTION IS BOTH TRAUMATIC AND APPARENTLY VITAL TO

GOOD RESPONSE.

IT IS ASSUMED BY THE INVENTOR THAT AT LEAST SOME OF THE SIDE

EFFECTS OF THIS THERAPY ARE DUE TO THE NON-SPECIFICITY OF THE

BACTERIAL EXTRACTS.

THE FOLLOWING WILL ILLUSTRATE APPLICATION OF PATENT.

24 YEAR OLD MALE PRESENTS WITH RECURRENCE OF OSTEOGENIC SARCOMA

.3 LESIONS IN THE RIGHT LUNG MEASURE 1.5-2 CM DIAMETER EACH, ONE 3

CM LESION IS PRESENT IN LEFT LUNG WITH LEFT LOWER ZONE PLEURAL

EFFUSION.ON PRIOR PLEURAL ASPIRATE CELLS OF OSTEOGENIC SARCOMA

WERE DEMONSTRATED IN THE FLUID.

PATIENT, HAVING FAILED PRIOR CHEMOTHERAPY AND RADIOTHERAPY

UNDERWENT COLEY VACCINE THERAPY . STANDARD THERAPY ADMINISTERED TO

HIM WAS FORMULATED AS FOLLOWS;

6 CULTURES OF STREPTOCOCCUS PYOGENES WERE INCUBATED FOR 24 HOURS

WITH 3 SEPARATE CULTURES OF SERRATIA MARASCESENS . EACH EACTERIA

WAS ISOLATED FROM PATIENT SAMPLES AND WERE NOT OTHERWISE DEFINED.

THE STREPTOCOCCI AND SERRATIA WERE CO-INCUBATED FOR TWO DAYS IN

TRYPTICATED SOY BROTH 500CC,THE SOLUTION WAS THEN BOILED FOR 15

MINUTES ON THREE CONSECUTIVE DAYS.

APPLICATION WAS INTRADERMAL (ALTHOUGH USUAL COLEY THERAPY IS

INTRAVENOUS OR INTRATUMOURAL , INTRADERMAL USE WAS APPLIED AS IT

WAS FELT THAT THE REACTION MAY BE LESS SEVERE AND PATIENT WAS

VERY NERVOUS)

DAY1-0.1CC

DAY2-0.2CC

DAY3-0.3CC

THEN 0.6CC WERE APPLIED EVERY 3RD DAY FOR 6 WEEKS

EVALUATION AT THAT POINT BY CT SCAN SHOWED INCREASE OF MASSES BY AN AVERAGE OF 60%, 2 NEW MASSES OF ICM DIAMETER WERE IDENTIFIED IN THE LEFT LUNG AND FLUID WAS TO MIDZONE BILATERALLY.

CLINICAL COURSE WAS ALSO VERY UNPLEASANT WITH SEVERE REACTIONS AND TEMPERATURE OF 1O2-104DEGREES FARANHEIT LASTING SEVERAL HOURS FOLLOWING EACH APPLICATION.

ALTHOUGH THE DESIRED REACTIONS MANIFESTED,THEY APPEARED TO HAVE NO SPECIFICITY FOR THE DISEASE.

TESTING FOR AND EXPANDING AFFINITY AND MAXIMISING SPECIFICITY.

TECHNIQUE IS AS PREVIOUSLY DESCRIBED,

LBS IS DEFINED BY INCUBATING ALL THE STRAINS OF STREPTOCOCCI AND SERRATIA USED IN THE PREPARATION OF THE COLEY VACCINE FOR 24 HOURS IN TSB.

REMOVAL OF ORGANISMS WITH HIGH AFFINITY FOR NORMAL TISSUE.

THIS PROCESS MAY BE DONE AT ANY STAGE(S) DURING AND/OR FOLLOWING PREPARATION OF THERAPY, AS THE AIM IS TO MINIMISE THE CHANCE OF PRODUCING COMPOUNDS WITH ANTI-NORMAL TISSUE ABILITY THE ORIGINAL ORGANISMS ARE WASHED TO REMOVE ANY (OR AT LEAST TO REDUCE THE NUMBER)OF ORGANISMS WITH AFFINITY FOR HEALTHY TISSUE. IN ORDER TO DO THIS,THE BACTERIA ARE CULTURED ,SAY IN TSB, FOR 24 HOURS THEN THE HEALTHY TISSUE WE WISH TO PROTECT IS WASHED AGAINST THE CULTURE. LET US USE, FOR EXAMPLE, THE PATIENT'S BLOOD;BLOOD(5CC) IS ADDED TO 10 CC OF CULTURE AND ALLOWED TO SETTLE/COAGULATE. SUPERTNATANT IS REMOVED AND INNOCULATED INTO 500CC OF TSB.FOLLOWING A 24 HOUR CULTURE A TEN CC VOLUME OF THE MIXED CULTURE IS REMOVED AND AGAIN WASHED AGAINST 5CC OF WHOLE BLOOD(THIS PROCESS IS DEMONSTRATED IN

EXAMPLES , VOLUMES MAY BE ALTERED ; PATENT COVERS OTHER METHODS OF WASHING INCLUDING CENTRIFUGE, OTHER PHYSICAL/CHEMICAL/BIOLOGICAL METHODS OF EXTRACTION, INCLUDING REFINED METHODS OF

IMMUNOLOGICALLY REMOVING ORGASNISMS WITH AFFINITY FOR NORMAL RECEPTORS PRESENT IN HEALTHY CELLS BUT NOT IN DISEASE,OR FOR EVEN GREATER PROTECTION, REMOVING ORGANISMS WITH AFFINITY FOR ANY NORMAL RECEPTORS/OTHER NORMAL CELLULAR COMPONENTS INCLUDING THOSE THAT MAY BE SHARED BY CANCER OR OTHER TARGET CELL-THE KEY FEATURE OF THIS PART OF THE PATENT IS THE WASHING OF VACCINES TO REMOVE ANY PART THAT MAY EFFECT NORMAL CELLS) THE WASHING AGAINST

PATIENT'S BLOOD WAS REPEATED THREE TIMES .(OTHER METHODS OF ELIMINATING ORGANISMS WITH AFFINITY FOR HEALTHY TISSUE INCLUDE THE SATURATION OF CELLS WITH ANTIBIOTICS TO INHIBIT ORKILL ORGANISMS THAT ATTATCH TO THEM OR TO DEVISE AN IMMUNOLOGICAL SYSTEM TO ATTACK AND ELIMINATE SUCH ORGANISMS INCLUDING THE RAISING OF AN ANTKISERUM AGAINST ORGANISMS ATTATCHED- TO THE HEALTHY CELLS FOLLOWING WASHING; IN TURN,WASHING THE SERUM AGAINST REQUIRED ORGANISMS WITH ANTI-DISEASE ACTIVITY WILL LEAVE ONLY THE PART OF THE SERUM WITH SPECIFIC ACTIVITY AGAIANST ORGANISMS THAT ATTATCH TO HEALTHY CELLS)

FOLLOWING THE THIRD WASH, CULTURES STILL DEMONSTRATED SERRATIA AND STREPTOCOCCI. THESE WERE INCUBATED FOR 24 HOURS IN TSB; IN THEORY THESE ORGANISMS HAD LITTLE AFFINIKTY FOR HEALTHY CELLS; IN ORDER TO SELECT THOSE WITH SPECIFIC ACTIVITY AGAINST DISEASED CELLS;THE ORGANISMS WERE WASHED AGAINST SARCOMA CELLS ISOLATED FROM THE PLEURAL EFFUSION. (SARCOMA CELLS WERE FIRST SPUN FROM EFFUSION SAMPLE TAKEN A WEEK BEFORE TERMINATION OF STANDARD COLEY THERAPY;AND WERE RESUSPENDED IN 10CC OF SALINE AT 10,000 BY TEN TO THE FIFTH CELL CONCENTRATION PER CC)TO THE TEN CC , IOO CC OF 48 HOUR CULTURES WAS ADDED; THE CELLS WERE SPUN DOWN AND THEN RESUSPENDED IN 10CC OF SALINE; ICC WAS ADDED TO TSB FOR

CULTURE; THE CELLS WERE THEN AGAIN SPUN DOWN AND RESUSPENDED IN SALINE 1OCC; ICC SAMPLE WAS REMOVED FOR CULTURE AND THE PROCESS WAS REPEATED.

RELATIVE STRENGTH OF AFFINITY IS DETERMINED BY HOW MANY SUCH WASHES ARE NEEDED TO REMOVE THE ORGANISM.

MULTIPLE PHASES MAY BE ESTABLISHED FOR BOTH THE SELECTION AGAINST AND THE SELECTION FOR CERTAIN ORGANISMS, THE WASHING PROCEDURE TO REMOVE ORGANISMS WITH ANTI-NORMAL CELL ABILITY CAN BE FOLLOWED THROUGH MANY PHASES WHERE REMAINING ORGANISMS ARE CULTURED AND REWASHED UNTIL, IN THEORY THE AMOUNT OF RECOVEREABLE ORGANISMS FROM NORMASL-CELL WASAHINGS WILL BE MINIMAL .SIMILARLY, IN

THEORY, THE MORE TIMES THE MIXED CULTURE IS WASHED AGAINST TARGET CELLS SUCH ASD CANCER CELLS , THE GREATER THE AFFINITY AND THE HIGHER PERCENTAGE OF CULTURE WITH AFFINITY WILL DEVELOP.BOTH BACTERIAL TYPES WERE RECOVERED FROM CENTRIFUGED CANCER CELL PELLET AFTER THREE WASHINGS AGAINST THE SARCOMA CELLS.

THESE CULTURES WERE THEN USED IN THE PREPARATION OF THE VACCINE.THE METHOD WAS IDENTICAL TO THAT DESCRIBED FOR THE

VACCINES WHICH WERE PREVIOUSLY USED.

IN ADDITION, THE MIXED CULTURE WAS ALSO GROWN FOR 48 HOURS WITH SARCOMA CELLS IN THE MEDIA(10 CC OF SUSPENSION AS PREVIOUSLY DESCRIBED WAS ADDED TO 100CC OF TSB CULTURE)THIS WAS DONE TO MAKE ADVANTAGE OF TAGGING AND TARGETING POTENTIAL.

A THIRD PREPARATION WAS DESIGNED TO RAISE ANTICANCER ACTIVITY IN THE ORGANISMS. THE BACTERIAL MIX WAS CULTURED IN A PELLET OF

SARCOMA CELLS;UTILIZING JUST THE CANCER FOR NUTRITION, IT WAS HOPED THAT THE ORGANISMS WOULD DEVELOP SPECIFIC ENZYMES AND OTHER ANTI-CANCER MECHANISMS .( IT IS POSSIBLE TO DO THESE CULTURES

INTERSPERSED WITH TSB CULTURES WITH OR WITHOUT TARGET TO MAINTAIN FULL BACTERIAL ACTIVITY)

THE VACCIE WAS THEREFORE COMPRISED OF THREE COMPONENTS ONCE THE

ANTI-NORMAL CELL FACTORS WERE REMOVED.

THE SARCOMA CELLS WERE SPUN INTO A PELLET INTO WHICH

CELLS

BACILLUS SUBTILIS ANTIBIOTIC ETC EVEN NOABIOTICS.

BILATERAL PLEURAL CANCER EFFUSIONS WERE PRESENT TO M1DZONE

COLEY, OTHER CANCERS ...

CANCER VS CANCER

USE OF PROTECTIUE PROTEIN TO TARGET

USE OF ANTISERUM AGAINST CANCER WTHOUT ANTIGENS/UNDIFFERENTIATED .

USE MULTIPHASE OTHER SPECIE/PERSON ANTIGENS

SEQUENTIAL MULTIVIRAL THERAPY

TAGGING TARGETING

BACTERIA-COLEY ETC

MULTIPHASIC CARRIER / TARGETING

YEAST IRT

NORMAL GENE AMPLIFICATION

IMMUNE/MULTIPHASIC ETC.

TISSUES OF SPECIES OF TARGET CELLS DEBULKING

I NDUCED REMI S S I ON THERAPY-OVERVI EW

INTRODUCTION- INDUCED REMISSION THERAPY IS THE TERM COINED BY THE INVENTOR TO REPRESENT A THERAPEUTIC TECHNIQUE BY WHICH THE PHENOMENON OF SPONTANEOUS REMISSION IS MIMMICKED, IMPROVED AND APPLIED TO A BROAD RANGE OF MALADIES AND APPLICATIONS.

FEATURES OF PATENT CLASSIFICATION PATENT ORGANISM/ORGAN RESISTANCE

MULTIPHASIC/MULTIMODAL THERAPY

LIBRARY MATCHING

-IMPROVED GRTH RATE/ANTIBODS

TAGGING THERAPY CARRIER THERAPY

AS WELL AS INTRODUCTION OF NEW THERAPEUTIC MECHASNISMS AND BIOLOGICAL ENHANCEMENT.

STUDIES OF SPONTANEOUS REMISSION HAVE LED MANY TO SEE THE RELATIONSHIP BETWEEN INFECTIONS AND CANCER REGRESSION (COLEY-EARLY INVESTIGATION OF CANCER ALSO LED TO THE ISOLATION OF MANY MICROORGANISMS THAT WERE THOUGHT RELATED TO THE DISEASE PROCESS, WORK BY SCOTT, ALEXANDER AND LIVINGSTON AS WELL AS MANY OTHERS EARLIER THIS CENTURY SUGGESTED AN INTIMATE IF NOT CAUSAL RELATIONSHIP OF THE ORGANISMS WITH THE DISEASE. IT HAS ALSO BEEN OBSERVED THAT CERTAIN INFECTIONS MAY CAUSE PROLONGATION OF CHEMOTHERAPY-INDUCED REMISSION, OR CAUSE PARTIAL REGRESSION OF DISEASE(OBSERVATIONS WITH MEASLES AND MUMPS INFECTIONS AND THEIR IMPACT ON THE DISEASE PROCESS OF LEUKEMIA HAS INDICATED THIS); AS YET OTHER INFECTIONS WHICH MAY OR MAY NOT BE RELATED DIRECTYLY TO THE DISEASE PROCESS, ARE CAPABLE OF ACCELERATING THE DISEASE PROCESS, CMV INFECTION, OTHER VIRAL/BACTERIAL PNEUMONIA,FOR

EXAMPLE, ARE CAPABLE OF FURTHER IMMUNOSUPPRESSION OF

PATIENT,ACCELERATING HIS DEATH OR DEBILITY EITHER BY DIRECT ACTION OR BY ALLOWING FOR ACCELERATION OF THE CANCER PROCESS. IT APPEARS ,THEREFORE, THAT ORGANISMS MAY CAUSER OR PREPETUATE A DISEASE CONDITION OR CAUSE DUSEASE RESOLUTION OR INHIBITION; AS MICROORGANISMS THAT ASSIST AND MICROORGANISMS THAT INHIBIT DISEASE MAY BELONG TO THE SAME SPECIES OR BE OTHERWISE RELATED, THIS OBSERVATION CAN LEED TO SOME CONFUSION, FOR THIS REASON, THE CLASSIFICATION SEGMENT OF THE PATENT WAS

DEVELOPED.THIS OBSERVATION IS NOT LIMITED TO THE CANCER PROCESS; ANY DISEASE PROCESS CAN HAVE A SET OF ORGANISMS/FACTORS ETC DEFINED WHICH WILL EITHER ASSIST THE SDISEASER PROCESS OR ASSIST THE HAOST IN ELIMINATING OR REDUCING THE DISEASE.

IN THE CASE OF AIDS FOR EXAMPLE,VIRUSES SUCH AS CYTOMEGALOVIRUS MAY ACCELERATE A PATIENT'S DECLINE AS MAY INFECTIONS OF

iΗEUMOCYSTIS AMONGST OTHERS; STAPHYLOCOCCAL ERYSIPELAS HAS BEEN NOTED BY AUTHOR,HOWEVER, TO CAUSE A RAISE IN T CELL COUNTS IN PATIENTS SUFFERING FROM AIDS.

EVEN LESS DRASTIC CONDITIONS DEMONSTRATE SIMILAR RELATIONSHIPS.HERPES, FOR EXAMPLE IS A VIRAL DISEASE THAT LAYS DORMANT UNTIL ACTIVATED BY A WEAKENED HOST CONDITION OR BY SYNERGISTIC ORGANISMS; SUCH ACTIVATION CAN OCCUR FOLLOWING VIRAL INFECTION SUCH AS WITH AIDS AND/OR THE FLU VIRUS;HERPES OUTBREAKS CAN BE SIGNIFICANTLY INHIBITED BY PHAGE THERAPY/MULTIPHASIC

IMMUNE RESPONSES.

AS IN TYHE CASE OF CANCER, PSORIASIS,AIDS,MS,ARTRHRITIS AND

MULTIPLE OTHER DISEASES PREVIOUSLY THOUGHT UNRELATED TO MICROBIAL ORGANISMS INCLUDING CARDIOVASCULAR, CHRONIC DEGENERATIVE,ACUTE AS WELL AS ALL OTHER DISEASE AND OTHER CONDITIONS; RELATED FACTORS AND ORGANISMS MAY BE ENCOUNTERED AND CLASSIFIED ACCORDING TO CLASSIFICATION SECTION OF PATENT; THIS IS IMPORTANT AS ORGANISMS AND FACTORS WHICH ASSIST THE DISEASE SHOULD BE NEUTRALISED WHEREAS THOSE THAT OPPOSE THE DISEASE MAY BE INCORPORATED INTO OR USED TO EXTRACT THERAPY.

OTHER FEATURES OF THIS PATENT INCLUDE THE USE OF TAGGING AND TARGETTING MECHANISMS AS WELL AS LIVING BIOLOGICAL SYSTEMS.

IDENTIFYING TARGETS

THERE ARE 3 MAIN TARGETS FOR INDUCED REMISSION THERAPY.

1-DISEASE MANIFESTATION (EG. CANCER CELL)

2-DISEASE CAUSE

3-SYNERGISTIC ORGANISMS/FACTORS

THE CANCER CELL HERE WOULD BE CONSIDERED THE MANIFESTATION OF DISEASE AS WOULD THE HIV INFECTED T-CELLS AND THE SCALY SKIN TISSUE IN PSORIASIS; IT IS POSSIBLE TO IDENTIFY THE DISEASE

MANIFESTATION EVEN WHERE THE CAUSE IS NOT FULLY KNOWN OR EVEN WHERE CAUSE IS TOTALLY UNKNOWN.

2-CAUSE-DISCUSSION HERE WILL BE INCLUDE CAUSATIVE ORGANISMS

WHETHER SUCH A RELATIONSHIP IS PROVEN OR HYPOTHESISED BY INVENTOR.

3-RELATED ORGANISMS-

SYNERGISTIC,ANTAGONISTIC, NEUTRAL, INFECTIVE, NEMESIS, INCLUDING

THEIR APPLICATION IN TAGGING AND CARRIER VACCINES.

INDUCED REMISSION THERAPY IS THEREFORE MULTI-TARGETED,

MULTIPHASIC AND MULTI-MODAL.

TARGET-SELECTION

-ORGANISMS OF HIGH DISEASE AFFINITY

ISOLATION OF ORGANISMS RELATED TO TARGET DISEASE MAY BE POSSIBLE VIA PROCESSING OF PATIENT SAMPLES INCLUDING BUT NOT RESTRICTED TO URINE, BLOOD, STOOL, SPUTUM,EAR SWAB, THROAT SWAB,BIOPSY. ORGANISMS MAY BE READILY EVIDENT OR DETECTED BY COMPARISON WITH NORMAL ORGANISM PARAMETERS IN HEALTHY CONTROLS AND/OR BY COMPARISON WITH SAMPLES TAKEN PRIOR TO ONSET OF DISEASE.

STRAIGHTFORWARD CULTURE PRACTISE MAY DETECT THESE ORGANISMS; IN DEALING WITH BIOPSIES AND BLOOD, IN PARTICULAR,AFFINITY MAY BE SO HIGH THAT SEVERE TISSUE DISRUPTION IS NEEDED TO RELEASE THE NOT TAKEN INTO CONSIDERATION

FOR THE PURPOSES OF INTERNATIONAL PROCESSING

ORGANISMS AND ALLOW THEIR CULTURE.

HIGH AFFINITY ORGANISMS CAN BE SEEN IN TISSUE BIOPSIES OF CANCER, FOR EXAMPLE. TWO FEATURES DISTINGUISH THESE ORGANISMS FROM OTHERS . FIRSTLY. THEY APPEAR RESTRICTED TO WELL-DEFINED

NESTS , SECONDLY AND PARADOXICALLY, THEY ARE NOT SURROUNDED BY ANY SIGNIFICANT IMMUNOLOGICAL RESPONSE. ORDINARY INFECTIONS WOULD BE EXPECTED TO ATTRACT SIGNIFICANT IMMUNOLOGICAL RESPONSE AND IN THE ABSENCE OF ADEQUATE RESPONSE WOULD OVERRUN THE AREA IN WHICH THEY ARE LOCATED YET THE ORGANISMS IDENTIFIED FROM TISSUE BIOPSIES OF DISEASE (CANCER, FOR EXAMPLE). IN THE ABSENCE OF AN IMMUNE

CHALLANGE, REMAIN IN WELL-CIRCUMSCRIBED NESTS. SUCH ORGANISMS MAY BE ISOLATED FROM SPECIMENS AND BIOPSY SAMPLES AS WELL AS FROM BIOPSIES (AS SEEN IN POST-MORTEMS )OF SEEMINGLY NORMAL TISSUE NOT OVERTLY INVOLVED WITH DISEASE. -SEE DIAGRAMS OF BIOPSIES FROM CANCER AND AIDS PATIENTS.

ISOLATION OF ORGANISMS FROM TUMOUR BIOPSIES AND/OR LEUKEMIA CELLS/BIOPSIES/BLOOD AND OTHER SAMPLES OF VARIOUS DISEASES MAY RERQUIRE TISSUE/CELLULAR FRAGMENTATION TO ALLOW RELEASE AND GROWTH OF ORGANISMS (AGAIN, IT SHOULD BE NOTED THAT GROWTH OF THESE ORGANISMS APPEARS RESTRICTED TO WELL-DEFINED NESTS IN- VIVO; AND MAY NOT EXPRESS GROWTH WITHOUT CELLULAR DISRUPTION VIA PHYSICAL, CHEMICAL OR BIOLOGICAL MEANS.

SIMPLE CULTURE ISOLATION TECHNIQUES.

TUMOUR BIOPSIES WILL BE USED TO EXAMPLIFY THIS ALTHOUGH OTHER SPECIMENS AND SAMPLES OF OTHER DISEASES AND CONDITIONS MAY ALSO BE USED WITH VARIABLE EFFICACY.

TUMOUR BIOPSY IS REMOVED UNDER STERILE PRECAUTIONS ; IT IS THEN DISSECTED USING STERILE PROCEDURE AND A SECTION OF 'HEALTHY' TUMOUR TISSUE IS REMOVED-THIS IS ONE WHICH IS NOT ULCERATED AND CONTAINS NO GROSS EVIDENCE OF INFECTION( INFECTED SECTIONS ALSO SERVE A PURPOSE AS THEY INDICATE INFECTING ORGANISMS WITH HIGH AFFINITY FOR CANCER TISSUE, UPON CLASSIFICATION, THEY TOO CAN BE PROCESSED AND USED).THESE 'STERILE' SAMPLES ARE FURTHER CUT INTO SECTIONS OF ABOUT HALF A CM IN DIAMETER.

ONE SUCH SAMPLE IS SMEARED ALONG AN AGAR PLATE, ANOTHER ACROSS A BLOOD AGAR PLATE. SAMPLES ARE SMEARED AND ALSO PLACED WHOLE ON VARIOUS SOLID MEDIA INCLUDING LOWENSTEIN-JENNSEN MEDIUM AS WELL AS OTHERS . AVAILABLE MEDIA IS USED BOTH IN SOLID AND LIQUID FORM SUCH AS TRYPTICATED SOY BROTH ETC.TO COVER AS LARGE A RANGE AS POSSIBLE TO SEARCH FOR ANY ORGANISMS ; VIRAL , BACTERIAL , FUNGAL , YEAST ETC.

BACTERIAL CULTURES WILL BE USED TO EXAMPLIFY THIS PROCEDURE THIS HOWEVER, IS NOT TO BE RESTRICTIVE TO PATENT TO BACTERIAL CULTURES.

IN MANY CASES OF SOLID TUMOUR BIOPSIES, SEVERAL BACTERIAL COLONIES WILL APPEAR WITHIN 24-72 HOURS OF PLATING ON BLOOD AGAR.

TRYPTICATED SOY BROTH WILL DEVELOP CLOUDINESS OVER THE SAME TIME PERIOD.

OTHER TISSUE BIOPSIES ARE PLACED INTO CULTURE MEDIA COMPRISED OF OR ALONG WITH SELECTED/DEFINED LIVING BIOLOGICAL SYSTEMS. BIOPSY SEGMENT OF ABOUT ICM DIAMETER IS ALSO IMPLANTED INTO LABORATORY ANIMALS SUCH AS SHEEP GOATS OR HORSES.

SOLID CARCINOMA BIOPSIES WILL OFTEN YEILD BIOLOGICAL CULTURES; SARCOMA BIOPSIES MAY NOT AS READILY GROW ORGANISMS , LEUKEMIA CELL COLLECTIONS HAVE ALSO PROVEN DIFFICULT TO YEILD ORGANISMS ON ROUTINE CULTURE PROCESSES.

BACTERIA SEEN IN TUMOUR HISTOLOGY OFTEN APPEAR COCCAL IN NATURE. CULTURE WILL OFTEN REVEAL ORGANISMS WHICH MAY BE STAPHYLOCOCCAL IN MORPHOLOGY . BACILLI ( GRAM POSITIVE AND NEGATIVE , ACID FAST ETC . ) AS WELL AS MANY OTHERS MAY ALSO BE REVEALED.

ONE OF THE MOST FREQUENTLY RECOVERED ORGANISMS FROM CARCINOMA IS SIMILAR TO STAPHYLOCOCCUS ALBUS IN APPEARANCE AND MORPHOLOGY.

COMPLEX CULTURE TECHNIQUES

WHEN ORGANISMS ARE INTIMATELY ENCLOSED IN CELLULAR OR TISSUE STRUCTURES THEY MAY NOT BE EASILY REVEALED BY ORDINARY CULTURE TECHNIQUES; TISSUE AND/OR CELLULAR DISRUPTION MAY BE NEEDED PRIOR TO ORGANISM GROWTH . DISRUPTION MAY BE ACCOMPLISHED PHYSICALLY AND/OR CHEMICALLY AND/OR BIOLOGICALLY AND THIS MAY ACCOUNT FOR THE INCREASED INCIDENCE OF INFECTIONS POST RADIOTHERAPY AND CHEMOTHERAPY(ESPECIALLY IN COMBINATION WITH IMMUNOSUPPRESSION THAT ALSO FOLLOWS THESE THERAPIES) . INTERESTINGLY, ONE OF THE MOST PROBLEMATIC INFECTIONS FOLLOWING BONE MARROW ABLATION IS MULTI- RESISTANT STRAIN STAPHYLOCOCCUS AUREUS; THIS ORGANISM OFTEN IS YEILDED FROM COMPLEX CULTURE TECHNIQUES OF CANCER TISSUE OR CANCER PATIENT SAMPLE.

PHYSICAL

PHYSICAL DISRUPTION OF CANCER TISSUE MAY EE ACHIEVED BY EXTREME HEAT(PASTEURISATION, EVEN BOILING FOR 10-15 MINUTES), FREEZING AND SUBSEQUENT THAWING OF SAMPLE MAY ALSO BE ADEQUATE TO ALLOW FOR THE SUBSEQUENT CULTURING OF ORGANISMS MAY BE MADE POSSIBLE. IT MAY BE ARGUED HERE THAT FREEZING AND BOILING SIMPLY PREPARE A MORE FERTILE SOIL FOR CONTAMINANT INFECTION, THIS IS STILL RELEVANT AS INFECTIONS THAT REPEATEDLY CONTAMINATE TUMOUR SAMPLES MUST HAVE AFFINITY FOR THEM.

FREEZING OF A TUMOUR BIOPSY OR A COLLECTION OF CANCER CELLS SUCH AS IN LEUKEMIC BLOOD, SUBSEQUENT THAWING AND CULTURE IN THE

INVENTOR'S EXPERIENCE HAS A GREATER CHANCE OF YEILDING BACTERIAL GROWTH THAN EXTREME HEAT , FURTHERMORE , RESULTANT CULTURES FROM THE SAME SAMPLE MAY DIFFER FOLLOWING HEAT THAN FOLLOWING COLD TREATMENT . THIS MAY BE DUE TO INAPPROPRIATE EXTREMES SELECTING FOR RESISTANT ORGANISMS. SOME BACTERIA MAY SURVIVE FREEZING AND

OUTGROW AN INHERENT OR CONTAMINANT FUNGUS WHEREAS BOILING MAY DESTROY THE BACTERIA AND ALLOW SURVIVING FUNGAL SPORES TO EXPRESS.

OTHER PHYSICAL DISRUPTION SUCH AS SONIFICATIO>\ELECTRICAL AND OTHER DISRUPTIVE PHYSICAL MECHANISMS HAVE BEEN EMPLOYED BY INVENTOR WITH VARYING DEGREES OF SUCCESS IN ELLICITING CULTURES WHERE WHOLE SAMPLES OR SPECIMENS HAVE FAILED TO PROVIDE ORGANISM GROWTH BY DIRECT CULTURE PROCESSES. CHEMICAL

VARIOUS CHEMICAL AGENTS HAVE BEEN USED BY AUTHOR IN DISSOLVING TISSUE STRUCTURES TO ALLOW FOR ORGANISM EXPRESSION SUCH TECHNIQUES HAVE INCLUDED THE EXPOSURE OF CANCER SAMPLES TO PH FLUCTUATIONS OR SIMPLY TO EXTREMES WHICH ALLOW FOR TISSUE AND OR

VARIOUS LEVELS OF HYDROXYUREA ADDED TO LEUKEMIA CELLS ALLOWED F_OR BREAKDOWN AND BACTERIAL GROWTH SIMILAR IN MORPHOLOGY AND CHARACTERISTICS TO STAPHYLOCOCCUS AUREUS . THIS SUGGESTS THAT

TREATMENT OF SAMPLE WITH CHEMOTHERAPY MAY FASCILITATE ORGANISM CULTURE .

BIOLOGICAL

INCUBATION OF CANCER BIOPSY/CANCER CELL SUSPENSION WITH VARIED FRAGMENTS OF ANIMAL BLOOD (TESTED FOR STERILITY), WI LL OFTEN YEILD POSITIVE CULTURE. ANIMALS MAY BE OF A LARGE VARIETY OF NON-HUMAN CREATURES INCLUDING HORSES GOATS AND SHEEP.ANIMAL BLOOD MAY

ORIGINATE FROM UNVACCINATED ANIMALS AND/OR FROM THOSE WHICH HAVE BEEN PREVIOUSLY CHALLANGED BY THE CANCER (OR A RELATED ONE) OR THOSE PREVIOUSLY CHALLANGED WITH HUMAN TISSUE. BOTH CELLULAR AND TUMOURAL ANTI-HUMAN AND/OR ANTICANCER RESPONSE CAN DISRUPT SAMPLE STRUCTURE AND ALLOW FOR BACTERIAL GROWTH. INVENTOR HAS FOUND THAT ENZYMATIC DIGESTION OF CANCER CELLS MAY ALSO FASCILITATE ORGANISM CULTURE PHYSICAL/CHEMICAL/BIOLOGICAL METHODS MAY BE USED SEPARATELY OR IN ANY COMBINATION . THE ORGANISMS YEILDED MAY VARY BY TECHNIQUE AND ART OFTEN NOT RESTRICTED TO PURE COLONIES.

DETERMINAT I ON OF CLASS IF I CAT ION .

PLEASE REFER TO CLASSIFICATION SECTION.

MANY ORGANISMS RECOVERED FROM DISEASE BIOPSIES OR FROM BLOOD OR OTHER SAMPLES OF PATIENTS, PARTICULARLY WHERE DISEASE IS

PROCEEDING UNCHECKED; WILL REPRESENT CAUSATIVE OR SYNERGISTIC ORGANISMS . NEMESIS OR ANTAGONISTIC ORGANISMS MAY BE RECOVERED IF THE PATIENT IS UNDERGOING (OR IN THE TIME PERIOD IMMEDIATELY PRIOR OR SUBSEQUENT TO) REGRESSION OR REMISSION.

DISEASES OTHER THAN CANCER WILL ALSO YEILD ORGANISMS ON POST- DISRUPTION CULTURE TECHNIQUES. ARTHRITIS AND OTHER AUTO-IMMUNE DISEASES MAY YEILD BACTERIA RESEMBLING STAPHYLOCOCCUS AUREUS AS MAY CULTURES OF AIDS BLOOD. SUCH ORGANISMS MAY ALSO BE ISOLATED FROM A VARIETY OF DISEASES AND PATIENT SAMPLES INCLUDING PSORIASIS , CARDIOVASCULAR DISEASE AND VIRTUALLY ANY DISEASE

CONDITION INVESTIGATED BY INVENTOR TO DATE INCLUDING GENETIC DISEASES SUCH AS DOWNS SYNDROME . BACTERIAL APPEARANCE MAY RESEMBLE STAPHYLOCOCCI, STREPTOCOCCI, BACILLI, COLIFORMS, PROTEUS ETC. A LARGE LIBRARY OF DISEASE AND RELATED CULTURES WILL BETTER DELINEATE, DEFINE AND ASSOSCIATE DISEASE WITH RELEVANT ISOLATED ORGANISMS.,

INVENTOR HAS FOUND THAT ISOLATED ORGANISMS MAY VARY IN MORPHOLOGY AND CHARACTERISTICS DURING VARIOUS STAGES OF DISEASE AND THERAPY. IT APPEARS THAT THE CANCER OR OTHER DISEASE STATE MAY BE PROTECTIVE OF SUCH ORGANISMS . AS ADMINISTRATION OF APPROPRIATE CONVENTIONAL ANTIBIOTIC, PARTICULARLY WHERE ORGANISM WAS ISOLATED FROM CANCER PATIENT WILL HARDLY IF EVER ELIMINATE THE ORGANISM. IT CAN USUALLY BE ISOLATED SOON AFTER AND SOMETIMES EVEN DURING ANTIBIOTIC THERAPY ; OFTEN WITH ALTERED ANTIBIOTIC RESISTANCE

PATTERN; IT MAY BE THAT THE CANCER CONDITION SOMEHOW SHIELDS THE ORGANISM(EG ORGANISMS DEEP WITHIN A LARGE TUMOUR MASS MAY ESCAPE THERAPEUTIC ANTIBIOTIC DOSES, THIS MAY ALLOW FOR PROTECTION AND TIME TO DEVELOP AND/OR SELECT FOR RESISTANT STRAINS.) IT IS ALSO HYPOTHESISED BY AUTHOR THAT CANCER CELLS MAY THEMSELVES DONATE RESISTANCE DIRECTLY TO THESE ORGANISM (AS IN CASES OF

LEUKEMIAS , FOR EXAMPLE WHERE THE ORGANISMS CANNOT SEEK REFUGE IN A LARGE TUMOUR MASS.

CREATING A LIBRARY AND MATCHING

A LIBRARY IS GENERATED AND CLASSIFIED ACCORDING TO CLASSIFICATION

PATENT. LIBRARY CLASSIFIES THE FOLLOWING

ORGANISMS ISOLATED FROM BIOPSIES

ORGANISMS ISOLATED FROM PATIENT SPECIMENS

ORGANISMS WITH AFFINITY AS NOTED EPIDEMIOLOGICALLY, CLINICAL

HISTORY, LIVING BIOLOGICAL SYSTEM TESTS, OR AS GENERATED/INDUCED

IN LABORATORY SITUATION.

ORGANISMS ARE THEN CLASSIFIED ACCORDING TO CLASSIFICATION PATENT.

1-

DISEASED CELLS .WHERE AVAILABLE, ARE PREPARED INTO VACCINES SUCH

AS ONCOLYSATES AS WELL AS BEING PLACED THROUGH ALL THE PROCESSES

OF MULTIPHASIC/MULTIMODAL THERAPY AS WELL AS USING TAGGING AND

TARGETING MECHANISMS.

2-

DISEASE-RELATED ORGANISMS/FACTORS ARE TARGETED IF THEY CAUSE OR

ASSIST THE DISEASE PROCESS -A LIBRARY OF HEAT-KILLED VACCINES AS

WELL AS OTHERS ARE PREPARED AS WELL AS A RANGE OF THERAPIES BASED

ON TAGGING, CARRIER, MULTIPHASIC/MULTIMODAL TECHNIQUES.

3-

ORGANISMS/FACTORS OPPOSING THE DISEASE PROCESS OR OPPOSING

DISEASE-RELATED SYNERGISTIC/CAUSATIVE ORGANISMS ARE

AUGMENTED/USED FOR THE CREATION OF THERAPY AND ARE AMPLIFIED/MADE

MORE SPECIFIC BY INCREASED EFFICACY AND SPECIFICITY GUIDELINES OF

PATENT.

AN EXAMPLE OF LIBRARY USE AND MATCHING WILL FOLLOW; THIS COMPRISES A FRACTION OT INDUCED REMISSION THERAPY PROTOCOLS ; ALONG WITH SPECIFIC PROTOCOLS AND NON-SPECIFIC MODALITIES SUCH AS THE USE OF LIVING BIOLOGICAL SYSTEMS TO CREATE AND STABILISE AN ENVIRONMENT IN THE PATIENT CONDUSIVE TO HEALTH

SPECIFIC PROTOCOLS

THIS TITLE REFERS TO MATCHING OF THERAPIES TO PATIENT AND DISEASE . RAISING THE THERAPY FROM AND AGAINST PATIENT BIOPSY AND SPECIFIC ORGANISMS FROM PATIENT AS PER CLASSIFICATION PATENT. SPECIFIC PROTOCOLS MAY THEORETICALLY BE MORE APPROPRIATE AND MEET WITH GREATER CHANCE OF SUCCESS BUT WOULD TAKE A FINITE PERIOD OF TIME TO DEVELOP PARTICULARLY WHERE MULTIPHASIC/MULTIMODAL THERAPY IS INVOLVED; IN MANY CASES THEREFORE, THE INVENTOR HAS OPTED TO FIRST MATCH AND EMPLOY LIBRARY THERAPY UNTIL THERAPY DEVELOPED FROM PATIENT'S OWN SAMPLES CAN BE DEVELOPED AND EMPLOYED.

GENERAL-/NON-SPECIFIC THERAPY

STANDARDISING THERAPY IS BETTER ACHIEVED IF CERTAIN CONDITIONS CAN BE CONTROLLED IN ALL PATIENTS . SUPPLEMENTATION WITH A COMPLEX LIVING BIOLOGICAL SYSTEM SUCH AS THAT PREVIOUSLY DESCRIBED ENABLES NOT ONLY THE ESTABLISHMENT OF BENEFICIAL BOWEL FLORA WHICH MAY PROVIDE NUTRITION, IMMUNOSTIMULATION AS WELL AS

ANTIDISEASE ACTIVITY. SUPPLEMENTATION WITH 5 GRAMS TDS MAY

DISPLACE PATHOGENIC ORGANISMS SUCH AS CANDIDA ALBICANS AND MAY , BY PROVIDING A STABLE ,MODIFYING INFLUENCE (REPRODUCIBLE BY SIMILAR ADMINISTRATION IN OTHER PATIENTS) ALLOW FOR ANTICIPATION OF BOWEL FLORA INVOLVEMENT IN DISEASE AND HOST STATE AS WELL AS INTERPLAY WITH THERAPY. IN THEORY , CONTROLLING BOWEL FLORA AS WELL AS SKIN FLORA(APPLICATION OF LIVING BIOLOGICAL SYSTEM IN COSMETIC FORM) ALONG WITH RESPIRATORY AND OLFACTORY FLORA CONTROL (SKIN AND BOWEL MODIFICATION IS BY SIMILAR FORMULATION TO THAT DISCUSSED PREVIOUSLY, INVENTOR BELIEVES THAT IN THE FORMULATION OF LBS FOR THE RESPIRATORY AND OLFACTORY TRACTS, BACTERIA (EVEN THOSE WHICH APPEAR BENEFICIAL)SHOULD NOT BE USED. DEPENDING ON SPUTUM AND SWAB CULTURES, PHAGE LBS CAN BE FORMULATED TO REMOVE ANY PATHOGENIC ORGANISM FROM ANY AREA BUT PARTICULARLY RESPIRATORY PASSAGES . BY USE OF LBS SUPPLEMENTATION, SYNERGISTIC ORGANISMS MAY BE

MINIMISED.BY CONTROLLING THESE FLORA, ORGANISMS WHICH MAY DONATE RESISTANCE TO TARGET OR OTHERWISE SYNERGISE WITH IT MAY BE MINIMISED. PHAGE AND ANTIBIOTIC ORGANISMS MAY BE ADDED TO THE LBS , HOWEVER , PHAGE OPTIMAL USE IS IN RELATIVELY STERILE AREAS SUCH AS THE LUNGS.

EXERTING SUCH AN INFLUENCE ON RESIDENT BODY FLORA MAY CORRECT AN IMBALANCE ASSOSCIATED WITH DISEASE; REPLACEMENT OF FLORA WITH KNOWN BENEFICIAL ORGASNISMS MAY REDUCE THE PRESENCE AND/OR

ABILITY OF SYNNERGISTIC ORGANISMS TO ASSIST DISEASE PROCESS AS WELL AS PERHAPS INFLUENCING THE CAUSATIVE ORTGANISMS AS WELL . MORE EXTENSIVE TECHNIQUES OF FLORA REPLACEMENT SUCH AS COLONIC/FLUSHING WITH OR WITHOUT ANTIBIOTIC/ANTISERA/IMMUNE RESPONSE/PHAGE SYSTEM TO ELIMINATE DISEASE-ASSOSCIATED FLORA PRIOR TO OR SIMULTANEOUSLY WITH ADDITION/RESEEDING WITH KNOWN FLORA.

LIVING BIOLOGICAL SYSTEMS CAN BE ADMINISTERED AS SUPPLEMENT OR USED TO INNOCULATE AND/OR PRODUCE FOODS AND DRINKS IN

BIOLOGICALLY ENHANCED FOODS FORMAT. BIOLOGICVALLY ENHANCED FOODS.

THIS TERM REFERS TO A NEW RANGE OF FOODS WHICH HAVE BEEN EITHER MANUFACTURED BY AND/OR REINFORCED WITH LIVING BIOLOGICAL SYSTEMS AS PREVIOUSLY DEFINED.

INTRODUCTION

A NUMBER OF MODERN AND ANCIENT FOODS AND DRINKS ARE FREPARED BY BACTERIAL FERMENTATION OF SUBSTRATE- SUBSTRATE PRODUCT

MILK CHEESE , YOGHURT , BUTTER , ETC

VEGETABLES PICKLES, SAURKRAUT

FRUIT WINE

MANY OF THESE FERMENTED FOODS CONTAIN RELATIVELY LOW LEVELS OF LIVING ORGANISMS/CELLULAR STRUCTURES AS THE USUAL FERMENTATION PROCESS CULMINATES IN CHANGES (SUCH AS LACTIC ACID BUILD UP, BACTERIAL ENDPRODUCT ACCUMULATION, PH CHANGES ETC.)WHICH ARE

INHIBITORY/LETHAL TO THE ORGANISMS USED IN FOOD/DRINK

MANUFACTURE.

INHIBITION/ELIMINATION/REMOVAL OF ORGANISMS IS OFTEN DONE TODAY TO EXTEND SHELF-LIFE AND PRESERVE FLAVOUR/CONSISTENCY ETC.

PATENT INTRODUCES FOODS MADE FROM/ENFORCED WITH LIVING BIOLOGICAL SYSTEMS WITH THERAPEUTIC/PREVENTATIVE/REGENERATIVE AS WELL AS OTHER BENEFICIAL PROPERTIES . ARRANGEMENT OF LBS MAY EE DESIGNED FOR SPECIFIC PURPOSE OR AS BROAD SPECTRUM. HIGH ORGANISM VIABILITY IS PREFERRED BUT NOT ESSENTIAL.

CHOOSING THE LIVING BIOLOGICAL SYSTEM

ORGANISMS USED IN PRIOR ART OFTEN BELONGED TO A RESTRICTED GROUP

OR SPECIE, EG YEA8TS/ACID0PHILUS ETC

DIFFERENCES FROM PRIOR ART INCLUDE;

1-LBS FORMULATION

2-ORGANISM DOSEAGE

3-NEW FOOD TYPES GENERATION

AND SUPPLEMENTATION.

SUPPLEMENTATION

GENERAL VS SPECIFIC.

GENERAL SUPPLEMENTATION INVOLVES USE OF PREVIOUSLY DEFINED LIVING

BIOLOGICAL SYSTEM FORMULA ADDED TO FOODSTUFF AND DRINKS AT ANY

DOSES DETERMINED BY PRODUCT.

BACTERIAL POWDER, FOR EXAMPLE, CANNOT BE ADDED IN LARGE DOSES

TO SOFT DRINKS ALTHOUGH DOSES OF SEVERAL MILLION UNITS DO NOT

USUALLY INTERFERE SIGNIFICANTLY WITH FLAVOUR OR

TEXTURE. SUPPLEMENTATION OF DAIRY FOOD, HOWEVER CAN EASILY SUPPORT

BILLIONS OF ORGANISMS MORE WITHOUT SIGNIFICANT CHANGE IN FLAVOUR

OR TEXTURE. BIOLOGICVALLY ENHANCED FOODS.

INTRODUCTION

A NUMBER OF MODERN AND ANCIENT FOODS AND DRINKS ARE PREPARED BY

BACTERIAL FERMENTATION OF SUBSTRATE-

SUBSTRATE PRODUCT

MILK CHEESE, YOGHURT, 3UTTER, ETC

VEGETABLES PICKLES , SAURKRAUT

FRUIT WINE

MANY OF THESE FERMENTED FOODS CONTAIN RELATIVELY LOW LEVELS OF LIVING ORGANISMS/CELLULAR STRUCTURES AS THE USUAL FERMENTATION PROCESS CULMINATES IN CHANGES (SUCH AS LACTIC ACID BUILD UP, BACTERIAL ENDPRODUCT ACCUMULATION, PH CHANGES ETC. )WHICH ARE INHIBITORY/LETHAL TO THE ORGANISMS USED IN FOOD/DRINK

MANUFACTURE .

PATENT INTRODUCES FOODS MADE FROM/ENFORCED WITH LIVING BIOLOGICAL SYSTEMS WITH THERAPEUTIC/PREVENTATIVE/REGENERATIVE AS WELL AS OTHER BENEFICIAL PROPERTIES .ARRANGEMENT OF LBS MAY BE DESIGNED FOR SPECIFIC PURPOSE OR AS BROAD SPECTRUM. HIGH ORGANISM VIABILITY IS PREFERRED BUT NOT ESSENTIAL.

CHOOSING THE LIVING BIOLOGICAL SYSTEM

ORGANISMS USED IN PRIOR ART OFTEN BELONGED TO A RESTRICTED GROUP

OR SPECIE,EG YEASTS/ACIDOPHILUS ETC

DIFFERENCES FROM PRIOR ART INCLUDE;

1-LBS FORMULATION

2-ORGANISM DOSEAGE

3-NEW FOOD TYPES GENERATION

AND SUPPLEMENTATION.

SUPPLEMENTATION

GENERAL VS SPECIFIC.

GENERAL SUPPLEMENTATION INVOLVES USE OF PREVIOUSLY DEFINED LIVING BIOLOGICAL SYSTEM FORMULA ADDED TO FOODSTUFF AND DRINKS AT ANY DOSES DETERMINED BY PRODUCT.

BACTERIAL POWDER, FOR EXAMPLE, CANNOT BE ADDED IN LARGE DOSES

JUST MENTION LBS EGSAMOL LACTOSE INTOLERANT CHOLESTEROL

IMMUNITY AND CHARACTERISTICS DURING VARIOUS STAGES OF DISEASE AND THERAPY. IT APPEARS THAT THE CANCER OR OTHER DISEASE STATE MAY BE PROTECTIVE OF SUCH ORGANISMS . AS ADMINISTRATION OF APPROPRIATE CONVENTIONAL ANTIBIOTIC, PARTICULARLY WHERE ORGANISM WAS ISOLATED FROM CANCER PATIENT WILL HARDLY IF EVER ELIMINATE THE ORGANISM. IT CAN USUALLY BE ISOLATED SOON AFTER AND SOMETIMES EVEN DURING ANTIBIOTIC THERAPY; OFTEN WITH ALTERED ANTIBIOTIC RESISTANCE

LEUKEMIAS, FOR EXAMPLE WHERE THE ORGANISMS CANNOT SEEK REFUGE IN A LARGE TUMOUR MASS.

AIMING CELLS DEFINE LIBRARY DEFINE MECHANISMS

VIRAL/UINF ALSO INTRFERANCE

ADDENDUM TO HYPERTHERMIA PATENT IN VIEW OF MULTIPHASIC/MULTIMODAL THERAPY AND INDUCED REMISSION THERAPY GUIDELINES AS WELL AS GUIDELINES OF ANTICIPATORY THERAPY.

AS WITH THE UNDERLYING THEORY OF HYERTHERMIA PATENT, CHANGES PHYSICAL. CHEMICAL OR BIOLOGICAL USED IN PREPARATION OF VACCINES OR IN ANY OTHER THERAPY SHOULD BE USED TO PREPARE THE TARGET AS WELL FOR OPTIMUM RESPONSE TO THERAPY . OTHER EXAMPLES OF THIS HYPOTHESIS WILL NOW FOLLOW.

BREAST CANCER 42 YEAR OLD FEMALE- ADENOCARCINOMA OF LEFT BREAST- MAMMOGRAPHY AND BIOPSY PERFORMED AS BASELINE.

TUMOUR HAD INCREASED IN SIZE FROM 3CM DIAMETER TO 15 CM BY 8 CM

OVER A THREE MONTH PERIOD.

VACCINE WAS PREPARED BY ENZYMATIC DIGESTION WITH PROPRIETARY

PREPARATION OF DIGESTIVE ENZYMES CALLED GADITAL( PRECISE

COMPOSITION IN GLOSSARY)

THIS LED TO GENERATION OF CELLULAR(AND POSSIBLE RELATED ORGANISM

EXTRACTS WHICH WERE USED TO GENERATE MULTIMODAL THERAPY BOTH

AGAINST CELLS AND RELATED ORGANISMS AS EXPLAINED IN INDUCED

REMISSION THERAPY PATENT.

VACCINES MADE AS PER IRT PATENT DETAILS WERE USED TO TREAT THE

PATIENT .

CANCER GROWTH WAS ARRESTED AS SHOWN IN THE FOLLOWING FILMS;

AFTER 4 WEEKS THERE WAS EVIDENCE OF NECROSIS BUT NO OVERT

SHRINKAGE.

ON THE 6TH WEEK , DIRECT INTRATUMOURAL INJECTION OF GADITAL WAS

ATTEMPTED AND RAPID SHRINKAGE FOLLOWED AS SHOWN IN THE FOLLOWING

FILMS.

IT SHOULD BE NOTED HERE THAT A SMALL 2CM LESION IN THE OTHERT

BREAST WAS PREVIOUSLY(PRIOR TO VACCINE THERAPY) INJECTED WITH THE

DIGESTIVE ENZYMES WITH NO RESULTING CHANGE.)

MOST DIGESTIVE ENZYMATIC CHANGES IN CELLULAR OR TISSUE STRUCTURE

WOULD PROBABLY RESOLVE WITHIN A DEFINED PERIOD OF TIME (SUCH AS

ONE CELL CYCLE)IN THE BODY, HENCE PRIOR TREATMENT WITH ENZYME

DIGESTION A LONG TIME PRIOR TO VACCINE THERAPY IS UNLIKELY TO BE

VERY USEFUL IN THIS SETTING; AS OPPOSED TO ENZYME TREATMENT

IMMEDIATELY PRIOR TO,AND/OR DURING AND/OR FOLLOWING THE

VACCINATION PROGRAM.

AS THE BODY WAS FIRST VACCINATED AGAINST DIGESTED STRUCTURES AND

WAS ABLE TO BUILD A STRONG RESPONSE AGAINST THESE; SUBSEQUENT

TREATMENT WITH THE SAME DIGESTIVE ENZYME (BY DIRECT INTRATUMOURAL

INJECTION) ALLOWS FOR THE EXPOSURE OF DISEASE STRUCTURES AGAINST

WHICH THE BODY HAS BEEN VACCINATED BY EXPOSING THE DISEASE IN

VIVO TO PART OR ALL OF THE PROCESSES USED IN PREPARING THE

VACCINE. THIS ALLOWS FOR DRAMATIC IMPROVEMENT IN RESPONSE TO

VACCINE AND ACCOUNTS FOR THE DRAMATIC IMPROVEMENT IN PATIENT.

VACCINATION WITH CERTAIN PREPARATIONS OF DISEASE WILL BE PAR MORE

EFFECTIVE IF THE DISEASE PRESENTATION CAN BE MADE TO MIMIC THE

STRUCTURES AGAINST WHICH THE RESPONSES WERE RAISED . THIS CAN BE

ACCOMPLISHED BY TREATING THE DISEASE WITH THE SAME PROTOCOLS BY

WHICH THE VACCINE WAS PREPARED AND/OR BY USING OTHER MEANS WHICH

LIBERATE IDENTICAL OR SIMILAR STRUCTURES FROM THE TARGET DISEASE

IN-VIVO.

WITH THE HYPERTHERMIA AND HEPATOMA AND THE EXAMPLE OF ENZYME DIGESTION WITH THE BREAST CANCER WE HAVE COVERED THE IMPROVEMENT OF VACCINATION PROGRAMS WITH PHYSICAL AS WELL AS BIOLOGICAL PROCESSING OF BOTH VACCINE AND DISEASE IN ORDER TO ALLOW FOR PROXIMITY OF THERAPY AND TARGET FORM.

ANOTHER EXAMPLE OF PHYSICAL CHANGES BEING EMPLOYED BOTH IN THE MANUFACTURE OF THERAPY AS WELL AS THE IN-VIVO, IN-SITU

PROXIMISATION OF STRUCTURE PRESENTATION TO THAT OF VACCINE AFTER BUILD UP OF IMMUNE REPONSE TO VACCINE MAY BE DEMONSTRATED BY THE USE OF SPECIFIC FREQUENCY GENERATORS.

AS AN EXAMPLE, LEUKEMIA CELLS FROM A CASE OF ACUTE MYELOCYTIC LEUKEMIA WERE DISRUPTED BY PROLONGED EXPOSURE TO 300 HZ PULSED OUT AT 150 WATTS FOR 48 HOURS.

THE LEUKEMIA CELLS WERE SEPARATED BY CENTRIFUGATION FROM BLOOD SAMPLE AND SUSPENDED IN NORMAL SALINE AT CONCENTRATION OF 100,000 CELLS BY 10 TO THE 9TH POWER PER CC.

THIS SUSPENSION WAS EXPOSED TO THE PULSED FREQUENCIES AS TRANSMITTED THROUGH A 150 WATT PLASMA GLOBE(CATHODE AND ANODE ARRANGEMENT THROUGH HELIUM GAS. SIMILAR TRIALS WERE ALSO DONE THROUGH OTHER TRANSMISSION MODALITIES SUCH AS SOLID ANTENNAE AND USING VARIOUS CARRIER WAVES WITH SIMILAR RESULTS)

AFTER 3 DAYS OF CONTINUEOS EXPOSURE TO PULSED FREQUENCIES AT ROOM TEMPERATURE; THE LEUKEMIA CELL SUSPENSION WAS FILTERED THROUGH 0.2 MICRONS TO REMOVE LIVING CELLS.

PATIENT WAS VACCINATED WITH THE FREQUENCY-ALTERED CELLS AT 3CC EVERY 3RD DAY.

PATIENT'S WHITE BLOOD CELL COUNT REMAINED LARGELY UNCHANGED OVER THE VACCINATION PERIOD. PATIENT WAS EXPOSED DAILY TO PULSED

FREQUENCY OF 300 HZ AT 150 WATTS.FOR 15 MINUTE SESSIONS.

WHITE BLOOD CELL COUNT AT START OF VACCINATION 154000, PRIOR TO PULSED FREQUENCY 157,000; 24 HOURS POST PULSED FREQUENCY-72,000 FOLLOWING ONE WEEK OF THERAPY COUNT REDUCED TO 24, 000. COUNT REMAINED AT 15-30,000 FOR 8 WEEKS; PATIENT THEN RELAPSED AND SUBSEQUENTLY DIED OF PNEUMONIA.

IT IS BELIEVED THAT MULTIPHASIC/MULTIMODAL THERAPY WOULD OBTAIN BETTER RESULTS.

MANY PHYSICAL/CHEMICAL/BIOLOGICAL PROCESSES MAY RELEASE

ASSOSCIATED ORGANISMS/ORGANISM STRUCTURES WHICH MAY ENHANCE ERFGFICACY OF PREPARATION PROVIDED THAT SUCH ORGANISMS DO NOT SURVIVE IN LIVING FORM, THIS WOULD JEOPARDISE RESPONSE

PARTICULARLY IF ORGANISM IS CAUSATIVE OR SYNERGISTIC IN WHICH CASE AGGRAVATION OF DISEASE CONDITION MAY RESULT.

L INK WITH MACHI NERY PATENT ( S )

AN EXAMPLE OF THE USE OF CHEMICAL MODALITY ENHANCEMENT OF VACCINE PROTOCOL FOLLOWS ;

42 YEAR OLD FEMALE SUFFERING FROM BREAST CANCER;ADENOCARCINOMA,

WITH LIVER SECONDARY DISEASE (SINGLE LESION OF 10 Cn DIAMETER IN

R LOBE OF

LIVER). PATIENT WAS ABOUT TO UNDERGO ADRIAMYCIN

CHEMOTHERAPY . BIOPSY SAMPLE WAS TAKEN AND SUSPENDED IN 10 CC OF

THE PATIENT'S BLOOD BIOPSY MEASURED 1 CM DIAMETER AND WAS PLACED

WHOLE INTO THE BLOOD . HALF A MG OF ADRIAMYCIN WAS ADDED TO THE

BLOOD.INCUBATION WAS ALLOWED FOR 3 HOURS. BIOPSY SAMPLE WAS RECOVERED THEN THE PROCESS REPEATED 3 TIMES. THE BIOPSY SAMLE WAS THEN RE COVERED , MANUALLY GROUND , RESUSPENDED AND SHAKEN IN 25CC OF NORMAL SALINE . BROAD SPECTRUM STAPHYLOCOCCAL PHAGES ( 10 TO THE 9TH POWER PLAQUE FORMING UNITS PER CC) 25CCWERE ADDED TO THE MIXTURE AND EVERYTHING THEN PASSED THROUGH A 0.2 MICRON FILTER. PATIENT WAS VACCINATED WITH 3CC EVERY 3RD

DAY . ULTRASOUND REVEALED LITTLE CHANGE IN TUMOUR SIZE AFTER 3 WEEKS OF THIS. ADRIAMYCIN SINGLE STANDARD DOSE WAS ADMINISTERED AT THIS POINT AND LIVER TUMOUR DISAPPEARED WITHIN 2 WEEKS.

PHAGES OF MIXED CULTURES OF STAPHYLOCOCCUS AUREUS WERE USED HERE AS IMMUNE ADJUVANTS. IDENTICAL PHAGE PREPARATIONS ALONE HAD NEVER PREVIOUSLY EFFECTED TUMOUR SIZE IN BREAST LIVER SECONDARIES ACCORDING TO INVENTOR'S EXPERIENCE . IT IS FELT THAT PRIOR EXPOSURE TO ADRIAMYCIN ALLOWED THE IMMUNE SYSTEM TO REACT AGAINST TUMOUR COMPONENTS DAMAGED BY CHEMOTHERAPY PRIOR TO ITS APPLICATION , HENCE A MAJOR IMMUNE REACTION FOLLOWED THE IN-VIVO CHANGES.

PATIENT REMAINED IN REMISSION FOR 4 MONTHS THEN DEVELOPED LIVER AND BONE RECURRENCE . SHE REFUSED FURTHER CHEMOTHERAPY AND DIED 6 MONTHS LATER.

AIDS PATIENT 28 YEAR OLD MALE.4 YEAR HISTORY

DIAGNOSIS . ASYMPTOMATIC , T-CELL COUNT 350 , T4/T8 RATIO

O.05 CC GOAT BLOOD WAS INJECTED INTRADERMALLY . DAY

DAY 3-T-CELL TOTAL-250, RATIO 0.8

DAY 10-T-CELL TOTAL-450 RATIO 0.9

AIDS PATIENT-45 YEAR OLD MALE , 2 YEARS SINCE DIAGNOSIS .

T-CELL TOTAL -240, T4/T8 RATIO 0.5

HORSE BLOOD 0.1CC CRUDE LYSED INJECTED SUBDERMALLY DAY 1

DAY 3-T CELL TOTAL 248 T4/T8 RATIO 0.5

DAY 10-T CELL COUNT 330 T4/TB RASTIO 0.6

AIDS PATIENT -50 YEAR OLD FEMALE- 6 MONTHS SINCE DIAGNOSIS.

T CELL TOTAL COUNT 150 T4/T8 RATIO 0.4

GOAT SERUM- 0.1 CC INJECTED INTRADERMALLY

DAY 3- TOTAL T CELLS-90 T4/T8 0.3

DAY 10- TOTAL T CELL 210 T4/T8 0.6

THE ABOVE CASES WERE ONLY PROVIDED TO DEMONSTRATE THAT THE OVERALL IMMUNOSTIMULANT ABILITY OF FOREIGN BLOOD FRACTIONS COULD BE ACHIEVED BY WHOLE BLOOD AND/OR EXTRACTS FROM A VARIETY OF ANIMALS AND IS OFTEN PREDATED BY AN INITIAL DROP IN PARAMETERS.

THE INITIAL DROP MAY BE ATTRIBUTEABLE TO EITHER THE ANTIHUMAN EFFECT OF ANIMAL BLOOD AND/OR TO THE LYSIS OF INFECTED /DISEASED CELLS.

THERE IS DATA TO SUGGEST THAT THE EFFECT OF DECREASE AND SUBSEQUENT AUGMENTASTION OF IMMUNE RESPONSE MAY BE MORE DRAMATIC WHEN THE ANIMAL HAS BEEN IMMUNISED AGAINST THE HIV/DISEASED

CELLS/BLOOD OF PATIENT .AGAIN, THE TWO PHENOMENON ARE THOUGHT TO BE AT LEAST PARTIALLY RESPONSIBLE.

REMOVING ANTIHUMAN COMPONENT

TECHNIQUES FOR THIS RANGE FROM SIMPLE TO COMPLICATED.

MANY WERE COVERED IN PRELIMINARY DISCUSSION THE SIMPLEST TECHNIQUE WILL BE DEMONSTRATED.

SERUM IS STORED AT 3 CELSIUS FOR 9 MONTHS.

PRECIPITATION FORMS AND IS REMOVED. IT WAS FOUND BY PREVIOUS WORKERS IN THE EARLY PARTS OF THIS CENTURY THAT PROLONGED COLD STOREAGE RESULTED IN ANTISERA WHICH DEMONSTRATED MARKEDLY DECREASED SIDE-EFFECTS AND THEREFORE WAS ASSUMED TO BE OF LESS ANTIHUMAN ACTIVITY.

IN THIS INVENTOR ' S FIELD OF EXPERIENCE , BOTH IMMUNISED AND NON- IMMUNISED BLOOD WAS STUDIED; THE DISADVANTAGE OF THE ABOVE

DEHUMANISING METHOD IS THE LONG TIME NEEDED TO MANUFACTURE SPECIFIC VACCINES . THE IDEA OF USING A LIVING RESISTANT EXTRANEOUS SYSTEM TO COMBAT HIV IS TO BE ABLE TO MODIFY THERAPY(AS IN

RAISING NEW ANTISERUM FOR EXAMPLE ) AS THE VIRUS MUTATES INTO A FORM THAT CAN INHIBIT/ELUDE/OTWERWISE SURVIVE PREVIOUS IMMUNE RESPONSE. PREPARATION OF BROAD SPECTRUM ANTISERA AGAINST A LARGE VARIETY OF HIV SAMPLES AS COLLECTED OR RAISED AND USE OF TYHAT OR THE SPECIFIC FRACTION OF IT SHOWN TO ACT SPECIFICALLY AGAINST THE PATIENT ' S VIRAL LOAD (AS PREVIOUSLY DISCUSSED , THIS WOULD BE THE FRACTION ALTETRED ELECTROPHORETICALLY AFTER EXPOSURE TO HIV; IT CAN THEN BE IDENTIFIED BY ITS PHYSICAL

CHARACTERISTI9CS;0THER METHODS OF PRECIPITATING IT OUT WITH TARGET CELL OR VIRUS THEN RECONSTITUTING IT MAY ALSO APPLY )MAY OVERCOME THIS PROBLEM AS WOULD THE USE OF MORE RAPID

'DEHUMANISING' TECHNIQUES SUCH AS WASHING SERUM AGAINST NORMAL BLOOD CELLS ETC.

PERHAPS THE GREATEST SUCCESS WAS NOTED WHEN THE ANTISERA WERE USED IAS PART OF MULTIMODAL/MULTIPHASIC APPLICATION. SEVERAL CASES WERE TREATED WITH ANTISERA ALONE TO DEMONSTRATE EFFICACY OF THIS SIMPLE PATHWAY AS SOLE THERTAPY AS WELL.

USE OF NON-IMMUNISED ANTISERA IN THE TREATMENT OF AIDS.

THE PREPARATIONS USED WERE CRUDE BY MODERN STANDARDS.

I YEAR OLD HORSE WAS BLED AND 100 CC OF SERUM WERE REMOVED

FOLLOWING CENTRIFUGATION OF BLOOD .SERUM WAS STORED AT 3ºC FOR

NINE MONTHS AS WERE SERA FROM SHEEP AND GOAT.

PRECIPITATES WERE MARKED BY 3 MONTHS AND ALL PRECIPITATE WAS

REMOVED BY 0.2 MICRON FILTRATION AT THE END OF NINE MONTHS.

USE OF HORSE SERUM

23 YEAR OLD FEMALE.18 MONTHS SINCE DIAGNOSIS. T CELL COUNT 320,

T4/T8 RATIO 0.8

0.6CC ANTISERUM ADMINISTERED INTRADERMALLY

DAY3-T CELL COUNT 280 T4/TB RATIO 0.6

DAY 10-T CELL COUNT 420 T4/T8 RATIO 1.0

DAY 30-T CELL COUNT 380 T4/T8 RATIO 0.9

45 YEAR OLD MALE 1 YEAR SINCE DIAGNOSIS T CELL COUNT 140;T4/T8

RATIO 0.5

0.1 CC GOAT ANTISERUM INJECTED INTRADERMALLY

DAY 3- T CELL COUNT 90 ;T4/T8 RATIO 0.3

DAY 10 -T CELL COUNT 210;T4/T8 RATIO 0.8

DAY 30- T CELL COUNT 340;T4/T8 RATIO 1.0

18 YEAR OLD MALE 8 MONTHS SINCE DIAGNOSIS. T CELL COUNT 200;T4/T8

RATIO 0.8

0.1 CC SHEEP ANTISERUM USED INTRADERMALLY

DAY 3- T CELL COUNT 210 T4/T8 RATIO 0.8

DAY 10 -T CELL COUNT 310 T4/T8 RATIO 0.8

DAY 30 -T CELL COUNT 280 T4/T8 RATIO 0.7

USE OF IMMUNISED ANIMAL ANTISERUM

ANTIHUMAN ANTISERUM WAS RAISED AGAINST NORMAL HUMAN BLOOD. POOLED BLOOD FROM AIDS PATIENTS WERE TREATED WITH ANTIHUMAN ANTISERUM AND INCUBATED FOR 3 HOURS (1CC OF ANTISERUM TO 10CC OF AIDS BLOOD).

1 CC OF SUPERNATANT WAS USED TO VACCirtATE HORSE INTRADERMALLY 3 TIMES A WEEK FOR THREE WEEKS. 100CC OF ANIMAL BLOOD WERE THEN DRAWN AND SERUM SEPARATED AND STORED FOR 9 MONTHS TO ALLOW FOR ANTIHUMAN FRAGMENT SEPARATION. PREPARATION OF ANTIHUMAN ANTISERUM

ANIMAL (HORSE)WAS INJECTED WITH 0.5CC OF HUMAN BLOOD POOLED FROM

HEALTHY DONORS EVERY THREE DAYS FOR THREE WEEKS.

SERUM WAS EXTRACTED ON FOURTH WEEK AND LABELLED ANTIHUMAN SERUM.

THIS WAS USED TREAT BLOOD ISOLATED FROM SEVERAL DISEASES IN ORDER

TO REMOVE NORMAL COMPONENTS AND LEAVE DISEASE-RELATED

ORGANISMS/FACTORS.

USE OF ANTISERA RAISED AGAINST THIS DISEASE-SPECIFIC FRAGMENT

RAISES A THEORETICALLY MUCH MORE SPECIFIC ANTISERUM.

ALL THE CASES AND EXAMPLES PRESENTED HERE ARE NOT OFFERED AS IRREFUTEABLE PROOF BUT RATHER AS EXAMPLES FOR PATENT COVER TO ALL ANIMAL BLOOD/WHOLE/EXTRACT/PROCESSES ETC.

THE BEST RESULTS AND THOSE WHICH RESPOND BEST SHORT AND LONGTERM OCCUR WHEN IMMUNE THERAPY IS USED IN MULTIPHASIC MODE IN COMBINATION WITH MULTIMODAL APPROACH.

MULTIPHASIC WOULD INVOLVE A SCENARIO EXAMPLED BY THE FOLLOWING; MULTIPHASIC GENERAL , RAISED BY REPETITION OF THE ABOVE PROCESSES OF MANUFACTURE SO THAT EVERY WEEK, BLOOD DRAWN FROM AIDS PATIENTS UNDER TREATMENT 3 TIMES A WEEK WITH ANTISERUM AT DOSEAGE OF 0.6 CC INTRADERMAL ; WOULD BE USED TO VACCINATE ANIMALS WHICH YEILDED PREVIOUS ANTISERA OR NEW ONES. POOLED BLOOD MAY BE USED DIRECTLY AND/OR FIRST PREPARED BY TREATMENT WITH ANTIHUMAN ANTISERUM.

COMPOUND MULTIPHASIC SERUM WOULD BE RAISED WHEN BLOOD IS USED FROM PATIENT TREATED WITH MULTIPHASIC SERUM HENCE GENERATING A SECOND GENERATION OF MULTIPHASIC RESPONSES,

USE OF MODERN PURIFICATION OF SERUM TECHNIQUES SUCH 'AS THOSE PREVIOUSLY MENTIONED IN PATENT COULD ACCELERATE THE PRODUCTION OF. SAFE PATIENT-SPECIFIC MULTIPHASIC SERA.

USE OF ANIMAL IMMUNE RESPONSE SUCH AS THAT OF A HORSE ALSO INCLUDES IN PATENT THE USE OF CELLS AND CELLULAR COMPONENTS INCLUDING TRANSFER FACTOR.

EFFICACY IS AMPLIFIED WHEN ANTISERUM IS USED AS PART OF MULTIPHASIC/MULTIMODAL THERAPY AND NEW PATHWAYS/MECHANISMS ARE ALSO GENERATED.IT IS POSSIBLE, FOR EXAMPLE TO TAG DISEASED CELLS WITH FRACTIONS AND THEN VACCINATE ANIMALS AGAINST EITHER THE TAGGING AGENT ALONE OR AGAINST THE TAGGING AGENT-DISEASE COMPLEX. THIS IS OF PARTICULAR IMPORTANCE IN THE TREATMENT OF CANCER BUT IS MENTIONED HERE TO COVER THE USE OF ANTISERA BY THIS MECHANISM IN AIDS.

EVERY PHASE OF THE USE OF EXOGENOUS ANIMAL ANTISERA CAN

DEMONSTRATE BENEFITS OF PREPARATIONS RANGING FROM THE CRUDEST USE

OF WHOLE BLOOD TO EXTRACTS CELLULAR/NON-CELLULAR TO THE USE OF

CRUDE AND PURIFIED ANTISERA.

AN EXAMPLE WILL BE GIVEN OF THE USE OF PURIFIED ANTISERA RAISED

AGAINST A GENERAL POOL OF AIDS BLOOD TREATED WITH ANTIHUMAN

ANTISERUM.

PATIENT 45 YEAR OLD MALE; 5 YEAR HISTORY SINCE DIAGNOSIS. T CELL

COUNT STABLE AT 900-1000 FOR THAT TIME. PRESENTS WITH INCREASING FATIGUE AND RAPIDLY DECREASING T CELL COUNT. READINGS TAKEN OVER

THE PREVIOUS MONTHS HAD SHOWN A MONTHLY DROP IN T CELL COUNTS BY

150-200 PER MONTH . AT PRESENTATION T CELL COUNT TOTAL 350 , T4/T8

RATIO 0.8.

SPECIFIC ANTISERUM (RAISED AGAINST POOLED AIDS BLOOD TREATED WITH

ANTIHUMAN ANTISERUM)

0.6CC WERE ADMINISTERED INTRADERMALLY 3 TIMES A WEEK

DAY 3-T CELL COUNT 340 T4/T8 RATIO 0.8

DAY 10- T CELL COUNT 310 T4/T8 RATIO 0.7

DAY 30- T CELL COUNT 400 T4/T8 RATIO 0.9

DAY 50- T CELL COUNT 510 T4/T8 RATIO 1.0

DAY 60- T CELL COUNT 480 T4/T8 RATIO 1.0

DAY 90- T CELL COUNT 550 T4/T8 RATIO 1.0

DAY 120 T CELL COUNT 515 T4/T8 RATIO 1.0

USE OF MULTIPHASIC ANTISERA

POOLED AIDS BLOOD WAS TREATED WITH ANTIHUMAN ANTISERA AND USED TO

VACCINATE HORSE AS PER ABOVE METHOD.

HORSE SERUM WAS ALLOWED TO STAND AT 3ºC FOR 9 MONTHS

PATIENTS (3) WERE INJECTED WITH 0.6 CC OF ANTISERUM 3 TIMES A

WEEK FOR THREE WEEKS; THEIR BLOOD WAS THEN POOLED AND PREPARED AS

PER PREVIOUS PROTOCOL TO REVACCINATE HORSE AS WELL AS VACCINATING

NEW ANIMALS. THE ANTISERUM RAISED AS PER PREVIOUS PROTOCOL WAS

THEN PROCESSED.ANTISERUM RAISED FROM PREVIOUSLY IMMUNISED ANIMAL

WAS LABELLED SECOND CHALLANGE ANTISERUM; ANIMALS VACCINATED DE-

NOVO GENERATE A PURELY SECOND GENERATION ANTISERUM.

THIS PROCESS MAY BE REPEATED INDEFINITELY. ORIGINAL ANIMAL WILL BE

IN ITS THIRD YEAR 3Y THE TIME THE THIRD PHASE IS READY(AS THIS

TECHNIQUE REQUIRES 9 MONTHS FOR DEHUMANISING) .OTHER TECHNIQUES

OF PREPARING ANIMAL SERA FOR HUMAN USE ; SUCH AS PLASMAPHARESIS

AND/OR WASHING AGAINST HUMAN BLOOD ETC. CAN GREATLY SPEED

MULTIPHASIC ANTISERA GENERATION.

PATIENTS TREATED WITH MULTIPHASIC ANTISERA ARE EXAMPLIFIED BY THE

FOLLOWING CASE;

MALE 52, 3YEAR HISTORY SINCE DIAGNOSIS-T CELL COUNT 220 T4/T8

RATIO 0.6.

TREATED BY 0,6 CC ANTISERA INTRADERMAL EVERY 3 DAYS.

DAY 3- T CELL COUNT 280 T4/T8 RATIO 0.8

DAY10- T CELL COUNT 350 T4/T8 RATIO 0.8

DAY 30 TCELL COUNT 413 T4/T8 RATIO 0.8

DAY 60 T CELL COUNT 410 T4/T8 RATIO 1.0

DAY 120 T CELL COUNT 400 T4/T8 RATIO 1.0

IN MOST OF THE ABOVE CASES PATIENTS WERE EITHER ASYMPTOMATIC OR SUFFERED FROM FATIGUE WHICH READILY RESOLVED WITHIN THE FIRST 24 HOURS .

WHERE PATIENTS PRESENTED WITH SPECIFIC INFECTIONS, WHICH RECURRED

FREQUENTLY OR WERE RESISTANT TO ANTIBIOTIC THERAPY,ANIMAL

SERA(BOTH GENERAL AND SPECIFIC) WAS USEFUL IN ELIMINATING THESE

DISEASES.

USING THE CULTURE TECHNIQUES PREVIOUSLY DESCRIBED IN THE INDUCED REMISSION THERAPY PATENT, ORGANISMS MAY BE ISOLATED FROM SAMPLES OF AIDS BLOOD; BIOPSIES OF KAPOSI'S LESIONS ETC OFTEN REVEALS A STAPHYLOCOCCUS AUREUS-TYPE ORGANISM AMONGST OTHERS . MANY SUCH ORGANISMS HAVE BEEN DEMONSTRATED BY DR ALAN CANTWELL IN BIOPSIES FROM AIDS PATIENTS POST MORTEM. IN FACT, SIMILAR ORGANISMS MAY BE SEEN IN MANY DISEASE CONDITIONS INCLUDING CARDIOVASCULAR AS WELL AS ACUTE AND CHRONIC DEGENERATIVE DISEASES.

WHETHER THE ORGANISMS ISOLATED FROM AIDS BLOOD PLAY A ROLE IN CAUSE OR SIMPLY SYNERGISE WITH THE DISEASE . RAISING VACCINES AND ANTISERA AGAINST THEM APPEAR BENEFICIAL, EVEN IN ABSENCE OF ANTI- HIV ANTISERA IN THERAPY.

AIDS BLOOD CAN BE LYSED BY PHYSICAL/CHEMICAL/BIOLOGICAL MEANS AS PREVIOUSLY DESCRIBED. PLATING ON BLOOD AGAR AND OR INNOCULATION INTO TSB AS WELL AS MANY OTHER MEDIA MAY BE USED.

500 CC CF TSB ARE INNOCULATED AND CULTURED FOR 3 DAYS. BACTERIAL GROWTH IS CENTRIFUGED AND RESUSPENDEI IN 30 CC OF NORMAL SALINE. SUSPENSION IS BOILED FOR 15 MINUTES EVERY THREE DAYS THEN USED TO IMMUNISE AN ANIMAL (HORSE)BY INJECTIONS INTRADERMALLY OF 1CC EVERY 3 DAYS . ANIMALS CAN ALSO BE INJECTED WITH LIVING ORGANISMS OR THOSE PREPARED IN ACCORDANCE WITH HYPERTHERMIA/VIBRATIONAL THERAPY PATENT . A REVIEW OF THOSE RESULTS CAN BE SEEN BY REFERANCE TO RELEVANT PATENTS.

ANTISERA RAISED AGAINST THE HEAT KILLED ORGANISMS AS DESCRIBED

ABOVE IS COMBINED WITH ANTISERA RAISED AGAINST THE LIVING

BACTERIA(SAME PREPARATION TECHNIQUE WITHOUT THE HEAT KILLING

AFTER RESUSPENSION IN SALINE)VACCINATION IS INTRADERMAL 0.5 CC

THREE TIMES A WEEK FOR THREE WEEKS , FOLLOWED BY ANTISERUM

PREPARATION AS PREVIOUSLY DESCRIBED.

ANTISERA RAISED AGAINST THESE ORGANISMS APPEAR CAPABLE OF

MAINTAINING IMMUNE STATUS AND AT LEAST PREVENTING DETERIORATION

IN THE CASES STUDIED.

PATIENT AGE 42 DIAGNOSED FOR 3 YEARS.T CELL COUNT DROPPING 80-IOO

POINTS PER MONTH OVER PAST 4 MONTHS. T CELL COUNT 311 T4/T8 RATIO

0.2.

PATIENT WAS TREATED WITH ANTISERUM ( 0.6 CC INTRADERMAL 3 TIMES A

WEEK)RAISED AGAINST ORGANISMS ISOLATED FROM HIS BLOOD AS PER

PREVIOUS DISCUSSION.

DAY 3- T CELL COUNT 330 T4/T8 RATIO 0.2

DAY 10 - TCELL COUNT 318 T4/T8 RATIO 0.2

DAY 60 -T CELL COUNT 350 T4/T8 RATIO 0.3

DAY 120 -T CELL COUNT 300 T4/T8 RATIO 0.3

DAY 180 - T CELL COUNT 315 T4/T8 RATIO 0.3

DAY 210- T CELL COUNT 322 T4/T8 RATIO 0.4

AS COVERED BY PATENT, MULTIPHASE ANTISERA MAY BE RAISED AGAINST THESE ORGANISMS FROM THE SAME OR/AND NEW ANIMALS PATENT IS NOT RESTRICTED TO PARTICULAR ANIMAL/(S) IT IS POSSIBLE THAT SOME ANIMALS ARE MORE SUITED TO DEVELOPPMENT OFCERTAIN DISEASE THERAPYU THAN OTHERS BY BEING MORE ABLE TO MOUNT EFFICIENT EFFECTIVE, RESPONSE . DIFFERENT ANIMALS MAY BE ABLE TO GENERATE SUCH THERAPY OVER DIFFERING TIME PERIODS . MIXTURES OF ANTISERA FROM VARIOUS ANIMALS MAY ALSO BE USED TOGETHER .D

PATENT AIMS TO COVER THE USE OF ANIMAL IMMUNE RESPONSE IN THE TREATMENT OF DISEASES THAT THE BODY SEEMS TO BE UNABLE TO

ELIMINATE ALONE ;BY TARGETING CELLS, INTERMEDIATES , CAUSATIVE AND SYNERGISTIC ORGANISMS .USE IS COVERED BY PATENT IN ALL FORMS FROM CRUDE . GENERAL TO REFINED AND SPECIFIC , ALONE AND/OR IN

COMBINATION WITH ANY OF THE OTHER MULTIPHASIC/MULTIMODAL ARMS OF THERAPY.

INDUCED REMISSION THERAPY- PART 1

LIVING BIOLOGICAL SYSTEM SUPPLEMENTATION

THE ORGANISMS IN THE LIVING BIOLOGICAL SYSTEM FORMULATION

PREVIOUSLY DISCUSSED REPRESENT A POSSIBLE FORMULATION THAT CAN

BE USED TO OPTIMISE PATIENT GENERAL AND SPECIFIC FUNCTIONS,

INHIBIT DISEASE IN GENERAL AND SPECIFIC METHODS ; BOTH DIRECT AS

WELL AS INDIRECT MECHANISMS APPLY.

LBS MAY BE SELECTED AND FORMULATED FOR PARTICULAR

FUNCTION, APPLICATION MAY BE MADE AS SUPPLEMENT, AS FOOD AND/OR AS

COSMETIC. INVENTOR HAS APPLIED OTHER MECHANISMS OF APPLICATION FOR

LBS AS THERAPEUTICS.

SUPPLEMENTARY LBS (AS WITH THERAPEUTIC ONES)MAY HAVE SOME OF

THEIR EFFECT AUGMENTED BY VITAMIN AND OR OTHER SUPPLEMENT

FORMULATION.

ONE ORGANISM FORMULATION FOLLOWS

LACTOBACILLUS ACIDOPHILUS (MANY STRAINS) -30 BILLION ORGANISMS

LACTOBACILLUS THERMOPHILUS (MANY STRAINS )-30 BILLION ORGANISMS

LACTOBACILLUS CREMORIS (MANY STRAINS )-30 BILLION ORGANISMS

LACTOEACILLUS BULGARICUS (MANY STRAINS INCLUDING LB-51)

KEFIR CULTURE - 30 BILLION ORGANISMS

RHIZOPUS JAPONICUS ATCC 20408- 30 BILLION ORGANISMS

RHIZOPUS OLIGOSPORUS SATO ATCC 2958- 30 BILLION ORGANISMS

THE ABOVE FORMULA CAN BE FURTHER REINFORCED WITH OTHER LACTIC ACID BACTERIA- DATA EXISTS SUGGESTING ANTICANCER , ANTI-CARDIOVASCULAR DISEASE AS WELL AS A MULTIPLE OF REGENERATIVE AND OTHER BENEFICIAL PROPERTIES .

AMONGST THESE IS THE DONATION OF ORGANISMS INTO THE POOL OF BOWEL FLORA TO ASSIST WITH DIGESTION OF SUCH FACTORS AS LACTOSE (FOR LACTOSE INTOLERANCE) AS WELL AS THE USE OF THESE AND OTHER

ORGANISMS SUCH AS ASPERGILLUS ORYZAE FOR THE DONATION OF THESE AND OTHER DIGESTIVE ENZYMES AS WELL AS OTHER BENEFICIAL PRODUCTS/FACTORS .

YEASTS MAY ALSO BE ADDED TO ENHANCE THE FORMULATION WITH VITAMINS AND OTHER NUTRATIVE FACTORS INCLUDING POWERFUL ANTI-OXIDANT

EWNZYMES AND AGENTS.

OTHER ORGANISMS/ORGANISM COMPLEXES SUCH AS KAMBUCHA MAY ALSO BE ADDED .

PATENT VARIES FROM PREVIOUS SUPPLEMENTS IN FORMULATION AND PROCESSING AS WELL AS IN APPLICATION-CUSTOMISING LIVING

BIOLOGICAL SYSTEMS IS ALSO UNIQUE TO THIS PATENT.

LBS THROUGHOUT THE PATENT WILL BE REFERRED TO BOTH AS THERAPY AND IN THE PREPARATION OF THERAPY.

LBS CAN BE USED IN NATURAL STATE, ARTIFICIALLY

ASSEMBLED , AUGMENTED , USED TO PROCESS THERAPY(SEE INTERMEDIATE/

ENDPRODUCT THERAPY), STIMULATED ETC.

LBS AS SUPPLEMENTS ARE PRESENTED BOTH IN LIVING FORM AS WELL AS

IN DISRUPTED FORM TO RELEASE INTERNAL STRUCTURES TO ALLOW THEM TO

BE MORE BIOAVAILABLE .

LBS MAY EE EXPOSED TO CONDITIONS TO AMPLIFY REQUIRED FUNCTION; AN EXAMPLE OF THIS WOULD BE THE EXPOSURE OF ORGANISMS TO

SUBSTRATE THAT FOR EXAMPLE, WE WISH TO RAISE DIGESTIVE ENZYMES AGAINST. IF THE ORGANISMS ARE PROVIDED WITH PROTEIN AS THEIR MAIN CALORIE SOURCE, THERE WILL BE INDUCTION OF THEIR PROTEOLYTIC

ENZYMES, MORE OF THESE WOULD THEN BE AVAILABLE FOR USE BY THE BODY , BOTH INDIRECTLY( IN THE ORGANISM ) AND DIRECTLY ( FROM LYSATE ) .

ORGANISMS IN LBS MAY BE PRESENTED AS FREEZE-DRIED POWDER OR AS

LIQUID MIX.

LBS MAY BE USED TO AUGMENT NORMAL FUNCTION, PROCESS FOOD

/MEDICATION ETC,

LBS MAY BE USED TO CONVEY /CONFER BENEFITS BY THEIR PRESENCE.

LACTASE RICH ORGANISMS , FOR EXAMPLE, MAY PROTECT/BENEFIT LACTASE-

DEFICIENT INDIVIDUALS UNLIKE PRIOR ART ORGANISMS HERE ARE ADDED

BOTH WHOLE AND IN LYSED STATE AS OPPOSED TO PURE ENZYME ADDITION;

THIS ALLOWS FOR THE PRESENCE OF IMPORTANT CO-FACTORS AS WELL AS A

CONTINUEOS SOURCE OF ENZYMES AND FACTORS AS PACKAGED IN

REPLICATING LIVING SYSTEMS.

THIS WOULD DIFFERENTIATE THIS FROM PRIOR ART IN THAT ENZYME

AND/OR CO-FACTOR SUPPLEMENTATION INCLUDING VITAMINS WOULD BE

CONTINUOUSLY GENERATED FOR THE LIFE OF THE CULTURE . DOSEAGE IS

THEREFORE REDUCED IN FREQUENCY.

EXAMPLES OF LIVING SUPPLEMENTATION AND INDUCTION.

LACTOSE-INTOLERANCE

10 PATIENTS -SIMILAR DEGREE OF LACTASE DEFICIENCY AS EVIDENCED

CLINICALLY;

LACTOSE CHALLENGE (GLASS OF MILK)GIVEN WITH EACH MEAL

following first meal all 10 experienced generalised abdominal discomfort and bloating.

WATERY DIARRHOEA WAS EXPERIENCED BY ALL WITHIN 6 HOURS.

TWO PATIENTS WERE TREATED WITH LACTAID SUPPLEMENTATION .SYMPTOMS RESOLVED FOLLOWING 24 HOURS OF CONTINUED CHALLANGE- SUPPLEMENTATION CONTINUED 3 TIMES A DAY.

2 PATIENTS WERE TREATED WITH ORAL DOSE OF LIVING BIOLOGICAL SYSTEM-A- 10CC ORAL LIQUID DOSE-CONTAINING THE ABOVE NUMBER OF ORGANISMS PER 10CC. SYMPTOMS SETTLED WITHIN 15-18 HOURS .SINGLE DOSE MAINTAINED EFFICACY FOR 6 FURTHER CHALLANGES .

2 PATIENTS WERE TREATED WITH ABOVE FORMULA, HALF OF WHICH HAD BEEN

SONICALLY LYSED A/L.IN THEORY , INCREASED BIOAVAILABILITY OF

ENZYMES FROM DISRUPTED CELLS WOULD ALLOW FOR FASTER

RESPONSE. SYMPTOMS RESOLVED WITHIN 12 HOURS AND REMAINED SETTLED

FOR SUBSEQUENT CHALLANGES.

2 PATIENTS WERE TREATED WITH FORMULA WHICH HAD BEEN CULTURED IN

MEDIA WHERE MAIN CALORIC INTAKE WAS LACTOSE ( FORMULA B). SYMPTROMS

ABATED WITHIN 10 HOURS AND SURVIVED SUBSAEQUENT CHALLANGES.

2 PATIENTS WERE TREATED WITH FORMULA B WHERE HALF WAS LYSED

SONICALLY(FORMULA B/L)-SYMPTOMS ABATED IN 3 HOURS AND SURVIVED

SUBSEQUENT CHALLANGES. THE ABOVE STUDY IS VERY LIMITED BUT APPEARS TO INDICATE THAT LIVING SYSTEMS PROVIDE FOR MUCH MORE PROLONGED COVERAGE AND PROTECTION THAN NON-REGENERATIVE SYSTEMS. IT ALSO APPEARS THAT LYSIS WITH MAINTENANCE OF INTERNAL FUNCTIONING ELEMENTS ENABLES GREATER BIOAVAILABILITY AND SPEED OF ACTION; FINALLY IT APPEARS THAT PRIOR CONDITIONING OF LBS ENABLES INDUCTION OF REQUIRED SYSTEM AS WELL AS ITS ANCILLIARIES, SO THAT IT FUNCTIONS AT

GREATER CONCENTRATION AND EFFICACY.

TESTING PATENT FOR ANTIOXIDANT/ANTI INFLAMMATORY ABILITY

ENHANCEMENT .

PATENT FORMULA AS ABOVE REINFORCED WITH SACCROMYCES CERVESIEA,

BACILLUS MACERANS, MICROCOCCUS RADIODURANS .BOMBAY DUCK

DIENOCOCCUS;

ADDITIONAL ORGANISMS AS ABOVE SELECTED FOR ANTIOXIDANT ABILITY AS

WELL AS REPAIR AND SURVIVAL

CAPACITY. THERMOPHILLICRADIORESISTANT, LONG-LIVING MICRO-ORGANISMS

MAL ALL BE EXPECTED TO EXERT SUCH BENEFICIAL EFFECTS.

LBS AND SPECIFIC INGREDIENTS MAY CONFER THEIR BENEFITS DIRECTLY TO THE BODY IN LYSED STATE (LYSIS MAY BE PHYSICAL CHEMICAL OR BIOLOGICAL).

PROTECTION MAY BE CONFERRED BY SIMPLE PRESENCE OF ORGANISMS

(DIGESTION OF COMPOUNDS INTO FORMS MORE EASILY ASSIMILATED BY THE BODY MAY BE ACCOMPLISHED BY LIVING ORGANISMS ; PRESENCE OF

ORGANISMS WITH ANTIOXIDANT/ANTI INFLAMMATORY SYSTEMS MAY

NEUTRALIZE HARMFUL FACTORS SIMPLY BY THEIR PRESENCE)

IN LIVING OR IN LYSED FORMS-GENETIC AND OTHER FACTORS MAY BE

DONATED TO HOST OR TO OTHER ORGANISMS WITHIN THE HOST-DIRECTLY , BY

PHAGE AND/OR PLASMID AND/OR BY ANY OTHER MEANS .BENEFICIAL

PROPERTIES MAY THUS BE CONFERRED.

IN LIVING OR IN LYSED FORMS LBS MAY BE BENEFICIAL ORAL AS

SUPPLEMENT/TOPICAL AS COSMETIC.

COSMETIC LIVING SYSTEMS MAY BE CHOSEN/CREATED/INDUCED TO PROVIDE

REGENERATIVE/EXFOLIATORY/PROTECTIVE ABILITIES ETC.

IN PREPARATION OF MEDICATION-ALL OTHER FORMS OF ADMINISTRATION APPLY.

IN PREPARATION OF BENEFICIAL FORMULATIONS PATENT COVERS ALL PREPARATION TECHNIQUES THAT ENABLE THE USE OF ORGANISMS TO BIOLOGICALLY ENHANCE BY AUGMENTING OR IMPROVING NORMAL BODY FUNCTION AS WELL AS PROVIDING BENEFICIAL FEATURES NOT NORMALLY FOUND IN THE HOST BODY.

EVEN PREPARATION TECHNIQUES WHICH KILL/DENATURE MANY BIOLOGICAL COMPONENTS MAY STILL BE OF BENEFIT.

IN USE OF MICROCOCCUS RADIODURANS SINGLY OR IN COMBINATION; BOILED EXTRACT ARE STILL OF USE. THIS MAY IMPLY THAT BIOLOGICAL

ANTIOXIDANT/

ANTIINFLAMMATORY/STIMULATING/ANTIRADIATION/ADAPTOGENIC PROPERTIES EXIST IN A FORM THAT CANNOT BE DENATURED BY HEATING OR THAT OTHER, PERHAPS INORGANIC COMPONENTS MAY BE USEFUL TO CARRY OUT DIRECTLY OR TO STIMULATE PRODUCTION OF OTHER FACTORS TO PRODUCE THESE EFFECTS.

INVENTOR HAS FOUND RADIORESISTANT ORGANISMS SUCH AS MICROCOCCUS RADIODURANS TO BE HIGHLY EFFECTIVE IN IMPACTING FAVOURABLY ON MANY CONDITIONS-EFFECT IS MARKED BOTH ON USE OF LIVING ORGANISM AND IN HEAT KILLED OR OTHERWISE PREPARED FORMULATIONS.

MICROCOCCUS RADIODURANS WAS CULTURED IN TRYPTICATED SOY BROTH

(TSB) 500CC FOR A PERIOD OF 2 MONTHS. A SINGLE 10CC DOSE WAS USED IN ALL CASES BELOW. A SIMILAR STUDY USING 10CC FROM CULTURE BIOLED FOR THREE HOURS LED TO SIMILAR RESULTS , HOWEVER , THE KILLED FORM APPEARED TO CONFER BENEFITS FOR A DURATION OF HOURS TO DAYS WHEREAS THE LIVING FORM WOULD CONFER BENEFITS LASTING DAYS TO WEEKS TO MONTHS.

INITIAL TRIALS SUGGEST THAT CELLS AND ANIMALS PROTECTED BY MRD/MRD EXTRACTS MAY RESIST RADIATION DAMAGE/REPAIR MORE RAPIDLY.

ATHLETIC ENHANCEMENT

LIMITED TRIALS USING SINGLE DOSE HAS DEMONSTRATED INCREASED ATHELETIC ABILITY/STRENGTH IN BOTH ANIMALS AND HUMANS. THIS IS POSSIBLY CONSEQUENT TO IMPROVED HEALING /CELL REPAIR DURING AND FOLLOWING EXERCISE.

PAIN/QUALITY OF LIFE ENHANCEMENT.

TERMINAL AIDS AND CANCER PATIENTS WERE GIVEN A SINGLE ORAL DOSE.

SHARP DECLINE IN PAIN LEVELS WAS NOTED FOLLOWING 3-8 HOURS.

THIS WAS ACCOMPANIED BY A RISE IN ENERGY , APPETITE AND FEELING OF

WELL-BEING.

EFFECT LASTED FROM SINGLE DOSE FOR SEVERAL DAYS.

MRD SINGLE DOSE /MULTIPLE DOSES HAVE PROVEN EFFECTIVE AS ORAL

DOSE /TOPICAL IN MANY OF THE FOLLOWING DISEASE CONDITIONS; LEADING

TO PATENT CLAIM THAT IT COULD BE APPLIED TO BENEFICIAL EFFECTS

OVER A LARGE, PERHAPS UNLIMITED RANGE OF CONDITIONS BY EITHER

DIRECT OR INDIRECT .SPECIFIC OR NON-SPECIFIC OR ANY COMBINATION

OF THE PRECEDING.

MULTIPLE SCLEROSIS-30 YEAR OLD 5 YEAR HISTORY-UNABLE TO WEIGHT

BEAR FOR WALKING FOR 6 MONTHS.

THE DAY FOLLOWING PATIENT WAS WALKING UNASSISTED , IMPROVEMENT

LASTED SEVERAL DAYS.

RHEUMATOID ARTHRITIS-60 YEAR OLD FEMALE- 20 YEAR HISTORY .EXTREME PAIN ON MOVEMENT IN HANDS ; SYSTEMIC DISEASE INCLUDING LIVER, KIDNEY AND LUNG DETERIORATION.

SINGLE DOSE CAUSED DRAMATIC IMPROVEMENT IN RANGE AS WELL AS EASE OF MOVEMENT WITH DECREASE IN PAIN AND INFLAMMATION .THIS LASTED 2 WEEKS .

ASTHMA AND EMPHYSEMA ALSO DEMONSTRATED MEASUREABLE IMPROVEMENT WITH SINGLE AND MULTIPLE DOSES.

INJECTABLE FORMAT ALSO HAS PROVEN SUCCESSFUL BUT WAS NOT TESTED OVER A SIGNIFICANT PATIENT BASE AT THIS TIME. CARDIOVASCULAR DISEASE INTERVENTION WAS ACCOMPLISHED SUCCESSFULLY BOTH IN THE STIMULATION AND PROMOTION OF GOOD BLOOD CIRCULATION IS WELL AS IN THE TREATMENT OF DEMENTIA AS WELL AS IN ACUTE SITUATIONS SUCH AS HEART ATTACKS.

CASES OF MAJOR INFARCTIONS AS MEASURED BY MARKED CHANGES IN ECG AND ENZYME ELEVATIONS EXPERIENCED DISAPPEARANCE OF ANGINA AND RAPID RETURN TO NORMAL OF LABORATORY AND ELECTRICAL PARAMETERS FOLLOWING SINGLE ORAL DOSE.

SHINGLES/TRIGEMINAL NEURALGIA/HERPES/

A LL THESE HAVE DEMONSTRATED GOOD RESPONSE TO SINGLE ORAL DOSE W ITH CLEARING OF SYMPTOMS AND SIGNS WITHIN 2-48 HOURS.

A IDS.

I N CASES TREATED THERE APPEARS TO BE AN ANTI -VIRAL EFFECT AS WELL I S THE GENERAL BOOST PREVIOUSLY DESCRIBED; PATIENTS TREATED ALL E XPERIENCED INCREASE IN ENERGY AS WELL AS AT LEAST TRANSIENT S TABILISATION OF T CELL COUNTS.

CHRONIC FATIGUE SYNDROME RESPONSE WITHIN MINUTES TO HOURS OF APPLICATION-LASTING I WEEK IN MOST; SEVERAL MONTHS IN 10%.

COMBINATION WITH THE BASE FORMULA AND INDUCTION OF ANTIOXIDANT CAPACITY OF ORGANISMS PRODUCED A FORMULA OF MUCH GREATER BENEFITS.

I NDUCTION OF ANTI-OXIDANT ABILITY IN THESE ORGANISMS IS

ACCOMPLISHED BY STRESSING THEM IN ANY NUMBER OF P HYSICAL/CHEMICAL/BIOLOGICAL METHODS .

STRESSING ORGANISMS IN A MANNER WHERE ITS SURVIVAL COMES CLOSE TO JEOPARDY ENABLES THE MAXIMAL MANUFACTURE OF SURVIVAL FACTORS I NCLUDING ANTIOXIDANTS,DNA/RNA, GENETIC REPAIR MECHANISMS/REPAIR MECHANISMS FOR OTHER CELLULAR STRUCTURES.

THE BUBBLING OF OZONE OR ADDITION OF LOW DOSE PEROXIDE TO THE CULTURE MEDIUM MAY PROMOTE THESE FUNCTIONS ( PROVIDED THAT

DESTRUCTION/PHAGE LYSIS IS NOT TRIGGERRED)

AN EFFECTIVE EMBODYMENT OF THIS PATENT WOULD THEREFORE INCLUDE THE BASE ORGANISMS EACH OF WHICH HAS SEPARATELY BEEN DEMONSTRATED

BY INVENTOR TO BE BENEFICIAL IN INDUCED STATE WITH PARTIAL LYSIS TO ALLOW FOR EASY BIOAVAILABILITY OF FACTORS.

VITAMINS/OTHER SUPPLEMENTS MAY BE ADDED FOR NUTRITION OF FORMULA ORGANISMS/HOST.

STRESS IS USUALLY NEUTRALISED PRIOR TO ADMINISTRATION OF FORMULA.

ADDITION OF THIS PREPARATION IS OFTEN ASSOSCIATED WITH GREATER DEMONSTRABLE, LASTING RESULTS , PARTICULARLY WITH AIDS WHERE T CELL INCREASES MAY BE NOTED.

IT IS POSSIBLE ALSO TO FORMULATE A LBS WITH ANTIBIOTIC RESISTANCE THE LIVING ANTIBIOTIC-GENERATING ORGANISM MAY THEN BE INCLUDED SO THAT CONTINUEOS PRODUCTION OF SAID ANTIBIOTIC ALOND WITH OTHER ANTIDISEASE FACTORS MAY BE CONSTANTLY GENERATED IN THE BODY. THIS IS USEFUL, NOT ONLY IN CASES WHERE PROLONGED COURSES OF LOW DOSE ANTIBIOTICS IS USEFUL, BUT ALSO IN MULTIPLE DISEASES WHEN CLASSIFIED BY CLASSIFICATION PATENT.

LBS AS A WHOLE OR IN PARTICULAR COMPONENTS MAY BE PROCESSED BY OR IN CONJUNCTION WITH MULTIPHASIC/MULTIMODAL GUIDELINES.

LBS MAY INCLUDE ORGANISMS THAT CAN SURVIVE AT TEMPERATURE EXTREMES, AT PRESSURE EXTREMES , RADIATION EXTREMES ; THOSE THAT CAN PROCESS AND NEUTRALISE TOXIC FACTORS/ETC.

MECHANISMS

INDUCED REMISSION THERAPY MODALITIES SEPARATELY OR IN COMBINATION

WILL INDUCE NEW MECHANISMS OF ACTION AS COVERED BY THIS PATENT.

RED BLOOD CELLS

THERE IS DRAMATIC EVIDENCE THAT THESE CELLS MAY BE CONVERTED INTO A VALUABLE ARM OF THE IMMUNE RESPONSE . THIS PATENT COVERS THE USE OF RBC'S AS EMPTY VESSELS FOR THE EXPRESSION OF INSERTED

GENETIC/OTHER MATERIAL. IN MATURE FORM THESE CELLS POSESS NO

NUCLEUS TO OVERRIDE GENETIC OR OTHER COMMANDS ; FURTHERMORE , ABSENCE OF A NUCLEUS ENABLES INSERTION OF GENETIC INFORMATION WHICH IS THEN INTERPRETED BY THE RED BLOOD CELL.

THE RED BLOOD CAN BE SEEN IN THE SERIES OF PHOTOGRAPHS TO BE UNDERGOING MORPHOLOGICAL CHANGE, OTHER STUDIES HAVE STAINED

NUCLEAR MATERIAL WITHIN THE USUALLY EMPTY AREA OF THE NUCLEUS. MORPHOLOGICAL CHANGES AS PHOTOGRAPHED DEMONSTRATE CRENATION- TYPE APPEARANCE AS WELL AS THE DEVELOPMENT OF EXTENSIONS- IN VIEW OF THIS NEWLY DEFINED MECHANISM , COULD A POSSIBLE

MECHANISM BY WHICH MALARIA EFFECTS AN ANTICANCER RESPONSE BE MEDIATED THROUGH ITS DONATION OF INSTRUCTIONS TO RED BLOOD CELLS?

COULD THE LATEST RESEARCH DEMONSTRATING MALARIA-INDUCED

IMPROVEMENT FROM AIDS BE BY THE SAME MECHANISM? RBC 'AS COULD

ATTACK DISEASE WITHOUT THE TARGET BEING ABLE TO MOUNT AN EFFECTIVE DEFENSE AS THIS NEW SYSTEM IS VERY RAPID IN ACTION AND DOES NOT EXPRESS ITSELF IN APPARENT ACTIVE FORM FOR MOST OF THE HOST'S LIFE. IT IS POSSIBLY DIFFICULT, THEREFORE FOR DISEASE TO EVOLVE RESISTANCE.

MANY DISEASES ARE ALSO ASSOSCIATED WITH ROULEAX FORMATION . THIS MAY BE PART OF THE RBC ANTI -DISEASE RESPONSE. IN STUDIES OF

LEUKEMIA, IT IS SEEN THAT LEUKEMIC CELLS BECOME ENTRAPPED IN

LACUNAE BETWEEN THE ROULEAX AND ARE DESTROYED AFTER ADDITION OF VACCINE.

PLATELETS HAVE ALSO BEEN OBSERVED TO BEHAVE STRANGELY ON ADDITION OF SOME VACCINE TYPES , PERHAPS THEY TOO CAN BE ACTIVATED BY

MECHANISMS IN THIS PATENT TO ENCRUST OR OTHERWISE INHIBIT/DISRUPT CANCER CELLS.

A MECHANISM OF CELL FUSION IS ALSO DEFINED BY THIS PATENT AND COVERED AS A NEW FORM OF ANTIDISEASE MECHANISM WHERE ANY PART OF INDUCED REMISSION THERAPY MECHANISMS ALONE OR IN COMBINATION WITH OTHER PARTS.

CELL FUSION CAN OCCUR BETWEEN RED BLOOD CELLS AND TARGET CELLS SUCH AS THE LEUKEMIA CELLS AS PICTURED. LEUKEMIA CELLS ARE ALSO STIMULATED TO FUSE MEMBRANE WITH EACH OTHER, AS EWELL AS EWITH POSSIBLY OTHER CELLS.

A HALLMARK OF TAGGING PHENOMENON WHERE ORGANISM FRACTIONS ARE MADE TO ATTATCH TO TARGET CELLS IS THAT NOT ONLY CAN ANTIGENICITY BE GIVEN OTHERWISE NEUTRAL STRUCTURES BUT ALSO IMMUNE SYSTEMS CAN BE TOTALLY REDIRECTED IN THAT NEUTROPHILS , FOR EXAMPLE .MAY BE MADE TO ATTACK CANCER OR AIDS INFECTED CELLS AS WELL AS OTHER CELLS THAT THEY NORMALLY WOULD NOT ADDRESS , BY ATTATCHING

BACTERIAL STRUCTURES TO THEM.

IT IS A FEATURE OF THIS PATENT THAT INEFFECTIVE IMMUNOLOGICAL RESPONSES ARE CHANGED TO OTHER MORE EFFECTIVE ARMS OF THE IMMUNE SYSTEM, SUCH THAT AN ANTIBACTERIAL RESPONSE MAY BE MADE TO ATTACK CANCERS, VIRUSES ETC.

IT IS A FURTHER FEATURE OF THIS PATENT THAT INEFFECTIVE IMMUNE RESPONSES RAISED AGAINST DISEASE HAY BE USED IN MECHANISMS TO DAMAGE DISEASE. AN EXAMPLE OF THAT WOULD BE THE USE OF ANTICANCER ANTIBODIES AS RAISED FROM THE PATIENT ( INEFFECTUAL BLOCKING

ANTIBODIES) TO TRAISE ANTISERUM TO IT FROM ANIMAL SUCH AS A HORSE SUCH THAT THE ANTISERUM (OR OTHER EG CELLULAR RESPONSE )WOULD EE USED TO DESTROY THE TARGET. SUCH AN ANTISERUM WOULD ALSO ACT AS A DEBLOCKER.

IMMUNOLOGICAL AND OTHER ANTIDISEASE ACTIVITY CAN BE ISOLATED FROM

ONE CANCER AGAINST ANOTHER , PATENT COVERS THE USE OF ASCITES

/OTHER EODY EFFUSIONS AS ADJUNCT OR PART OF

MULTIPHASIC/MULTIMODAL OR UNDER OTHER MODIFICATION GUIDELINE OF

PATENT .

INVENTOR HAS FOUND OVARIAN AND BREAST CANCER ASCITES POSESSES

GREAT ANTIPROSTATE CANCER ABILITY-DFOSES OF ASCITIC FLUID

COLLECTED STERILE AND FILTERED TO REMOVE DEBRIS (ALTHOUGH THAT

STAGE IS NOT ESSENTIAL) FROM10CC UP TO 150CC

INTRATUMOURAL/SUBCUTANEOUS HAVE BEEN USED WITH SUCCESS ESPECIALLY

WHEN PRIMED BY OTHER FEATURES OF PATENT SUCH AS TARGETING.

TARGETING REFERS TO TRAISING AN IMMUNE SYSTEM AGAINST A PARTICULAR ANTIGEN WHICH IS THEN ATTATCHED TO THE TARGET. IN OTHER WORDS RAISING AN IMMUNE RERSPONSE TO THE TAG, TAGGING THEN USING THE RAISED RESPONSE FOR TREATMENT, ASCITIC FLUID MAY BE MADE MORE POTENT BY VACCINATING THE CARRIER OF ASCITES ( ANIMAL OR OTHER) AGAINST THE TAG.

CARRIER REGFERS TO THE ABILITY OF CERTAIN ORTGANISMS TO CANNABALISE AND EXERT ANTIGENS FRON SUBSTRATE .THIS ENABLES THE CULTURING OF INNOCUOUS/AND OR IMMUNOGENIC ORGANISMS ON THE SUBSTRATE TO BE TARGETED/TAGGFED/VACCINED AGAINST.

THIS WOULD ENABLE PREPARATION OF VACCINES AGAINST TARGETS THAT ARE NOT TERRIBLY IMMUNOGENIC/ARE DANGEROUS .VACCINATION AGAINST A CARRIER SYSTEM WHICH CONTAINS NO LIVING PATHOGEN CONTAINS OBVIOUS ADVANTAGES .

AN EXAMPLE OF THIS MECHANISM CAN BE SEEN WITH THE FOLLOWING EXAMPLE-EXAMPLE PROVIDES PROOF OF HYPOTHESIS AND IS NOT INTENDED TO LIMIT PATENT TO THE FOLLOWING APPLICATION-IT IS POSSIBLE NOT ONLY TO RAISE AN IMMUNIZATION USING THIS TECHNOLOGY BUT ALSO TO IMMUNISE AGAINST STRUCTURES OF LOW ANTIGENIC POTENTIAL AND FORMULATE BOTH ACTIVE AND PASSIVE THERAPY.

PREPARING CARRIER VACCINES

THE ADVANTAGE OF THIS IS THAT OCCASSIONALY, DELAYED ACTIVITY OF

PATHOGE OR SLOW VIRUSES MAY SAUSE DISASTEROUS CONSEQUENCES EG. SUBACTE SCLEROSING PANENCEPHALITIS ; THIS IS SEPARATE TO THE MORE COMMON CREATION OF DISEASE BY VACCINE AS HAS BEEN REPORTED EG ORCHITIS POST MUMPS VACCINATION . OR POLIO AS WELL AS THE DANGER OF VACCINATING IMMUNODEFICIENT/IMMUNOCOMPROMISED INDIVIDUALS SUCH AS CANCER AND AIDS PATIENTS.

BY ALLOWING HARMLESS BUT POSSIBLY IMMUNOGENIC ORGANISMS TO CO-CULTURE WITH PATHOGENIC ORGANISMS OF THE SAME OR DIFFERENT SPECIES; THESE MAY CANNIBALISE AND/OR EXPRESS ANTIGENS OF THE PATHOGEN SO THAT WHEN LYSED; ANIMALS/IN VITRO SYSTEMS EXPOSED TO THE LYSATE CAN REACT TO PATHOGEN ANTIGENS .THE CARRIER FRAGMENT OF THE CARRIER ORGANISM MAY BE MILDLY OR MAXIMALLY IMMUNOSTIMULANT.

THIS MECHANISM IS ALSO CAPABLE OF ALLOWING A CHANGE OF NORMAL IMMUNE RESAPONSE. CARRIER FRAGMENT CAN BE USED TO DETERMINE WHICH ARM OF THE IMMUNE SYSTEM ATTACKS THE DISEASE AND/OR IS IMMUNISED AGAINST IT.

CANCER AND CANCER -RELATED ORGANISMS AS WELL AS HIV ETC MAY BE HANDLED IN THIS METHOD AS CAN ALL VACCINE PROGRAMS.

A MODEL USED TO TEST THIS THEORY INVOLVES CANINE DISTEMPER VIRUS(CDTV). CHRONIC LYMPHOCYTIC LEUKEMIA WAS(CLL) EXPOSED TO CDTV CYTOPLASMIC AND INTRANUCLEAR INCLUSION BODIES RESULTED WITHIN 3 DAYS. CELL LYSIS COMMENCED WITHIN 24 HOURS .

THIS MODEL WAS USED TO CHECK VIRAL VIABILITY.

YEAST (SACCROMYCES CEREVISEA) WAS FERMENTED FOR 6 DAYS ALONG WITH CDTV(30 PELLETS AS PROVIDED FOR VETERINARY USE) IN 500 CC OF TSB AUGMENTED DAILY WITH 30 % GLUCOSE SOLUTION.

TEAST WAS THEN REMOVED AND ADDED TO 500 CC OF 30% GLUCOSE .THIS WAS THEN FERMENTED FOR 24 HOURS. THE YEAST CELLS WERE THEN

CENTRIFUGED, RESUSPENDED IN SALINE 1000CC AND SONICATED.

SOLUTION WAS FILTERED THROUGH 0.2 MICRON FILTER.

FILTRATE WAS USED(2CC INTRADERMAL) AS SINGLE IMMUNISING DOSE IN

HORSE,

3 WEEKS LATER SERUM WAS TESTED FOR ANTIVIRAL ACTIVITY.

CDTV INCUBATED WITH ORDINARY HORSE SERUM (1 VIAL IN 10CC HORSE

SERUM) INCUBATION FOR 3 HOURS THEN CLL ADDED-CAUSED VACUOLATION

AND LYSIS IN CLL

CDTV INCUBATED WITH HORSE SERUM OF HORSE VACCINED WITH LYSED

YEAST FRAGMENTS THAT HAD NOT BEEN PREVIOUSLY CO- INCUBATED WITH

CDTV- INCUBATION FOR 3 HOURS THEN ADDITION OF CLL-VACUOLATION AND

LYSIS PERHAPS DELAYED BUT DEFINITELY PRESENT.

YEAST-CDTV VACCINE ANTISERUM INCUBATED WITH CDTV FOR 3 HOURS THEN

CLL ADDED-NO VACUOLATION OR LYSIS.

OTHERR BACTERIA/VIRUSES HAVE BEEN TESTED AS CARRIER VACCINES WITH

SUCCESS.

RAISING IMMUNE RESPONSE CAN ALSO BE DONE IN VITRO FROM HOST CELLS

WHICH ARE REINJECTED WHEN ACTIVATED AND/OR STORED FOR LATER USE.

HOST OR OTHER IMMUNE CELLS CAN BE USED TO PROVIDE FACTORS SUCH AS

TRANSFER FACTOR TO EDUCATE HOST CELLS. USE OF ANIMAL ANTIHUMAN ANTISERA MAY BE USED AGAINST SPECIFIC/BROAD CHOICE OF CELLS TO INHIBIT A BAD RESPONSE AND FAVOUR ENHANCEMENT/IMPROVEMENT.

INDUCED REMISSION THERAPY INVOLVES MULTIPHASIC MULTIMODAL APPROACH WHERE TARGET MAY BE DEFINED AS DISEASE/DISEASE

MANIFESTATION/ASSOSCIATED FACTORS OR ORGANISMS.

USE OF THAT APPROACH WHERE THE TARGET IS CANCER CELL/RELATED ORGANISMS/FAULTY IMMUNE RESPONSE ETC-THE FOLLOWING RESULTS WERE OBTAINED.

EFFICACY OF INDUCED REMISSION THERAPY EXTENDS TO ALL KNOWN DISEASES AND CONDITIONS.

Patents include any and all techniques/old/new and yet to be invented, methods of inserting information, genetic or otherwise, into red blood cells or related cells/cell fragments [to some extent platelets are also subject to such manipulation techniques] . Such cells ma be induced to amplify normal functions, or to carry out entirely new functions and perhaps even abandon to them selectively or non-selectively such tasks. All cells which enucleate are left with a hiatus/space/void/vacancy or the like by a vacant area of control that may serve as vectors for genetic engineering and other applications. Such cells may exist in nature with such vacancies or such vacancies may be

induced/created etc. by pschoplasmic and/or nuclear inclusion to create vaculation induced by organisms including viruses, as well as certain immunological/biological/physical/ chemical/ agents and responses or other dominant genetic information bases. This patent covers the use of red blood cells in humans and any other species and any othe cell- related organisms/mechanisms/pseudo-cells/artificial

cells/etc. identifiied by lack of a nucleus of other dominant genetic information base. The use of the red blood cells in this patent as a vectior for the expression of genetic and other information is intended to exemplify but not restrict application of this patent in regard to red blood and white blood cells.

Precis of patent work by Chachoua:

The following patents may be constructed from the 163 and all previous pp.

1. system ofclassificatin which breaks down to:

factors, agents, systemsk compound living or non-livingwhole, part, extract, producti, derivative singly or in combination with whole, part, extract product/erivative, singly or in cmbination. The patent also includes methods of inducing changes which can stregthen and/or alter classification and characteristics. All of these classifications manifest themselves in all diseases with particular attention to AIDS and cancer and are defined within the spectrum: causative. synergistic, neutral, infective, antagonistic and nemesis. A. causative= cause of underlyging conditions e.g. hiv is the officially designated cause of AIlDlS

B. synergistic= work with causative factors to estab. certain condition, e.g. estrogen can be synergistic with breast cancer

C. neutral =exists in the presence of other classification factors [such as causal] but is not active in its promotion e.g. flu coexisting in a patient with skin cancer. It is not a factor in any way with the

commencement of his cancer.

D.infective= may be an agent etc. which lodgesin the body of a person with disease and may be causative of thatt disease or neutral or synergistic if it weakens tthe host or antagonistic if it inhibitts the disease.

E. antagonistic= directly or indirectly inhibi or interfer

with the disease process. e.g. would be effective chemo or a nemesis orrganism such as malaria which acts an anti disease element in the presence of lung cancer.

F.nemesis is a mixture of all the above classifications in addition to being an organism which may be causitive of itself of disease but acts as an anti-disease in the presence o other disease agents such as cancer, e.g. e.g. syphilis may be capable of causing by various means anti disese responses in the host, as in reversing breast cancers

2. All these classifications work within the phenomena of spontaneous remission, organ resistance and organism

resistence and can be induced artificially to mimic the accidental response of nature deliberately and by design in order to cause remission of disease.

They can be used to diagnose, prevent as in immunize, andtreat disease in the hostwhich can bedefined asa

pathaological condition leading todeath of the host. All phases of diagnoses, preventin, immunizatin and treatment are induced through the processes of spon rem. tagging of the diseasesed cells by specific antigens, or utilizing organ or organism resistance thrrough the overran procedure called induced remission therapy in all clasifications which intervenes to protect the host frrom the effects of disease as propogated by viruses, bacteia, easts, fugii and other microorganism.

Specific remedy patents include the following:

1. staph and strep infections causing erysipelas raise t cell counts in AiDS

2. mumps virus raises response tto kaposis's with improvement of t cell counts

It is important to note that in the utilisatin of the following disease patents, various intermediate phase leading to sep. intervention therapy and using heretofore unutilised vectors, hs never been used or addressed before. (identify intermed. therapy such as the pleomorrphic forms of the cancer microbe so that a therapy can be addressed to each form intermediately and a vecttor such as rb0.

Specific Patents:

1. taging therapy, attachment of protein around cancer cell membrnes to identify and unmask it for the immune system; p.143-144

2. anti-human anti sera and/or anti lymphocite antisera

raised in animals for ╌dys lower concentrations of antisera in hos in order to effect healthy cell lysis.

3.multiphasic antiiotic therapy generated by penicillup in stage 1 when incubated witth targett organism; phese2 antigiotic generates multiple phases activeagainst organism prior phases. Phas 3 antibiottic addresses therapy prog, designed to eutiralise anticipated resitnt group off

organisms, p. 103-109 gives gives specific, formulations 4. P. 114-1155 preparation of vaccine culture using

hypertthermia, radiofreq. and electro-mag. energy

5. vaccines orserausing liing biol. sys. pp 130-135f provide multi modal multiphasic approach to altering disease mechanisms.

6. 2mea, copper p. 136

7. p 137-138 penicillin -sttrep

8. p. 138-141 horse antiserum

9. viral/bacterial and other biol. agents vaccine pp 146-154

10. vectors pp 154-1633

PATENT

Inventor: Samir Chachoua, M.D.

Filed:

U.S. Claim:

International Claim:

Field of Search: (Use patent nos.)

References Cited:

Abstract This invention concerns a totally new conceptual therapy for preventing, diagnosing, treating, ameliorating, placing into remission and curing disease and disease-mimicking conditions which assault humans and animals physically, mentally, and emotionally either through infection, genetics, biology, alteration of RDA/DNA, radiation and/or nucleic or

chromosomal damage. It utilizes a heretofore unknown and unused arm of the immune system with a new technology and it provides for the use of disease-provoking organisms (fungi, parasites, microbes, viruses, phages, anti-biotics and particles recently discovered which are smaller than viruses) which, with other particles, cells, living or dead forms, extracts, sera, anti-sera, phages, concoctions, infusions, mixtures, broths, etc. cause remissions. The total concept of the new therapy embraces three aspects of healing:

organisms and immunology; electromagnetic energy, mechanical and other electrical devices for healing and surgenics, and a new science involving advanced genetics, Nemesis organisms, and immunology called Surgenics. This can be expressed by the ensuing diagram under whose grid or umbrella are embodied all the components of this science of new healing.

Causative

or

Infective Synergistic Affinity Neutral Antagonistic Nemesis

B. Electromagnetic Energy, Mechanical, and other Electrical

Devices For Healing

C. Surgenics: A New Science Involving Advanced Genetics,

Nemesis Organisms, and Immunology

No. of claims

No. of diagrams

No. of slides, photos, etc.

I.

Name of Invention

Induced Remission Therapy or Nemesis Extracts Therapy

2 .

Background of Invention Modern Medicine dates from Pasteur's germ theory of the last century which holds that germs alone are the causative factor of disease. As a result, allopathic medicine was formulated from chemicals and drugs to counteract what has been

perceived as the cause of all human and animal diseases. Many chemically-based therapies for tumorous conditions or other diseases ( degenerative, auto-immune, infectious, or genetic) involve the use of anti-mitotic and anti-biotic drugs such as adriamycin, vincristine, cisplatin, daunomycin and

methotrexat which all have strong undesirable side-effects on the normal cells of the patient. These side effect include hair loss, nausea, vomiting, fatigue, weakness, sterility, damage to the kidneys and heart and can impact severely the body's immune system.

Immuno-deficient diseases are thought to be caused by microbes so well camouflaged that the immune system has difficulty distinguishing these microbes from normal tissue components which the disease attacks. Physicians have attempted to overcome this deficiency by using immunosuppressive agents to keep the body from being flooded with infected T-cells, as in AIDS. There is a need, therefore, for anti-disease and anti-cancer agents which have greater specificity in their targeting capability without damaging normal cells such as treatments which are capable of inducing a broad range of different elements in the body's total immune system (e.g. neutrophils, eosinophils, basophils, etc.) into action which may not be as susceptible to the targeted infection. Also needed are methods effective in eliminating less massive, non-tumorous pathogenic cellular materials, such as independent

microorganisms contained in bodily fluids, tissues, and muscles.

Current chemical therapy targets the cellular lysis of such pathogenic materials. However, these treatments tend to affect the non-targeted cells also. Some current treatments focus on inducing a specific immune response and, therefore, are not as effective as an antigen having the ability to elicit a broader immunological response. Problems arise with these therapies when resistance to a particular agent develops.

Such recent attempts have generally stiumulated the formation of tumor specific T-killer cells by immunizing the patient with oncolysates, or lysates from tumor cells. However, such cell lysates tend not to be sufficiently immunogenic and so fail to induce sufficient stimulation of the patient's immune systems in order to prevent effectively the formation of metastases in the case of cancer and proliferation in the case of other diseases.

One significant advantage of the present invention over such non-living therapeutic systems is the ability to counter quickly the transformations made by therapeutic agents. A related dillema occurs when a therapy will center on surgery, as in bone marrow transplants, and work for a time before the cancer-causing agents remaining in the body transform the bone marrow into cancerous tissue.

Chief rival to Pasteur's germ theory was a scientist equally famaous at another university named Antoine Bechamps who held that the germ theory was erroneous and that cells had within them the causative factors of disease, that they were not extrinsic necessarily.

The present inventor, on the basis of the invention of this technology, feels that every disease has various causative factors, many of which can be linked to a micro-organism. Some earlier researchers, however, have linked only one causative organism . Among these have been, in recent years, Dr. John E. Gregory (Pathogenesis of Cancer. 1955), the late Dr. Virgina Livingston (The Conquest of Cancer. 1984) and Dr. Alan Cantwell's The Cancer Microbe . i990).

Other physicians for the last several hundred years, however, have made similar observations and based their successful treatment of diseases upon these observations. They have noticed an antagonistic action between certain infections and cancer.

Over two hundred years ago, a French physician, Dr. Didot, observed that prostitutes infected with syphilis suffered fewer cancers than the general population. Reasoning that syphilis must exert an anti-cancer effect, he treated several cancer patients successfully by inoculating them with syphilis. The Academy of Medicine at Lyons (1773) spoke of cancer as an infection and sixty years later (1836)

Dr . Johannes Mueller (Germany) described the pathology of the infection. Professor Antoine Bechamps (1816-1908) felt disease was born of us and was in us. Campbell De Morgan reported in The Lancet (15 July 1871) the contagiousness of cancer. Dr. Crisp, speaking 17 March 1874 at the

Pathological Society of London said it was "positively a parasitic disease." Dr. Ernst Scheurien in 1887 discovered the organism he thought to be the cause of cancer when he isolated a bacillus from a breast cancer. Dr. Guelliot of Reims in Etiology and Parthogenesis of Cancer observed by the end of the century that the transmission of cancer was contagious.

More scientific evidence was forthcoming: Erwin F. Smith in the Journal of Cancer Research (April 1916) reported the discovery of Bacterium tumerfaciens. The German scientists, Blumenthal, Auler et al. writing in Zeitschrift Fluer Krebs Forschung (26 August 1924) reported the results of

inoculation that had been made with the same cancerous materials into plants, mice and rats. All developed tumors.

Dr. James Young (reported in The British Medical Journal, 25 June 1921) how he had isolated the life cycle of a human carcinoma. A year later he reported isolating the same organism in three cases of leukemia. Young's work was corroborated by Arthur B. and Sydney M. Smith of Cambridge. These doctors made vaccines from the organism and tried them on forty cases of cancer with great success.

In Surgery, Gynecology and Obstetrics (March 1925), Dr.

Coley expressed the belief that the parasitic theory was the only one that offered hope of controlling the disease. He cultured bacteria from a skin infection acquired by a patient just prior to his undergoing a miraculous remission. Dr. Coley used these bacteria as the basis for one of the most successful anti-tumor vaccine therapy programs ever

instituted. He used extracts of streptococcus pyogenes and serratia maracescens to mimic the effect of erysipelas. Thus, several solid tumors disappeared in terminal patients. Many others followed with variations of Coley 's toxins, as well as the utilization of many other bacteria and their extracts, including gonoccocci and treponema.

Other researchers such as Deaken and Glover in America, and Issels in Germany, along with many others have reported varying rates of success with cancer vaccines, yet no systematic investigation of these claims have ever been made by any medical research facility or governmental health agency with the sole exception of the massive vaccination of millions of infants in China during the last decade with BCG. The result has been that the incidence of leukemia was astronomically reduced. This report, although made with the joint efforts of physicians from a distinguished medical institution in Chicago, has never been given any publicity in the United States. And greater numbers of children in America than ever before are coming down with leukemia, (q.v. H.

Christine Reilly, Microbiology and Cancer Therapy: a. Review, 1953).

It is the inventor's contention that there exists for each disease associated organism a naturally occurring cytotoxic or "Nemesis" organism which is capable of substantially inhibiting morbid effects of the particular disease without preciptating significant pejorative side effects.

The inventor has observed three naturally occurring phenomena which affect disease cures and are primary sources for Nemesis organisms. These are:

1. Spontaneous remission;

2. Organ and Species resistance; and 3. Cellular redifferentiation.

Miraculous healings of incurable diseases have been reported since ancient times. The majority of cases describe a healing crisis ranging from hours to days, during which time dramatic acute symptoms manifest. These may include fever, chills, and perspiration, the known features of acute infection. Such cases are indicative of the existence of various pathogenic micro-organisms which may demonstrate a therapeutic effect upon cancer and other so-called incurable diseases.

Connell (Canadian M. A. J. 33:363-370, 1935) reported the first article describing an attempt to instill specific anti-cancer activity into a bacterial extract by first incubating the bacteria with cancer tissue. This publication provided encouraging data related to clostridium hystolyticum. In 1947 the same organism was used in an attempt to mark cancer cells with bacterial antigens which were then treated successfully with an antitoxin (q.v. Parker et al., Proc Soc Exper Biol and Med. 66:461-467, 1947). More recently, Volker Schirrmacher disclosed in his United States patent (#

5,273,745 and F.R.G. patent # 3806565), a similar technique in which inactivated autologous tumor cells are marked by incubating the same with similarly inactivated Newcastle Disease Virus (NDV) in a serum-free medium. Because of the natural ability of the NDV to activate tumor-specific T-cells, the number of such T-cells which are ultimately activated against the tumor is sufficiently greater than the number of such cells the tumor itself is able to activate. A particular problem which Schirrmacher's research attempts to address is the well-known capability of a cancer-type malignancy to hide itself from the defenses of an immune system. Such concealment is accomplished via the stimulation by the cancer of only a small and highly specific immune response which results in the precipitation of various blocking anti-bodies that coat the diseased cells with structures from the patient's own body. Unfortunately,

Schirrmacher's research shows how to increase T-cells but such cells comoprise less than one per cent of the body's total known immune system. Thus, this aforementioned patent fails to include a greater portion of a body's defense system against the target disease, and it does not add the benefits of a live micro-organism which demonstrates an antagonistic behavior toward the tumor, as does this invention. It is well-known that certain organs and systems of the body, such as the spleen, small intestine and muscular system, are rarely infected by metastatic diseases which readily encroach upon more susceptible bodily organs and systems, such as the lungs, liver and skeletal system. (q.v. Lewisohn et al. Am. J. Pathol. 17:251-260, 1941; and Chachoua et al., Clinical Oncology Society of Australia Precis, 1981). This indicates either an inherent resistance within the uninvolved tissue or the presence of a powerful local immune system operating within the unaffected tissue. It may also be indicative of a heretofore unknown presence of a particular micro-organism which may or may not be a natural part of the host organ, but which is antagonistic toward such metatastic diseases. By utilizing the method of the present invention, such

metatastic resistance of these bodily organs, tissues and micro-organisms may be used in the production of disease- specific therapeutic agents for use in other, more

susceptible areas of the body.

it is further known that certain non-microscopic, non-human life forms are resistant to the ravages of cancer and other various diseases. Although such knowledge and research appear to be promising, great diffulty has been found

generally in using such anti-disease sera extracted from animals. The limitation of this promising technique has lain usually in the non-specificity of anti-sera developed from such non-human life forms, especially with the tendency of such sera to include high levels of an anti-human factor which has often proven to be quite toxic.

In utlizing the method of the present invention, however, it has been discovered that various tumor-specific antigens for therapeutic use can be raised in vivo in such non-microscopic life forms and subsequently "washed" against other anti-bodies raised in a similar animal for destroying the anti-human factor. Similarly, disease-specific therapeutic agents can be raised in vitro and are covered by this patent.

In regard to cellular redifferentiation, many reports exist of cases in which malignant tumors have suddenly

redifferentiated into normal cells. Such reports have noted the association of the redifferentiating tumors with some other abnormal occurrence within the body. For example, such redifferentiation has been reported in leukemia after the occurrence of a staphyloccal infection. Redifferentiation of cancer cells has also been found in tumor masses which were placed in proximity to a developing notochord, or grafted onto a salamander's regenerating stump. The ability of such diverse situations to cause redifferentiaon in various tumor types strongly suggests that cancer cells are not

irreversible, but rather, under certain situations, can be returned to a normal state (q.v. Laclau, Compt. Rend. Soc. de Biol. 92:840-842, 1925; Nevorojkin, Vestnik Roentgenol

Radiol. 15:344-345, 1935; Maisin, Compt. Rend. Soc. de Biol. 127:1477-1478, 1938; Protti, Tumori 22:222-229, 1948; Protti, Tumori 24:14-24, 1950; Lewisohn, Science 94:70-71, 1941;

Lewisohn, Cancer Research 1:799-8066, 1941; and Suiguira, AAAS Approaches to Tumor Chemotherapy. 208-213, 1947).

Basically, all current research has, for the most part, an inappropriate immunological response because vaccines, sera, chemo and all other therapies stimulate an inappropriate immune response due to threshold phenomona, abundance of causative agents which mask themselves within the cells, and activation of partial or miniscule immune responses as well as cell resistance to the therapy and the destruction of normal cells and diseased ones. This new invention addresses itself to all these factors which are overcome by the technology described. Description of Invention

This new therapy with its concomitant technology is based on the following six aspects of human and animal disease which can be utiised to cover every disease, every organism causing the disorder and every possible cure raised against the disease. These are: Causative (or Infective), Synergistic, Affinitive, Neutral, Antagonistic and Nemesis. In total, they provide a comprehensive method for the prevention, diagnosis and treatment of the disease, disease organisms, degenerative diseases, auto-immune diseases, genetic, cardio-vascular as well as those diseases originating from what Nobel Laureate Bjorn Nordestrom has identified more than twenty years ago as a defect of the electro-magnetic circulatory system of the body (cite bibliographical note here); this system further provides for the health, immunisation against the disease and longevity of the patient. Thus, this invention also utilises a method for repairing body cells and extending the normal lifespan. This technology, for optimum effectiveness, also uses the inventor's orginal electromagnetic and other machines as well as surgenics, a new science involving genetics, immunology, and the Nemesis organisms. All are covered by this patent.

There is a basic library of disease organisms which can be raised against any bacterium, fungus, virus, parasite, phage, or yeast and which has an affinity for normal tissue. When one vaccinates against the organism causing the disease, the host's immunity against the disease-producing organism is raised. Thus the patent targets three things within the superstructure of the six aspects of the disease and disease- fighting mechanisms: the disease cell, the cause of the diseased cell; everything that is antagonistic to the diseased cell; raising the organisms to be specific against the diseased cells; and organisms specific against all causative and all synergistic organisms. Thus, this

invention covers AIDS, cancer, pathogenic angiogenesis and vascularizion, systematic lupus erythromatosis, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, Alzheimer's disease, muscular distrophy, asthma, chronic fatique syndrome, ALS, ITP. This patent covers all currently known diseases and all diseases which may develop in the future due to external facters such as environmental

pollution; radiation, chemical and or biological poisoning, etc. Whether the disease is caused by an infectious agent or an opportunistic infectious agent, autoimmune or genetic, it is covered by this invention. In fact, new diseases such as

Eboli and some that have not even surfaced yet are curable with the new technology covered by this invention. There is no disease that cannot be eradicated now or in the future with this invention.

This new technology can be expressed by the ensuing data and descriptions.

This system defines the cause of disease, the use of different therapeutic agents (organisms, extracts, parts thereof), regulates reroutes until efficient immunological mechanisms and general immune reactions can be developed. This can be accomplished with red blood cells, for example, an original discovery inherent in this invention which can act as a vector or new immune system that can generate totally new enveloping immune responses which are effective in combatting all existing and future auto-immune, infectious degenerative, genetic diseases and cancers.

The red blood cell is a cell without a nucleus so it becomes a vector expressing the biological cell and makes an ideal vessel for physical, biological and chemical agents that can modify the cell function. For example, it can become an alternate immune system and can be used in binding immunabilty using bacterial, phage, biological and chemical extracts. (See illustrations pictures and text accompanying illustrations, cite p. number) This is the first use ever of this newly identified immune system to fight cancer and all diseases. It is this inventor's sole discovery.

This new therapy has remarkably few side-effects, especially when compared with other forms of treatment for cancer, which employs adjuvant chemotherapy or high dose application of lymphokines or radiation or bone marrow transplants.

The differences between previous attempts to use viruses, bacteria, phages, antibiotics, fungi, yeasts, and sera and this new technology lay in the expression of various categories (as seen below) and their logical progression through a library of disease organisms. This has never before been done and, as such, creates an entirely new branch of medical science called, as previously stated, "Induced

Remission Therapy," or "Nemesis Extracts Therapy."

This invention provides for the following: A. A. method for creating disease-specific therapeutic agents from organisms, extracts or parts thereof (which are viral, microbial, parasitic, fungal, bacterial, phagial or antibiotic) and whose origin are animal, chemical, botanical, biological, organic or inorganic substances, elemental, molecular, metalurgical, electro-magnetic machines with varying frequencies and coils, (Sam, in this category we can include all the machines so as not to have a separate set of patents) and which will destroy the cause of disease or render it harmless;

B. To conduct a spectrum search of all known and possibly unknown disease organisms in order to compile a library of such specific organisms against which to raise vaccines along the lines described in this invention;

C. A method for enhancing a patient's immune system to the point where it can respond effectively to any disease.

1. organisms and Immunology

2. Electromagnetic Energy, Mechanical, and other Electrical

3. Devices For Healing

G. Surgenics: A New Science Involving Advanced Genetics,

Nemesis Organisms, and Immunology

D. Disease

Causative or Infective; (Organisms which cause disease or cause it to proliferate).

This category includes all conditions which cause insult to the body so that it exhibits abnormal manifestations of ailments, diseases, etc. either physical, emotional or mental.

Clinical studies using microbial extracts in the treatment of cancer have usually demonstrated the expected elevations in levels of Interferon, Interleukin,, and T-cells. A perhaps unanticipated finding of this study is that red blood cells may play an active role in the immunological defense system of man.

Certain microbial extracts are capable of causing a

morphological change in the appearance of the red blood cells. These alterations may be functional and may assist in movement and in perforation of the cancer cell membrane.

A phenomenon of considerable interest, which may accompany these morpholoical changes, is that of cell membrane fusion. It is important to note at this juncture that the

morphological changes occurring in these red blood cells are temporary, and often resolved from within a few hours to a few days. The cellular fusion, however, may be a more permanent condition.

Points of contact between leukemia cells and red blood cells, or red blood conglomerations demonstrate areas of cellular fusion where the membrane boundary appears to dissolve, and cytoplasmic and nucleic contents in leukemia cells appear to empty into red blood cells. These observations appear to illustrate a hitherto unreported function of red blood cells in human beings, which demonstrate their capability of playing an active roll in the immunological process.. It is of interest to note that these changes were observed in leukemia cells immediately prior to remission or during marked improvement of the patient.

The implications of the findings of this continuing study shed new light on a theory which has long preoccupied this author. Genetic engineering has concentrated on modification of cells with intricate pre-existing nuclear structure, whereas the human red blood cell might serve as an ideal empty vessel or receptacle, being without a nucleus. It certainly appears capable of responding to, or expressing genetic information carried by certain microbial extracts.

The impact of such applications would be staggering. Disease would be attacked by cells to which they could not have developed evolutionary resistance. If none of the other modalities proposed by this patent even existed, this singular fact would be sufficient to bring any agent into the crucial impact necessary to kill any disease or disease organism that exists now or will exist in the future.

An interesting footnote to this theory would be the high number of cases of spontaneous remissions reported following acute malaria infection, an infection which could feasibly do more to the red blood cell than merely parasitise it. It is possible that genetic information from the malarial infection can transform the red blood cell in a similar manner as stated above, into an active arm of the immune system.

E. Organisms Causing Disease

The library of organisms, listed below, are found in all diseases which are chronic, auto-immune, all inflammatory diseases, cardio-vascular diseases, infectious, genetic diseases and all cancers and cell-proliferative diseases. 1. virus

When disruption of cancer cells (physical, chemical or biolgoical) is such that the cancer cells are fragmented, they can then be passed through a micro-filter which will only pass viruses as a cell wall-deficient form. Placing this sterile "filtrate" into a culture medium will allow some cell walldeficient viruses to reconstitute their walls and as cell walldeficient viruses can usually only exist

intracellularly; then these viruses are likely to be causa tive viruses which reconstitute with .2 micron filter. 2. bacterium

a. When disruption of cancer cells (physical, chemical or biological) is such that cancer cells are fragmented, they can then be passed through a micro filter which will only pass bacteria as a cell wall- deficient form. Placing this sterile "filtrate" into a culture medium will allow some cell wall- deficient bacteria to reconstitute their walls and as cell wall-deficient bacteia can usually only exist

intracellularly. Then these bacteria are likely to be causative bacteria which recostitutes with a .2 micron filter.

b. Microbiological interference means an infection with certain bacteria will make harmful effects of other bacteria impossible. Two different kinds of cancer caused by two different bacteria would therefore be impossible.

3. fungus

When disruption of cancer cells (physical, chemical or biolgoical) is such that the cancer cells are fragmented, they can then be passed through a micro-filter which will pass fungi as a cell wall-deficient form. Placing this sterile "filtrate" into a culture medium will allow some cell wall-deficient fungi to reconstitute their walls and as cell wall-deficient fungi can usually only exist intracellularly; then these fungi are likely to be caustive fungi which reconstitute with .2 micron filter.

4. parasite

When disruption of cancer cells (physical, chemical or biolgoical) is such that the cancer cells are fragmented, they can then be passed through a micro- filter which will pass parasites as a cell wall- deficient forms. Placing this sterile "filtrate" into a culture medium will allow some cell wall- deficient parasites to reconstitute their walls and as cell wall-deficient parasites can usually only exist intracellularly; then these parasites are likely to be causative parasites which reconstitute with .2 micron filter.

5. yeast

When disruption of cancer cells (physical, chemical or biolgoical) is such that the cancer cells are fragmented, they can then be passed through a micro-filter which will pass yeast as a cell wall-deficient form. Placing this sterile "filtrate" into a culture medium will allow some cell wall-deficient yeasts to reconstitute their walls and as cell wall- deficient yeasts can usually only exist

intracellularly; then these yeasts are likely to be causative yeasts which reconstitute with .2 micron filter.

6. phage

When disruption of cancer cells (physical, chemical or biolgoical) is such that the cancer cells are fragmented, they can then be passed through a micro filter. When

irradiated, bathed in ultra-violet light or treated with phenol, a phage can be raised which will pass as a cell wall- deficient form. Placing this sterile "filtrate" into a culture medium will allow some cell wall- deficient phages to reconstitute their walls and as cell wall- deficient phages can usually only exist intracellularly; then these phages are likely to be causative phages which reconstitute with .2 micron filter.

7. antibiotics

Synergistic (organisms which live within a host organism in a beneficial relationship to a targeted disease.) D. Disease

1. Diagnosis:

Samples of a patient's blood or diseased tissue may be tested in vitro against a library of prior-found organisms. Any precipitation may indicate the presence of free-floating antigens associated with the disease, and further indicate thereby the potential association between such disease and the tested organism. Also in vitro testing of antibodies from the patient's immune system may indicate how any of the patient's normal antibodies may be useful as a disease- associated organism against the targeted disease. Very low titers from the in vitro tests of the patient's immune system components may indicate no prior exposure of the immune system components to the disease, or a suppressed immune system with regard to a particular agent, which agent should then be considered a possible synergistic or causative organism. Such indication would be confirmed with significant antigen titers in serum. Conversely, high titers of antibody or dermal reactivity may indicate previous exposure which may again be indicative of a possble synergistic or causative organism. Again, confirmation of this would be given by the occurrence of significant antigen titers in serum. In tests where there is a low antigen titer, a high reactivity to a particular organism or organism fraction may indicate the presence of a very useful tagging or immuno-stimulating organism. Titers of antibodies or antigens of any of the causative synergistic or otherwise antagonistic organisms may also indicate the presence or susceptibilty of the patient to another disease which is associated with such organism. Thus the spectrum search of the patient's body may be further useful as a method for monitoring the potential threat to the patient by a previously undiagnosed disease. Such a spectrum search may be used, therefore, to diagnose the presence of various diseases in a patient's body which diseases can be subsequently vaccinated against by use of various organisms in the existing library of known Nemesis organisms.

E. Organisms Causing Disease

Should a first organism antagonistic toward a secnd organism be found in slight amounts in a patient's body having a target disease, and the second organism is susceptible to various components of the body's immune system, an affnity could be raised between the second organism and the targeted disease in order to permit the first organism to attack indirectly any immune factors in the target disease by precipitating a direct attack by the first organism on the second organism. Thus the second organism may be co- incubated in a hormone fortified medium with cells of the target disease. As both the second organism and the disease cells digest the hormones of the medium, an affinity between the diease cells and the second organism may grow so that when the cells of the second organism are injected into a patient having a targeted immuno-suppressed disease, the disease will coat the second organism with the same immune factor with which it is coated. This would allow targeting of the second organism by the first antagonist organism to result in an indirect attack on the anti-immune factors of the disease.

1. virus

bacteria

3. fungi

4. yeasts

5. parasite

6. phage

7. antibiotics

Affinity

(These organisms carry direct, sometimes curative

anti-disease activity. They have an affinity for the disease and live in harmony with it in the host.)

D. Disease

E. Organism Causing Disease

1. viruses 2. bacteria

3. fungi

4. yeasts

5. parasites

6. phages

7. antibiotics

Neutral

(Acts as a tagging agent to identify the disease organism so that the immune system is drawn to the diseased cell as by a magnet and can target thereby its destruction) .

D. Disease E. Organism causing Disease

1. viruses

2. bacteria

3. fungi

4. yeasts

5. parasites

6. phages

7. antibiotics

Antagonistic (disease-causing organism or disease causing process.)

They have universal stimulating activity; they direct organisms to be an effective arm of the immune system.

They carry physiological, metablical, biological and

chemical changes to the host which may benefit against disease. This categorry depends on the Nemesis phenomenon; it acts as an interference phenomenon; regenerates or reroutes or utilizes a more appropriate response phenomenon.

D. Disease

1. Antagonistic organisms include lactic acid bacteria. The antagonistic agent works against the disease organism, the cancer, against the causative organism, and against the synergistic organism. 2. Once a set of disease-associated antagonistic organims has been procured, a culture of the organisms should be prepared for raising the organisms in both standard and hormone fortified media. An anti-biogram may then be conducted to reveal whether the organisms or organism exracts found display a sufficent antagonistic effect toward the targeted disease to warrant further investigation. The use of an antibiogram has been most helpful also in identifying organisms not ortherwise known to be antagonistic toward a targeted disease. Although an antibiogram will generally improve sufficent comparative information. Other in vitro tests which are well-known may be conducted to determine the degree of antagonism for the targeted infectious agent which is held by each found organism. The next step is to prepare a vaccine from each of the cultured antagonistic organisms via well- known methods.

E. Disease Ccausing Organisms

Spectrum search should include epidemiological search for organisms which are known to exist in global geographical areas having a low incidence of the targeted disease. This search might also include, but not be limited to, organisms brought back by space probes into other planetary systems, such as moon dust and moon rocks brought back to earth in 1966. These would then be isolated as the Nemesis

organism(s) being antagonistic to said disease or group of diseases.

Inherent in the genetic "disease organisms" are understood other cancers as a source of potential nemesis or

antagonistic orrganisms since it is well known that once one type of cancer is evident, it prrotects the host from another type. It has also been demonstrated by this inventor that ascitic fluid from a breast cancer patient will exert very powerful anti-cancer activity against prostrate cancer, as indicated by the pronounced shrinkage of tumor masses within minutes to hours of application in with the methods herein outlined. Cardiovascular maladies and cancer also appear to be antagonistic. Initial findings by the inventor further indicate that enzymes extracted from penicillium notatum may have a cyto-toxic effect upon the HIV virus.

The spectrum search for antagonistic /Nemesis organisms include those organisms which may be found in vivo within a patient who is undergoing a remission from the targeted disease. A biopsy of the remissive disease in such a patient will likely reveal an organism which is actively attacking the cancer, which is attacking anotther element that has tagged the cancer or which is attacking another organism that is in a synergistic relationshiup with the cancer. A search in the remissive patient's blood, nose, throat, ears, urine and stool should also be made of organisms not normally associated with said patient's body. It has been found that effective sources of antigens and disease-specific antibodies exist in ascites, plural effusions and other tumor effusions of remissive patients and of patients having a similar disease. it has been found, for instance, that some tumors elicit strong responses against unrelated tumors. The use of sterile human effusions and ascites have shown only few side- effects when administered intramuscularly, subcutaeously, intradermally, or intratumorally with doses up to and exceeding 150 CC. It is futher believed that vaccinating a patient with an identical cancer type from another individual may stimulate the patient's immune system against the foreign tissue, and in doing so may trick the patient's immune system into recognizing its own cancer cell mateial which has been previously "hidden" from the immune system as being similar to the foregin material and therefore attack said previously hidden cancer cell material.

1.viruses

a. Smaller antagonistic organisms such as viruses may be readily carried to target disease cells by combing them with larger microbial affinitive organisms such as bacteria and fungi. Such a combination may be accomplished by culturing in a diet- restricted medium the organisms which are

antagonistic to the targeted disease (or extracts or

modification of these antagonistic organisms) with the microbial affinitive organisms.

2. bacteria

a. Where no apparent attraction exists between a potential antagonistic organism and a targeted disease, such attraction may be bred into the organism via co-incubating the potential antagonistic organism with cells of the targeted disease in a partially deprived medium. It has been found that after the nutrition in the medium is exhausted, the antagonistic organism will adapt to its surroundings and develop only attraction which may be needed for procuring the nutrients which are available to it in the targeted disease. It has also been found that such bred-in attraction becomes a substantially permanent chareteristic of the antagonistic organism. This mechanism may be used for both creating a disease-specific lytic antagonism in cells of a selected organism which has not previously demonstrated antagonism toward a targeted disease, as well as for enhancing the degree of any antagonism which may already exist in an antagonistic organism. It has also been found that vaccines prepared from such antagonistic organisms which are not attracted to a targeted disease can be effective when administered via direct injection into diseased tissue. Such non-attracted antgonistic organisms or extracts thereof may also be linked to other organisms which have been found to have strong microbial-affinithy to the targeted disease.

3. fungi

4. yeasts

5. parasites

6. phages a. Smaller antagonistic organisms such as phages may be readily carried to target disease cells by combining them with larger microbial affinitive organisms such as bacteria and fungi. Such combining may be accomplished by culturing in diet restricted media the organisms which are antagonistic to the targeted disease (or extracts or modification of these antagonistic organisms) with the micro;bial affinitive organisms. The phage will often be transfused from the microbial affinitive organism after attachment to the

membrane of a disease cell, through the membrane and into the cytoplasm of the disease cell.

b. Phage destruction of antaonistic organisms, affinitive organisms, cells of disease and diseased tissue or any particle thereof yelds an effective oncolysate against the targeted disease. Such phage destruction or denaturing can be stimulated by :

1. Allowing each isolated organism, disease cell or diseased tissue to grow in vitro in limited media until a phage arises spontaneously out of the culture; and induces a stress upon the culture for precipitating a phage. Such stress may be administered via any of a variety of ways, including

physical, chemical, thermal, biological, ultra-violeat light and radiation bombardment of pH stimulation etc. allowing a combination of targeted disease cells and an antagonistic organism to grow in vitro until an oncolysate is formed as the targeted disease cells are consumed and until the nutrition of the medium is outgrown and natural degeneration of the disease cells occurs.

Presentation of such lance fragments and phages to the infected body can stimulate an effective immunological function and other therapeutic responses concerning the targeted disease.

7. antibiotics

Nemesis (organisms which carry anti-disease activity.) D. Disease

In vivo spectrum search should look for organisms occurring in the bodies of non-human hosts (including mammals and non- mammalian lower forms) which are known to be resistant to the targeted disease; the method is to inoculate the non-human host with any of the following agents that have been extracted from the patient:

1. cells of the targeted disease;

2. lysed fragments of diseased tissue (specifically from cellular membrane, mitochondria, goigi apparatus, lysosomes, or the like) or

3. any of the found disease-associated organisms; The non-human host will then raise antibodies against the disease cells which may be extracted. A second non-human host of the same species should then be inoculated with normal cells from the patient. This will raise anti-human antibodies in the second non-human host which can then be extractd and applied in vitro to the sera extracted from the first non-human host for the purpose of precipitating the anti- human factor out of the first host sera and thereby leaving the anti-disease antibodies in the sera for use in the patients. A third non-human host may then be

intentionally challenged at a later date by an animal disese of identical type as the human target disease. The initial "memory" immune response of the third non- human host against the animal disease will be an anti-animal disease, not anti-human; and, therefore, will be effective against both the animal and the human- tarteted diseases.

E. Disease causing organism

Spectrum search should include isolating organisms resident within the patient. A patient suffering from a carcinoma should have his tumor biopsied and cultured. It has been found that the bacteria staphylococcus albus will grow readily from "clean" tissue samples from such a patient.

Cultures from non-infected portions of the person's body should also be taken. This indicates the presence of

inhibiting activity due to an antagonistic organism, an immune factor in the uninfected tissue, or a bi-product of a combination of an antagonistic organism and an uninfected tissue. These unaffected parts include the spleen, small intestine and muscular system. It has been found that Peyers Patches from the patient or a donor may be extremely useful in the present invention, due to the inherent ability of such tissue to withstand a large variety of diseases. it has also been found that ascitic fluid itself from a carcinoma or a sarcoma patient may have general anti-cancer activity toward the targeted disease. It has also been found that extracts of a muscle biopsy when activated via enzymatic, biological organisms, fortification or amplification by any other means, have a strong therapeutic effect. Intramuscular injection of a hypo-osmotic solution will also release some components of muscle cells so that they may exert some therapeutic action.

1. viruses

a. These organisms cause viral interference i.e., some viruses will stop other viruses from protecting the body, except for bacteria and fungal interference.

2. bacteria

3. fungi

4. yeasts

5. parasites

6. phages

7. antibiotics

induce re-differentiation

grnen (? ) /receptor

Ighe- IGC Healing

of dedicated animal

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

PCT Prefential Culture Techniques

-AIM- developing of specificity

awakening/isolating/coating properties A-Enriched

B-Selective

C-Minimal

A-Enriched, raises majornumber of mutant of which one or more may carry activity

B. Selective favors growth of one or more organisms

C. Minimal media for one/more or all organisms to create new mutation and competition.

Examples of use

Enriched+/- mutating agents

eg

UV ozone/peroxide etc.

enables mutation & mutational support

so maximum pool.

e.g. culture penicillin-species with staph species

in media nutritores for both,

conjointly or separately

when mixed these will bea great variety of staph and

penicillines

when cultured together in enriched media the staph is able to generate many pen resistant species, pen is able to counter. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

B. Selective Media

the degree of selectivity in mutation

enables the preferred organism to have a biological "edge" ie. a penicillin resistant staph starved

of adequate ntritional support will be less likely to mutate away from enhanced penicillan response.

Penicillin response and diversity promoted by medium.

C. Minimal media

promotes active mutation of competieon (?) between species especially when each only has the other as a food supply

e.g. Penicillin mold starved of othernutrition will develop antibiotics and/or other responses to kill/breakdown/digest and utilize bacteria or bacterial gragment in minimal media.

For example, a penicillin resistant staph can be placed

whole or in part/fragment with penicillian mold in minimal mediato allow penicillin to develop new antibiotics/enzymes/other techniques to kill/digest/neutralize/utilize staph.

In nuetrally restricted medium one of the organisms will triumph over the other.

By their passaging that organism through selective/enriched +/- mutating factors

Many of its possible presentations /resistent mutations

will then manifest and can have mutating strategies

e.g. 1. vaccinating against R forms

2. Raising new antibiotics

Many R mutant can be

specifically neutralized by pne techniques giving better in effective organism mold start as frag. ⃒

CAN also ⃒

efficacy of antibiotic by vaccinating or antisera against R

eg anti plasmid or anti penicillian

⃒

⃒ SPECIFICITY of antibiotic

by washing with normal cells,

ornormal gut flora to remove

antibiotic strain

spectrum analysis

visual interferance of t cell counts

It is important to note that in the utilisatin of the following disease patents, various intermediate phase leading to sep. intervention therapy and using heretofore unutilised vectors, hs never been used or addressed before. (identify intermed. therapy such as the pleomorrphic forms of the cancer microbe so that a therapy can be addressed to each form intermediately and a vecttor such as rbO.

Specific Patents:

3.

The cure Against Disease

raised to make vaccines, sera, anti-sera, anti-anti-sera to fight every disease. In concept, this is similar to the Hela cell being used as a cell line except this is safe whereas the Hela cell isn't because the nemesis organisms is being reaised in different media to neutralize its virulence.

Clinical studies using microbial extracts in the treatment of cancer have usually demonstrated the expected elevations in levels of Interferon, Interleukin,, and T-cells. A perhaps unanticipated finding of this study is that red blood cells or erythrocytes may play an active role in the immunological

60

defense system of man. It has long been assumed that the red blood cell has only a mninor role, if any, in the body's immune system. Yet this inventor has observed the red blood cell is the most abundant cell in the human body. Because red blood cells have no nucleus and appear to be little more than a high resilient empty vessel for carrying water and

hemoglobin throughout the cirrculatory system, the red blood cell appears fully capable of responding to and perhaps even expressing genetic information carried by certain microbial extracts.

Certain microbial extracts are capable of causing a morphological change in the appearance of the red blood cells. These alterations may be functional and may assist in movement and in perforation of the cancer cell membrane, thus having a terapeutic effect with regard to a targeted disease, (q.v. such morphological changes in illustrations 1 and 2 in which red blood cells with tentacles formed in the membrane and vacuoles formed in the cytoplasm are shown.) Although it has been known that red blood cells react to a high level of acidity by swelling into spiked balled (called

echinoc;ytes), similar transformation apart from such acidity has not be observed heretofore. Such morphological changes as those noted in these illustration occurred apart

61

fromthe presence of such acidity and were only temporary, resolving within a period of between a few hours and a few days. The inventor believes such changes may be fuctional, such as for assisting in the movement of the red blood cells or assisting in the perforation of the cancer cell membrane.

A phenomenon of considerable interest, which may accompany these morpholoical changes, is that of cell membrane fusion, (q.v. illustrations 3 and 4 in which the cell membrane fusion between adjoing red blood cells in a conglomeration and between red blood cells and adjoining leukemia cells are seen.) Although resolved in a few hours to a few days, the cellular fusion, however, may be a more permanent condition.

Points of contact between leukemia cells and red blood cells, or red blood conglomerations demonstrate areas of cellular fusion where the membrane boundary appears to dissolve,and cytoplasmic and nucleic contents in leukemia cells appear to empty into red blood cells. These observations appear to illustrate a hitherto unreported function of red blood cells in human beings, which demonstrate their capability of play an active roll in the immunological process.. It is of interest to note that these changes were observed in leukemia

62

cells after application of a vaccine created from feline panleucopenia virus. Similar morphological changes and anti- leukemia cell activity has been observed after appplication of vaccine created from canine distemper virus immediately prior to remission or marked improvement of the patient.

Illustration 45 is a blood sample plate from a 59 year old female having chronic lymphocytic leukemia. Illustration 46 is a blood sample from the same patient taken within two hours (not a misprint) during which time the patient was administered vaccines prepared in accordance with the medthod of the present invention. The white blood cell count has more than halved. A complete remission further occured in this patient within several weeks. Vaccines had changed many of the cancer cells into normal cells (via redifferentiaion), hence a gher count persisted till the transformed cells lived out the lifespan of a normal cell. Illustration 47 is a blood sample plate from a 24 year old male having acute myeloblastic leukemia. Illustration 48 is a blood sample from the same patient taken seven days later during which time the patient was treated with vaccines prepared in accordance with the method of the present invention. The latter plate revealsa complete remission of the disease. This

63

phenomenon cannot be explained apart from red blood cell activity since such reduction had to involve cells of a number which surpassed that of the white blood cells and the leukemia cells.

The implications of the findings of this continuing study shed new light on a theory first promulgated by this

inventor. Genetic engineering has concentrated on

modification of cells with intricate pre-existing nuclear structure,, whereas the human red blood cell might serve as ideal empty vessel, vector or receptacle, being without a nucleus. It certainly appear capable of responding to, or expressing genetic information carried by certain microbial extracts . Two possibilities exist: either the red blood cell was transferred by the applied affinitive organism or was awakened from a genetic memory (q.v.Cure 3.c) within the red blood cells via administration of the applied affinitive organism.

The impact of such applications would be staggering. The red blood cell may be manipulated into functioning as a member of the immune system via genetic programing (q.v. Cure 3 c.) precipitating such activity in vivo. Disease would be

64

attacked by cells to which they could not have developed evolutionary resistance.

An interesting footnote to this theory would be the high number of cases of spontaneous remissions reported following acute malaria infection, an infection which could feasibly do more to the red blood cell than merely parasetise it. It is possible that genetic information from the malarial infection can transform the red blood cell in a similar manner as stated above, into an active arm of the immune system. In order to create autogenous biological enhancement, take cells out of the organism, process them and purify them, then reinsert them. This produces power to organisms supposed to be ?- - -

In cancer, leukemia and some other diseases the bone marrow shuts down. Generally, bone marrow transplants have been used to reseed with normal bone marrow cells. This has resulted in temporary improvement until these normal cells are once again transposed into abnormal cells by the disease mechanism. A new method of making bone marrow dispenses with the surgery and is safer and can be utilized a multiplicity of times. To

65

make bone marrow; culture Peyers Patches in the spleen with the organism; you allow them to raise anti-bodies; you precipitate the antibody by dropping the Ph. Pass it through a 0.2 filter and add bone marrow. Attach to a salt or ammonia crystal for a pure form. The bone marrow injection is given intermuscularly or intrveously. Tlhen the vbone marrow stem cells will find their way to the bone marrow, (a biological mechanism). This will give biological enhance ment. This can be done with a biopsy of any organism by culturing and purifying. Causative or Infective

(tags disease cell in order to cause the immune system to drawn as with a magnet to the tagged cell in order to destroy it).

Tagging

In cancer cases, the patient makes a protein which coats the cancer. it can be precipitated at low Ph's between 5.5 and 6.5 Ph. This antibody is 1. highly specific for cancer cells but doesn't damage normal cell and;

2. Attach this protein to something that will kill the cancer

66

cell by shaking it up in a test tube, inject it back, and it will head back to the cancer like a magnet and tag it for recognition by the immune system.

Causative or Infective

Nemesis organisms raised as causative or infective agent result in products which destroy cancer.

a. Viruses A virus may be alternatively passaged from enriched to minimal broth until desired organism is obtained. Keep passing it back and forth between the minimal and the

enriched media. Repeat until you have a highly specific viruses

2. Then put them in enrriched broth; viruses will flourish in enriched broth;

3. Grow a new colony. Add fresh cancer cells;

4. Tlhe result is that each time this is done, the viruses which will attack the fresh cancers in minimal media will

67

have greater and greater affinity, which will attach the fresh cancrs

Use of nemesis organism to block off AIDS sites in white blood cells result in distructions of CD4 receptors so the HIV virus cannot lodge on it. This makes a lot of CD4s by culturing and extracting them from white blood cells. This is injected into the body so CD4s can mop up all the decoys. The technique to cause denucleaztion: Take cell membrane in a centrafuge. Spin out quickly the njucleu so there is a phantom cell or shell and all CD4s are on the outside.

Inject this as a decoy. AiDS virus will stick to it and cannot replicate.

To tag the disease organism, place something that kills HIV virus in the phantom/shell cell like bacterial antigens and when the decoy cell breaks down (because of age) all CD4

68

receptors will be tagged to a bacterial extract and the body would destroy them. REsult; CD4 with the HIV antibody attached to it can kill HIV and the decoy can pick up a spare HIV cell.

Bacteria

1. To cure genetic diseases: teach bacteria to eat an abnormal piece of DNA ;

2. most genetic disease can be back- engineered into a

bacteriall phase. Making antibodies against these bacteria will remove the abnormal gene.

3.

a. you make a serum against the bacterium in an animal; b. you treat organisms with high affinity for cancer or disease with anti-normal cell serum.

c. anti-normal cell serum is raised against the

69

organism, whole parts or extracts or produs of extracts with an affinity for normal cells and activity against normal cells,

c. you raise anti-serum to

4. Raise a phage to destroy a bacterium:

Culture the bacteria from cancer patient's blood (put it into a restrictive medium);

Find a phage which would devour it.

Certain bacteria can be repeatedly cultured from AIDS blood and Kaposi's phages raised against those, have optimum activity against HIV. It is imperative that Beta be availble on the page so we are not potentiating the phage which is carrying damaged genetic information.

There is a library of phages obtainable from the American

70

Type Culture Collection, known hereafter as ATCC.

Streptoccoal phages can be used to destroy sarcomas;

Staphloccocal phages affect carcinomas.

Fungi fungus

Range of amtibiotics produced by fungi: Fungi will produce anti-cancer anti-biotics; e.g. penicillin mold will generate a whole range of antibiotics capable of killing or

inactivating cancer cells.

1. To cure genetic disease: teach fungi to eat an abnormal piece of DNA;

71

2. Most genetic disease can be back-engineered into a fungal phase. Making anti-bodies against these fungi will remove the abnormal gene.

Yeasts Parasites

Phages

use pure phage:

1. anti-phage sera will cause breakdown wherever the phage is targeted.

2. sera could be raised in an animal.

3 By using heat, phenol and with or without an ativant, one can vaccinate against the causative and antagonistic

organisms. They can be used as tagging agents

72

Phages which are viruses that infect microbes, bacter and caused strong interference phenomena with HIV; therefore the virus infects bacteria which has no affinity for infecting human cells, being capable of preventing as well as treating AIDS

Antibiotics Synergistic

viruses

AIDS produces opportunistic viruses such as cytomegalovirus, Epstein-Barre and herpes.

AIDS: 1. Make antibodfies against AIDS CD4 receptors which AIDS virus binds to cell. Inject these into a horse. Get

73

antibodies against CD4 receptors. Wash anti-human factor from resulting antibodies. inject antibodies into person with AIDS or HIV. This should effectively kill off the AIDS (HIV) organisms.

AiDS Vaccine

1. inject AIDS cells into horse;

2. The hore will make antibodies against AIDS

3. Wash the antibodies and filter them out;

4 you use the horse antibodies to make avaccineagainst the HIV antibodies. bacteria

Nemesis organisms for synergistic bacteria produce products against cancer itself

j1. sera can be raised in an animall

74

2. by using heat, phenol and with or without an ativant, one can vaccinate against the synergistic organism. Tlhey can be used as tagging agents.

fungi parasites

phages

To create a phage:

phages can be raised from any organism by;

1. exposing it to radiation.

2. ultraviolet light

3. growing it out in a restricted medium

75

antibiotic

Affinity

these organisms carry direct, sometimes curative

anti-disease activity. It is preferred that each vaccine is prepared from organism fractions rather than from whole organisms, in order to reduce the possibillity of any systematic immune response against the vaccine. The patient should be vaccinated intially with the affinitive organisms and then vaccinated with the antagonist organism.

Another method for creating disease-specific therapeutic agents according tto the present invention involves the identificatin and use of organisms which demonstratean affinity towarda targeted disease . There are two types of affinity which such organisms may demonstrate: a microbial affinity toward actual cells of the targeted disease or a synergistic affinity toward the diseace such as that the

76

affinitive organism llives in harmony with the disease in the host ' s body . A specrum search for these type organism along with a spectru search for antagonistic organism and an epidemiologicalseach for the organisms which thrive in areas having a high incidence of the targeted diseases. An in vivo search should begin in the patient's body. A bipsy of the patient's diseased tissue may reveal an affinitive organism which is attracted to either cells of the actual disease or to diseased tissue. The the targeted disease is of the type whichj precipitates the production of blocking antibodies for coating diseased cells in order to protect them from the remainder of the body's immune system, the search for such affinitive organisms should include isolating the blocking anti-bodies which can normally be accomplished via pH precipitation techniques, the antibodies themselves may be used to carry antagonistic organisms or extracts thereof to the cells of a targeted disease.

bacteria

The general therapeutic approach in using the fo;und

affinitive organisms is:

1) Using the affinitive organism which are attracted to the

77

disease cells or diseased tissue as cyto-markers for othe organisms which are antagonistic to the affinitive organsm It has been found that an effective atttack against such cyto-markers by such antagonistic organisms will also be effectie against the targeted disease.

2. using other antagonistic organisms to attack the

synergistic organsms which are protected bhy the diseases's anti-immne factors, in order to break kdown the targeted disease's anti-immune factors. Process ;

Anti-normal cell serum: 1. raised against organism; whole parts or extracts with affinity for normal cells and activity against normal cells

2. Treat with anti-serum to the ones with affinity to normal cells: this has activity against disease

3. Result: removing from the anti dieseased ones, all the anti-normal mutants. The ultimate result is organisms highly selective for attacking desease.

78

fungi

yeasts parasites

phages

To create a phage:

phages can be raised from any organism by;

1. exposing it to radiation.

2. ultraviolet light

3. growing it out in a restricted medium

79

antibiotics

Neutral

In all morbid disease mechanisms, the hemoglobin generally diminishes. To make hemoglobin, inject spleen extract from PH patch extracts: The result is that the hemoglobin rises.

In cancer, leukemia and some other diseases the bone marrow shuts down. Generally, bone marrow transplants have been used to reseed with normal bone marrow cells. This has resulted in temporary improvement until these normal cells are once again transposed into abnormal cells by the disease mechanism. A new method of making bone marrow dispenses with the surgery and is safer and can be utilized a multiplicity of times. To make bone marrow; culture Peyers Patches in the spleen with the organism; you allow them to raise anti-bodies; you precipitate the antibody by dropping the Ph. Pass it through a 0.2 filter and add bone marrow. Attach to a salt or ammonia crystal for a pure form.

80

Normal Cell Vaccine

Inject a sheep with normal cells;

2. Sheep makes antibodies against normal cells and normal cell fragments;

3. This antibody will take anything out of the mixture that's normal.

Alternative normal Cell lV accine 1. Saturate an animal at birth with human cells; 1

2. Continue to saturate it with human cells througnhout its adult life;

3 The result will be; tolerance of human cells; it will stop making antibodies against human cells.

Tomake an anti-aging vaccine;

Take cells out of body. Age them in test tube. Then inject them into horse. This will make antibodies against aging cells. Wash them to remove anti-human factor. Then put anti-bodies into testtube of old cells. Then vaccinate against old age.

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viruses

1. Take virus without affinity for cancer;

2. Put it in broth with cancer;

3. Give it ultraviolet light or UPU

4. The result will mutate and go off to the cancer;

5. It is now trained to be aggressive to cancer. bacteria

Take bacteria without affinity for cancer:

1. put it in broth with cancer

2. Give it ultraviolet light or upu

3. This results in mutation which would go off to the cancer

4. it isnow trained to be aggressive to cancer.

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Mycrococus radiodurans group of organisms and durans

bacterial agents are anti-oxidants which neutroze stressful chemical by hyperoxygenating patients' blood. it can be boiled, broken, fragmented, injected, taken orally, inhjaled, inserted rectally or in nose, regenerates and can reverse AIDS. Universal antidote. To make an athlete 30% more powerful or racehorses 30% more capable, makes radiation resistant, repairs cells fungi

TAke a fungus without affinity for cancer

1. put it in a broth with cancer;

2. Give it ultraviolet light or UPU

3. then it will mutate and go off to the cancer

4. it is now trained to be aggressive to cancer

yeasts

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Take a yeast without affinity for cancer

1. put it in a broth with cancer

2. give it ultraviolet light or UPU

3. then it will mutate and go off to the cancer

4. it is now trained to be aggressive to the cancer

parasites Take a parasite without affinity for cancer

1. put it in a broth with cancer

12. give it ultraviolet light or UPU

3. then it will mutate and go off to the cancer

4. it is now trained to be aggressive to the cancer

phages

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To create a phage:

phages can be raised from any organism by;

1. exposing it to radiation.

2. ultraviolet light

3. growing it out in a restricted medium

antibiotics Antagonistic

virues

bacteria

organism produce specific enzymes for digestion of diseased cells or disease-causing bacteria.

each found and tested organism is lysed or fractioned via

85

physical lysis, chemical lysis, biological lysis, etc) in orde to reduce each organism to fractinswhich are sfficentl small sudh that when placed inside the patientk a systematic immune response against the antgonistic organism is

prevented. it has been observed that fractions which are filtered so that no comoponent thereof greater in size than 0.02 microns is utilized in the prepared vaccine, elicity only little, if any systematic immune response. Further advantages which are gained in not using entire antagonistic o;rganisms ina vaccine include the abilty to have a more controlled breakdown or die-off rate of the targeted disease and the occurrence of fewer side effects. fungi

yeasts

parasites

phages

To create a phage:

86

phages can be raised from any organism by;

1. exposing it to radiation.

2. ultraviolet light

3. growing it out in a restricted medium

use pure phage:

1. anti-phage sera will cause breakdown wherever the phage is targeted.

2. sera could be raised in an animal.

3By using heat, phenol and with or without an ativant, one can vaccinate against the causative and antagonistic

organisms. They can be used as tagging agents

antibiotics

Nemesis

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nemesis organisms compete for substrate nutrition or metabolic products with the disease by secreting compounds into diseased metabolism, function and growth and by inducing immunology and other responses detrimental to the disease

Libray of different digested enz;ymes from different

Nemeis organisms

The pprocess of using the Nemesis organism is as follows; 1. Isolate clear mortric form of cancer's specific organism; 2. have the nemesis organism raised against it or

antagonistic organism raised against it;

3. Tlhis results in all mutations of the cancer cell or

4. organisms raised against them;

5. Have them all tagged by specific organisms;

6. Raise anti-sera against cancer cells;

7. Raise Various pre-motric forms of causative and

synagistic organisms;

8. Raise anti-sera against the tagging you're going to do.

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Plate cancer cells in order to obtain chemotherapeutic agents

AIDS Cure:

2 mEA (mecap2 Ethylamanime) also called systime or cisteomine combined with an antiviral agent such as Metralater

Hydroxitolomene BHT or combined witha nemesis organism and related thiols and aminothiolsmakes a therapeutic agent.

This patent is based on research that cysteamine or related thiols/aminothiols demonstrated documentedeffects in

improving T4/T8 aratios in animals and beings generally immunostimulant.

viruses

v. stimulate the organism to produce interferon

organisms are used to tag diseased cells, then anti-sera can

89

be raised to attach tagged cells. The advantage is one knows what the side effects are of a nemesis organis one has put in to stretch out the cell membrane.

Leukemia: Feline Leukopenia virus drops white cell count; 1. Take patient's leukemia cells and feed them to Leukopenia virus, then inject it back. teria ge-lysed staphylococcus albus has been found to be well- generated when used as a therapeutic agent in doses of 2 . 5 CC Try second or third day. In ivo testing be conducted intradermally in order to observe the cutaneous reaction to vaccine. Initial dosage should be in the 0.1 CDC range s dosage may be increased via doubling daily until the e of the local reaction is six inches or greater. The ient's temerature will often rise to 103 degrees F and

90

t a few hours. Depending on the size and activity of the pounds , co;ntinuing administration my be intradermal, ravenous, sub-cutaenous intradermal, intramuscula or oral. :line of the targeted disease, such as tumor shrinkage, uld be demonstrable in blood tests within a few days after : inital vaccination. Tumor shrkage should be demonstrable x-ray within two or three weeks. If such disease decline not observwd, the same treatment should be repeated with :ernate vaccines from other of the cultured pathogens until :her such effect is observed or allof the prepared vaccines 'e been tried. Then Animal B will make anti-anti- human antibodies What you have left is an antibody system which is highly specific for a cancer and cancer bacteia after you've precipitated out the anti-human antibodies

Plate out bacteria cultured from cancer patients' blood. Plate out chemo to see the best one for the cancer;

Get the nemesis organism to feed on nothing but cancer bacteria and/or cancer cells.

Result: highly specific chemo agent.

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Make 3 organism types;

1. Feed organism cancer;

2. Feed organism bacteria

3. Feed organism both bacteia and cancer

4. Place nemesis organism with normal cells.

5. if new organism kills normal cells, uu look of amutant strain of it.

6. You plate it until it stops eating normalcells.

There are normal comoponents also to a cancer cell:

mytrochardin and nuclear tissue. You remove everything norrmal. Then bacteria are taught to feed off the disease.

fungus

yeasts

parasites

phages

93

To create a phage:

phages can be raised from any organism by;

1. exposing it to radiation.

2. ultraviolet light

3. growing it out in a restricted medium

Staphloccocyl phages and phage licates may have anti- streploccal and anti-cancer properties aswell asanti-other desease activity. Lung cancer is treated by metrastaphloccoccal phages. But because of resistance, phage must be changed every week.

Carcinoma responds to streptoccocal phages.

antibio;tics

B

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Electromagnetic Energy, Mechanical, and other Electrical

Devices For Healing

C.

Surgenics: A New Science Involving Advanced Genetics, Nemesis Organisms, and Immunology

This new science of genetics is used in accordance with the previously mentioned new technologies involving the Nemesis organisms and raising the immune system but it is principally employed to dislodge and generally destroy all so-called genetic diseases which are thought TO BE incurable by present scientific standards and principles but which this inventor has been able to cure and stop entirely so that it

95

is no longer passed on to future generations.

Surgenics generally supports and perpetuates the reseach in corn and maize genetics which revolutionized the field of botany in the publications of the late Nobel Laureate Dr. Barbara McClintock. While her considerable publications over more than seventy years (cite bibliog here) dealt only with botany, it suggested to this inventor new ways in which genetics and genetic engineering, unlike anything practised or known by science today can be utilized to eradicate all human and animal genetic disease. Causative or Infective

Three things adumbrate this new scenece:

1. Demonstrating the capability of raising an immune response against dieased cells from bacterial organisms isolated from patients' specimens, although bacterial cannibalism of cellular structures could allow for crossanti-genicity, this is a much more intimate phenomeno;n as evidenced by

96

2. Antibodies raised against such bacterial genetics will cause lesions in diseased cells' nucleii, thereby firmly suggesting that the diseased cell (e.g.,

cancer cell) and the associated bacteria share genetic material.

3. Current definitive evidence to support this observations is being sought by the use of poly merase chain reaction or PCR amplification of cell and related bacterial genetics.

Affinity Perhaps even more intriguing is the pheomeno;n of isolation of cell-wall deficient bacteria from leukemia cells and similar organisms from children with Down's syndrome. There two disease conditions show some cell-wall stable bacterial and are linked clinically by the frequent progress of Down's syndrome sufferers into full-blown leukemia, in vitro and in vivo data have shown the ability to eliminate leukemia cells by raising vaccines aaist such orgnisms. Laboratory work has also been done to show that vaccines raised against bacterial genetics will cause a leukemia cell either to die or

redifferentiate into normal while blood cells. Preliminary work also suggests whnat titrated doses of lsuch vaccines

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maybe capable of selective removalof the genetic abnormally in Down's Syndrome.

This leads the way to curing genetic and aroany other

diseases. It is also further possible to culture microorganisms in a base of compounds one wishes to address selectively or remove such that the organisms will

cannibalize and express those compounds. For example, culturing a virus or a bacteria in a broth rich in abnormal genes will lead to the expression of that gene by the bacteria or other organisms and multiply laboratory and clinical applications. Furthermore, antibodies can be made in the animal system or in vitro for elimination of such targeted compounds. Explorations in these suggested areas will lead to an entirely new science, morphology and

subsequent discoveries, some of which I have already been working on.

Genetic transfer of characteristic which have been identified as desireable from a micro-organism to a patient as disease¬specific therapeutic agents can be effected. It is known that various bacteria, viruses and other simple organism have capabilities beyond those which are currently available in

98

the body of man. For instance, some bacteria have been identified as having sufficent heat resistance for allowing the bacter to thrive within boiling volcanic pools. Other bacteria have sufficient thermal resistance to allow them to live in arctic regions. Still other bacteria are capable of photosyntheis (athe ability to transform sunlight into oxygen and forms of energy). Yet other bacteria have shown a high resistance to radiation. Bacteria brought back from outer space exhibit other characteristics. It may be further deduced that the extra-regenerative capabilitis of the salamander or the frog, for example, can be ultimately identified and linked to either a micro-organism or another biological factor. It is the belief of this inventor that such characteristics can be transferred toman via the methods outlined in the present invention in order to create whole new families of therapeutic agents.

Synergistic

It has already been observed that certain regnerative characteristics from micro-organism having an extra-regenerative capability such as those organism which are thermally resistant or those which are radio-resistant, can

99

be transferred from one species to another. In fact, the inventor has prepared vaccines from various radiodurans which demonstrate such an extra-regenerative capability. When these vaccines were administered to laborator rats, the survival stamina of the rats as demonstrated by their ability to stay aloat unsupported in a body of water was

increasedfrom an average of 45 minutes to well over six hours. Such a vaccine was also administered at a dose of to a human patient who had undergone extreme radiation poisoning and had exhigited damage to the heart and

Within twenty-four hours, the patient (a twenty-eight year old male) had undergone a complete recovery and demonstrated no sign of either damage or scarring of the heart and . (this must be backed up by ekgs) Two lasting side effect have further been -exhibited in this patient.

(Sami, you're speaking of yourself here, aren't you?) The first involves the patient's normal energy level. Prior to undergoing the single dose treatment of the radioduran vaccine, the patient exhibited average sleeping patterns and habits. For three years since the treatment, however the patient has been able to stay awake continuously for periods of from three to four days without any apparent loss of alertness or other mental functin, as that which loss normall accompanies prolonged periods of sleeplessness. (Sami, this

100

needs to be proven by tests which measure alpha waves etc. It is too anecdotal.) The second lasting side effect

exhibited in the patient also concern his energy level but is associated with his athletic ability. Without any increase in normal physical activity, such as exercise or practice, the patient has repeatedly demonstrated the ability to lift an amount of weights which exceeds the maximum anout he was able to lift priot to the treatment by as much as three times. Still further, although lifting such amounts of weight has caused tears in various involved muscle groups, such tears have been completely healed within a couple of days. Similar effects have bneen observed in terminally ill cancer patients using vaccines made from extracts or organisms which demonstrate similar extra-regenerative characteristics. Two symptoms which are common during the final stages of a cancer area lack of energy and a high level of pain. When such patients have been treated with vaccines prepared

fromorganisms exhibiting such extra-regenerative

characteristics in accordance with the method of the present invention, the aptients have exhibited an exceptional loss of pain and a significant increase in overal energy levels. No negative side effects of the treatment have been observed.

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Antagonistic

Another common mlady which the inventor believes may be readily treatable via the method of the present invention is that of old age. This involvesaging in vitro various cells which have been extracted from a pateint's body. After such cells have been aged, and any afctor isolated from the cells which may be associated with aging , m it is necessary to identify or raise organisms which are antagonistic toward the identified aging factors, preparing vaccines from these antagonistic organisms as with earlier described embodiemts of the present inventio;n, testing and treating the patient with the vaccines.

One method of identifying the aging factors involves nonhuman hosts. A first non-human host is inoculated with the aged cells. It will then raise antibodies against the aged cells which may be subsequently extracted for the first nonhuman host via means which are known. in order to "wash" any anti-human factor from the sera extracted from the first nonhuman nhost, a second non-human host of the same type is inoculated with normal, non-aged cells from the patient.

This will raise anti-human antibodies in the second non-human

102

host, which can then be extracted and applied in vitro to the sera extracted from the first non-human host, for

precipitating the anti-human factor out of the first host sera and thereby leaving the anti-age factor antigodies in the sera for use in the patient. The resulting vaccine can be used not only for life extension as indicated above but to cure a genetic disease (give name here) which is seen in children born with the "defective" gene and who age horribly both in their cells, organs and in physical appearance by the time they reach puberty at which time they die of "old age."

Monitoring of the Hay Flick limit is another method that can be used to identify and exculpate aged cells. It is known that the Hay-Flick cell division equals approx. 50 per human during a lifetime. Tlhus, the ability to replace aging cells is finite and determined by the insults and stress to the cells (causing more acceleratedcell divisions) during the individual's lifetime. The number of cell division remaining in each cell can be determined as a base time-interval betwen each cell division. To extend the cell division, thereby making the individual better able to fight disease insults and extend his lifespan, take an ameoba. make extracts and add to normal cells. These cells will divide two to six time more than normal. Will extend the lifespan by that count.

103

Dose;5cc The efficacy of the vaccine can be detemined by checking the base-time interval between each cell division before commencement of treatment, during the treatment and after the treatment.

Neutral

The inventor has also created certain extradermal, cosmetic, and oral preparations utilizing the organisms described herein for therapeutic, biolgically enhancing, as well as physically pleasing aspects to the course of intervention in the disease-producing aspects inherent in human evolution. These inventions augment the efficcy of the aforementioned inventions, act as a disease preventive and as synergistic agents for the immune system. They include:

a. food products:

a. cheeses;

b. yogurts

b. immune enhancing products:

1. vitamins: Gold Formula

104

2 . life elixirs

c. creams and lotions

NENESXS

Identifying the genesis of chemotherapeutic agents which have been used therapeutically against targeted disease, although commercially prepared using conventional time- consuming and expensive drug development techniqus can be effected by understanding how said agents can point to an original Nemeisis organism from which it was derived. In such cases, the original Nemesis organism my be utilized to develop still other derivatives for therapeutic use against various modifications of a targeted diseased that may develop as cells of said disease respond to the chemotherapeutic agent by evolving into forms which are resistant to said chemotherapeutif agent. In fact the forms that can be caused to orginate in this way can be said to be infinite.

An antagonism in the Nemesis organism may be raised or

105

enhanced via methods earlie described herein and then co- incubated in a nutrition-deprived media with cells of the targeted disease. As is known, the disease cells will attempt to mutate in order to prevent annihilation by the Nemesis organism. Unlike non-living therapeutic agents, the Nemesis organism will likewise evolve in order to retain an affectity against the disease cells (because the desease cells has become its nutritional source as described earlier).

The evolved Nemesis organism, extracts or modifications thereof, may then be used effectively against the

associatedmutated strains of the targeted disease. Accomplishing such mutations in vitro is an economican and an improved effective technique of preparing vaccines targeting potential in vivo mutations of a targeted disease. It is the inventor's recognition of the unique ability of microorganism to adapt quicking to their that led him to many of the therapies and methods for creating therapeutic agents according to the present invention. As he further observed, the speed at which micro-organisms adapt to environmental changes maybe used to prepare a library of Nemesis organim extracts andmodifications which can be used to prevent a targeteddisease from gaining a perpetuaing resstance to the theraputic agens. The inventor has furher discovered that

106

the simultaneous or near-simultaneous use of such a library canbe very effective in completely destroying a target disease. In the case of AIDS, for example, which is known to mutate in minutes so that the various forms of HIV being seen in the laboratories today is quite different from the virus which was first seen in 1978 at the recognition of the commencement of the disease, a built-in mutational factor can be incorporated into the vaccine so that it can mutate along with the virus, thus causing the diseases demise more quickly and effectively.

Anlother aspect to the method of creating disease-specific therapeutic agents according to the presentinventio;n involves chemotherapeutic agents which are non-specific for disease. The specificity of such chemotherapeutic agents can be enhanced by incoroporation in their application affinitive organisms which have been identified as hving a high affinity for the targeted disease instead of vaccinating a patient directly with a chemotherapeutic agent. Such agent can be applied in vitro to an affinitive organism, thereby tagging the affinitive organism which is prepared in accordance with the methods of the present invention and administered to the patient. The affinitive organism, or extracts or

modifications thereof used in the vaccine will carry the

107

chemo therapeutic agent directly to cells of the targeted disease. Should it be desirable to limit further the effect of such chemotherapeutic agent on the patient's body, organisms which are antagonistic to the chemotherapeutic agent may be raised by preparing vaccines in accordance with the method of the present invention so rthat these

aforementioned vaccines may be used to shorten the life the the chemotherapeutic agent inside the patient's body;

4. Illustrations of the Efficacy of Using the Inventions described in this application in vivo Plate 1 ullustrate a case of intraductal carcinoma of the breast in a 48 year old female. Pate 2 is the same breastas in Plate 1 after 21 days of therapy in accordance with the methods of the present invention. Note that the tumor is better defined and regressed from the skin.

Plate 3 illustrates a case of inflammatory breast cancer in a 68 year old female.

Plate 4 is the same breast as in Plate 3 after tweve days of

108

terapy in accordance with the method of the present

invention. Note the significant amount of tumor shrinkage.

Plate 5 illustgrates a case of an ulcerating adenocarcinoma in a 73 year old female.

Plate 6 is the same breast as in Plate 5 following two weeks of therapy in accordance with the method of the present invention. Note the marked shrinkage.

Plate 7 illustrates a case of adenocarcinoma of the right breast in a 42 year old female.

Plate 8 is the same breast as in plate 7 following three months of therapy in accordance with the method of the present invention. Please note the marked reduction in size and density of the diseased tissue.

Plate 9 illustrates the left breast of the patient of Plates 7 and 8, also diseased with adenocarcinoma.

109

Plate 10 is the same breast as in plate 9 following three months of therapy. Note themarked flattening of the tumor.

Plate 11 illustrates a case of aggressive adenocarcinoma in a 40 year old female.

Plate 12 is the same breast as in plate 11 following two months of therapy in accordance with the method of the present invention. Note the slight change in size of the tumor. Plates 15 and 16 show the same breast after the third and fourth months respective, of therapy.

Plate 13 illustrates a case of an ulcerating adenocarcinoma in a 70 year old female.

Pate 14 is the same breast of plate 13 following ten days of therapy in accordance with themethod of the present

invention. Note the dramatic reduction in both size and density of the tumor.

110

Plate 15 illustrates a case of squamous cell carcinoma of the right lung in a 56 year old male.

Plate 16 is the same patient as in plate 15 following two weeks of therapy in accordance with themethod of the present invention. No;te the marked shrinkage.

Pates 17 and 18 are close-up view of the same patient as in Plates 15 and 16. Plate 17 reveals hepatoma encapsulating the right lung while plate 18 reveals elimination of the heptoma after two weeks of therapy. Plate 19 is a CT brain scan illustrating two brain lesions which are a secondary infection from small cell lung carcinoma in a 73 year old female.

Plate 20 is a CT brain scan of the same patient as in Plate 19, revealing complete disappearace of one tumor mass and shrinkage of the other after two months of therapy in accordance with themethod of the present invention.

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[list all the illustrations to be used. Do they come from the gold book? If yes, then I can add them all here]

4.

Preparation and Demonstration of Antiodies Produced by

Nemesis Organism in vitro

Bacterial/Viral Methodology

A. Culture Media

1. enriched media raise major number of mutants of which one or more may carry activity; when mutating agents treated with ultra violeat light or ozone/peroxide, etc. enables mutation and mutational support so there is a maximum pool e.g., culture penicillin-species with staphyloccus species as in media nutritious for both, conjointly or separately. When mixed, these will be a great variety of staph and penicillins.

When cultured together in enriched media the staph is able to generate many penicillin- resistant species, then penicillin is able to counter.

2. selective media favors growth of one or more organisms.

The degree of selectivity in mutation enables the

preferred organism to have a biological "edge", ie. a

112

penicillin- resistant staph starved of adequate

nutritional support will be less likely to mutate away from an enhancd penicillin response. The penicillin response and diversity is promoted by the medium.

3. minimal media for one/more or all organisms to create new mutation and competition. It promotes active mutation of competition between species especially when each only has the other as a food supply. e.g., Penicillin mold starved of other nutrition will develop antibiotics and/or the responses to kill/breakdown/digest and utilize bacteria or bacteria fragments in minimal media. For example, a penicillin- resistant staph can be placed whole or in part/fragment with penicillin mold in minimal medium to allow penicillin to develop.

in a neutrally restricted medium, one of the organisms will triumph over the other, by their passaging, that organism through selective/enriched +/- mutating factors. Many of its possible presentations will be resistent mutations which will then manifest and can have mutating strategies, e.g. vaccinating against R forms; or raising new antibiotics.

113

(Sami, following are notes and I don't understand them.

Please explain)

a. Many R mutants can be specifically neutralized by pne techniques giving better results in effective organism mold which start as a fragment |

Can also |

115

efficacy of antibiotic can be tested by vaccinating or raising antisera against R. e.g. anti plasmid or anti penicilla n |

|

3 specificity of antibiotic

By washing with normal cells or normal gut flora to remove antibiotic strain.

Spectrum analysis

visual interference List of Ingredients Grams per Liter

Bacterial Vaccine for the Treatment of Cancer

To induce Rediffentiation;

PLRI

amplify each phas

- - RNA/DNA the coding for redif ferentiatin .

plasmid

116

Exact Directions Follow

11. Organism

Isolation of Nemesis

The reaction is:

1. How much per weight was given in controls (in vitro or in vivo) ? 2. How much per weight was given in patients?

5.

Results

It is believed that - - - - - - - vaccine can do - - - - - - - . The tests demonstrat that this diminuation of tumor resulted in days.

The culture was obtained from - - - - - - - - - , place - - - - - - - - - , lotno . - - - - - -

6.

Alternate Preparation Methods;

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Radio immuno-assay technique for Isolation of - - - - - - - -derived from - - - - - - - -.

(Describe in accurate detail listing amts. etc.).

List ingredients and "recipes" for each of the vaccines you wish to include here.

7.

Significance of the Experimental Evidence that is produced by - - - - - - - - - - -in vitro or in vivo.

(Cite a publication here) Recent evidence that - - - - - - -appears to slow down or diminish tumor growth has been presented by - - - - - - - - - . Breaking the chain host dominance by - - - - - - may havetherepeutic value. (Describe how vaccine accomplishes this purpose here).

The production of the Nemesis Vaccine in vitro by - - - - - - -. its Neutralization by tagging in vitro and in vivo - - - - - .

The Nemesis. Describe what happens.

The Microbe

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The Virus

The Fungus

The Parasite

Other embodiments

Basicallyt It is the inventor's contention that there exists for each disease associated organism a naturally occuring cytotoxic or "Nemeis" organism which is capable of

substanially inhibiting morbid effects of the particular disease without preciptating significant pejorative side effects.

The inventor has observed three naturally occuring phenomena which affect disease cures and are primary sources for Nemesis organisms. These are:

1. Spontaneous remission; 120

Organ and Species resistance; and

Cellular redifferentiation.

It is further claimed that this inventor has created a new technology which embraces all aspects of healing : organisms and immunology; electromagnetic energy, mechanical and other electrical devices for healing and surgenics, a new science involving advanced genetics, Nemesis organisms, and immunology.

Moreover, this new technology provides direction whereby there is a method

i. of preventing , diagnosing, definining the cause of the disease, treating, ameliorating, and curing disease and

121

disease-mimicking conditions which assault humans and animals physically, mentally, and emotionally either through infection, genetics, biology, alteration of

RDA/DNA, radiation and/or chromosomal damage.

ii. of treating cancer and other diseases, both human and non-human, whiether physical, emotional, ormental, by creating and using different disease-specific therapeutic agents (organisms, extracts, parts thereof), regulates reroutes until efficient immunological mechanisms and general immune reactions, which are biological, botanical, viral, parasitic, microbial, fungal,yeast, antibio;tic,phagel, genetic, electric, mechanical, electromagnetic, can be targeted and appropriate vaccines which will cause the immune system to generate totally new enveloping immune responses which are effective in combatting all autoimmune, degenerative, genetic diseases and cancers and fight off these insults successfully by rendering said organisms pwoerless. iii. diagnosing and disease causing disease-causing

organisms by performing a spectrum search for organisms associated with targeted diseases both in vitro and in vivo, through a library of such organisms and by global geographic

122

search;

iv. by testing each new found disease-associated organism in vitro and/or in vivo to gauge the type and level of its acivity toward the targeted diseas and

v. by preparing a vacinne, serum, 1 compound, effusion, mixure, etc. from the disease-associated organisms as per the categories of causative, synergistic, affintive, antagonistic, neutral, and nemisis as described herein with its aattendant categories of causative agents (microbial, bacterial, viral, fungal, parasitic, phagic, antibiological) as described herein. vi. by presenting the human and non-human host with an assortment of tools, as described over, inherent within this new technology so as to provide disease-provoking organisms (fungi, parasites, microbes, viruses, and particles recently discovered which are smaller than viruses) which, with other particles, extracts, sera, anti-sera, phages, concoctions, infusions, mixtures, broths, etc. cause remissions.

vii. by using the red blood cell which is a cellwithout a

123

nucleus so it becomes a vector expressing the biological cell and makes an ideal vessel for physical, biological and chemical agents that can modify the cell function. For example, it can become an alternate immune system and can be used in binding immunabilty using bacterial, phage, biological and chemical extracts. See the additional pictures and text.

viii. by providing a new therapy which has remarkably few side-effects, especially when compared with other forms of treatment for cancer, for example which employs adjuvant chemotherapy or h igh dose application of lymphokines orradiation or bone marrow transplants.

This invention provides for the following:

1.a method for creating disease-specific therapeutic agents from organisms, extracts or parts thereof (which are viral, microbial, parasitic, fungal, bacterial, phagial or

antibiotic) and whose origin are animal, chemical, botanical, biological, inorganic substances, elemental, molecular, metalurgical, electro-magnetic machines with varying

124

frequencies and coils, (Sam, in this category we can include all the machines so as not to have a separate set of patents) and which will destroy the cause of disease or render it harmless;

2 to conduct a spectrum seach of all known and possibly some unknown diseases organisms in order to compile a library of said organisms against which to raise vaccines along the lines described in this invention;

3. a method for enhancing a patient' s immune system to the point where it can effectively respond to any disease.

a method of creating and using phages before preparing a vaccine so that the targeted diseasemay e subjected to the effects of associate phage lysis.

4. a mthod for crating disease specific therapeutic agents by using ultraviolet/radiation/phenol/alcohol/heat and other means before the step of preparing a vaccine so that the targeted disease may be subjected to radiation from the associated organism or extracts thereof

125

5. a method for using other organisms within a patient's body forr obtaining agents with which to fight disease and disease-causing organisms;

6. a method for creating disease specific therapeutic agents wherein the targeted disease is cancer related, due to degeeration of body tissue by natural causes, where the targeted disease is AIDS or AIDS related, genetic, or auto-immune.

7. a method for regeration the cells of the patient both to ameliorate the factors imposed by the disease or disease causing organism, to alleviate pain and discomfort, or to create greater endurance, strength, alertness, energizing, etc. factors and tol lengthen the life span of the

individual

8. a method of inculcating disease-fighting and immune- boosting factors into various food, oral, and interdermal products.

9. a method of creating and using electromagnetic machines,

126

devices, and electric and/other such machines, devices etc. to be used alone orr in conjunction with the other therapies herein descibed to fight disease or disease-causing

organisms, to boost electrophoresis in the individual and/or to change or cause mutation in organisms used in conjunction with healing and longevity, rto cause the patient to be sujected to bombardment by a wide band of electro-magnetic induced frequencies for stiulating the cells of the patient's body and cells of the atarget disease to resonate at naturl resonance levels such that diseased cells maybe

differentiated from normal cells. 10. a method wherein the disease specific therapeutic agents may be used to mo;onitor the targeted disease within the host's body;

11. a method for utilizing deprived, medium, and rich media to culture cells or disease-causing elements;

12. a method for administering the resulting vaccines and sera interdermally, intermuscularly, cub-cuteously, or orally or extradermally.

127

13. a method for obtaining and utilizing cells from Other souces of cells with comoponents which maintain integrity in the facet of most disease such as muscle tissues . Extracts of these seem to have potent antidisease activity. llA patient may have extracts of a muscle biopsy activated( enzymatic or biolical organism fortification or amplification by any other means) and injected or may have animal extracts inected.

Intramuscular injection of a hypo-osmotic solution will also release some components of muscle cells so that they may exert same therapeutic action.

14. a method of adminsitration of vaccines raised against opportunistic organisms utilizing one or more of the following methods:

a. modifying/denaturing orr mixing whole/fragment or extracts of this or related or attenuated orgaisms alive or dead with adjuvants;

b. Culturing using or raising Nemeses organismst against the oppornistic organisms;

c. using or raising an animalls' immune and other response against opportunistic organisms.

128

d. prophylactic vaccines may be raised as preventative

agents. This includes autogenis vaccines. For example, one may develop cancer in vitro from normal human cells (or aged cells) and prepare treatment modalities as outline above.

e. a natural method for making bone marrow

f. a natural method for making blood platelets g. a natural method for repairing all living cells

h. utilizing all the methods and modalities ooutlined in this patent, any disease, disease causing organism which afflict human and non-human hosts, even old age and degeneratio;n, may be anticipated and treated.

10.

129

iii. The method of Claim 1 wherein said carrier is iv. List all processes here for each claim.

induce re-differentiation

132

PLR1 amplify each phase

- - - RNA/DNA

plasmid

the coding for re differentiation

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

2-MEA and related thiols and aminotthiols in the treatment of AIDS

other viral immunodefeicient

or immunodejefunctional (sp/?)

states

133

Autoimmune states

(such as SLE)

diseases of free-radical

gendration

Degenerative/ inflammatory disease

As adjunct to chemotherapy/radiology Introduction

Cyseamine/ 2MEA used previously as treatment for cysteeuire (?)

and some experiments to confer radioresistance

this patent covers and is based on observation that

cysteamine x/or related thiols/aminothiols also demonstrated

134

documented effects in improving T4/T8 ratios in animals and

beings generally immunostimulant.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - pretetum

crude pes

female

fed MN etc repetative

chemo teething

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

in pure or organically bound form.

With or without other compounds such as BHT, Ciemetidue,

135

activated Lecithin, Acidophilus/orther living organisms

- - - effective Rx

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Horse serum

Horse/other animal immune system W/PE

TF/serum etc,

Penicilli vs disease

Chemo W/PE

DSE p/c/biol sep from NCE

Select those with appetites/ raise appetites

136

1} Radio

2) Imaging

3) MEA

4) Penicillin notation us aid

as us ton sarcoma ok +/-egbt/T 5) Chemo

Pern /antibiotics - - - prepetial Rx

6) Horse Serum as HIV routates

and oe (?) antibods

DSF Resistance SP

pen + DSF plasmid/RNA DNA

etc

137

- - - inhibit resitance

Plasmid resistance

Genetic engineering to get plasmid

effect antibodies penicilli + antipenicilluase antibody.

|

Pat to | efficacy of antibodies

Horse serum/ immune entracts etc.

3D

- - - - - grnen(?) /receptor

138

Ighe- IGC Healing

of dedicated animal

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

PCT Prefential Culture Techniques

-AIM- developing of specificity

awakening/isolating/coating properties

139

A-Enriched

B-Selective

C-Minimal

B. Selective favors growth of one or more organisms C. Minimal media for one/more or all organisms to create new mutation and competition.

Examples of use

Enriched+/- mutating agents

eg

UV

ozone/peroxide etc.

140

enables mutation & mutational support

so maximum pool.

e.g. culture penicillin-species with staph species

in media nutritores for both,

conjointly or separately

when mixed these will bea great variety of staph and penicillines

B. Selective Media

the degree of selectivity in mutation

enables the preferred organism to have a biological "edge"

ie. a penicillin resistant staph starved

141

Penicillin response and diversity promoted by medium.

C. Minimal media

promotes active mutation of competieon (?) between species especially when each only has the other as a food supply e.g. Penicillin mold starved of othernutrition will develop antibiotics and/or other responses to kill/breakdown/digest and utilize bacteria or bacterial gragment in minimal media.

For example, a penicillin resistant staph can be placed

whole or in part/fragment with penicillian mold in minimal mediato allow penicillin to develop

142

new antibiotics/enzyroes/other techniques to

kill/digest/neutralize/utilize staph.

Many of its possible presentations /resistent mutations will then manifest and can have mutating strategies

e . g . 1 . vaccinating against R forms

2. Raising new antibiotics

Many R mutant can be

specifically neutralized by pne techniques giving better in effective organism mold start as frag.

143

|

CAN also |

efficacy of antibiotic by vaccinating

or antisera against R

eg anti plasmid

or anti penicillian

|

| SPECIFICITY of antibiotic by washing with normal cells,

ornormal gut flora to remove

antibiotic strain

spectrum analysis

visual interference

144

Surgenics

A New Science

Three things which support and perpetuate McClintock 's genetic theories:

1. Demonstrating the capability of raising an immune response against diseased cells from bacterial organisms isolated from patients' specimens, although bacterial cannibalism of cellular structures could allow for cross- anti-genicity. This is a much more intimate phenomenon as evidenced by

2. Antibodies raised against such bacterial genetics will cause lesions in diseased cells' nucleii, thereby firmly suggesting that the diseased cell (e.g. cancer cell) and the associated bacteria share genetic material.

3. Current definitive evidence to support this observation

145

is being sought by the use of poly-merase chain reaction or PCR amplification of cell and related bacterial genetics.

Perhaps even more intriquing is the phenomenon of isolation of cell-wall deficient bacteria from leukemia cells and similar organisms from children with Down's syndrome. There two disease conditions show some cell-wall stable bacterial and are linked clinically by the frequent progress of Down's syndrome sufferers into full-blown leukemia. In vitro and in vivo data have shown the ability to eliminate leukema cells by raising vaccines against such organisms. Laboratory work has also been done to show that vaccines raised against bacterial genetics will cause a leukemia cell either to die or redifferentiate into normal white blood cells. Preliminary work also suggests that titrated doses of such vaccines may be capable of selective removal of the genetic abnormality in Down's Syndrome.

This leads the way to curing genetic and many other diseases. It is also further possible to culture microorganisms in a base of compounds one wishes to address selectively or remove such that the organisms will

cannibalize and express those compounds. For example, culturing a virus or a bacteia in a broth rich in an abnormal gene will lead to the expression of that gene by the bacteria

146

or other organism and multiple laboratory and clinical applications. Furthermore, antibodies can be made in the animal system or in vitro for elimination of such targeted compounds. Explorations in these suggested areas will lead to an entirely new science , morphology, and subsequent

discoveries. RAISING AND PROCESSING OF LYTIC PHAGES.

MANY BACTERIA WILL UNDERGO PHAGE LYSIS WHEN EXPOSED TO

TRAUMATIC/OTHER ENVIRONMENTAL CHANGES WHICH MAKE BACTERIAL

SURVIVAL DIFFICULT IF NOT IMPOSSIBLE.

SUCH CONDITIONS MAY INCLUDE MEDIA DEPLETED OF NUTRIENTS, CHANGES

IN OSMOLARITY,PH,ADDITION OF ANTIBIOTICS ETC.

PHAGE ACTIVATION MAY BE PRECIPITATED BY OZONE,UV RADIATION

AMONGST OTHER FACTORS OR AGENTS.PATENT COVERS ALL THESE

TECHNIQUES AS WELL AS THE USE OF PRE-EXISTING PHAGES

PHAGES EXTRACTED FROM TARGET ORGANISM

PHAGES CAN BE EXTRACTED FROM CULTURES OF TARGET ORGANISM BY CULTURING IN CLOSED OR IN OPEN SYSTEMS. SYSTEMS ARE CLASSIFIED AS OPEN OR CLOSED DEPENDING ON HOW ACCESSABLE THEY ARE TO OUTSIDE ORGANISMS/INFLUENCES;OPENNESS MAY EXIST IN VARIOUS DEGREES.

CONTINUOUS CULTURING OF BACTERIA WILL OFTEN LEED TO SPONTANEOUS

LYSIS FROM ACTIVATION OF INHERENT PHAGES.

OPEN SYSTEMS WHICH PERMIT INTERACTION WITH OTHER FORCES AND/OR

FACTORS MAY ACCELERATE THE PROCESS.AN EXAMPLE BEING EXPOSURE TO

U.V LIGHT, IONIZING RADIATION AND OR CHEMICAL STRAIN SUCH AS BY

OZONE OR PH EXTREMES OR BY BIOLOGICAL FACTORS SUCH AS

ENZYMES.ANTIBIOTICS ETC.AN OPPEN SYSTEM MAY THEREFORE BE ABLE TO

EXPOSE TARGET TO EXTRANEOUS SOURCES OF PHAGE AND/OR FACTORS WHICH

PRECIPITATE PHAGE ACTIVATION WITHIN THE TARGET ORGANISM

CULTURES OF LIMITED ACCESS ARE OF BENEFIT AS PRECISE CONTROL MAY

INDICATE CONDITIONS THAT CAN BE DUPLICATED IN-VIVO TO GENERATE

PHAGE ACTIVITY IN-SITU.

RAISING PHAGES FROM TARGET CAN OFTEN BE ACCOMPLISHED BY ALLOWING

BACTERIA TO GROW IN MEDIUM UNTIL FOOD/VITAL NUTRIENT SUPPLY IS

EXHAUSTED.

AN EXAMPLE OF CULTURE IN A LIMITED OPEN SYSTEM IS THE

INNOCULATION OF STAPHYLOCOCCUS AUREUS INTO 500CC OF TRYPTICATED

SOY BROTH.UPON EXPOSURE FOR 20 MINUTES TO ELECTRIC SPARKS

GENERATED BY 4 MILLION VOLTS OF ELECTRIC DISCHARGE ON DAY 3 OF

CULTURE,PHAGE ACTIVITY WAS APPARENTLY ACTIVATED BY THE UV,OZONE

AND ELECTROMAGNETIC FIELDS ASSOSCIATED WITH THE

DISCHARGE.CLEARING OF THE MEDIA OCCURRED ON DAY 4 INDICATING

PHAGE LYSIS. INNOCULATION OF MEDIA AFTER DASY 3 INTO OTHER

ESTABLISHED CULTURES CAUSED THEIR LYSIS ALSO.

THE TIME PERIOD FOR PHAGE GENERATION AND NUMBER AND AMOUNT OF

FACTORS INDUCTIVE OF PHAGE ACTIVATION REQUIRED IS VARIABLE.

RAISING OF PHAGE TITRE MAY BE ACCOMPLISHED BY

DIALYSIS.ULTRACENTRIFUGATION ETC. IT IS ALSO POSSIBLE TO RAISE COUNTS BY ADDING FRESH BACTERIAL CULTURES REPEATEDLY TO PHAGE RICH SOLUTION.

IF THIS PROCESS IS REPEATED IT WILL OFTEN BE FOUND THAT CLEARING FAILS TO OCCUR AFTER SEVERAL PASSAGES PARTICULARLY IF THE OTHER CONDITIONS OF CULTURE ARE CONDUSIVE TO BACTERIAL SURVIVAL;THIS MAY BE EITHER TO RESISTANCE DEVELOPING TO PHAGE ACTION,LOSS OF PHAGE EFFICACY,SYMBIOSIS DEVELOPING BETWEEN PHAGE AND BACTERIA AND/OR THE PRESENCE OF RESISTANT MUTANTS OF BACTERIA.

EXPOSING THE RESISTANT BACTERIA TO AGENTS SUCH AS U.V.,OZONE OR ANY OTHERS AS MENTIONED ABOVE,AND/OR OTHERS WILL OFTEN INDUCE

PHAGE ACTIVATION AND PHAGE LYSIS BY SECOND PHASE PHAGE.

IT IS POSSIBLE TO REPEAT THE PROCESS UNTIL SEVERAL PHASES OF LYTIC PHAGE ARE DEVELOPED.DEPENDING ON BACTERIA AND PHAGE

GENERATED.EACH PHAGE WILL BEAR GREATER ACTIVITY AGAINST ITS PHASE OF BACTERIAL CULTURE BUT MAY BE MORE OR LESS EFFECTIVE AGAINST LOWER PHASES. IT HAS ALSO BEEN OBSERVED WITH PHASED PHAGES AS WELL AS WITH PHASED ANTIBIOTICS THAT AS TARGET ORGANISM PASSES THROUGH SEVERAL PHASES, SENSITIVITY TO AN ANTIBIOYIC OR PHAGE OF EARLIER (BUT NOT PRIOR) PHASE MAY REVERT.

IN CASE OF STAPHYLOCOCCI TESTED,TREATMENT WITH 3 OR MORE

COPNSECUTIVE PHASES OF PHAGE RESULTED IN IN-VIVO INFECTION

AS WITH PHASED ANTIBIOTIC THERAPY, IT MAY BE POSSIBLE TO

TARGETING MECHANISMS TO BE DISCUSSED LATER.

PHAGE/PLASMID USES/CAUTION

CULTURE TECHNIQUES AS THOSE SUGGESTED PREVIOUSLY AS WELL AS OTHERS GENERATE PLASMIDS.PLASMIDS AS WELL AS PHAGES ARE CAPABLE OP CARRYING GENETIC INFORMATION INTO BACTERIAL STRUCTURES. IT IS POSSIBLE TO USE PLASMIDS FROM EARLY PHASE TO GIVE LATTER PHASES REGRESSED SENSITIVITY TO EARLIER PHASE AGENTS IE. PLASMIDS AND PHAGES OF EARLY PHASES MAY CARRY EARLY PHASE GENETIC INFORMATION IN-VITRO TRIALS

THESE WERE DESIGNED TO DEMONSTRATE THE EFFICACY AND APPLICATION OF MULTIPHASED THERAPY.

METHOD

STAPHYLOCOCCUS AUREUS CULTURED FROM A SKIN LESION WAS INNOCULATED

INTO 300 CC OF TRYPTICATED SOY BROTH FOR THREE DAYS.AT THIS TIME

BROTH WAS CLOUDY WITH BACTERIAL GROWTH.

BROTH WAS SHAKEN AND 10CC DOSES WERE INNOCULATED INTO VARIOUS

TEST BROTH BOTTLES AS IDENTIFIED BELOW.THESE 10CC DOSES ARE

CALLED CHALLANGING DOSES OF TARGET ORGANISM (TO)

MULTIPHASED ANTIBIOTIC PREPARATION EFFICACY WAS DEMONSTRATED BY CRUDE PENICILLIN EXTRACTS (CPE),THEIR PHASE BEING NOTED BY

SUBSEQUENT NUMBERS.

DEFINITIONS AND PREPARATION

MULTIPHASED CRUDE PENICILLIN EXTRACT PREPARATION IS BY COINCUBATION OF PENICILLIUM WITH TARGET ORGANISM(S ) ,THE NUKBEROF BACTERIAL STRAINS AND TYPES BEING CO-INCUBATED DETERMINE HOW BROAD OR RESTRICTED(SPECIFIC) THE CRUDE PENICILLIN EXTRACT IS. FURTHER SPECIFICITY CAN BE ATTAINED BY SELECTIVE CULTURE PROCESSES AS DEFINED PREVIOUSLY.

THE CRUDE PREPARATION OF CO-INCUBATION WITH PENICILLIUM,BACTERIAL CULTURE IN TRYPTICATED SOY BROTH, CELL DEBRIS,BYPRODUCTS ETC. FOR PURPOSES OF THIS TRIAL, THECRUDE PREPARATIONS WERE SIMPLE

FILTRATES OF CO-CULTURE. IT SHOULD BE UNDERSTOOD THAT CULTURE MEDIUM,TYPE,DURATION OF CO-INCUBATION AND OTHER FACTORS ARE VARIABLES ALTHOUGH DEFINED HERE.

THE TERM ACTIVATED FORM OF THE MULTIPHASED ANTIBIOTIC IS USED HERE TO REPRESENT CRUDE EXTRACT OF CULTURES OF ANTIBIOTIC ORGANISM(S)COINCUBATED WITH TARGET ORGANISM(S) , PREPARED BY CO- CULTURING UNTIL THERE IS CLEARING OF THE TARGET ORGANISM(S)AT THIS POINT, THE TREATING ORGANISM(TO)OR ANTIBIOTIC ORGANISM IS CONSIDERED ACTIVATED. FILTRATION 0.2 MICRON OF THE BROTH AND CULTURES AT THIS STAGE IS CONSIDERED ACVTIVATED CRUDE PREPARATION FOR THE PURPOSES OF THIS EXPERIMENT. IT SHOULD BE UNDERSTOOD THAT PATENT ALSO COVERS THE USEFULNESS OF ALL STAGES OF FILTRATION AND PURIFICATION OF PRODUCTS YEILDED BY THE MULTIPHASIC SYSTEM.

THE CRUDE ACTIVATED PRODUCT HERE IS RICH IN ENZYMES,NUCLEIC ACIDS AND MANY OTHER FRAGMENTS OF TREATMENT AND TARGET ORGANISMS.MANY OF THESE FRACTIONS WHEN PURIFIED RETAIN USEFUL FUNCTION BOTH DIRECTLY AND INDIRECTLY,LYSED TARGET FRAGMENTS CAN,FOR

INSTANCE,BE USED AS IMMUNOSTIMULATING AGENT.SOME BENEFICIAL PROPERTIES ARE RETAINED EVEN WHEN BOILED REPEATEDLY,THESE ARE NOT RESTRICTED TO IMMUNOSTIMULANT ACTIVITY.

PATENT COVERS MULT I PHASE ASPECT OF THRAPY GENERATION

AND APPLICATION . IT IS DEMONSTRATED BY BUT NOT RESTRICTED TO THE FURITY AND/OR PRECISE FORMULATIONS OF PODUCTS GIVEN.

WHEN THE ACTIVATED ANTIBIOTIC ORGANISM IS SEPARATED FROM THE CO-INCUBATION AND CULTURED SEPARATELY,AND/OR IS ISOLATED IN NEUTRAL LIQUID SUCH AS SALINE, IT MAY BE ALLOWED TO CONTINUE PRODUCING ITS ANTIBIOTIC PRODUCT(S). THE CONCENTRATION OF THESE WILL DEPENE ON MEDIUM,TIKE SINCE CO-INCUBATION AND TIME SPENT IN THE ISOLATION MEDIUM.

ONCE ISOLATED,A CONCERNTRATE OF THE FUNGUS OR OTHER THERAPEUTIC ORGANISM MAY BE MADE BY SONICATION AND/OR PRESSURE DISRUPTION AND OR OTHER PHYSICAL /CHEMICAL/BIOLOGICAL METHOD OF DISRUPTING THE LIVING ORGANISDM FOLLOWED BY FILTRATION.

IN THIS EXPERIMENTAL PROTOCOL, PENICILLIUM MOULD IS TESTED VBOTH IN ACTIVATED FORM AS WELL AS BEING REMOVED FROK CO-INCUBATION AND ALLOWED TO CULTURE SEPARATELY FOR 6 WEEKS IN TRYPTICATED SOY BROTH-500CC. EXTRACTS OF THIS FREPARATION(FITERED THROUGH 0.2 MICRONS) IS TERMED CRUDE PENICILLIN EXTRACT (CPE).

EXPERIMENT 1

OF TRYPTICATED SOY BROTH IN WHICH STAPHYLOCOCCUS HAS BEEN CULTURED FOR 3 DAYS.

ALONG WITH 10 MILLION UNITS OF PROCAINE PENICILLIN.

STAPHYLOCOCCUS CHALLANGE

GROUP D.

CPE PREPARATIO, SURPRISING PRE ALSO HELPED, LYSATES INC BACT

PRODUCT. FURITY AND/OR PRECISE FORMULATIONS OF PODUCTS GIVEN.

WHEN THE ACTIVATED ANTIBIOTIC ORGANISM IS SEPARATED FROM THE CO-INCUBATION AND CULTURED SEPARATELY,AND/OR IS ISOLATED IN NEUTRAL LIQUID SUCH AS SALINE, IT MAY BE ALLOWED TO CONTINUE PRODUCING ITS ANTIBIOTIC PRODUCT(S).THE CONCENTRATION OF THESE WILL DEPENE ON MEDIUM,TIME SINCE CO-INCUBATION AND TIME SPENT IN THE ISOLATION MEDIUM.

AGAIN.IT IS NOT THE PREPARATION TECHNIQUE THAT IS VITAL IN THIS PATENT BUT RATHER THE FACT THAT USEFUL CHANGES OCCUR BY PHASING THE THERAPEUTIC ORGANISMS AND THAT CULTURTES OF VARIOUS DEGREES OF BIAS ALONGST WITH CULTURES OF SPECIFIC TARGET FRAGMENTS CAN BE USED TO INCREASE SPECIFICITY,DECREASE SIDE-EFFECTS AS WELL AS ALLOW A THERAPEUTIC ORGANISM TO MODIFY ITS ACTIVITY AND PRODUCT TO RESTORE ITS EFFICACY OR TO ACQUIRE EFFICACY AGAINST RESISTANT TARGETS .

EXPERIMENT 1

STAPHYLOCOCCUS AUREUS WAS INNOCULATED INTO 3000CC OF TRYPTICATED

SOY BROTH AND CULTURED FOR 3 DAYS.

BROTH WAS CLOUDY AT THIS TIME.

CHECKS SHOWED PURE CULTURE OF STAPHYLOCOCCUS AUREUS.

THIS BROTH WAS DIVIDED INTO 30 BOTTLES OF 100CC EACH AND CULTURED

AT ROOK TEMPERATURE.

PROCEDURE

BOTTLE1 - IO MILLION UNITS OF PROCAINE PENICILLIN WERE ADDED.

SOME LESSENING OF CLOUDINESS OCCURRED OVER 24 HOUR PERIOD BUT

RETURNED TO PREVIOUS CLOUDINESS WITHIN 48 HOURS.

CULTURE THEN SHOWED PURE CULTURE OF STAPHYLOCOCCUS AUREUS WHICH

"WAS PENICILLIN RESISTANT.

BOTTLE 2- 10CC OF CRUDE PENICHLLN EXTRACT WERE.ADDED.

SLIGHT LESSENING OF CLOUDINESS WITHIN 12 HOURS RETURNED TO

PREVIOUS CLOUDINESS WITHIN 72HOURS.

CULTURE THEN SHOWED PURE CULTURE OF STAPHYLOCOCCUS AUREUS WHICH WAS PENICILLIN RESISTANT

BOTTLE 3- 10CC OF ACTIVATED CRUDE PEN

CLEARING OF CLOUDINESS COMPLETE WITH CLOUDINESS.

CULTURE NEGATIVE. BOTTLE 4-CRUDE PENICILLIN EXTRACT PHASE 1 5CC AND PHASE 2 5CC WERE ADDED. CLEARING OCCURRED IN 24 HOURS BUT RETURNED TO A LESSER EXTENT WITHIN 48 HOURS.

CULTURE SHOWED PURE STAPHYLOCOCCUS AUREUS,PENICILLIN RESISTANT.

BOTTLE 5-ACTIVATED PENICILLIN EXTRACT PHASE 1,2,- 3.33 CC OF EACH WERE ADDED.

TOTAL CLEARANCE WITHIN 24 HOURS.NO RETURN OF CLOUDINESS

CULTURE NEGATIVE.

BOTTLE 7- ACTIVATED PENICILLIN EXTRACT PHASES 1,2 AND 3 WERE ADDED.TOTAL CLEARANCE WITHIN 24 HOURS.NO RECURRENCE.

CULTURE NEGATIVE.

EACH TEST WAS REPEATED 3 TIKES WITH IDENTICAL RESULTS.

I DROP OF BOTTLES 3 OR 5 OR SEVEN WERE CAPABLE OF CAUSING PLAQUE FORMATION IN STAPHYLOCOCCAL CULTURES AS DID A DROP OF ACTIVATED PENICILLIN OF ANY PHASE.THIS SUGGESTS THAT AT LEAST PART OF THE EFFICACY OF SUCH PREPARATIONS IS DUE TO PRESENCE OF PHAGES IN THE PREPARATIONS.

PENICILLIN-RESISTANT STRAINS RAISED IN BOTTLES1,2 AND4 WERE ELIHINATED BY ANY OF THE FOLLOWING;CPE123, ACPE1,2 ACPE123.

ALONG WITH 10 MILLION UNITS OF PROCAINE PENICILLIN.

GROUP C- 5 ANIMALS WERE INJECTED WITH PHASE 1 AND PHASE 2 CRUDE PENICILLIN EXTRACT (CPB)5cc OF EACH ALONG WITH 5CC OF

STAPHYLOCOCCUS CHALLANGE

GROUP D.

CPE PREPARATIO,SURPRISING PRE ALSO HELPED, LYSATES INC BACT

PRODUCT. INTO LATTER PHASES AND RETURN,AMONGST OTHER THINGS, THEIR

SENSITIVITY.PLASMIDS OF LATTER PHASES CAN ALSO BE IMMUNOLOGICALLY

TARGETED AS WILL BE DI SCUSSED IN IMMUNOLOGICAL PHASED THERAPY .

MRD IN BIOL ENHANCEMENT

INHIBITION OF PLASKIDS/ENZYMES ETC.

CHANGES SUGGESTED BY OTHER MECHANISMS

INTERESTINGLY,WHEN THE CO-CULTURED MEDIUM WAS CHALLANGED-FASTER

THAN PURE PEN MORE IN 2 DAYS.

ALSO PHAGE/PLASMID RESISTANCE TRANSFER

ALSO ON LEUK/AIDS

PEN/PHAGE/ANTISERA TO R PLASMID/PHAGE/OTHER CHANGE USE OF HYPERTHERMIA IN COMBINATI ON WITH VACCINE THERAPY INDIVIDUALLY/AS PART OF PRECURSOR/INTERMEDIATE/ENDPRODUCT

THERAPY .

INTRODUCTION

AN IMPORTANT ISSUE NOT ADDRESSED BY CURRENT IMMUNOTHERAPEUTIC REGIKENS IS THAT CHANGES MADE TO TARGETS WHICH ENABLE THE GENERATION OF AN IMMUNOLOGICAL RESPONSE MAY CHANGE THE TARGET TO A POINT WHERE IT LOSES AND/OR ALTERS CHARACTERISTICS TO THE POINT WHERE THE VACCINE EFFICACY WHERE IT RELATES TO THE OVERLAP OR RESEMBLANCE TO THE IN-VIVO APPEARANCE OF DISEASE.

IN PREPARING AN ANTIBACTERIAL VACCINE,FOR EXAMPLE, IT MAY BE

STRUCTURE CAUSED BY INACTIVATION OR OTHER PROCESS IN PREPARATION OF VACCINE LOSES,ALTERS AND/OR ADDS STRUCTURES/CONFIGURATIONS NOT INTRINSIC IN THE ACTUAL DISEASE.

TO OVERCOME THIS ONE OR ALL OF THREE MODIFICATIONS NEED TO TAKE PLACE

1 -MAKING THE VACCINE RESEMBLE THE

DISEASE MORE CLOSELY .

2-MAKING THE DI SEASE RESEMBLE THE

VACCINE MORE CLOSELY .

3-MAKING THE HOST SYSTEM/ IMMUNE SYSTEM

RECOGNI SE VACCINE/DISEASE WITH

IDENTI CAL , EFFECTIVE RESPONSES .

ANOTHER SHORTCOMING OF VACCINES AND RELATED IKMUNOTHERAPlES IS THAT WHEREAS SUCH MEASURES MAY BE OF BENEFIT IN PREVENTION OR IN DEALING WITH A SMALL AMOUNT OF DISEASE;PROCESSES SUCH AS THE WELL DEFINED THRESHHOLD INHIBITION PHENOMENON RESTRICT IMMUNOLOGICAL RESPONSE WHEN THE CHALLANGING LOAD IS OVERWHELMING.

THIS POINT MAY BE DEALT WI TH BY DIRECTING THE RESPONSE AGAINST PART OF THE DI SEASE WHICH I S IN MINIMAL EXPRESSION AND/OR WHICH IS GRADUALLY MADE TO ATTATCH/EXPRESS AT A RATE WITH WHICH THE HOST SYSTEM MAY COPE.

1-MAKING THE VACCINE RESEMBLE THE

DISEASE MORE CLOSELY.

1-RAISING VIRUS IN TARGET AND/OR OTHER CELLS OF HOST TO BE

VACCINATED-THIS ENABLES SCREENING FOR AND REJECTION OF ANY

VARIANTS WHICH MAY BE GROSSLY PATHOLOGICAL TO THE RECIPIENT.

USE OF TEMPORAL EXTRAPOLATION PATENT CAN ALSO TEST

FOR SPECIFIC SYSTEMS/SITUATIONS/INTERACTIONS IN

NORMAL/REDUCED/ACCELERATED TIME FORMATS TO PREDICT FUTURE

EFFECTS. (CELL DIVISION MAY BE ACCELERATED IN VITRO/OTHER ANIMAL SYSTEMS TO STUDY FURTHER GENERATION IMPACT,SLOWED DOWN TO STUDY CELLULAR IMPACT;SIMILAR PROCEDURES WITH DISEASE PROCESS CAN ACCELERATE OR RETARD ITS GROWTH SO ITS INTERPLAY MAY BE STUDIED WITH OTHER FACTORS, CELLS, DISEASES ETC.)

VARIABLES BUT IN-VITRO AND DEDICATYED ANIMAL FECHNOLOGY ALSO ENABLES THE VACCINE TO BEST RESEMBLE THE ACTUAL APPEARANCE OF INFECTION IN THIS PARTICULAR INDIVIDUAL AS WELL AS ALLOWING FOR THE RAISING OF IMMUNITY AGAINST INTERMEDIATE STAGES SUCH AS INFECTED CELLS AS WERLL AS PREPARING ENDPRODUCT IMMUNE RESPONSES TO ELIMINATE DISEASE.

2-MAKING THE DISEASE RESEMBLE THE

VACCINE MORE CLOSELY.

THIS IS THE MAIN POINT TO BE DEMONSTRATED AND EXPLOITED BY THIS PATENT.

MAKING THE DISEASE RESEMBLE THE VACCINE MORE CLOSELY AT A GRADUAL SPACE CAN BE AVCCOMPLISHED IN SEVERAL WAYS , ONE WILL BE OUTLINED BELOW;

THE CONCEPT IS TO TREAT THE DISEASE IN THE SAME MANNER USERD TO GENERATE THE VACCINE AND THEN TO ALLOW AN IMMUNE SYSTEM HONED BY PRIOR ADMINISTRATION OF VACCINE TO ATTACK THE DISEASE .

VACCINES PREPARED BY HEAT INACTIVATION WILL BE USED TO DEMONSTRATE THE APPLICATION OF THESE GUIDELINES BUT ARE NOT INTENDED TO LIMIT PATENT APPLICATION . PATENT APPLIES TO ANY METHODOLOGY WHICH AIMS TO TREAT THE DISEASE CONDITION IN A MANNER WHICH ALTERS IT TO A FORM THAT CAN BE BETTER DEALT WITH BY THE BODY;PARTICULARLY A BODY PREPARED TO DEAL WITH SUCH CHANGES. FOR EXAMPLE ,BY PRIOR VACCINATION.

STEP ONE

PREPARE VACCINE BY CULTURING ORGANISM/TARGET THEN HEAT

INACTIVATION.

STEP2

USE VACCINE PREPARATION TO RAISE IMMUNE RESPONSE .

STEP 3

USE HYPERTHERMIA TO EXPOSE/ALTER DISEASE STRUCTURE TO FORMAT

CONFORMING TO THAT OF THE VACCINE USED TO GENERATE IMMUNE

RESPONSE.

AS THE HEAT CAUSES STRUCTURES TO ALTER AND THE EXPOSURE OF

PREVIOUSLY COATED AND/OR OTHERWISE DISGUISED;THE IMMUNE SYSTEM

ALREADY STIMULATED AGAINST THEM BY THE VACCINE WOULD BE ACTIVATED

DEVASTATINGLY.

EASILY SEEN APPLICATIONS THAT FOLLOW FROM THESE GUIDELINES IS THAT IN THE TREATMENT OF CANCER,FOR EXAMPLE;BIOPSIES SHOULD BE TREATED WITH WHATEVER RADIOTHERAPEUTIC OR CHEMOTHERAPEUTIC PROTOCOL ARE TO BE IMPLEMENTED UPON THE PATIENT;THE RESULTANT SURVIVING AND ALTERED CELL STRUCTURES SHOULD THEN BE USED IN THE PREPARATION OF A VACCINE.THIS COULD BE USED AS A SUPERIOR IMMUNE PROTOCOL AND/OR AS AN ADJUNCT TO VACCINES PREPARED FROM INITIAL BIOPSY. FURTHER INACTIVATION PROCEDURE SUCH AS HEAT KILLING OF CELLS MAY ALSO BE USED ON THE DISEASE IN ORDER TO CLOSER M,ATCH THE VACCINE.

WHAT THEN FOLLOWS IS THAT BY USING THIS NEW PATENT FIELD OF

ANTICI PATORY IMMUNOLOGY THE BODY WILL BE

1-ABLE TO KOUNT AN EFFICIENT IMMUNE RESPONSE WITHOUT RESTRICTION BY THRESHOLD INHIBITION.AS IT IS BEING TARGETED AGAINST ANTIGENS AND OTHER COMPLEXES NOT NORMALLY EXPOSED TO ANY GREAT EXTENT BY THE DISEASE.

POSSIBLY ALSO REMOVING PRIOR DOMINANT /EXPRESSED ANTIGENS AND OTHER STRUCTURES USED TO AVOID THE IMMUNE AND OTHER RESPONSES OR TO CAUSE THEM TO ACT TO THE BENEFIT OP THE DISEASE.

3-THIS TECHNIQUE ALSO ENABLES EFFECTIVE ADJUNCTIVE IMMUNOTHERAPY WHICH AIMS TO ATTACK CELLS ALTERED AND POSSIBLY NOT DESTROYED BY THE THERAPY AS WELL AS RESISTANT CELLS WHICH SURVIVED THE THERAPY PROTOCOL IN THE KANUFACTURE OF THE VACCINE. THE FOLLOWING CASE DEMONSTRATES APPLICATION.

PA TIENT N.B. PRESENTED WITH PRIMARY HEPATOMA WHICH HAD PERFORATED HI S DIAPHRAGM AND ENCIRCLED HIS RIGHT LUNG.CANCER ADVANCED

DESPITE CHEMOTHERAPY,RADIOTHERAPY AND IMMUNOTHERAPY.

TH E VACCINE WAS MANUFACTURED FROM BIOPSY TISSUE WHICH HAD BEEN FRAGMENTED PHYSICALLY AND BOILED FOR 15 MINUTES EVERY DAY FOR 3 DAYS.

HYPERTHERMIA USING RADIOFREQUENCY 'MAGNETRODE' EQUIPMENT WAS APPLIED FOR 3 SESSIONS OF 20 MINUTES EACH.ON CONSECUTIVE DAYS. THAT FOLLOWED WAS AS PREDICTED BY THEORY.

IN EACH OF THE HYPERTHERMIA SESSIONS THE BODY WAS HEATED TO 102 DEGREES.

THE FOLLOWING DAY AND FOR 1 WEEK SUBSEQUENTLY PATIENT

SPONTANEOUSLY DEVELOPED A CONTINUEOS FEVER RANGING FROM 100-104 DEGREES.PA1N RAPIDLY SUBSIDED.THERE WAS A MEASUREABLE

LYMPHOCYTOSIS AND LEUKOCUTOSIS BUT NO INFECTIVE FOCUS WAS FOUND AND REPEATED BLOOD CULTURES WERE NEGATIVE. IT WAS AS PREDICTED AT HYPERTHERMIA EXPOSED STRUCTURES ON THE DISEASE MASS TO WHICH THE BODY HAD BEEN PREVIOUSLY IMMUNISED AND MASSIVE IMMUNE REJECTION THEN RESULTED.

INDUCED REMISSION THERAPY WAS PREVIOUSLY DISCUSSED UNDER

INDUCED REMI SS ION THERAPY PATENT BY SAME

BIOLOGICAL ORGANISMS-VIRUSES , BACTERIA, FUNGI , YEASTS ETC WHICH DISEASE PROCESSED AS EITHER SYNERGISTIC OR ANTAGONISTIC TO THE WHEN VACCINATING AGAINST THE SYNERGISTIC ORGANISMS INVENTOR HAS USED PHYSICAL( SUCH AS SONICATION) , CHEMICAL (CHLORINE/PHENOL/OTHER ) AND BIOLOGICAL MEANS (SUCH AS ENZYMATIC DEGRADATION) TO PREPARE VACCINES . LET US CONSIDER BY EXAMPLE ALTHOUGH IT SHOULD BE

UNDERSTOOD THAT PATENT IS NOT RESTRICTED TO THIS EXAMPLE THE CASE OF VACCINES WHICH ARE HEAT KILLED.

LET US CONSIDER THE DISEASE CANCER.

SUCH ORGANISMS APPEAR INTEGRAL IN THE DISEASE PROCESS . AS

WHEN THE SAMPLES ARE DISRUPTED BY PHYSICAL, CHEMICAL, BIOLOGICAL AND OR EVEN IMMUNOLOGICAL PATHWAYS SUCH AS BY SPECIFIC OR POOLED ANIMAL/HUMAN/OTHER SERUM, STAPHYLOCOCCAL -LIKE CULTURES KAY

FOLLOW. ACTUALLY, A VARIETY OF ORGANISMS INCLUDING E . COLI AND ACTINOMYCETES MAY BE CULTURED DEPENDING ON THE MEDIUM AND CONDITIONS USED AS WELL AS TIME.

AS THESE ORGANISMS DO NOT APPEAR TO ATTRACT A SIGNIFICANT IMMUNOLOGICAL RESPONSE FROM THE PATIENTS, PREPARATION OF VACCINE IS BENEFITED BY ALTERATION OF PRESENTATION SUCH AS BY PHYSICAL AND/OR CHEMICAL AND/OR BIOLOGICAL TREATMENT AS PREVIOUSLY

DISCUSSED.

ORGANISM. CULTURE IS GROWN FOR 2-3 DAYS THEN BOILED FOR 15 MINUTES ON 3 CONSECUTIVE DAYS.PREPARATRION IS THEN REPLATED ON BLOOD AGAR AND REINNOCULATED IN TSB TO ENSURE NO GROWTH.

ANIMALS VACCINATED WITH THE HEAT-KILLED VERSION OF THE ORGANISMS WILL GENERATE BOTH LOCAL AND SYSTEMIC REACTIONS WHICH ARE DOSE- DEPENDANT. IN TESTING LIVING ORGANISK INNOCULATIONS INTO IDENTICAL ANIMALS, IT IS FOUND THAT THEY RARELY CAUSE AN ACUTE RESPONSE AT LOU DOSEAGE. SIMILAR LOW DOSEAGE OF THE HEAT-KILLED PREPARATIONS YEILDS

SIGNIFICANT LOCAL REDNESS AS WELL AS SYSTEMIC SIDE-EFFECTS SUCH AS HIGH TEMPERATURES.OBVIOUSLY, THEREFORE THE VACCINE DIFFERS IN IMMUNOLOGIC PROPERTIES TO THE ORGANISM.THE PROTECTIVE FACTORS AND/OR AGENTS APPEAR TO BE REMOVED AND/OR NEUTRALISED BY HEAT , STRONGLY IMMUNOGENIC FACTORS APPEAR TO BE GENERATED/EXPOSED BY HEAT.AS THESE ORGANISMS APPEAR RELATED TO THE CANCER

PROCESS;WHETHER BELIEVED TO BE CAUSATIVE, SYNERGISTIC OR INFECTIVE OR NEUTRAL,THEY OBVIOUSLY DISPLAY AFFINITY FOR THE DISEASE

PROCESS AS THEY CAN CONSTANTLY BE CULTURED FROM PATIENTS AND ROUTINELY ARE RECOVERED FROM DISEASE BIOPSIES.AN IMMUNE RESPONSE AGAINST THESE ORGANISMS WILL THEREFORE IMPACT FAVOURABLY AGAINST DISEASE.

SEVERAL CASES HAVE DEMONSTRATED TEMPORARY BENEFICIAL TUMOUR SHRINKAGE FOLLOWING ADMINISTRATION OF HEAT-KILLED VACCINES.AGENTS USED TO GENERATE SYSTEMIC HEAT WHICH WOULD PREVIOUSLY ONLY LAST FOR LIMITED DURATION( PHYSICAL/CHEMICAL/BIOLOGICAL)WILL OFTEN GIVE RISE TO LONG LASTING AND GREATER TEMPERATURE RISES ONCE THE VACCINES HAVE GENERATED SIGNIFICANT IMMUNE RESPONSE,"AT THAT POINT HYPEDRTHERMIA,EVEN FROM A HIGH DOSE VACCINE OR FROM

HYPERTHERMIA ALONE IS KNOWN TO SOMETIMES CAUSE EXCELLENT RESPONSES ,OTHER THAN HEAT'S DESTRUCTIVE ABILITY, THIS EXPLANATION ALSO GIVES ANOTHER MECHANISM OF ALTERATION OF IMMUNOLOGICAL PRESENTATION OF TARGET;UNFORTUNATELY,USE OF HYPERTHERMIA WITH VACCINE THERAPY IS VERY LIMITED.

HYPERTHERMIA IS USUALLY USED ALONE AND/OR IN COMBINATION WITH RADIOTHERAPY AND/OR CHEMOTHERAPY.UNDER THESE CIRCUMSTANCES IT IS VERY LIKELY THAT THE IMMUNE SYSTEM WILL BE FLOODED WITH ANTIGENIC MATERIAL AND MAY SUCCUMB TO THRESHOLD INHIBITION (AT WORST IF HYPERTHERMIA IS USED ALONE). IT IS THEORETICALLY MORE DAMAGING IMMUNOLOGICALLY IF THE HYPERTHERMIA IS USED SIMULTANEOUSLY WITH CHEMOTHERAPY AND/OR RADIOTHERAPY THEN ALTHOUGH SUCH SYSTEMS MAY SYNERGISE IN THEIR TUMOUR-DESTRUCTIVE ABILITY THE IMMUNE SYSTEM WILL ALSO BE WEAKENED BY THE COMBINATION THERAPY AND OVERWHELMED BY THE NEW ANTIGENIC INFORMATION. IT APPEARS PREFERABLE,THEREFORE

TO PRECEDE SUCH PROCEDURES WITH 2 WEEKS OF ANTICIPATORY

IMMUNOTHERAPYWHERE THE BODY IS STIMULATED AGAINST DISEASE PRESENTATION AFTER IT HAS BEEN TREATED OUTSIDE THE BODY BY SUGGESTED PROTOCOLS TO BE INSTITUTED 2 WEEKS LATER . THE 2 WEEK LAG PERIOD IS SELECTED TO ALLOW THE BODY TO GENERATE SIGNIFICANT SERUM IMMUNITY TO THE CHANGES ABOUT TO OCCUR. SOME DEMONSTRATIVE CASES NOW FOLLOW; MULTIPHASED PHAGE THERAPY

BROTH WAS THEN DIVIDED INTO 100 CC BOTTLES

PHAGES WERE RAISED BY ALLOWING BACTERIAL CULTURE IN TSB TILL NUTRIENT DEPLETION AND LYSIS.BROTH WAS THEN CHECKED FOR PLAQUE- FORMING ABILITY IE PRESENCE OF PHAGES.THE INITIAL BROTH IS

CONSIDERED CRUDE PHAGE PREPARATION WAS PURIFIED BY DIALYSIS AND CONCENTRATED BY ELECTROPHORESIS TO 10 TO THE NINTH POWER PFU'S PER CC OF SALINE IN WHICH THEY WERE RESUSPENDED.THIS WAS THEN CALLED PURIFIED PHAGE EXTRACT.THE BACTERIAL; DEBRIS WAS LABELLED CRUDE BACTERIAL LYSATE CBL AND PROVED EFFECTIVE IN

IMMUNOSTIMULATION PARTICULARLY IN ANTICIPATORY

IMMUNOTHERAPY.

BOTTLE 1

PHASE ONE CRUDE PHAGE PREPARATION WAS ADDED AT DOSE OF 1CC PFU'S

WERE ABOUT 10 TO TH 5TH POWER.

CLEARING OF CLOUDINESS OCCURRED IN 48 HOURS

CULTURE NEGATIVE.

AN IMPORTANT DIFFERENCE SHOULD BE POINTED OUT HERE BETWEEN ANTIBIOTIC AND PHAGE THERAPY.

ANTIBIOTICS ARE ESSENTIALLY NON-LIVING PRODUCTS AND HENCE WILL NOT SIGNIFICANTLY ALTER IN BEHAVIOUR.PHAGES , ON THE OTHER HAND ARE LIVING AND MAY DO SO .TO DEMONSTRATE THIS .BOTTLES THAT WERE TREATED WITH MULTIPHASED ANTIBIOTIC THERAPY THAT HAD REMAINED CLEAR IN PREVIOUS SECTION AND NOT CULTURED ANY ORGANISMS SUBSEQUENT TO TREATMENT WERE RECHALLANGED.BY 10CC OF ORIGINAL STAPHYLOCOCCAL CULTURE.

TREATED CULTURES RESISTED AT LEAST 3 SUCH CHALLENGES.

PHASE 1 CRUDE PHAGE PREPARATION PHASE 1 CLEARED PRELIMINARY CULTURE BUT DID NOT REMAIN ACTIVE AFTER 2 OR SOMETIMES EVEN ONE RECHALLANGE.

BOTTLE-2

PURIFIED PHAGE PREPARATION-PHASE 1 ADDED ICC

CLEARING OF BROTH WITHIN 24 HOURS.

SURVIVED 3 RECHALLANGES BUT THEN APPEARED TO LOSE ACTIVITY.

BOTTLE THREE

CRUDE PHAGE PREPARATION PHASE 1 AND 2 ADDED 0.5CC OF EACH

CLEARING OF BROTH WITHIN 24 HOURS.CULTURE NEGATIVE

SURVIVED 4 RECHALLANGES BUT THEN APPEARED TO LOSE ACTIVITY

WITH NEW GROWTH

BOTTLE 4

PURIFIED PHAGE PREPARATION PHASED 1 AND 2 0.5CC OF EACH

CLEARING OF BOTTLE WITHIN 24 HOURS

SURVIVED 6 RECHALLANGES THEN REGROWTH. BOTTLE 5-

CRUDE PHAGE PREPARATION PHASE 1,2 AND 3

CLEARING OF BOTTLE WITHIN 24 HOURS CULTURE NEGATIVE

SURVIVED OVER 6 RECHALLANGES.

BOTTLE 6-

PURIFIED PHAGE PREPARATION PHASES1,2 AND 3

CLEARING OF BOTTLE WITHIN 24 HOURS CULTURE NEGATIVE.

SURVIVED OVER 6 RECHALLANGES.

IT SHOULD BE NOTED THAT THE EFFECTS SHOWN ON SUCCESSFUL

RECHALLANGE MAY NOT BE SIMPLY DUE TO DECREASE IN THERAPEUTIC

DOSEAGE.

THE PHENOMENON OF ADAPTATION AND CO-SYNERGY MAY BE BEST

DEMONSTRATED BY PLEURIPOTENT PHAGES.

IT IS LIKELY THAT PHAGES DEVELOP SYNERGY WITH THEIR BACTERIAL

HOST.

IF SUCCESSFUL RECHALLANGE IS DUE TO WEAKENING DOSEAGE OF PHAGE

MIX THEN IT SHOULD ONLY BE A MATTER OF REESTABLISHING THE

DOSE, HOWEVER, PHAGE WHICH PREVIOUSLY CAUSED CLEARING OF BROTH

WOULD ONLY CAUSE PARTIAL IF ANY CLEARING AS PREDICTED FROM

REPEATED PASSAGE WORK IN ESTABLISHING PHAGE PHASE.

THIS WOULD HAPPEN WITH ORIGINAL BACTERIAL CULTURE AS WELL AS WITH

LATTER PHASE CULTURES INDICATING THAT THE ADAPTATION IS NOT ONLY

BACTERIAL BUT ALSO OF PHAGE.

THIS SHOULD NOT BE SURPRISING AS WE ARE DEALING WITH TWO LIVING PRODUCTS.IT VDOES HOWEVER SUGGEST COMBINING THIS THERAPY WITH ONE THAT WILL NOT DEVELOP SYNERGY WITH INITIAL CULTURE,SUCH AS PHASED ANTIBIOTIC THERAPY AND/OR PHASED IMMUNE THERAPY.

PHASED IMMUNE THERAPY.

DIRECT/INDIRECT.

DIRECT

DIRECT IMMUNOTHERAPY INVOLVES THE RAISING OF AN IMMUNE RESPONSE

IN-VITRO OR IN-VIVO BY USE OF HUMAN AND/OR OTHER SYSTEM.DIRECT

RELATES TO RAISING OF A SYSTEM CELLULAR,HUMORAL,OR OTHER AGAINST

TARGET ORGANISMS.

ALLOWING THE TWO SYSTEMS TO INTERACT IN AN OPEN OR CLOSED SYSTEM

AND/OR INDUCING MULTIPLE MUTATIONS/PRESENTATIONS OF TARGET

ORGANISH(S) (AS DISCUSSED PREVIOUSLY).

AS RESISTANT/ELUSIVE STRAINS EMERGE,NEW IMMUNE RESPONSES ARE RAISED TO COPE WITH THE CHANGES OF TARGET HENCE PHASED IMMUNE REPONSE IS ALSO POSSIBLE.

PREPARATION OF HORSE SERUM

FOR PURPOSE OF THIS DEMONSTRATION,A HORSE WAS INJECTED WITH BACTERIAL PELLETS OF 3X 10 TO THE 8TH POWER

INDIRECT

IT IS ALSO POSSIBLE TO USE ANTISERUM TO TARGET RESISTANCE- SPECIFIC FACTORS SUCH AS PLASMIDS CARRYING GENETIC MESSAGE FOR PENICILLIN RESISTANCE.

RAISING OF ANTISERUM -AFTER INJECTION WITH IMMUNISING DOSE 3TIMES A WEEK FOR THREE WEEKS INTRADERMALLY(DOSE ,MANNER AND AREA OF

INJECTION ARE ALL VARIABLE FACTORS)

IN-VITRO TEST

BROTH WAS DIVIDED INTO 100 CC BOTTLES.

THE FOLLOWING EXPERIMENTS WERE THEN DONE AND REPEATED; BOTTLE ONE;

PROCAINE PENICILLIN 500,000 U WAS ADDED TO STAPHYLOCOCCUS

CULTURE

SOME CLEARING OCCURRED WITH REGROWTH WITHIN 6 DAYS.

CULTURE THEN YEILDED PENICILLIN-RESISTANT STAPHYLOCOCCUC AUREUS.

THE BROTH WITH REGROWTH WAS INNOCULATED INTO A HORSE(50CCS WERE

SPUN DOWN AND BACTERIAL PELLET WAS IMPLANTED INTRACUTANEOUSLY

INTO A HORSE, 5 CCS OF SAME BROTH WAS INJECTED INTRADERMALLY

EVERY 3 DAYS FOR 3 WEEKS

50CC OF HORSE BLOOD WAS THEN COLLECTED , SPUN DOWN YEILDING SERUM.

AS THE HORSE WAS VACCINATED WITH BACTERIA AS WELL AS THE BROTH IN

WHICH RESISTANCE OCCURRED , IT IS LIKELY THAT THE HORSE WAS ALSO

INNOCULATED AGAINST PLASMIDS AND ENZYMES SUCH AS

PENICILLINASE(SUBSEQUENT TESTS IN WHICH BACTERIA WERE SONICALLY

LYSED PRIOR TO IMMUNISATION APPEARED TO INCREASE EFFICACY OF THIS

STEP.

BOTTLE2

ANTI-PHASE 2 BACTERIA ANTISERUM WAS ADDED 1CC DOSE TO 500,000

UNITS OF PENICILLIN.

BOTTLE CLEARED AND REMAINED CLEAR.UP TO I WEEK LATER, CUTURE

NEGATIVE.

BOTTLE THREE- ANTI-PHASE 2 ANTISERUM WAS ADDED ICC DOSE. -NO

RESPONSE CULTURE-STAPH AUREUS -PENICILLIN SENSITIVE.

IT THEREFORE APPEARS THAT AT THIS DOSEAGE,THE MAJOR EFFECT OF

ANIMAL SERUM IS TO PREVENT THE RISE OF RESISTANCE.

AT HIGHER DOSEAGES SOME DIRECT ANTIBACTERIAL EFFECTS WERE OBSERVED;THESE WERE EVEN MORE MARKED IF WHOLE BLOOD WAS USED. IN VIVO-CRUDE TO REFINED IMMUNE RESPONSES ELLICITED EXCELLENT RESPONSE.

FOLLOWED.

SUPPORT OF PHAGE AND ANTIBIOTIC MULTIPHASE THERAPY BY MULTIPHASE IMMUNE SUPPORT CAN BE ACCOMPLISHED BY SERUM AND/OR CELLULAR COMPONENTS OF IMMUNISED ANIMAL'S BLOOD.

THERAPY AS PERTAINING TO CANCER .

DEVELOPMENT OF ANTICANCER ANTIBIOTICS/MULTIPHASIC CHEMOTHERAPY

INTRODUCTION

A LIMITING FEATURE OF CURRENT CHEMOTHERAPEUTIC THERAPY IS THE COMMON DEVELOPMENT OF RESISTANCE BY THE TARGET DISEASE. THE STANDARD RESPONSE AT THIS POINT IS TO EITHER INCREASE DOSEAGE AND/OR ADD TO OR TOTALLY ALTER THERAPEUTIC REGIMEN. IN MOST CASES OF CANCER IT IS LIKELY THAT CHEMOTHERAPEUTIC OPTIONS WILL BE EXHAUSTED PRIOR TO ELIMINATION OF DISEASE,THE CANCER WILL THEN PROGRESS TO DEATH OF PATIENT.

DEMONSTRATION OF CLASSIFICATION PATENT AS APPL IES TO MULTI PHAS IC THERAPY .

INTRODUCTION

THE CLASSIFICATION PATENT STATES THAT FOR EVERY CONDITION

,ORGANISMS,FACTORS AND AGENTS CAN BE SUBDIVIDED INTO THOSE THAT PROMOTE, INHIBIT OR ARE NEUTRAL TO THE CONDITION. SOME MAY BE CAUSATIVE WHEREAS OTHERS ARE NEMESES OR CUREATIVE.

EPIDEMIOLOGY

THE SUGGESTION THAT INFECTIONS MAY BE ANTAGONISTIC TO DISEASES SUCH AS CANCER IS BORNE OF OBSERVATIONS THAT WHERE CERTAIN INFECTIONS DOMINATE ANN ATREA OR AN ERA,CANCER WAS SCARCE.CASES CAN BE MADE FOR TUBERCULOSIS,MALARIA AND SYPHILLIS BEING SUCH AGENTS. IT IS ALSO TRUE THAT MANY OF THESE CONDITIONS WHICH

INHIBIT CANCER GROWTH IN ACUTE STATE MAY CAUSE OR PROMOTE IT IN CHRONIC STATE

IT IS KNOWN ,FOR EXAMPLE, THAT CHRONIC TUBERCULOUS FOCI MAY LEAD TO DEVELOPMENT OF LUNG CANCER,CHRONIC MALARIA TO LYMPHOMA AND

CHRONIC SYPHILLIS TO OTHER TYPES OF CANCER.

INTERESTINGLY AN OFTEN CITED INFECTION ASSOSCIATED WITH SPONTANEOUS REMISSION IS THAT OF ERYSIPELAS.THIS IS OFTEN CAUSED BY STAPHYLOCOCCAL OR STREPTOCOCCAL INFECTION.AS THESE INFECTIONS IN ACUTE FORM CAN ACT TO ELIMINATE DISEASE,IT IS PROBABLY MORE THAN COINCIDENCE THAT TUMOUR BIOPSIES APPEAR TO INDICATE AT TIMES SIMILAR INFECTIONS COEXISTING IN CHRONIC MANNER WITH THE .IN CHRONIC INFECTIONS,THERE IS USUALLY AN IMMUNE RESPONSE INCAPABLE OF ELIMINATING THE INFECTION.IN BACTERIAL AND OTHER INFECTIONS INTIMATELY ASSOSCIATED WITH CANCER THERE MAY BE ALMOST TOTAL ABSENCE OF VISIBLE IMMUNE RESPONSE-SEE PHOTOGRAPHS WITH

CONSPICIOUS ABSENCE OF LOCAL INFLAMMATORY CELLS IN AREAS OF BACTERIA OR OTHER ORGANISMS IN CLOSE PROXIMITY TO CANCER CELLS. THIS MAY SUGGEST THAT THESE ORGANISMS ARE EITHER INHERENTLYT ELUSIVE/RESISTANT TO IMMUNOLOGICAL RESPONSES AND/OR ARE USING THE CANCER MASS TO ELUDE SAID RESPONSE.IT IS ALSO LIKELY THAT THE SAME MECHANISM BY WHICH CANCER ELUDES SAID RESPONSE AS THE ORGANISMS ARE OFTEN CULTUREABLE FROM BLOOD AS WELL AS FROM MANY TISSUES IN PATIENTS WITH DISEASE. (THE PRESENCE OF

CAUSATIVE, SYNERGISTIC,NEUTRAL, INFECTIVE,ANTAGONISTIC AND NEMES1S ORGANISMS IS NOT RESTRICTED TO CANCER BUT VIRTUALLY TO ALL DISEASE AND OTHER CONDITIONS)SEE PHOTOS OF CANCER,AIDS, TISSUES ETC.

MANY OF THESE BACTERIA APPEAR STAPHYLOCOCCAL OR STREPTOCOCCAL IN ORIGIN.

ALTHOUGH CONVENTIONAL; MEDICAL THINKING DOES NOT CREDIT THESE ORGANISMS WITH ANYTHING MORE THAN NEUSANCE CONTAMINANT VALUE, IT WAS NOT ALWAYS THE CASE.AT THE TURN OF THE CENTURY,ORGANISMS ISOLATED FROM CANCER PATIENTS WERE THOUGHT DIRECTLY LINKED AND CAUSATIVE TO THE DISEASE PROCESS.THE WORK OF GLOVER,SCOTT,GREGORY AND LIVINGSTON LED TO THE IDENTIFICATION OF MANY ORGANISMS ASSOSCIATED WITH CANCER.LIVINGSTON AND OTHERS DESCRIBED AN

APPARENT PLEOMORPHIC ABILITY TO THESE ORGANISMS.VARIOUS VACCINES AND ANTIBIOTIC THERAPIES PROVED TO HAVE A VARIABLE DEGREE OF EFFICACY.IT IS NOT SURPRISING,THEREFORE, THAT MANY EFFECTIVE CHEMOTHERAPEUTIC REGIMENS ACTUALLY HAVE ANTIBACTERIAL ACTIVITY-IT IS POSSIBLE TO EVALUATE CHEMOTHERAPEUTIC EFFECTIVENESS BY TESTING IT AGAINST BACTERIAL AND OTHER ORGANISM CULTURES-BY SYSTEMS INTRODUCED BY INVENTOR.- KNOWING A LIBRARY OF ASSOSCIATED

IT IS ALSO KNOWN THAT ANTIBIOTIC THERAPY MAY CAUSE TEMPORARY IMPROVEMENT IN CANCER AND OTHER PATIENTS-MORE RECENTLY ALSO IN ARTHRITIS AND ULCERS,DISEASES UNTIL RECENTLY NOT THOUGHT RELATED TO BACTERIAL DISEASE.WHILE TEMPORARY IMPROVEMENT MAY BE DUE TO THE CLEARING OF A SUPERADDED INFECTION, IT IS HARD TO EXPLAIN THE OCCASSIONAL REMISSION OF CANCER FOLLOWING ANTIBIOTIC THERAPY BY THIS REASONING.IT IS HOWEVER ALSO LIKELY THAT THE INFECTION BEING TREATED WAS ITSELF THE CAUSE OF THE REMISSION.

IT IS ALSO CONVENTIONALLY RECOGNISED THAT MANY VIRUSES MAY BE IDENTIFIED IN CANCER CELLS.THESE HAVE BEEN NOTED AS OF DUBIOUS SIGNIFICANCE ALTHOUGH ANIMAL CANCERS MAY OFTEN-BE CAUSED IN A LABORATORY BY VIRUSES.BACTERIA,FUNGII ETC WERE ALSO AT SOME TIME THOUGHT TO BE RELATED TO CANCER.MUCH WORK NOW SUGGESTS LINKS BETWEEN VIRUSES SUCH AS HEPATITIS,POLYOMA AND CANCER;FUNGII SUCH AS ASPERGILLUS FLAVUS, PARASITES SUCH AS SCHISTOCOMYCETES.ETC. IT IS NOT THE OPBJECT OF THIS PATENT TO CLAIM CAUSATIVE FUNCTION OF MICROORGANISMS IN DISEASES OF UNKNOWN AETIOLOGY;BUT TO

MULTIPLE PHOTOS OF DR.CANTWELL DEMONSTRATING ORGANISMS SHOULD

INSERTED HERE.

IT SHOULD BE NOTED THAT THERE IS MUCH EVIDENCE LINKING THESE

ORGANISMS TO CANCER AND OTHER DISEASES;THEY ARE FREQUENTLY

ISOLATED FROM BIOPSIES,BLOOD,OTHER SPECIMENS;THEY CAN BE

IDENTIFIED IN DISEASE FRAGMENTS; INJECTED INTO ANIMAL MODELS THEY

CAN CAUSE DISEASE AND THEN BE ISOLATED AGAIN FROM INDUCED

DISEASE. (LIVINGSTON AND ALEXANDER 1950-1970)

MORE RECENTLY,THE INVENTOR HAS FOUND THAT A WIDE RANGE OF

ORGANISMS RANGING FROM STREPTOCOCCAL-LIKE,STAPHYLOCOCCAL-LIKE

ORGANISMS,YEASTS, FUNGII ETC.CAN BE ISOLATED FROM TUMOUR SAMPLES

AND FROM BLOOD AND OTHER PATIENT SAMPLES WHEN INJECTED INTO A

TUMOUR- BEARING ANIMAL,WILL SELECTIVELY LODGE IN TUMOUR

MASSES.THIS MAY BE SECONDARY TO MANY MECHANISMS BUT APPEARS TO

INDICATE AT LEAST AFFINITY FOR THE ORGANISMS AND CANCER.

THE INVENTOR HAS ALSO DEMONSTRATED THAT ANTISERA RAISED AGAINST

ORGANISMS ISOLATED FROM VARIOUS CANCERS WILL EXERT ACTIVITY

AGAINST THE CANCER CELLS THEMSELVES. THIS CAN BE DEMONSTRATED BOTH

WITH ORGANISMS ISOLATED FROM THE CANCER CELLS AND/OR FROM

ORGANISM LIBRARY OF SIMILAR/RELATED CANCERS EVEN AS BROAD A MATCH

AS CARCINOMAS AND SARCOMAS.

SEVERAL ORGANISM AND ORGANISM TYPES HAVE BEEN DEFINED BY AUTHOR

AS RELATE TO CANCER AETIOLOGY, SYNERGY AND THERAPY.THE OBSERVATION

OF SEVERAL ORGANISMS HAS LED MANY TO BELIEVE THAT THE CANCER

ORGANISM IS PLEOMORPHIC; IT HAS BEEN USED BY MORE TO SUPPORT THE

CONTENTION THAT THESE ORGANISMS ARE CONTAMINANTS.ALTHOUGH ABOVE

EVIDENCE TENDS TO SUGGEST OTHERWISE ,THE INVENTOR WISHES TO

INDICATE THAT EVEN IF SUCH INFECTIONS ARE CONTAMINANTS THAT ALONE

MAY INDICATE AFFINITY OF ORGANISMS FOR TUMOUR MASSES.

MULTIPHASIC THERAPY CAN BE APPLIED IN TERMS OF

CHEMOTHERAPY, IMMUNOTHERAPY,RADIOTHERAPY AND INTERPLAY OF THESE

AND OTHER THERAPIES.

ISOLATION OF ORGANISMS

IN-VITRO THERAPIES MAY BE CAPABLE OF 100% CANCER CELL KILL

IMPORTANTLY,EVEN AFTER SUCH IN-VITRO 'INACTIVATION' INJECTION OF IN-VITRO'KILLED' PREPARATION OF CANCER TISSUE WHERE CELLS HAVE BEEN DISRUPTED SONICALLY,CHEMICALLY, IMMUNOLOGICALLY .OTHER

THIS POINT IS ALSO OF RELEVANCE WHEN ONE CONSIDERS THE NUMER VACCINES CULTURED ON CONTINUEOS CELL-LINES.

IT IS CURRENTLY STANDARD PRACTICE TO CULTURE VIRAL VACCINES ON

CONTINUEOUS CELL LINES .

CONTINUEOUS CELL LINES ARE IMMORTAL CELL LINES,ESSENTIALLY CANCER

CELLS .RESEARCH WORK BY INVENTOR INDICATES THAT DAMAGED/DEGRADED

CANCER CELL PREPARATIONS,EVEN WHEN FILTERED TO REMOVE LIVING

CELLS. STILL MAY CONTAIN FACTORS/AGENTS/ORGANISMS WHICH MAY

INITIATE /AGGRAVATE DISEASE CONDITION.

THIS POINT IS STRESSED TO STATE LINK AND RELEVANCE WITH NEW

VACCINE MANUFACTURE PATENT.

MULTI PHAS I C SYSTEM APPROACH WOULD THEN AIM TO

ATTEMPT TO DEFINE OTHER LIVING SYSTEMS THAT MAY BE ACTIVE IN THE

DISEASE PROCESS.

THE SEARCH FOR LIVING SYSTEMS WAS CONDUCTED ON THE FOLLOWING

BASIS;

1-EVIDENCE FOR LIVING SYSTEMS BEING PRESENT WITH PROXIMITY TO

DISEASE AND DISSEMINATED THROUGH DISEASED BODY ON BIOPSY.

2-ABILITY TO REPEATEDLY CULTURE ORGANISMS FROM

BLOOD, SERUM,URINE,BIOPSIES AND OTHER SAMPLES FROM HOSTS OF CANCER

AND/OR OTHER DISEASES.

3-WORK BY DR.LIEDA MATTMAN DEMONSTRATING PRESENCE OF CELL-WALL - DEFICIENT ORGANISMS IN DISEASES SUCH AS CANCER,AIDS .ARTHRITIS

ETC.

4-WORK BY INVENTOR DEMONSTRATING THE ABILITY TO CULTURE ORGANISMS

FROM PATIENT SAMPLES

5-PREVIOUS WORK BY LIVINGSTON,ALEXANDER, SCOTT AMONGST MANY OTHERS

INDICATING THAT A VARIETY OF ORGANISMS ISOLATED FROM DISEASES

SUCH AS CANCER CAN GENERATE DISEASE OFTEN SIMILAR IF NOT

IDENTICAL TO THE ORIGINAL AND FROM WHICH ORGANISMS MAY OFTEN BE

RECOVERED.

6-WORK BY INVENTOR DEMONSTRATING THE ABILITY OF ORGANISMS TO

CAUSE/INDUCE/ASSIST/ACCELERATE/AGGRAVATE DISEASES SUCH AS CANCER

AND THAT IMMUNOLOGICAL AS WELL AS OTHER THERAPIES TARGETING THESE

ORGANISMS WOULD OFTEN REFLECT WITH IMPROVEMENT IN DISEASE

CONDITION.

FOR THE PURPOSE OF ILLUSTRATION WE WILL CENTRE ON THE DISEASE CANCER,ALTHOUGH THIS IS BY NO MEANS INTENDED TO RESTRICT PATENT OR APPLICATIONS AS THE CLASSIFICATION PATENT AND EMERGENT THERAPIES ASPPKLY TO ALL DISEASE AND OTHER CONDITIONS.

THE MULTIPHASIC APPROACH WOULD ALLOW FOR THE FOLLOWING LOGIC- DISEASE A IS RESPONSIVE TO DISEASE THERAPY ANTI-A,AS THE DISEASE DEVELOPS RESISTANCE TO AND/OR RECURRS AFTER TREATMENT IT IS LIKELY TO HAVE CHANGED IN SOME FORM OR TO HAVE ACTIVATED INTRINSIC/EXTRINSIC METHODS FOR COPING WITH THERTAPY. EXTRINSIC METHODS MAY INCLUDE ACTIVATION OF SOME DEFENSIVE RELATIONSHIP WITH CAUSATIVE AND/OR SYNERGISTIC ORGANISM.

THE MULTIPHASIC APPROACH AS APPLIED TO CANCER CAN BE SUMMARISED SIMPLY;AS MANY CHEMOTHERAPEUTIC AGENTS ORIGINATE FROM LIVING ORGANISMS, (THESE MAY BE CLASSIFIED AS ANTAGONISTIC OR NEMESES DEPENDING ON EFFICACY)AND AS CERTAIN ORGANISMS APPEAR CAPABLE OF CO-EXISTING WITH CANCER AND SOMEHOW EXERT AN EFFECT FAVPOURABLR TO THE DISEASE;THESE MAY BE CATAGORISED AS CAUSATIVE OR

SYNERGISTIVC,THESE MAY ALSO HAVE DEFINED ANTAGONISTS AND

AS CANCER CELLS DEVELOP RESISTANCE TO A PARTICULAR THERAPY; CO-INCUBATION AND BIASSED CULTURES ALLOW DEVELOPMENT OF MORE EFFECTIVE THERAPY.

CO-INCUBATION MAY BE USED TO DEVELOP THERAPY DE-NOVO.

THE OBJECT OF THIS PATENT IS TO DEMONSTRATE

1-GENERATION OF THERAPY

2-MINIMISATION OF SIDE-EFFECTS

3-CRUDE/PURIFIED USE

4-CO-TEMPORAL UPGRADING OFD THERAPY

5-USE AS MULTIPHASIC THERAPY

6-INTERACTION WITH OTHER MULTIPHASIC THERAPIES

7-INTERACTION WITH OTHER MODALITIES IN INDUCED REMISSION THERAPY B-NEWLY-DEFINED MECHANISMS

9-LINK WITH MACHINE THERAPY.

IMMUNOLOGICAL INC ASCITES

OPP PEGENERATUON

ORGAN ORGANISM BUG

REINFORCE NORMAL FUNCTION

PEN AND OTHER UDSED DIRECT/VS Asstd inf

SOME CULTURE SYSTEMS/METHODS FOR DELINEATING LEVEL ONE CLASSIFICATION.

ALL TECHNIQUES/GUIDELINES/TECHNOLOGIES AS WELL AS THEIR UNIQUE METHOD AND REASON OF APPLICATION ARE COVERED BY THIS PATENT.

CULTURES MAY BE ENRICHED/MINIMAL OR DEFICIENT WITH ALL GRADES IN BETWEEN BEING REPRESENTED.THE TYPE OF MEDIUM/MEDIA IN WHICH ANTICANCER ACTIVITY PRESENTS ITSELF MAY BE USED TO GRADE/CLASSIFY POTENCY/AFFINITY OF RESPONSE.VARIATIONS IN MEDIA MAY ALSO BE USED TO STIMULATE/INDUCE/AUGMENT OR INHIBIT/NEUTRALIZE/WEAKEN

RESPONSE

AN ORGANISM MAY BE RATED AS A MORE AGGRESSIVE ANTAGONISTIC AGENT IF ITS ANTI-CANCER VRESPONSE IS SUPERIOR AND/OR MAINTAINED UNDER MEDIA AND CULTURE CONDITIONS WHICH ARE INCREASINGLY MORE DIFFICULT FOR THE ORGANISM'S SURVIVAL.AN INDUCTION PHENOMENON WILL BE NOTICED WITH SOME ORGANISMS WHERE ,AS CONDITIONS OF MEDIA AND CULTURE BECOME INCREASINGLY DIFFICULT, INHERENT MECHANISMS PERHAPS PREVIOUSLY DORMANT, BECOME ACTIVATED TO ATTACK AND

ELIMINATE THE CANCER CELLS COMPETING FOR SOME OF THEIR NUTRITION/SUBSTRATE AND/OR UTILIZE CANCER CELLS AND THEIR

BREAKDOWN PRODUCTS FOR NUTRITION.AS MENTIONED SUCH SURVIVAL TECHNIQUES MAY HAVE BEEN INHERENT BUT DORMANT OR THEY MAY ARISE BY MUTATION.SELECTIVE CULTURES IN ENRICHED MEDIA AND RESTRICTED MEDIA ALONG WITH FACTORS SUCH AS EXPOSURE TO PEROXIDE OR UV.FOR EXAMPLE TO PROMOTE AND CULTIVATE MUTATIONS WHICH HAVE BENEFICIAL PROPERTIES ARE COVERED BY THIS PATENT.

CAUTION:SUCH CULTURE MANIPULATIONS MAY ALSO LEED TO DEVELOPMENT OF ORGANISMS THAT WILL SYNERGISE WITH CANCER CELLS ;A DEGREE OF INSURANCE AGAINST THIS MAY BE GAINED BY EITHER HAVING THE CANCER CELLS IN POOR CULTURE CONDITIONS AT THE SAME TIME (DANGER HERE OF CANCER DEVELOPING SYNERGY WITH ORGANISM FOR ITS OWN SURVIVAL ),OR BETTER YET, IN FRAGMENTS (THIS STILL ALLOWS THE ORGANISM TO

DEVELOP AFFINITY AND MAY BE A GOOD TOOL FOR THE DEVELOPMENT OF TAGGING AND/OR CARRIER VACCINES-TO BE DISCUSSED

LATER.ALTERNATIVELY,THE CANCER CELLS MAY BE TOTALLY ABSENT AS SERIAL ENRICHED AND RESTRICTED MEDIA CULTURES ARE MADE WITH OR WITHOUT MUTATING AGENTS TO INCREASE THE PRESENTATIONS OF THE ORGANISM TO BE TESTED.

ORGANISMS CAN BE INDUCED OR MUTATED RANDOMLY ;ALONE, IN THE

PRESENCE OF CANCER CELLS OR CANCER-CELL FRAGMENTS,MADE TO COMPETE WITH CANCER CELLS AND/OR CAUSATIVE AND/OR SYNERGISTIC ORGANISMS OR OTHER F/A/P'S ETC. ORGANISMS COULD BE SELECTIVELY BRED TO CONSUME NUTRIENTS ESSENTIAL TO CANCER CELL GROWTH AND SURVIVAL, FOR EXAMPLE.

IN ANY LIVING SYSTEM,THE TARGET OF AGGRESSION MAY MUTATE OR MODIFY TO BETTER SURVIVE THE ATTACK,SHOULD SUCH A SITUATION ARISE,THE PROCESS MAY BE REPEATED TO YEILD NEW ACTIVE F/A/P'S ETC. AGAINST THE NEW OR MUTATED FORMS OF THE DISEASE.

TO FULLY UNDERSTAND THE IMPORTANCE OF THE FINAL STATEMENT; IT NEEDS TO BE EXAMPLIFIED IN TWO IMPORTANT SYSTEMS AND PATENT FOR NEW IMMUNOLOGIC TECHNOLOGIES RELATING TO

-THERAPY

-DIAGNOSIS

±SPECIFICITY

-PROGNOSIS-

-MONITORING

-NEW VACCINE TECHNOLOGY-ACTIVE

-PASSIVE

-SUPPORT TO CHEMOTHERAPY

-SUPPORT TO ANTIBIOTICS

-DIRECT TAGGING

-INDIRECT/INDUCED TAGGING EG. GENETIC

-ANTI-PLASMID/INDUCED ENZYMES/OTHER BIOLOGICAL/PHYSICAL/CHEMICAL,

WHOLE/PART/EXTRACT/PRODUCT-WHOLE/PART/EXTRACT.

-IN-VITRO. IN-VIVO GENERATION/ISOLATION/PURIFICATION . OWN/ AUTOLOG

-OUS/AUTOGENOUS.

SPECTRUM OF APPLlCATION-ALL DISEASES OF KNOWN OR UNKNOWN

AETIOLOGY/KNOWN OR UNKNOWN MECHANISMS AND EVEN CONDITIONS OR PROCESSES NOT GENERALLY CONSIDERED AS DISEASE4 STATES EG AGING

-HAYFLICK PHENOMENON AS DIGNOSTIC/PROGNOSTIC/MONITORING DEVICE FOR DISEASE AND THERAPY. (EG NO. OF DIVISIONS LEFT TO POPULATION OF T CELLS IN AIDS OR NUMBER OF CELL DIVISIONS LEFT TO CANCER CELLS FOLLOWING EXPOSURE TO THERAPEUTIC AGENT.ALSO AS NEW ASSAY TECHNOLOGY IN DETERMINING USE/SAFETY AND EFFICACY WITH EVALUATION OF TARGETED AND OTHER SYSTEMS.

CELL DIVISION MONITORING CAN ALSO FORM EFFECTIVE TOOL EG SOME CELLS MAY BE MORE SENSITIVE TO AGENTS NOT ONLY DURING SPECIFIC TIMES IN THEIR CELL DIVISION CYCLE BUT ALSO AT DIFFERENT TIMES DURING CELL LIE AS DETERMINED BY NUMBER OF DIVSIONS.

CELL DIVISION MONITORING OR CULTURE OF ORGANISM IN PRESENCE OF THERAPEUTIC AGENT ALSO ENABLES MORE PRECISE DEVELOPMENT OF THERAP

-EUTIC PROTOCOLS WHICH CAN EVALUATE AND TIME AND CUNTER OR

PREVENT RESISTANCE.

INVITRO CELL DIVISION CAN BE ACCELLERATED SO THAT POSSIBLE CHANGE MANIFESTS IN TUBES OR IN LIVING SYSTEMS PRIOR TO ITS APPEARANCE IN THE SUBJECT. IMMUNOLOGICAL OR OTHER MARKERS CAN BE RAISED TO DETECT THEIR ARRIVAL AND/OR AID IN THEIR NEUTRALIZATION.

ESTIMATION OF CYCLE RATEIN-VITRO/IN VIVO COMPARED TO RATE IN TARGET SYSTEM EG PATIENT MAY BE USED TO ESTIMATE TIMES OF CHANGE AS CHANGES ARISE THEY CAN BE GRAPHED IN BOTH SYSTEMS TO ASSIST IN CORKELATION. TEST DONE UNDER THE FOLLOWING PATENT;EVERYTHING CAN

BE CLASSIFIED UNDER THE

CAUSATIVE/SYNERGISTIC/NEUTRAL/INFECTIVE /ANTAGONISTIC/NEMESIS. TITLES, IN WHICH CASE , UNDER THE DEFINED PARAMETERS OF THEIR CLASSIFICATION ONE CAN KNOWWHETHER THEY SHOULD BE INDUCED/SUPPORTED/AUGMENTED OR

INHIBITED/NEUTRALISED/ELIMINATED.

A MARKED FEATURE OF SEARCHES BASED ON THIS CLASSIFICATION, THEREFORE, IS THAT THEY,UNLIKE PRIOR ART, YEILD A VERY HIGH PERCENTAGE OF USEABLE DATA AND PROVIDE THE BASIS OF AN ENTIRELY NEW FORM OF MEDICINE.

PRECURSOR / INTERMEDIATE AND ENDPRODUCT THERAPY. TECHNOLOGY OF THERAPY

/PREVENTION OF RESISTANCE AND

INTRODUCTION

CURRENT TECHNOLOGY ADDRESSES A PARTICULAR FEATURE OF A SITUATION AND ALTHOUGH OCCASSIONALLY A DISEASE THERAPY MAY BE ADDRESSED BY ATTEMPTING TO EXPLOIT VARIUOS WEAKPOINTS, THE SCOPE OF CURRENT ENDEAVOUR IS SEVERELY RESTRICTED. PICTURE FOR EXAMPLE COMBINATION CHEMOTHERAPY; THE USE OF MULTIPLE POISONS WHEN TRYING TO KILL CANCER,AT ONE END OF THE SPECTRUM THE NARROWNESS OF THE FIELD IS SEEN AS ALL ATTEMPT TO POISON THE CANCER CELL,LARGELY BY

INCREASINGLY FREQUENT PRACTISE OF INCORPORATING 'IMMUNOTHERAPY' (EQUALLY INEFFECTIVE) TO IMPROVE EFFICACY OF THERAPY AND MINIMISE OR OFFSET IMMUNOSUPPRESSIVE ACTIVITY OF CHEMOTHERAPY BY CALLING ON AN ENTIRELY DIFFERENT SYSTEM LEANSA TOWARDS THE OTHER END OF THE SPECTRUM.THE INTERPLAY OF SUPPRESSION AND STIMULATION

THE OBJECT OF THIS PATENT IS TO PROVIDE A NEW SCIENCE OF LIMITLESS APPLICATIONS.THE MEDICAL MODEL WILL BE USED TO

EXAMPLIFY ONE VEIN OF APPLICATION.

CHEMOTHERAPY.

MANY CHEMOTHERAPEUTIC AGENTS ARE DERIVED FROM MICROORGANISMS SUCH AS FUNGII, THE FAMILY OF ACTINOMYCETES,FOR EXAMPLE,YEILDS

ACTINOMYCIN-D,AN ANTIBIOTIC AND CHEMOTHERAPEUTIC AGENT.

THE DIFFICULTY WITH MOST CHEMOTHERAPEUTIC REGIMENS STEMS NOT JUST FROM TOXICITY AND GENERAL LACK OF EFFICACY,AND LACK OF

SPECIFICITY BUT ALSO FROM THE FACT THAT EVEN WHERE EFFICACY CAN BE DEMONSTRATED, IT IS GENERALLY SHORT-LASTING.DISEASE RESISTANCE USUALLY EMERGES.CURRENT ART IN OFFSETTING OR POSTPONING THE EMERGENCE OF RESISTANCE INVOLVES COMBINATION THERAPY WHERE A GROUP OF TOXIC AGENTS ARE COMBINED BY SOME PROTOCOL, IN THE HOPE THAT THE CANCER WILL NOT BE ABLE TO DEVELOP RESISTANCE AS EASILY TO A COCKTAIL OF POISONS OF VARIED MECHANISMS AS IT DOES TO A SINGLE POISON.REGARDLESS OF COMBINATIONS AND PROTOCOLS,CANCER USUALLY DEVELOPS RESISTANCE IN A PERIOD OF WEEKS TO MONTHS AND VERY RARELY,YEARS.THE FAILURE OF THIS STRATEGY(COMBINATION

CHEMOTHERAPY) IN ADULT CANCER IS BEST DEMONSTRATED BY THE MINIMAL ALTERATION IN CANCER SURVIVAL RATES OVER THE PAST 80 YEARS.

ONCE CHEMOTHERAPY HAS BEEN PROCESSED INTO AN INANIMATE CHEMICAL,DEALING WITH RESISTANCF IS DIFFICULT. IF,HOWEVER,WE RETURN TO THE FUNGUS OR OTHER ORGANISM OF ORIGIN( EVEN WHJERE THE AGENT IS A BOTANICAL, CELL CULTURES OF THE PLANT OF ORIGIN MAY BE USED,OR AN IN-VIVO MODEL MAY BE DEVISED) .LIVING SYSTEMS MAY BE MANIPULATED SO THAT THEY DEAL WITH RESISTANCE,EITHER BY ALLOWING THE RESISTANT DISEASE TO BE EXPOSED TO THE ORGANISM OR ORGANISMS WHICH PREVIOUSLY DEMONSTRATED ANTI-DISEASE ACTIVITY AND ALLOWING THEM TO TO CHANGE OR MUTATE TO OVERCOME THE DISEASE RESISTANCE. THIS MAY BE DONE BY SERIAL ENRICHED AND RESTRICTED CULTURES WITH OR WITHOUT MUTATING AGENTS OR FACTORS ,WHERE THE ORGANISM MAY, FOR EXAMPLE ,BE CULTURED IN RESTRICTED MEDIUM WITH THE RESISTANT CANCER CELLS BEING ITS ONLY OR MAJOR SOURCE OF NUTRITION;THE ORGANISM IS LIKELY TO DEVELOP NEW WAYS TO KILL THE RESISTANT CANCER CELLS IF ITS SURVIVAL DEPENDS ON THAT.PLACING THE CANCER CELLS IN COMPETITION FOR A VITAL SUBSTRATE IS ANOTHER WAY OF INDUCING SUCH A CHANGE IN THE ORGANISM.FOLLOWING THE RESTRICTED CULTURE,THE ORGANISMS WITH IMPROVED CANCER KILLING ABILITY MAY THEN BE CULTURED IN ENRICHED MEDIA TO STRENGTHEN THEM ,WITH OR WITHOUT MUTATING F/A/P'S ETC. BY WHICH TO INCREASE THE ORGANISM POOL; INTRODUCING THE NEW POOL TO THE FORMERLY RESISTANT CANCER CELLS ALLOWS FOR THE SELECTION OF EVEN MORE SUPERIOR STRAINS FOR THE DEVELOPMENT OF ONGOING THERAPY.

DISEASE RESISTANCE CAN BE ANTICIPATED BY ALLOWING EXPOSURE OF DISEASE TO THERAPY IN EITHER IN-VITRO OR IN-VIVO SYSTEMS.FOR EXAMPLE,TO INDUCE CANCER RESISTANCE TO A PARTICULAR

AGENT,CONTINUOUS CULTURE WITH THE AGENT AT SUB-LETHAL DOSES MAY ALLOW THE EXPRESSION CT RESISTANT CANCER STRAINS OR THE INDUCTION OF SYSTEMS THAT FASCILITATE TOLERANCE.ALTERNATIVELY, CULTURING CANCER CELLS IN ENRICHED MEDIA WITH INCREASINGLY TOXIC LEVELS OF THE AGENT ±MUTATING F/A/P'S ETC COULD ALSO CAUSE DEVELOPMENT OF PRECURSOR / INTERMEDIATE AND ENDPRODUCT THERAPY. TECHNOLOGY OF THERAPY

/PREVENTION OF RESISTANCE AND

INTRODUCTION

EXAMPLIFY ONE VEIN OF APPLICATION.

DEFINITION OF TERMS WILL BE FOLLOWED BY AN EXAMPLE AND DEMONSTRATION OF A NEW THERAPEUTIC TECHNOLOGY OUTLINING THE IMPROVEMENT OF EFFICACY OF THIS THERAPY IN MANAGEMENT OF INFECTIONS. USE OF VIRUSES, BACTERIA,YEASTS FUNGII AND OTHER MICROORGANISMS WITH OR WITHOUT THE INTERPLAY OF HIGHER SYSTEMS AND ORGANISMS IN THE TREATMENT OF DISEASE.

HISTORY-

1-VACCINE MANUFACTURE-

VIRUSES-

THESE AGENTS HAVE BEEN CLASSICALLY USED IN ATTENUATED FORMS TO IMMUNISE AGAINST VIRULENT DISEASE.THIS USUALLY INVOLVES

ATTENUATION OF THE CAUSATIVE ORGANISM SUCH AS IN THE CASE OF MEASLES AND MUMPS VACCINES BUT ALSO INCLUDES THE COWPOX VACCINE BEING USED TO IMMUNISE AGAINST SMALLPOX. OCCASSIONALLY,VIRUSES HAVE BEEN USED IN THE PREPARATION OF CANCER VACCINES. PREVIOUS ATTEMPTS TO TREAT CANCER BY INFECTION WITH VIRUS HAVE LARGELY FAILED.

BACTERIA

STREPTOCOCCUS/STAPHYLOCOCCUS/KLEBSIELLA/E.COLI ETC. , ALL OF WHICH

ARE LARGELY OF VERY LIMITED EFFICACY.

CURRENT PATENT TECHNIQUES AND GUIDELINES WILL SIGNIFICANTLY

INCREASE SAFETY AND EFFICACY.

ANTIBIOTICS ARE THE MAIN THERAPEUTIC DERIVATIVES OF BACTERIA AND

FUNGI WHEREAS YEASTS HAVE VERY LIMITED THERAPEUTIC USE IN MODERN

MEDICINE.SOME EXTRACT ENZME PREPARATIONS MAY ALSO BE PREPARED

FROM THIS GROUP.AGAIN, IT IS POSSIBLE TO IMPROVE ON ALL OF THE

ABOVE METHODS/APPLICATIONS, SUGGEST ALTERNATIVES AND INTRODUCE NEW

USES AND TECHNOLOGIES FOR THEM.

HIGHER ORGANISMS.

THE INTERPLAY BETWEEN THE ADMINISTERED THERAPY AND THE TARGET HOST OR .HOST SYSTEM OR PART THEREOF USUALLY TAKES PLACE IN SAID HOST; IN OTHER WORDS.WHEN AN ANTIBIOTIC OR A VACCINE IS APPLIED TO THE BODY, IT IS THE FINAL STEP OF THIS THERAPY OR PRIOR TO

EVALUATION OF EFFICACY .THIS PATENT WILL TEACH IN-VITRO AND IN- TOLERANT AND RESISTANT STRAINS. INCUBATION IN MINIMAL MEDIA WHERE THE CANCER CELLS NEED THE ORGANISM FOR NUTRITION(PARTICULARLY WHERE THE ORGANISM IS PARTICULARLY RESTRICTED, STRAINED OR EVEN PROVIDED IN FRAGMENTS)ALLOWS THE DEVELOPMENT OF RESISTANT

STRAINS. THE THERAPEUTIC ORGANISM(S) CAN THE BE PLACED IN CULTURE WITH THE RESISTANT CANCER CELLS TO DEVELOP EFFECTIVE THERAPIES.ALTHOUGH IT IS LIKELY THAT THE ORGANISMS WILL ADJUST THEIR CHEMOTHERAPEUTIC PRODUCT TO DEAL WITH CANCER RESISTANCE, THIS PATENT IS NOT LIMITED TO THE USE OF SUCH AGENTS BUT ALSO ALL OTHER MECHANISMS DEVELOPED BY THE ORGANISM INCLUDING METABOLIC,ENZYMATIC ETC. DIRECT/INDIRECT/IN ASSOSCIATION WITH BODY IMMUNE OR OTHER SYSTEM.

WHAT WE HAVE JUST DISCUSSED THEREFORE PRESENTS MECHANISMS FOR DEVELOPING ONGOING THERAPY REGARDLESS OF DISEASE CHANGE OR MUTATION AS WELL AS A PROCESS FOR ANTICIPATING DISEASE RESISTANCE AND DEVELOPING AGENTS OR AGENT COMBINATIONS(OR F/A/P'S ETC.) TO DEAL WITH THEM BEFORE OR AS THEY ARISE.

BY COMPARISON OF THERAPY-RESISTANT FORMS WITH THE THERAPY- SENSITIVE FORMS OF THE DISEASE AND ANALYSING THE DIFFERENCES BY PHYSICAL/CHEMICAL OR BIOLOGICAL MEANS, RESISTANCE-SPECIFIC

F/A/P'S ETC CAN BE DEMONSTRATED AND SENSITIVITY OR

SUSCEPTABILITY-SPECIFIC(SS) F/A/P'S ETCCAN BE IDENTIFIED.AND SENSITIVE F/A/P'S ETC CAN BE INDUCED/AUGMENTED/SUPPORTED, WHEREAS RESISTANCE -SPECIFIC (RS)F/A/P'S ETC. CAN BE

NEUTRALISED/INHIBITED/ELIMINATED.ONCE SUCH F/A/P'S ETC HAVE BEEN IDENTIFIED, SELECTIVE CULTURE PROCEDURE CAN BE USED TO DEVELOP FURTHER STRATEGIES,THE HOST'S IMMUNE RESPONSE MAY ALSO BE BROUGHT TO PLAY.

IT WOULD BE POSSIBLE, FOR EXAMPLE TO SELECTIVELY CULTURE ORGANISMS WITH RESISTANCE SPECIFIC F/A/P'S ETC. TO ALLOW ORGANISMS TO DEVELOP RESISTANCE TO THE RS F/A/P'S ETC.OR TO DEVELOP

SYSTEMS, PRODUCTS ETC (ANTI-RS F/A/P'S ETC. )TO NEUTRALIZE OR DESTROY THESE ENTITIES .IN A RESTRICTED MEDIUM, FOR EXAMPLE WHERE THE ORGANISM IS DEPENDANT ON THE RS F/A/P'S ETC FOR

NUTRITION,ENZYMES MAY BE DEVELOPED TO BREAK THEM DOWN.

IT MAY ALSO BE POSSIBLE TO RAISE AN IMMUNE RESPONSE AGAINST THE RESISTANT CELLS OR THE RS F/A/P'S ETC. , PARTICULARLY IF THESE CAN BE IDENTIFIED AND VACCINES GENERATED OUTSIDE THE HOST BEFORE MANIFESTING TO ANY SIGNIFICANT DEGREE WITHIN THE HOST.MANY CANCER PATIENTS HAVE AN IMMUNE SYSTEM OVERWHELMED BY THE DISEASE AND SUPPRESSED BY A PHENOMENON KNOWN AS THRESHHOLD INHIBITION, IF THE RESISTANT CELLS OR RS F/A/P'S ETC ARE OR CAN BE MADE INTO A SUFFICIENTLY ANTIGENIC FORM (EG BY TAGGING OR CARRIERS,MECHANISMS TO BE EXPLAINED LATER), SUCH THAT AN IMMUNE RESPONSE CAN BE RAISED AGAINST THEM PRIOR TO THEIR INCEPTION IN-VIVO OR AT LEAST PRIOR TO THEIR PASSING IMMUNOLOGICAL INHIBITION THRESHHOLD,A POWERFUL THERAPEUTIC ALLY CAN BE UTILISED.

THE IMPORTANCE AND FLEXIBILITY OF THIS DISCOVERY CAN BE BEST DEMONSTRATED WITH ANTIBIOTIC THERAPY. ASSAY/DIAGNOSTIC /THERAPY PREPARATION TECHNOLOGY INCLUDING BROAD SPECTRUM DESIGN TECHNOLOGY WITH EMPHASIS ON TAGGING/CARRIER THERAPEUTIC TECHNOLOGY AND CANCER/INFECTION THERAPEUTIC

TECHNOLOGY UNDER THE MEDICAL MODEL.

TECHNOLOGY APPLIES TO ALL APPLICATIONS AND CLASSIFICATIONS OF

F/A/P'S ETC UNDER GUIDELINES OF PATENT BUT WILL BE DEMONSTRATED BY EXAMPLES UNDER THE MEDICAL MODEL.

BROAD SPECTRUM SCREENING EXAMPLES OF SUCH SCREENING COULD BE ACCOMPLISHED IN A NUMBER OF EMBODYMENTS;TWO WILL BE DISCUSSED. AGAIN, PATENT TECHNOLOGY AND GUIDELINES CAN BE APPLIED TO A MYRIAD SITUATIONS. F/A/P'S ETC AND COMBINATIONSBUT DISCUSSION HERE WILL BE RESTRICTED TO A SEARCH FOR ORGANISMS WITH ANTCANCER ABILITY.

SYSTEMATIC SEARCH OF ORGANISMS CAN BE DONE BY A SYSTEMATIC SCREENING OF ORGANISM AND ORGANISM COMBINATIONS AND CANCER CELLS OR MIXINDICATED BY BY SYUDIES/FUNCTIONS ETC. OR COMPLEX OR MIX ETC.

REASONABLY SAFE TO USE TO INTERFERE WITH THE AIDS VIRUS.SUCH VIRAL AND BACTERIAL AGENTS MAY BE SELECTED AND MODIFIED TO HAVE MINIMAL AFFINITY FOR NORMAL HEALTHY TISSUE/CELLS BY TECHNIQUES WE WILL REVIEW AND WHICH ARE DISCUSSED IN THE CLASSIFICATION PATENT BY THE SAME INVENTOR. IT IS ALSO PRUDENT TO HAVE ANTISERA

DEVELOPED AND PURIFIED FOR USE IF NEEDED.

A SIMPLE GUIDELINE TO MINIMISE RISK OF HARM TO PATIENT IS TO USE VIRUS OR INFECTION WHICH IS OF ANOTHER SPECIE AND WHICH WON'T OR RATHER CAN'T ACT ADVERSELY ON HEALTHY HUMAN CELLS AS HUMANS (OR WHATEVER SPECIE OF HOST TO BE TREATED) HAS NO TARGET ORGAN AND/OR NO SPECIFIC RECEPTORS FOR ORGANISM TO ATTATCH TO.FOR EXAMPLE, BACTERIAL PHAGES ARE VIRUSES WHICH SPECIFICALLY INFECT BACTERIA AND ARE LARGELY INCAPABLE OF CAUSING DISEASE IN HIGHER ORGANISMS

INTERFERANCE PHENOMENA-IN

DIAGNOSIS,MONOTORING-PROGRESS OF

DISEASE AND EFFICACY OF THERAPY,

PROGNOSIS AND THERAPY.

AS PREVIOUSLY MENTIONED MICROORGANISMS CAN EXERT INTERFERANCE ON OTHERS.CELLS ARE ALSO CAPABLE OF THIS . INTREFERANCE PHENOMENA HAVE BEEN OBSERVED AND DEMONSTRATED BY THE INVENTOR AMONGST CANCER CELLS,EXTRACTS AND HOST INDUCED RESPONSES.ALTHOUGH USE OF CANCER TISSUE FOR IMPLANTATION INTO CANCER PATIENTS AS A FORM OF THERAPY WAS ATTEMPTED EARLIER THIS CENTURY AND MET WITH SOME SUCCESS;THIS CRUDE FORM OF THERAPY INITIATED A RANGE OF IMMUNOLOGICAL RESPONSES AMONGST OTHERS NOT RELATED TO INTERFERANCE PHENOMENA; AS A THERAPY,THIS WAS NEVER PATENTED. IT IS THE OBJECT OF THIS PATENT TO INCLUDE METHODS AND CONCEPTS BY WHICH SUCH THERAPY COULD BE MADE SAFE AND EFFECTIVE (SEE CANCER SECTION FOR

PURIFICATION AND IN-VITRO, IN-VIVO MODELS FOR PROCESSING CANCER AND /OR IMMUNE OR OTHER RESPONSE) . INTERFERANCE THERAPY OFFERS THE POTENTIAL FOR THE PURIFICATION OF F/A/P'S ETC WHICH CAN SAFELY NEUTRALIZE OTHERS WITH OR WITHOUT INVOLVEMENT OF THE HOST DEFENSE OR OTHER SYSTEMS.METHODS AND TECHNIQUES WILL BE DISCUSSED TO ENABLE THIS.-HOWEVER THER EXISTS ANOTHER WAY OF UTILIZING THIS PHENOMENA WITH RELATIVE SAFETY,A DISCUSSION OF THIS WILL FOLLOW WITH AIDS BEING USED AS THE MEDICAL TREATMENT MODEL.

INTERFERANCE CLASSIFICATION AND USE

EARLY THIS CENTURY WORK WAS DONE INVESTIGATING THE INTERFERANCE NOTED BETWEEN SOME ORGANISMS. INVESTIGATION OF THIS PHENOMENON BETWEEN BACTERIA WITH OTHER BACTERIA OR WITH HIGHER ORGANISMS LED TO THE DEVELOPMENT OF SOME EARLY ANTIBIOTICS.THE OBSERVATION THAT SOME VIRUSES INTERFERE WITH OR INHIBIT THE DEVELOPMENT OF OTHER VIRAL INFECTIONS SIMULTANEOUSLY OR SOON AFTER IN ANIMAL OR TEST TUBE MODELS LED TO THE DEVELOPMENT OF INTERFERON NAMED BECAUSE OF THE INTERFERENCE PHENOMENON. IT IS THE INVENTOR'S CONTENTION THAT THE INTERFERENCE PHENOMENON IS FAR MORE COMPLICATED THAN THE SIMPLE PRODUCTION OF INTERFERON. INTERFERENCE PHENOMENA HAVE BEEN OBSERVED BY AUTHOR IN SYSTEMS WHERE INTERFERON GENERATION IS NOT POSSIBLE. LIVING ORGANISMS CAN INTERFERE DIRECTLY WITH OTHERS.AT THIS POINT ONE SHOULD OUTLINE A CLASSIFICATION SYSTEM FOR ALL ORGANISMS WITH INTERFERENCE PHENOMENON IN MIND.

ALL ORGANISMS WILL EITHER SYNERGISE AND ASSIST OTHERS, BE NEUTRAL TO THEM OR SUPPRESS/INHIBIT THEIR GROWTH/SURVIVAL.HENCE

INTERFERENCE CLASSIFICATION CAN BE; SYNERGISTIC

NEUTRAL INHIBITORY VIVO METHODS OF FURTHER DEVELOPING THE THERAPY BY INTERPLAY WITH HOST ,HOST SYSTEMS OR PARTS THEREOF AND OF RAISING AN ENTIRELY NEW ARM AND TECHNIQUE OF THERAPY.

INTRODUCTION

IT IS THE OBJECT OF THIS PATENT TO INTRODUCE NEW MODIFICATIONS OF PREEXISTING TECHNOLOGY AS WELL AS TECHNIQUES FO AMPLIFICATION OF EFFICACY,SPECIFICITY AND SAFETY.WHETHER INDIVIDUALLY OR BY

COMBINATION WITH OTHER MICROORGANISMS,HIGHER ORGANISMS OR BY USE OF BIOLOGICAL FRAGMENTS NOT BEFORE APPLIED IN THERAPY AT LEAST NOT IN THIS MANNER, PATENT WISHES TO INTRODUCE A NEW LINE OF THERAPIES AND APPLICATIONS INCLUDING DIAGNOSIS,PROGNOSIS WITH GUIDELINES TO DEVELOPING CARRIER SYSTEMS, TAGGING SYTEMS,

THE CONCEPT OF INTERFERANCE VIRAL/BACTERIAL/FUNGAL OR OTHER IS ALSO TO BE DEMONSTRATED IN THERAPY.THE ABILITY AND EFFICACY OF GUIDELINES IN CHOOSING BIOLOGICAL ORGANISM FROM POOL OR BY STRINGENT TESTING FOR INHERENT FEATURES OR TO DEVELOP OR CARRY AND REPRODUCE DESIRED FEATURES IN A MANNER DIFFERENT TO THAT OF CURRENT GENETIC ENGINEERING WILL ALSO BE DEMONSTRATED.

INTERFERANCE PHENOMENON AS THERAPY

INTERFERANCE PHENOMENA HAVE BEEN OBSERVED WITH MANY ORGANISMS BOTH WITHIN A PARTICULAR CLASSIFICATION EG BACTERIA AS WELL AS FROM OTHER GENUS/SPECIES . INTERFERANCE PHENOMENA CAN BE DIRECT SUCH AS BY PRODUCTION OF ANTIBIOTIC INHIBITORY OR LETHAL TO OTHER ORGANISMS OR INDIRECT SUCH AS BY COMPETITION FOR A COMMON NUTRIENT OR SUBSTRATE. INTERFERANCE BY THIRD PARTY IS A TERM GIVEN BY INVENTOR TO THE ABILITY OF ONE ORGANISM TO INTERFERE WITH THE SURVIVAL OF ANOTHER BY EITHER DIRECTLY OR INDIRECTLY ALERTING THE HOST TO THE PRESENCE OF THE OTHER (TARGETED INTERFERANCE) OR TO THE PRESENCE OF BOTH SUCH AS BY SHARED ANTIGENICITY(NON-SPECIFIC INTERFERANCE) WHEN BOTH ORGANISMS ARE COEXISTING IN TIME ,THE LATTER MECHANISM MAY ALSO FALL UNDER THE CATEGORY OF SUICIDAL INTERFERANCE, SUICIDAL INTERFERANCE MAY ALSO BE DEMONSTRATED WHEN AN ORGANISM ATTATCHES TO ANOTHER,THE EFFECTS OF WHICH DIRECTLY OR INDIRECTLY(SUCH AS BY IMMUNE MECHANISM) CAUSING THE DESTRUCTION OF BOTH.THIS FIRST MECHANISM WILL BE USED TO DEFINE ONE

IN A COMPLEX ENVIRONMENT THERE ARE MANY POSSIBILITIES;

IF ORGANISM A IS SYNERGISTIC WITH B WHEN THE TWO ARE CULTURED ALONE BUT IS MORE SYNERGISTIC WITH C IN A MIXED SETTING,AND IF C IS ANTAGONISTIC TO B THEN IN THIS MIXED SETTING A IS SYNERGISING WITH AN INHIBITOR AND IS THEREFORE NOW CLASSIFIED AS INHIBITORY. SIMILARLY CLASSIFICATIONS MAY CHANGE ONCE INSIDE A LIVING SYSTEM. AN ORGANISM MAY BE NEUTRAL WITH RESPECT TO ANOTHER BUT INDUCE SUCH A MASSIVE IMMUNE RESPONSE THAT BOTH ARE ELIMINATED FROM A LIVING HOST. IN THIS SETTING ITS STRONG IMMUNOGENIC PROPERTIES WOULD CLASSIFY IT AS INHIBITORY.

SOME IMMEDIATE APPLICATION.

THE AIDS MODEL.

AN APPEAL OF INTERFERENCE THERAPY IN THE TREATMENT OF AIDS IS THAT LIVING SYSTEMS OF COMPATIBLE SURVIVAL SKILLS CAN BE USED TO HIV.CAUTION NEEDS TO BE TAKEN THAT SUCH AGENTS ARE PURELY

INHIBITORY AND HAVE NO PROPENSITY FOR SYNERGY WITH DISEASE OR HARM OF HOST. INHIBITORY OR INTERFERENCE -SPECIFIC FRACTIONS OR FRAGMENTS CAN BE PURIFIED OR EXTRACTED BY USE OF SUCH TECHNIQUES AS PRESENTED IN CLASSIFICATION PATENT. (SELECTIVE TESTING OF FILTERED OR CENTRIFUGED FRAGMENTS CAN INDICATE BY TESTING,WHICH PROMOTES MAXIMAL INHIBITION)

INVENTOR HAS STUDIED SEVERAL CASES OF AIDS AND GAUGED THEIR RESPONSE TO INFECTIONS ACQUIRED SPONTANEOUSLY AS WELL AS RESPONSE TO INHIBITORY ORGANISMS ADMINISTERED.WE SHALL CONCENTRATE ON SOME ORGANISMS FOUND TO BE INHIBITORY.

STAPHYLOCOCCAL AND STREPTOCOCCAL INFECTIONS CAUSING SIGNIFICANT ERYSIPELAS WERE FOUND TO RAISE T CELL COUNTS IN SOME INSTANCES BUT TO CAUSE THEM TO DROP IN OTHERS. ANTIBIOTIC THERAPY FOR SUCH INFECTIONS OFTEN LESSENED THE DEGREE OF CHANGE INDUCED.WHERE DISAPPEARANCE OF BACTERIA WAS SPONTANEOUS,SOME MAJOR CHANGES WERE NOTED. THIS IS OF PARTICULAR IMPORTANCE LATER IN PATENT.

RE-EXPOSURE TO A VIRAL CONDITION SUCCESSFULLY FOUGHT IN THE PAST AND TO WHICH RESIDUAL MEMORY REMAINS OFTEN RESULTED IN CLINICAL IMPROVEMENT.ONE PARTICULAR SUCH CASE WAS OBSERVED TERMINAL AIDS PATIENT SUFFERING FROM WIDESPREAD KAPOSI'S SARCOMA WAS TREATED WITH THE MUMPS VIRUS. DRAMATIC SHRINKAGE OF THE LESIONS FOLLOWED ALONG WITH IMPROVEMENT IN T-CELL COUNTS .

EVEN IN ADVANCED CASES OF AIDS IT IS LIKELY THAT MEMORY WILL EXIST FOR VIRAL INFECTION OF CHILDHOOD.THESE WOULD THEN BE USE OF VIRUSES, BACTERIA, YEASTS FUNGII AND OTHER MICROORGANISMS WITH OR WITHOUT THE INTERPLAY OF HIGHER SYSTEMS AND ORGANISMS IN THE TREATMENT OF DISEASE.

HISTORY-

1-VACCINE MANUFACTURE-

VIRUSES-

ATTENUATION OF THE CAUSATIVE ORGANISM SUCH AS IN THE CASE OF MEASLES AND MUMPS VACCINES BUT ALSO INCLUDES THE COWPOX VACCINE BEING USED TO IMMUNISE AGAINST SMALLPOX. OCCASSIONALLY,VIRUSES HAVE BEEN USED IN THE PREPARATION OF CANCER VACCINES.PREVIOUS ATTEMPTS TO TREAT CANCER BY INFECTION WITH VIRUS HAVE LARGELY FAILED.

BACTERIA

STREPTOCOCCUS/STAPHYLOCOCCUS/KLEBSIELLA/E.COLI ETC , ALL OF WHICH

ARE LARGELY OF VERY LIMITED EFFICACY.

CURRENT PATENT TECHNIQUES AND GUIDELINES WILL SIGNIFICANTLY

INCREASE SAFETY AND EFFICACY

ANTIBIOTICS ARE THE MAIN THERAPEUTIC DERIVATIVES OF BACTERIA AND

FUNGI WHEREAS YEASTS HAVE VERY LIMITED THERAPEUTIC USE IN MODERN

MEDICINE.SOME EXTRACT ENZME PREPARATIONS MAY ALSO BE PREPARED

FROM THIS GROUP.AGAIN, IT IS POSSIBLE TO IMPROVE ON ALL OF THE

ABOVE METHODS/APPLICATIONS,SUGGEST ALTERNATIVES AND INTRODUCE NEW

USES AND TECHNOLOGIES FOR THEM.

HIGHER ORGANISMS.

THE INTERPLAY BETWEEN THE ADMINISTERED THERAPY AND THE TARGET HOST OR HOST SYSTEM OR PART THEREOF USUALLY TAKES PLACE IN SAID HOST; IN OTHER WORDS.WHEN AN ANTIBIOTIC OR A VACCINE IS APPLIED TO THE BODY, IT IS THE FINAL STEP OF THIS THERAPY OR PRIOR TO

EVALUATION OF EFFICACY .THIS PATENT WILL TEACH IN-VITRO AND IN- VIVO METHODS OF FURTHER DEVELOPING THE THERAPY BY INTERPLAY WITH HOST HOST SYSTEMS OR PARTS THEREOF AND OF RAISING AN ENTIRELY NEW ARM AND TECHNIQUE OF THERAPY.

INTRODUCTION

IT IS THE OBJECT OF THIS PATENT TO INTRODUCE NEW MODIFICATIONS OF PREEXISTING TECHNOLOGY AS WELL AS TECHNIQUES FO AMPLIFICATION OF EFFICACY, SPECIFICITY AND SAFETY.WHETHER INDIVIDUALLY OR BY

COMBINATION WITH OTHER MICROORGANISMS,HIGHER ORGANISMS OR BY USE OF BIOLOGICAL FRAGMENTS NOT BEFORE APPLIED IN THERAPY AT LEAST NOT IN THIS MANNER, PATENT WISHES TO INTRODUCE A NEW LINE OF THERAPIES AND APPLICATIONS INCLUDING DIAGNOSIS,PROGNOSIS WITH GUIDELINES TO DEVELOPING CARRIER SYSTEMS, TAGGING SYTEMS ,

INTERFERANCE PHENOMENON AS THERAPY

INTERFERANCE PHENOMENA HAVE BEEN OBSERVED WITH MANY ORGANISMS BOTH WITHIN A PARTICULAR CLASSIFICATION EG BACTERIA AS WELL AS FROM OTHER GENUS/SPECIES. INTERFERANCE PHENOMENA CAN BE DIRECT SUCH AS BY PRODUCTION OF ANTIBIOTIC INHIBITORY OR LETHAL TO OTHER ORGANISMS OR INDIRECT SUCH AS BY COMPETITION FOR A COMMON NUTRIENT OR SUBSTRATE. INTERFERANCE BY THIRD PARTY IS A TERM GIVEN BY INVENTOR TO THE ABILITY OF ONE ORGANISM TO INTERFERE WITH THE SURVIVAL OF ANOTHER BY EITHER DIRECTLY OR INDIRECTLY ALERTING THE HOST TO THE PRESENCE OF THE OTHER (TARGETED INTERFERANCE) OR TO THE PRESENCE OF BOTH .SUCH AS BY SHARED ANTIGENICITY(NON-SPECIFIC INTERFERANCE) WHEN BOTH ORGANISMS ARE COEXISTING IN TIME , THE LATTER MECHANISM MAY ALSO FALL UNDER THE CATEGORY OF SUICIDAL INTERFERANCE, SUICIDAL INTERFERANCE MAY ALSO BE DEMONSTRATED WHEN AN ORGANISM ATTATCHES TO ANOTHER,THE EFFECTS OF WHICH DIRECTLY OR INDIRECTLY(SUCH AS BY IMMUNE MECHANISM) CAUSING THE DESTRUCTION OF BOTH.THIS FIRST MECHANISM WILL BE USED TO DEFINE ONE

APPLICVATION OF THIS PATENT. INTERFERANCE PHENOMENA-IN

DIAGNOSIS, MONOTORING-PROGRESS OF

DISEASE AND EFFICACY OF THERAPY,

PROGNOSIS AND THERAPY.

AS PREVIOUSLY MENTIONED MICROORGANISMS CAN EXERT INTERFERANCE ON OTHERS. CELLS ARE ALSO CAPABLE OF THIS. INTREFERANCE PHENOMENA HAVE BEEN OBSERVED AND DEMONSTRATED BY THE INVENTOR AMONGST CANCER CELLS,EXTRACTS AND HOST INDUCED RESPONSES.ALTHOUGH USE OF CANCER TISSUE FOR IMPLANTATION INTO CANCER PATIENTS AS A FORM OF THERAPY WAS ATTEMPTED EARLIER THIS CENTURY AND HET WITH SOME SUCCESS;THIS CRUDE FORM OF THERAPY INITIATED A RANGE OF IMMUNOLOGICAL RESPONSES AMONGST OTHERS NOT RELATED TO INTERFERANCE PHENOMENA; AS A THERAPY, THIS WAS NEVER PATENTED. IT IS THE OBJECT OF THIS PATENT TO INCLUDE METHODS AND CONCEPTS BY WHICH SUCH THERAPY COULD BE MADE SAFE AND EFFECTIVE (SEE CANCER SECTION FOR

PURIFICATION AND IN-VITRO, IN-VIVO MODELS FOR PROCESSING CANCER AND /OR IMMUNE OR OTHER RESPONSE) . INTERFERANCE THERAPY OFFERS THE POTENTIAL FOR THE PURIFICATION OF F/A/P'S ETC. WHICH CAN SAFELY NEUTRALIZE OTHERS WITH OR WITHOUT INVOLVEMENT OF THE HOST DEFENSE OR OTHER SYSTEMS.METHODS AND TECHNIQUES WILL BE DISCUSSED TO ENABLE THIS;HOWEVER THER EXISTS ANOTHER WAY OF UTILIZING THIS PHENOMENA WITH RELATIVE SAFETY,A DISCUSSION OF THIS WILL FOLLOW WITH AIDS BEING USED AS THE MEDICAL TREATMENT MODEL.

INTERFERANCE CLASSIFICATION AND USE

EARLY THIS CENTURY WORK WAS DONE INVESTIGATING THE INTERFERANCE NOTED BETWEEN SOME ORGANISMS. INVESTIGATION OF THIS PHENOMENON BETWEEN BACTERIA WITH OTHER BACTERIA OR WITH HIGHER ORGANISMS LED TO THE DEVELOPMENT OF SOME EARLY ANTIBIOTICS.THE OBSERVATION THAT SOME VIRUSES INTERFERE WITH OR INHIBIT THE DEVELOPMENT OF OTHER VIRAL INFECTIONS SIMULTANEOUSLY OR SOON AFTER IN ANIMAL OR TEST TUBE MODELS LED TO THE DEVELOPMENT OF INTERFERON NAMED BECAUSE OF THE INTERFERENCE PHENOMENON. IT IS THE INVENTOR'S CONTENTION THAT THE INTERFERENCE PHENOMENON IS FAR MORE COMPLICATED THAN THE SIMPLE PRODUCTION OF INTERFERON. INTERFERENCE PHENOMENA HAVE BEEN OBSERVED BY AUTHOR IN SYSTEMS WHERE INTERFERON GENERATION IS NOT POSSIBLE.LIVING ORGANISMS CAN INTERFERE DIRECTLY WITH OTHERS.AT THIS POINT ONE SHOULD OUTLINE A CLASSIFICATION SYSTEM FOR ALL ORGANISMS WITH INTERFERENCE PHENOMENON IN MIND.

INTERFERENCE CLASSIFICATION CAN BE; SYNERGISTIC

NEUTRAL INHIBITORY ALL ORGANISMS WILL FALL SOMEWHERE IN THIS CLASSIFICATION; IT IS IMPORTANT TO NOTE THAT CLASSIFICATION MAY VARY DEPENDING ON WHETHER THE ORGANISMS ARE TESTED ALONE, IN COMBINATION WITH OTHERS OR IN A LIVING SYSTEM,

IN A COMPLEX ENVIRONMENT THERE ARE MANY POSSIBILITIES;

IF ORGANISM A IS SYNERGISTIC WITH B WHEN THE TWO ARE CULTURED ALONE BUT IS MORE SYNERGISTIC WITH C IN A MIXED SETTING,AND IF C IS ANTAGONISTIC TO B THEN IN THIS MIXED SETTING A IS SYNERGΣSING WITH AN INHIBITOR AND IS THEREFORE NOW CLASSIFIED AS INHIBITORY. SIMILARLY CLASSIFICATIONS MAY CHANGE ONCE INSIDE A LIVING SYSTEM. AN ORGANISM MAY BE NEUTRAL WITH RESPECT TO ANOTHER BUT INDUCE SUCH A MASSIVE IMMUNE RESPONSE THAT BOTH ARE ELIMINATED FROM A LIVING HOST. IN THIS SETTING ITS STRONG IMMUNOGENIC PROPERTIES WOULD CLASSIFY IT AS INHIBITORY.

SOME IMMEDIATE APPLICATION.

THE AIDS MODEL.

RE-EXPOSURE TO A VIRAL CONDITION SUCCESSFULLY FOUGHT IN THE PAST AND TO WHICH RESIDUAL MEMORY REMAINS OFTEN RESULTED IN CLINICAL IMPROVEMENT.ONE PARTICULAR SUCH CASE WAS OBSERVED TERMINAL AIDS PATIENT SUFFERING FROM WIDESPREAD KAPOSI'S SARCOMA WAS TREATED WTTH THE MUMPS VIRUS. DRAMATIC SHRINKAGE OF THE LESIONS FOLLOWED ALONG WITH IMPROVEMENT IN T-CELL COUNTS .

EVEN IN ADVANCED CASES OF AIDS IT IS LIKELY THAT MEMORY WILL EXIST FOR VIRAL INFECTION OF CHILDHOOD.THESE WOULD THEN BE REASONABLY SAFE TO USE TO INTERFERE WITH THE AIDS VIRUS.SUCH VIRAL AND BACTERIAL AGENTS MAY BE SELECTED AND MODIFIED TO HAVE MINIMAL AFFINITY FOR NORMAL HEALTHY TISSUE/CELLS BY TECHNIQUES WE WILL REVIEW AND WHICH ARE DISCUSSED IN THE CLASSIFICATION PATENT BY THE SAME INVENTOR. IT IS ALSO PRUDENT TO HAVE ANTISERA

DEVELOPED AND PURIFIED FOR USE IF NEEDED.

BACTERIAL PHAGES NEED TO BE TESTED TO HAVE NO OR MINIMAL DISRUPTION ON USEFUL BACTERIAL OR OTHER COMPONENTS OF THE HOST SYSTEM.A FURTHER CAUTION IS THAT THE PHAGE DOES NOT CARRY

TO DEMONSTRATE THE ABOVE POINTS,THE INVENTOR HAS CARRIED OUT SOME PRELIMINARY TRIALS.

PHAGES WERE ISOLATED FROM THREE SOURCES AND TESTED IN LIMITED TRIALS FOR EFFICACY IN INTERFERANCE WITH GROWTH OF VARIOUS STRAINS OF CARCINOMA IN-VIVO ANIMAL MODELS,THESE WERE CHOSEN IN FAVOUR OF IN-VITRO MODELS AS THEY ALLOW STUDY OF COMPLEX

INTERPLAYS-INTERFERANCE BOTH DIRECT AND INDIRECT AS WELL AS TAGGING AND OTHER PHENOMENON SUCH AS GENERAL AND SPECIFIC IMMUNOSTIMULATION. PHAGES ACTIVE AGAINST STRAINS OF STAPHYLOCOCCI WERE TESTED AS WERE PHAGES WITH ACTIVITY AGAINST LACTOBACILLI AND A THIRD GROUP HAD ACTIVITY AGAINST SERRATIA MARASCECENS .EACH DOSE WAS STANDARDISED TO 10 TO THE 12TH POWER PLAQUE FORMING UNITS PER ML.

IT APPEARED THAT IN THE ANIMAL MODEL,THE GENERAL DEGREE OF

IMMUNOSTIMULATION WAS COMPARABLE (AS ASSESSED BY BLOOD PARAMETERS AND AREA OF VISIBLE REACTION FOLLOWING INTRADERMAL INNOCULATION) EFFICACY IN RESTRICTION OF TUMOUR GROWTH,HOWEVER,DIFFERED GREATLY AS DID THIR ABILITY TO SUSTAIN IMMUNOSTIMULATION AND OTHER EFFECTS

STAPHYLOCOCCAL PHAGES APPEARED FAR SUPERIOR TO SERRATIA PHAGES IN CARCINOMA INHIBITION (A LIMITED SERIES SHOWED GREATER SERRATIA PHAGE ACTIVITY AGAINST SOME SARCOMAS),WHEREAS THE LACTOBACILLI PHAGES APPEARED TO ULTIMATELY INHIBIT EFFECTIVE IMMUNE RESPONSE AND STIMULATE OR ENCOURAGE CANCER GROWTH. SOME INSIGHT INTO REASONS FOR THESE PRELIMINARY OBSERVATIONS CAN BE GAINED FROM THE CLASSIFICATION PATENT WITH PARTICULAR REFERANCE TO DATA PRESENTED BY DR ALAN CANTWELL JUNIOR AND OTHERS.SIMPLY PUT, IF THE AGENT BEING TESTED INHIBITS OR OTHERWISE INTERFERES WITH F/A/P'S ETC. WHICH ARE USEFUL TO HOST IN GENERAL OR IMPORTANT IN MAINTANANCE OF INTEGRITY OF NORMAL F/A/P'S ETC. OR IMMUNE RESPONSE (SUCH ASD IN THE CASE OF LACTOBACILLI PHAGES TESTED PERHAPS) OR EVEN WHERE THE ANTI-HOST EFFECT IS MINIMAL OR ABSENT BUT THE ANTI-CANCER OR ANTIDISEASE F/A/P'S ETC. EFFECT IS NOT SIGNIFICANTLY PRESENT THEN EVEN A STRONG IMMUNOSTIMULATOR MAY END UP BEING DETRIMENTAL AS IT MAY INTERFERE WITH THE IMMUNE RESPONSE AGAINST THE DISEASE .IN OTHER WORDS, IN BALANCE, THE AGENT MUST CAUSE MORE OF A

DETRIMENTAL EFFECT AGAIST DISEASE CAUSATIVE OR SYNERGISTIC

F/A/P'S ETC.THAN ON HEALTH RELATED F/A/P'S ETC. OR MORE OF A BENEFICIAL ACTION ON HEALTH RELATED F/A/P'S ETC THAN ON DISEASE CAUSATIVE OR SYNERGISTIC F/A/P'S ETC. EVEN A NEUTRAL EFFECT MAY BE DAMAGING IF IMMUNE STIMULATION BY THE NEUTRAL F/A/P'S ETC. DISTRACTS OR DEVIATES THE IMMUNE SYSTEM FROM THE MAIN THREAT. SUCH COMPEX INTERPLAYS MUST THEREFORE BE EVALUATED FOR DISEASE,HOST AND THERAPIES.SERRATIA PHAGES MAY PROVE TO BE USEFUL OR HARMFUL DEPENDING ON THE SITUATION. IT APPEARS THAT IN SOME CARCINOMATOUS CONDITIONS THEY MAY BENEFIT DISEASE OR SYNERGISTIC F/A/P'S ETC WHEREAS IN SOME SARCOMAS TESTED THE EFFECT WAS DIFFERENT,ElTHER INHIBITORY ON THE DRFAP'S ETC OR BENEFICIAL TO THE HRFAPS ETC. IT IS IMPORTANT TO RECALL ALSO THAT THESE RESULTS ARE OF A LIMITED SERIES AND ONLY SPEAK FOR THE PARTICULAR PHAGES USED ,THERE ARE MANY RELATED TO EACH ORGANISM,THE INVENTOR DOES NOT RELATE THESE RESULTS AS REPRESENTATIVE OF THE GENRE BUT MORE AS GUIDELINES FOR EVALUATION AND EXPLANATION. IT IS ALSO IMPORTANT TO REALISE THAT TIME MAY BE A FACTOR IN THE USEFULNESS OF THE AGENT. MANY PHAGES MAY EXERT USEFUL ANTIDISEASE ACTIVITY IN PRELIMINARY USE BUT,AT LEAST IN THE CASE OF CANCER,THERE MAY SOON DEVELOP A TOLERANCE, RESISTANCE AND EVEN REVERSAL OF EFFICACY.AT LEAST NINE PHENOMENA DIRECTLY OR IN COMBINATION, MAY ACCOUNT FOR THIS.

1-MUTATION OF DISEASE OR DRF/TARGET SITE OF ACTION

2-SATURATION FOLLOWED BY THRESHOLD INHIBITION OF IMMUNE RESPONSE. 3-DEVELOPMENT OF SYNERGY BETWEEN DISEASE AND THERAPY- THIS WAS DEMONSTRATED BY AUTHOR IN USE OF PHAGES AS WELL AS OTHER THERAPIES INCLUDING IMMUNOLOGICAL ONES. ONE PARTICULARLY DRAMATIC EXAMPLE CAN BE DEMONSTRATED BY THE USE OF FELINE PANLEUKOPENIA VIRUS AND OR THE CANINE DISTEMPER VIRUS IN THE TREATMENT OF LEUKEMIA. INITIALLY CYTOPLASMIC AND NUCLEAR VACUOLATION PRECEDE LARGESCALE DESTRUCTION OF THE MALIGNANT CELLS.THE LEUKEMIA OFTEN RECURS,HOWEVER AND USUALLY WILL STILL DISPLAY

VACUOLATION, INDICATING THAT DESPITE PERSISTANT VIRAL ACTIVITY,THE VIRUS AND CANCER CELL NOW CO-EXIST IN SOME HARMONIOUS MANNER. 4-THE IMMUNE SYSTEM MAY DEVELOP A RESPONSE AGAINST THE TREATMENT AGENT AND DISABLE IT FROM TAGGING OR INTERFERING WITH THE DISEASE

5-MUTATION OF PHAGE OR OTHER INTERFERANCE ORGANISM TO SYNERGISE WITH DISEASE.WHEN LIVING ORGANISMS INTERFERE OR TAG,THEY ARE OFTEN DESTROYED AS WELL;EVENTUALLY THIS WILL CASUSE GENERATION AND OR SELECTION OF THOSE THAT WILL NOT HAVE THIS EFFECT.

6-DESTRUCTION OF TARGET. IF PHAGE TARGETS ,FOR EXAMPLE, A

BACTERIA SYNERGISING WITH CANCER AND DESTROYS IT,THEN IT NO LONGER SERVES A PURPOSE AND REPEATED ADMINISTRATION MAY FURTHER DISTRACT A TAXED SYSTEM.

LACTOBACILLI OFTEN SERVE A USEFUL FUNCTION IN THE BODY AND HAVE NOT BEEN DEMONSXKATED TO HAVE ANT MAJOR RELATED FACOR IN CANCER

,HENCE IT IS NOT SURPRISING THAT PHAGES THAT DESTROY THEM MAY CAUSE AGGRAVATION OF DISEASE CONDITION.

F/A/P'S ETC.

9-ENTRANCE OF NEW F/A/P ETC. INTO SYSTEM .THIS MAY CAUSE STRAIN

OR MORE LETHAL CONSEQUENCES.

STRAIN COULD RESULT SIMPLY BY MAINTENANCE OF STRONG ANTICANCER

ACTIVITY IN THE FACE OF A MORE ACUTE THREAT EG. PNEUMONIA

REQUIRING IMMUNE ATTENTION MORE URGENTLY.

LETHAL CONSEQUENCES MAY FOLLOW EXTREME CONDITIONS SUCH AS THOSE

ABOVE OR MAY FOLLOW SOME INTERPLAY,AN EXAMPLE OF THE LATTER IS ;

SHOULD E COLI PHAGES EXERT GOOD ANTI-DISEASE ACTIVITY AND THE

BODY THEN ACQUIRE A STRAIN OF E.COLI WHOSE TOXIN PRODUCTION IS

INDUCED BY A PHAGE BEING USED OR A MUTANT THEREOF THEN THE RISK

CAN BE SEEN.

THE ABOVE POINTS STRESS THE IMPORTANCE OF KNOWING DETAILS OF THERAPY AND DISEASE(PARTICULARLY AS OUTLINED IN CLASSIFICATION PATENT BY SAME INVENTOR )AS WELL AS CONSTANTLY RE- EVALUATING, REASSESSING AND IF NECESSARY,MODIFYING OR RENEWING THERAPY.

INTERFERANCE DOES NOT EVEN NEED TO BE AT THE WHOLE ORGANISM LEVEL,USEFUL F/A/P'S ETC NEED TO BE SCREENED FOR EFFECTS AGAINST TARGETED AGENT OR DISEASE, INTERACTION WITH HOST AND HOST

COMPONENTS , INTERPLAY OF ALL THREE WITH AND WITHOUT OTHER

VARIABLES SUCH AS OTHER THERAPY.

ENDPRODUCT THERAPY PATENT BY SAME INVENTOR.

CHEMOTHERAPY/RADIOTHERAPY AND IMMUNOTHERAPY.

INTERPLAY OF INTERFERANCE PHENOMENON PRECURSOR/ INTERMEDIATE/ENDPRODUCT

CONCEPTS AS APPL IED TO ANTIB IOTI C THERAPY .

PRECURSOR PHASE COMMENCING AT PRECURSOR PHASE RAISES THERAPEUTIC POTENTIALS AND POSSIBILITIES UNUSED BY MODERN THERAPEUTIC TECHNIQUES. KNOWLEDGE OF TARGET ORGANISM AND THERAPEUTIC ORGANISM AND THEIR MODIFICATIONS CAN BE APPLIED AS FOLLOWS.

1- IF THE ORIGINAL MATCH OF TARGET AND THERAPEUTIC ORGANISM IS A GOOD ONE THEN IT IS IMPORTANT TO MAINTAIN SUCH A RELATIONSHIP UNTIL RESOLUTION OF DISEASE. THIS MAY BE ACCOMPLISHED BY ONE OF

2-ALLOWING THERAPEUTIC ORGANISM(S) TO REDEVELOP THERAPEUTIC POTENTIAL AGAINST THE MUTATED TARGET DISEASE.

2-IF PRFELIMINARY MATCH IS NOT A GOOD ONE THEN PRECURSOR

3 -PRECURSOR MATCHES CAN ALSO BE MADE FOR INTERFERANCE PHENOMENA NOT RELATED NECESSARILY TO ANTIBIOTIC EFFECT AS WELL AS PRECURSOR THERAPY TO IMMUNISE AGAINST OR OTHERWISE TARGET THE EMERGENCE OF RESISTANCE, PRECURSOR CARRIER VACCINES AND PRECURSOR PREPARATIONS OR IMMUNISATION AGAINST F/A/P'S ETC. THAT INDUCE MUTATIONS OR CHANGES RESISTANT TO THERAPY.ALTERNATIVELY, THERAPIES CAN BE DEVELOPED AT THE OUTSET OR CO-TEMPORALLY WITH THERAPY TO DEAL WITH RESISTANCE. REASONABLY SAFE TO USE TO INTERFERE WITH THE AIDS VIRUS. SUCH VIRAL AND BACTERIAL AGENTS MAY BE SELECTED AND MODIFIED TO HAVE MINIMAL AFFINITY FOR NORMAL HEALTHY TISSUE/CELLS BY TECHNIQUES WE WILL REVIEW AND WHICH ARE DISCUSSED IN THE CLASSIFICATION PATENT BY THE SAME INVENTOR. IT IS ALSO PRUDENT TO HAVE ANTISERA

DEVELOPED AND PURIFIED FOR USE IF NEEDED.

PRECURSOR / INTERMEDIATE AND ENDPRODUCT THERAPY. TECHNOLOGY OF THERAPY

/PREVENTION OF RESISTANCE AND

INTRODUCTION

CURRENT TECHNOLOGY ADDRESSES A PARTICULAR FEATURE OF A SITUATION AND ALTHOUGH OCCASSIONALLY A DISEASE THERAPY MAY BE ADDRESSED BY ATTEMPTING TO EXPLOIT VARIUOS WEAKPOINTS, THE SCOPE OF CURRENT ENDEAVOUR IS SEVERELY RESTRICTED.PICTURE FOR EXAMPLE COMBINATION CHEMOTHERAPY; THE USE OF MULTIPLE POISONS WHEN TRYING TO KILL CANCER, AT ONE END OF THE SPECTRUM THE NARROWNESS OF THE FIELD IS SEEN AS ALL ATTEMPT TO POISON THE CANCER CELL, LARGELY BY

EXAMPLIFY ONE VEIN OF APPLICATION.

DEFINITION OF TERMS WILL BE FOLLOWED BY AN EXAMPLE AND DEMONSTRATION OF A NEW THERAPEUTIC TECHNOLOGY OUTLINING THE IMPROVEMENT OF EFFICACY OF THIS THERAPY IN MANAGEMENT OF INFECTIONS. PRIOR TO PROVIDING SOME DEFINITIONS, I NEED TO POINT OUT A FEW SHORTCOMINGS OF CURRENT THERAPY WHICH DIRECTLY STEM FROM LACK OF CONSIDERATION OF SUCH PARAMETERS IN THERAPY.

CHEMOTHERAPY INVOLVES THE APPLICATION OF TOXIC AGENTS FOR THE PURPOSE OF POISONING CANCER CELLS SYSTEMICALLY. ALTHOUGH IT IS ROUTINE PRACTISE TO CHECK INFECTIONS FOR ANTIBIOTIC SENSITIVITY REPEATEDLY IF UNRESOLVING AND TRACKING THEM AS THEIR SENSITIVITIES CHANGE SO THAT THE MOST EFFECTIVE AGENTS CAN BE USED, SOME INDICATION IS ALSO AVAILABLE OF DEGREE OF SENSITIVITY TO A PARTICULAR ANTIBIOTIC AND THEREFORE DOSEAGE MAY BE EVALUATED;THERE IS EVEN MONITORING OF BLOOD LEVELS TO ENSURE OPTIMAL THERAPEUTIC AND MINIMAL TOXIC EFFECTS (THIS IS ALSO TRUE OF OTHER MEDICATIONS SUCH AS DILANTIN,TEGRETOL,DIGOXIN ETC). IN YHE CASE OF GENTAMYCIN ,AN ANTIBIOTIC WITH KIDNEY AS WELL AS AUDITORY TOXICITY,FOR EXAMPLE, THE SENSITIVITY OF A PARTICULAR ORGANISM TO IT AS DETERMINED BY LABORATORY CULTURE AND SENSITIVITY TESTING, CAN DETERMINE ITS DOSEAGE, (ALONG WITRH OTHER PARAMETERS SUCH AS KIDNEY FUNCTION,WEIGHT OF PATIENT,ETC ) IN MANY CASES,COMBINATION ANTIBIOTIC THERAPY WILL BE INITIATED TO OBTAIN BETTER COVER AND DEAL WITH RESISTANT VARIANTS. IT IS NOT UNCOMMON.,FOR EXAMPLE, TO COMBINE GENTAMYCIN WITH A PENICILLIN AND METRONIDAZOLE FOR DEALING WITH A STRONG INFECTION.ANTIBIOTIC AGENTS WHICH ARE TOXIC ARE MONITORED FOR LEVELS AND EFFECTS ON THE BODY AS WELL AS THE ORGANISM. (IT IS INTERESTING TO NOTE HERE THAT IT WOULD BE LOGICAL HERE TO TEST THE COMBINATIONS AGAINST THE ORGANISMS TO EVALUATE OPTIMAL COMBINATIONS AND DOSEAGE; THIS IS NOT ROUTINELY DONE, IF AT ALL. AND IS INCLUDED IN THIS PATENT AS PART OF TESTING PRECURSOR/INTERMEDIATE /ENDPRODUCT THERAPY FOR SAFETY,EFFICACY AND TO DETERMINE IF OTHER

INTERMEDIATES/ENDPRODUCTS ARE GENERATED BY THESE

COMBINATIONS,ANIMAL MODELS MAY BE DESIGNED TO CARRY THE PATIENT'S DISEASE ALONG WITH DISEASED SAMPLE/RESPONSE ETC BY USE OF SUCH SYSTEMS AS NUDE MICE OR SKID RATS.)WHEN AN INFECTION FAILS TO RESOLVE,RETESTING OF SENSITIVITIES AND NEW COMBINATIONS/AGENTS ARE TRIED.THIS IS NOT OPTIMAL .IN THE OPINION OF THE

INVENTOR, INFECTIONS AND CULTURES SHOULD BE REPEATED

EVEN IN CURRENT PRACTICE,ANTIBIOTIC CHOICE,DOSEAGE AND EVALUATION ARE DONE WITH MUCH GREATER LOGIC AND PRECISION THAN CHEMOTHERAPY PROTOCOLS.THE SITUATIONS CAN BE COMPARED AS MANY

CHEMK,OTHERAPEUTIC AGENTS CAN BE SEEN AS ANTIBIOTICS OF HIGH TOXICITY WHILE CANCER IS , IN THIS MODEL,A CHRONIC INFECTION WITH GREAT ABILITIES TO DEVELOP RESISTANCE TO THERAPIES. ALTHOUGH MANY CHEMOTHERAPEUTIC AGENTS ARE INDEED ANTIBIOTICS OF HIGH TOXICITY THE ANALOGY OF CANCER TO CHRONIC INFECTION IS ONLY DONE TO ILLUSTRATE AN IMPORTANT POINT.CURRENT TECHNIQUES AND PROTOCOLS MONITOR THE SUCCESS/FAILURE OF TREATMENT BY WHETHER OR NOT THERE ARE SIGNIFICANT ENDPOINT RESPONSES AS DETERMINED BY LABORATORY TESTING OF INVOVED PARAMETERS SUCH AS LIVER FUNCTION WHEN CANCER INVOLVES THE LIVER OR BY DIMENSIONAL EVALUATION AS WELL AS EVALUATION OF CONSISTENCY AS DETERMINED BY X-RAY AND OTHER

IMAGING MODALITIES AT INTERVALS OF WEEKS TO MONTHS. CANCER

1-CHEMOTHERAPY(OR OTHER THERAPY) SCREENING PRIOR TO INITIATION OF THERAPY

2-CHOOSEΑ NORMAL CELL MODEL SUCH AS LIVING CELLS(EG BLOOD CELLS AND/OR OTHERS ISOLATED FROM BIOPSY)FROM PATIENT TO TEST AND BEST DOSE-TITRATE THERAPY.OTHER NORMAL CELLS CAN ALSO BE USED FROM LIBRARY /HUMAN /ANIMAL OR OTHER;ALTHOUGH THE PATIENT'S OWN CELLS WOULD MORE LIKELY FORM A MORE SPECIFIC SYSTEM.

3-ISOLATE PATIENT SERUM AND OR WHITE BLOOD CELLS TO USE IN MIXED CULTURES.THIS IS A VERY IMPORTANT OMITTED FACTOR IN ALL THERAPIES IT IS IMPORTANT NOT ONLY TO GAUGE EFFICACY AGAINST DISEASE, AND ESTIMATE DETRIMENTAL EFFECTS AGAINST HEALTHY CELLS/TISSUES

ETC.BUT ALSO TO GAUGE THE INTERACTION BETWEEN THERAPY AND

DISEASE, THERAPY AND NORMAL CELLS,THERAPY,NORMAL SYSTEMS AND HOST'S ANTIDISEASE RESPONSE.THE INTERPLAY OF ALL THESE F/A/P'S ETC. IS NECESSARY TO MONITOR AND ASESS FOR OPTIMAL EVALUATION. EVEN AS FAR AS ANTIBIOTIC THERAPY IS CONCERNED,AIDS HAS PROVEN HOW INEFFECTIVE 1

ARE SIGNIFICANT ENDPOINT RESPONSES AS DETERMINED BY LABORAT_ORY TESTING OF INVOVED PARAMETERS SUCH AS LIVER FUNCTION WHEN CAN_CER INVOLVES THE LIVER OR BY DIMENSIONAL EVALUATION AS WELL AS EVALUATION OF CONSISTENCY AS DETERMINED BY X-RAY AND OTHER

IMAGING MODALITIES AT INTERVALS OF WEEKS TO MONTHS. CANCER

1-CHEMOTHERAPY(OR OTHER THERAPY) SCREENING PRIOR TO INITIATION OF THERAPY .

ETC. BUT ALSO TO GAUGE THE INTERACTION BETWEEN THERAPY AND

DISEASE, THERAPY AND NORMAL CELLS,THERAPY, NORMAL SYSTEMS AND HOST'S ANTIDISEASE RESPONSE.THE INTERPLAY OF ALL THESE F/A/P'S ETC. IS NECESSARY TO MONITOR AND ASESS FOR OPTIMAL EVALUATION. EVEN AS FAR AS ANTIBIOTIC THERAPY IS CONCERNED, AIDS HAS PROVEN HOW INEFFECTIVE STANDARD ANTIBIOTIC REGIMENS ARE IN THE ABSENCE OF A FUNCTIONAL IMMUNE RESPONSE. THIS WOULD SUGGEST THAT

OPTIMISATION OF THERAPY BY THE AFOREMENTIONED TECHNIQUES WOULD BE OF VITAL VALUE IN THIS DISEASE , IT ALSO SUGGESTS THAT USE OF SPECIFIC IMMUNE FRAGMENTS/MANIPULATIONS WHETHER SERUM/CELLULAR ,DIRECT IMMUNE SUPPLEMENTATION/AUGMENTATION OR MANIPULATION SUCH AS WITH VACCINES GENERAL OR SPECIFIC. INVENTOR WILL DISCUSS

ANTICIPATION THERAPY WHERE IN-VITRO, IN-VIVO

PREPARATIONS(AUTOGENOUS OR OTHER) ARE MADE FOR ANTICIPATED

PATHOLOGY AND/OR RESISTANCE TO THERAPY.

576 1-MAINTENANCE OF EFFICACY.

1-MAINTENANCE OF DIRECT RELATIONSHIP USING TECHNOLOGY TO RESTRICT

AND/OR MINIMISE THE RAISING OF MUTATIONS.

THIS INVOLVES ;

A- MAINTENANCE OF ENVIRONMENTAL STABILITY EG PH ETC.

B- MAINTENANCE OF GENETIC/OTHER STABILITY.ONE SIMPLE WAY TO DO

THIS IS TO BATHE THE ORGANISM WITH ORIGINAL GENETIC/OTHER

EXTRACTS.

C- VACCINE AGAINST RESISTANT FORMS / ORGANISMS THAT DONATE

RESISTANCE.VACCINE AGAINST FRACTION THAT DONATES RESISTANCE.

IT IS POSSIBLE TO VACCINATE ORIGINAL ORGANISM AS WELL AS AGAINST ITS RESISTANT FORM WHETHER SPONTANEOUS/GENERATED IN-VITRO OR IN-VIVO AS WELL AS AGAINST PLASMIDS ETC AS WELL AS OTHER GENETIC/OTHER MODALITIES OF IMMUNITY DEVELOPMENT.

INVENTOR'S EXPERIENCE THAT INTERNAL AS WELL AS EXTERNAL CELLULAR COMPONENTS MAY BE IMMUNOGENIC; FUTRTHERMORE, IT IS POSSIBLE TO DIRECTLY EFFECT GENETIC FRAGMENTS/ENZYMES ETC. OR TO DO SO AFTER TAGGING. IT HAS BEEN DEMONSTRATED BY PRIOR RESEARCHERS THAT

INACTIVATION/REMOVAL/INHIBITION OF INTRACELLULAR COMPONENTS.THIS NEW FIELD OF INTRACELLULAR IMMUNE MANIPULATION WILL BE DISCUSSED FURTHER BOTH DIRECTLY AND AS A CONSEQUENCE OF CARRIER VACCINE THERAPY.

IT HAS JUST BEEN STATED THAT IT IS UNLIKELY THAT GENETIC CHANGE WILL LEAD SOLELY TO SIMPLE UNDETECTABLE CHANGE. PLASMIDS CODE FOR SUBTLE CHANGES IN BACTERIAL METABOLISM AND OTHER CHANGES AND HAVE BEEN CREDITED WITH BEING AN IMPORTANT ELEMENT IN THE RISE IN ANTIBIOTIC RESISTANCE.IT APPEARS THAT BACTERIA WHICH POSESS RESISTANCE TO CERTAIN ANTIBIOTICS ARE NOT JUST CHOSEN FOR BY OVERUSE OF ANTIBIOTICS BUT ARE ACTUALLY ABLE TO SHARE THEIR RESISTANT ABILITIES WITH VULNEREABLE ORGANISMS.THIS IS

CLASSICALLY UNDERSTOOD TO HAPPEN BY PACKAGES OF GENETIC INFORMATION KNOWN AS PLASMIDS WHICH DONATE THIS INFORMATION FROM RESISTANT ORGANISMS TO THOSE WITH LOWER ANTIBIOTIC RESISTANCE. THE INVENTOR HAS FOUND PHAGE AND OTHER MECHANISMS TO BE ACTIVE IN RESISTANCE ACQUISITION AND/OR AUGMENTATION AND EVEN HIGHER AND LOWER ORGANISM SPECIES MAY PARTICIPATE IN THIS PROCESS.

MUCH OF THIS IS DISCUSSED UNDER 'PLEOMORPHISM'AND DEFINITION OF INTERACTIVE LIFECYCLES-A THEORY WHICH LINKS LIVING ENTITIES AND DEMONSTRATES THERAPIES FOR GENETIC CORRECTION IN CANCER AND GENETIC DISEASES AS BY MECHANISMS SIMILAR TO YHOSE WHICH RID ACELL OF HIV. LET US NOW CONSIDER HOW THE AVAILABLE DATA ENABLES THE EMPLOY OF PRECURSOR/INTERMEDIATE/ENDPOINT PATENT TO YEILD EFFECTIVE

THERAPY.

LET US CONSIDER A CASE OF A STREPTOCOCCUS INFECTION WHICH IS SENSITIVE TO PENICILLIN.USE OF PENICILLIN MAY BE CUREATIVE

OR,DEPENDING IN PART ON THE IMMUNOLOGICAL COMPETENCY OF THE HOST, THE INFECTION MAY LINGER, ACQUIRING PENICILLIN RESISTANCE FROM OTHER ORGANISMS SAY VIA PLASMIDS (ONE SIMPLE TECHNIQUE DISCOVERED BY INVENTOR DOES NOT EVEN REQUIRE EVOLVED TRANSFER MECHANISMS SIMPLY REQUIRES ONE ORGANISM TO BE IN PROXIMITY OF GENETIC OR OTHER FRAGMENTS OF RESISTANT ORGANISM TO ACQUIRE A MEASURE OF RESISTANCE. IT IS ALSO POSSIBLE THAT BY MECHANISMS OP BIOLOGICAL ENHANCEMENT PATENT BY SAME INVENTOR THAT THE PROXIMITY OF THE RESISTANT ORGANISM TO THE SENSITIVE ONE MAY PROTECT OR SYNERGISE WITH IT. (MECHANISMS FOR GENERALISED OR SPECIFIC

BIOENHANCEMENT ARE OUTLINED IN THAT PATENT. WE HAVE A SITUATION THEREFORE THAT CAN BE SUMMARISED AS A SENSITIVE ORGANISM DEVELOPING RESISTANCE BY SOME PROCESS WHERE THE SENSITIVE ORGANISM AND SENSITIVE SYSTEM ALONG WITH INITIAL HOST CONDITION AND PRELIMINARY THERAPY COULD BE CLASSIFIED AS INITIAL OR PRECURSOR PHASE IF WE CHOOSE TO LABEL THE NEWLY RESISTANT BACTERIA AS WELL AS HOST STATUS AT THE TIME AND THE NOW INEFFECTIVE ANTIBIOTIC AS ENDPOINT/ENDPRODUCT PHASE THEN THE PROCESS IN AND DURING WHICH THE ORGANISM ACQUIRES RESISTANCE AND ALL RELATED F/A/P'S ETC.AS WELL AS HOST STATUS AT THE TIME WOULD BE TERMED INTERMEDIATE PHASE.ANY OF THESE F/A/P'S ETC CAN ALSO BE IDENTIFIED, MAGNIFIED AND CLASSIFIED.

AN EXAMPLE OF IDENTIFICATION, MAGNIFICATION AND CLASSIFICATION IS DEPENDANT ON SOURCE OF REFERANCE; FOR EXAMPLE , ONE COULD LIMIT THE CLASSIFICATION TO THE ANTIBIOTIC ITSELF WHERE PENICILLIN WOULD BE THE PRECURSOR,THE DISASSEMBLED/DESTROYED/NEUTRALISED ANTIBIOTIC WOULD BE ENDPOINT/ENDPRODUCT AND F/A/P'S ETC BETWEEN THE TWO WOUKLD BE CLASSIFIED AS INTERMEDIATE,

PRECURSOR INTERVENTION ANTIBIOTIC/CHEMOTHERAPY MODEL.

REFERRING TO THE ABOVE SITUATION, THE PRECURSOR SYSTEM PRECEDING ALL WOULD BE THE INTERPLAY OF THE DISEASE ORGANISM WITH THAT OF THE ANTIBIOTIC ORGANISM IE. TWO ABSOLUTE PRECURSORS WOULD BE THE BACTERIA CAUSING THE DISEASE AND THE PENICILLIUM FROM WHICH THE THERAPY IS ISOLATED. (IT IS IMPORTANT TO NOTE HERE THAT ONCE CELLS/TISSUES/ORGANS ETC. ARE INFECTED .DEPENDING ON POINT OF REFERANCE, THEY FORM INTERMEDIATE PHASES-LEADING TO SEPARATE THERAPY AS YET UNTAPPBD BY MODERN MEDICINE ). PRECURSOR APPLICATION ENABLES FINE-TUNING, IMPROVING EFFICACY, SPECIFICITY; ANTICIPATION AND NEUTRALISATION /DEVELOPING COPING MECHANISMS TO RESISTANCE AS WELL AS CO-TEMPORAL PROCESSING, AS WELL AS PREMATCHING AND PRECALIBRATING LIBRARIES OF PRECURSOR/INTERMEDIATE/ENDPRODUCT AND COPING

MECHANISMS/MODALITIES TO OVERCOME RESISTANCE.

CULTURE-ORGANISM- HOST INTERPLAY.

THE PENICILLIUM MOULD PLACED IN CULTURE MEDIUM WITH THE TARGET ORGANISM WILL KILL ALL SENSITIVE BACTERIA BY USE OF ITS PRODUCT ANTIBIOTIC , PENICILLIN. DEPENDING ON CULTURE CONDITIONS, RESISTANTR BACTERIAL STRAINS MAY ARISE, BE PROMOTED, INDUCED OR CAUSED

SPECIFICALLY. TO CLARIFY THIS POINT, A WELL BALANCED NUTRITIONAL MEDIUM FOR BACTERIA AND MOULD AS WELL AS IDEAL CONDITIONS OF TEMPERATURE ETC. MAY LEAD TO SPONTANEOUS GENERATION OF RESISTANT MUTATIONS. IF THE MEDIUM OR CULTURE CONDITIONS FAVOUR THE

BACTERIA AND ARE IN ANY WAY INHIBITORY TO THE MOULD OR TO PENICILLIN PRODUCTION; THE GREATER THE FAVOURING OF THE BACTERIAL SURVIVAL (TERMED MARGIN OF BIAS MOB),THE MORE CHANCE OF PROMOTING THE DEVELOPMENT OF BACTERIAL RESISTANCE AS WELL AS THE POSSIBLE DEVELOPMENT OF F/A/P'S ETC TO OPPOSE OR ATTACK THE MOULD. KNOWN RESISTANT ORGANISMS(WHOLE/PART/EXTRACT/PRODUCT/DERIVATIVE ETC) AND/OR PLASMIDS AND /OR PHAGES CARRYING DATA CODING FOR

PENICILLIN RESISTANCE COULD BE ADDED TO THE CULTURE TO INDUCE RESISTANCE.

LEFT TO THEIR OWN DEVICES THE TWO ORGANISMS WILL OFTEN WAGE A BATTLE OF OFFENSIVE AND DEFENSIVE MOVES UNTIL ONE EMERGES TOTALLY TRIUMPHANT . THIS SEE-SAW CAN BE MANIPULATED BY IN-VITRO, IN-VIVO TECHNIQUES AND DEGREE OF BIAS.

SEPARATELY OR IN COMBINATION, THE BACTERIA AND MOULD CAN BE

CULTURED UNDER CONDITIONS OR IN THE PRESENCE OF F/A/P'S ETC WHICH PROMOTE MUTATION AND DIVERSITY (EG UV LIGHT, PLASMIDS ETC). THIS ENABLES DEVELOPMENT OF A POPULATION OF WHICH SOME BACTERIA WILL BE RESISTANT TO PENICILLIN AND A VARIETY OF MOULD MUTATION, SOME OF WHICH MAY HAVE DEVELOPED CAPACITY TO DEAL WITH THE RESISTANT BACTERIA. MANIPULATION OF MEDIA, CULTURE CONDITIONS AND DEGREE OF BIAS CAN DEVELOP SUCH PROPERTIES FOR A LIBRARY OR COTEMPORALLY WITH THERAPY TO OVERCOME RESISTANCE DURING TREATKENT. THIS APPLIES TO BACTERIA AND ANTIBIOTICS AS WELL AS TO CANCER AND CHEMOTHERAPY AS WELL AS MANY OTHER SITUATIONS .

IN-VITRO AND IN-VIVO MODELS CAN ALSO BE ESTABLISHED TO MINIMISE AFFINITY OF THERAPY FOR HEALTHY TISSUE AND HENCE MINIMISE SIDE- EFFECTS BY THIS AS WELL AS BY OTHER METHODS . RAISING OF SELECTIVE AFFINITY NOT ONLY RAISES SPECIFICITY AND MINIMISES SIDE-EFFECTS BUT ALSO RAISES EFFICACY AND THERAPEUTIC INDEX.

MARGIN OF BIAS CAN ALSO BE USED IN-VITRO AND IN-VIVO TO RAISE EFFICIENT IMMUNE AND OTHER RESPONSES. MAINTENANCE OF EFFICACY

1-TARGET ORGANISM

PRODUCT/DENATURATION/OTHER INHIBITION OF FEEDBACK SYSTEM IS DESIREABLE,.IT IS IMPORTANT TO SOMETIMES CONSIDER LIVING OR BIOLOGICAL REACTIONS WITH THE SAME SIMPLICITY THAT WE VIEW CHEMICAL AND OTHER REACTIONS . EQUILIBRIUM IS REACHED BETWEEN PRECURSORS) AND ENDPRODUCT (S) , REMOVAL OF ENDPRODUCTS BY REMOVAL OF BREAKDOWN PRODUCTS,COUPLED WITH OPTIMAL BALANCING OF

PRECURSORS AND INTERMEDIATES WILL FAVOUR A REACTION FLOW BIAS

(RFB) THIS TERM AND PHENOMENON AS DESCRIBED BY AUTHOR CAN BE USED TO FAVOUR A USEFUL REACTION AND INHIBIT AN UNFAVOURABLE ONE.IT WILL LATER BE SHOWN HOW RFB AND OTHER TECHNIQUES CAN BE USED TO EFFECTIVELY INHIBIT HEALTHY CELL DAMAGE..

AS PROOF OF THE ABOVE TEACHING, INVENTOR HAS DEMONSTRATED

IMPROVED EFFICACY OF SEVERAL MODALITIES OF THERAPY WHEN A SIMPLE PROCEDURE SUCH AS DIALYSIS IS IMPLEMENTED.EFFICACY IMPROVES AS SPECIFICITY OF REMOVED FRACTION IS DEFINED.GREATER DETAIL WILL BE COVERED IN SECTION ON ENDPRODUCT/ENDPOINT THERAPY.

WHEN CONDITIONS ARE STABILISED, FEEDBACK REMOVED , IMMUNE AND OTHER

PATHWAYS ARE BROUGHT IN FOR FAST, EFFECTIVE RESPONSE ALONG WITH

THE CORRECT ANTIBIOTIC, WHAT THEN REMAINS IS TO EFFECTIVELY

ISOLATE THE ORGANISM FROM MUTATION, RESISTANT ORGANISMS AND DONOR

MECHANISMS.IT IS POSSIBLE TO IMMUNOLOGICALLY ;

1-TARGET ORGANISM

2-TARGET AND INHIBIT REPRODUCTIVE CYCLE

3-TARGET AND INHIBIT SPECIFIC RECEPTORS AND/OR F/A/P'S ETC.

INVOLVED IN THE ACQISITION OF RESISTANCE.

IMMUNOLOGICAL TARGETS CAN BE PREPARED BY SPECIFIC F/A/P'S ETC. GUIDELINES IN SPECIFI F/A/P'S ETC PATENT BY SAME INVENTOR.

1-SPECIFIC TARGETING OF ORGANISM, FOR EXAMPLE, CAN BE DONE

CRUDELY AS IS THE CURRENT PRACTISE OF CULTURING AN ORGANISM, ATTENUATING, DISRUPTING OR OTHERWISE KILLING IT . OR REPRODUCING/DUPLICATING IMMUNOGENIC FRAGMENT BY PROCESSES

INCLUDING GENETIC ENGINEERING. DESPITE ALL CURRENT SOPHISTICATION IN PREPARATION OF VACCINE WHJICH ARE COVERED IN THIS USE BY THIS PATENT(CURRENT VACCINE USE IS IN PREVENTION OF INFECTION, CURRENT PATENT COVERS CONVENTIONAL AND NEW VACCINES IN THERAPEUITIC APPLICATION AS WELL AS IN USE TO PREVENT THE RISE OF RESISTANCE. MAINTENANCE OF EFFICACY

1 -TARGET ORGANISM

ESTABLISHED AND MAINTAINED. IT IS ALSO IMPORTANT THAT CELL OR ORGANISK DESTRUCTION/INHIBITION/NEUTRALISATION IS NOT ALLOWED TO GIVE MAXIMAL FEEDBACK TO SURVIVING ORGANISMS FOR THE NEED TO MUTATE, HENCE ELIMINATION OF BACTERIAL BREAKDOWN

PRODUCT/DENATURATION/OTHER INHIBITION OF FEEDBACK SYSTEM IS DESIREABLE,. IT IS IMPORTANT TO SOMETIMES CONSIDER LIVING OR BIOLOGICAL REACTIONS WITH THE SAME SIKPLICITY THAT WE VIEW CHEMICAL AND OTHER REACTIONS.EQUILIBRIUM IS REACHED BETWEEN PRECURSORS) AND ENDPRODUCT(S) .REMOVAL OF ENDPRODUCTS BY REMOVAL OF BREAKDOWN PRODUCTS, COUPLED WITH OPTIMAL BALANCING OF

PRECURSORS AND INTERMEDIATES WILL FAVOUR A REACTION FLOW BIAS

AS PROOF OF THE ABOVE TEACHING, INVENTOR HAS DEMONSTRATED

IMPROVED EFFICACY OF SEVERAL MODALITIES OF THERAPY WHEN A SIMPLE PROCEDURE SUCH AS DIALYSIS IS IMPLEMENTED. EFFICACY IMPROVES AS SPECIFICITY OF REMOVED FRACTION IS DEFINED. GREATER DETAIL WILL BE COVERED IN SECTION ON ENDPRODUCT/ENDPOINT THERAPY.

WHEN CONDITIONS ARE STABILISED, FEEDBACK REMOVED , IMMUNE AND OTHER

PATHWAYS ARE BROUGHT IN FOR FAST, EFFECTIVE RESPONSE ALONG WITH

THE CORRECT ANTIBIOTIC, WHAT THEN REMAINS IS TO EFFECTIVELY

ISOLATE THE ORGANISM FROM MUTATION, RESISTANT ORGANISMS AND DONOR

MECHANISMS.IT IS POSSIBLE TO IMMUNOLOGICALLY ;

1-TARGET ORGANISM

2-TARGET AND INHIBIT REPRODUCTIVE CYCLE

3-TARGET AND INHIBIT SPECIFIC RECEPTORS AND/OR F/A/P'S ETC

INVOLVED IN THE ACQISITION OF RESISTANCE.

1-SPECIFIC TARGETING OF ORGANISM, FOR EXAMPLE, CAN BE DONE

CRUDELY AS IS THE CURRENT PRACTISE OF CULTURING AN ORGANISM,ATTENUATING, DISRUPTING OR OTHERWISE KILLING IT , OR REPRODUCING/DUPLICATING IMMUNOGENIC FRAGMENT BY PROCESSES

VINCLUDING GENETIC ENGINEERING. DESPITE ALL CURRENT

SOPHISTICATION IN PREPARATION OF VACCINE WHJICH ARE COVERED IN THIS USE BY THIS PATENT(CURRENT VACCINE USE IS IN PREVENTION OF INFECTION, CURRENT PATENT COVERS CONVENTIONAL AND NEW VACCINES IN THERAPEUITIC APPLICATION AS WELL AS IN USE TO PREVENT THE RISE OF OF ALL CURRENT VACCINE, THE ONLY ONE THAT HAS BEEN USED FOLLOWING INFECTION BY A PARTICULAR AGENT, IN AN ATTEMPT TO OVERCOME AN INFECTION IN PROGRESS IS THE RABIES VACCINE.THI6 IS DUE TO THE RELATIVELY LONG INCUBATION PERIOD AFTER INFECTION. THIS PATENT COVERS SUCH PROCEDURE FOR ALL OTHER INFECTIONS/DISEASES

/CONDITIONS/ AS WELL AS ALL (RABIES INCLUDED) ONCE DISEASE HAS

AN OVERVIEW OF DEFINING SPECIFIC FACTORS WILL NOW BE PRESENTED.

PHYSICAL/CHEMICAL AND BIOLOGICAL TECHNIQUES MAY BE USED TO DEFINE AND DELINEATE DIFFERENCES BETWEEN TARGET ORGANISMS(TO) AND OTHER TO BE PROTECTED ENTITIES(PE) .

DIFFERENCES BETWEEN T.O. AND P.E.CAN BE DELINEATED IN WHOLE OR PART BY VARIOUS PHYSICAL/CHEMICAL AND BIOLOGICAL MEANS. ENTIRE ORGANISMS AND CELLS CAN BE COMPARED AND /OR LYSED OR DISASSEBLED COMPONENTS CAN BE COMPARED BY METHODS SUCH AS PHYSICAL;

ELECTROPHORESIS,GRADIENT FILTRATION, FOR EXAMPLE, CHEMICAL; SUCH AS ACID/BASE PRECIPITATION OR BIOLOGICAL SUCH AS ENZYMR DIGESTION OR IMMUNOLOGICAL SEPARATION.PATENT COVERS ALL SUCH METHODS AND PROPOSED USE. IMMUNNE METHODS WILL BE FURTHER

HIGHLIGHTED.

IMMUNE IDENTIFICATION OF SPECIFIC FACTORS MAY BE DONE IN-VITRO, IN-VIVO OR BY COMBINATION OF BOTH. HEALTHY CELLS/ORGANISMS CAN BE LYSED SONICALLY OR BY OTHER METHOD AND AN ANIMAL MAY BE VACCINED WITH ALL OR SPECIFICALLY DEFINED FRAGMENTS OF THE YEILD, AS

DEFINED, FOR EXAMPLE, BY P/C/B PARAMETERS, WATER SOLUBLE FRAGMENT WSF OF HEALTHY CELLS FOR EXAMPLE COULD BE COMPARED WITH WSF OF THE DISEASE ORGANISM LYSED IN THE SAME MANNER OR PARTICLES OF

CRUDE IMMUNOLOGICAL SEPARATION.EXAMPLE;

ANIMAL OR OTHER SYSTEM IS IMMUNISED AGAINST A BROAD SPECTRUM OR ALL OF P.E. FRAGMENTS THE ENTIRE P.E IS ALSO USED TO INDUCE AN IMMUNE RESPONSE IN THIS OR OTHER SYSTEM. THE IDENTICAL PROCESS IS NOW DONE TO THE T.O.

WHEN THE T.O. IS EXPOSED TO THE IMMUNE RESPONSE RAISED BY THE P.E., ALL IMMUNOLOGICALLY AND/OR ANTIGENICALLY COMMON FEATURES WILL BE REMOVED , ALL THAT WILL REMAIN IMMUNOLOGICALLY UNBOUND CAN BE TERMED TARGET ORGAN SPECIFIC. ALTERNATIVELY, ANTI T.O. IMMUNE RESPONSE WASHED AGAINST P.E. W/P/E F/A/P/ ETC. SO AS TO REMOVE ANTI-P.E.COMPONENTS COULD BE TERMED SPECIFIC ANTI-T.O. IMMUNE RESPONSE . SPECIFIC ANTI T.O. IMMUNE RESPONSE COULD BE ELLICITED BY VACCINATION USING ONLY THE T.O.SPECIFIC FRAGMENT.

IMPROVED PURITY AND SPECIFICITY CAN BE OBTAINED BY IMPROVING THE SPECIFICITY AND DEFINITION OF COMPARABLE ISOLATES E.G. -T.O MITOCHONDRIAL SPECIFIC OR P.E.SPECIFIC LIQUID SOLUBLE,MEMBRANE EXTRACTED PROTEIN BAND OF...FEATURES .

2ND AND 3RD ETC. GENERATIONS OF SUCH PURIFICATION TECHNIQUES MAY LEAD TO INCREASED SPECIFICITY. IT IS ALSO POSSIBLE TO GAUGE AND IMPROVE GENERATED EFFICACY AS WELL AS YEILD BY VACCINATING AN ANIMAL WITH THE SPECIFIC FRAGMENTS AND THEN CHALLANGING IT WITH THE ENTIRE ORGANISM OR USING AN ANIMAL OR SYSTEM WHICH HAS SUCCESSFULLY DEFENDED ITSELF AGAINST THE DISEASE TO GENERATE RESPONSE AFTER SPECIFIC T.O. CHALLANGE . OR TO REPEATEDLY IMMUNISE AN ORGANISM WITH SPECIFIC T.O. CHALLANGE UNTIL RAPID SUCCESSFUL RESPONSE REPELS T.O. CHALLANGE. ANY COMBINATION OF THIS

MANIPULATION COUPLED WITH THE DEMONSTRATION BEING NEUTRAL TO SPECIFIC P.E. CHALLANGE AS WELL AS ENTIRE P.E. CHALLANGE , WILL YEILD EFFICIENT SPECIFIC IMMUNE RESPONSES. IT IS ALSO POSSIBLE TO GENERATE SPECIFIC ANTI-T.O. RESPONSES USING HOST IMMUNE CELLS INVITRO OR IN-VIVO, PERHAPS IN IMMUNOCOMPROMISED ANIMALS SUCH AS NUDE MICE OR SKID RATS.ANIMALS CAN BE MADE TOLERANT TO PE AND PE FAP'S ETC BY OVERLOADING WITH THE SAME TO ABOVE IMMUNE THRESHOLD LEVELS. A WIDE VARIETY OF OTHER MANIPULATIONS MAY BE DONE SUCH AS RAISING AN IMMUNE RESPONSE AGAINST THE ANTI-P.E. IMMUNE RESPONSE AND USING THAT TO FURTHER PURIFY THE ANTI-T.O. IMMUNE RESPONSE.

AN EFFECTIVE SPECIFIC RESPONSE E.S.R. IS THAT WHICH SPECIFICALLY AND EFFECTIVELY ELIMINATES DISEASE ORGANISM F/A/P'S ETC WITHOUT SIGNIFICANT ANTI-P.E. ACTIVITY.

OTHER BIOLOGICAL METHODS FOR DEVELOPING P.E. SPECIFIC F/A/P'S ETC INCLUDE DEVELOPING ORGANISMS OR ENZYME SYSTEMS WHICH ARE DEVELOPED SPECIFICALLY TO DIGEST/DENATURE/REMOVE T.O.SPECIFIC F/A/P'S ETC., AT VARIOUS TEMPERATURE AND OTHER VARIABLE FACTORS. THE TREATMENT OF IMMUNISING PREPARATION OF T.O. WITH THESE WOULD LEAVE ONLY T.O. SPECIFIC PREPARATION.

IT IS IMPORTANT THAT THESE AND OTHER TECHNIQUES OF EPECIFIC EXTRACTION AND SPECIFIC RESPONSE FORMATION IS DEFINED IN TIME, PHASE AND OTHER VARIABLES . SPECIFIC PREPARATIONS WILL VARY

DEPENDING, FOR EXAMPLE ON THE STAGE OF CELL DIVISION.

STRUCTURES WHICH ARE SPECIFIC FOR ORGANISM MUTATION/ENTRY OF PLASMID ETC. TO BLOCK THESE RECEPTORS AND OTHER STRUCTURES AND HENCE DISABLE ACQUISITION OF MUTATION. DEVELOPING MECHANISMS TO RESTRICT OR INHIBIT T.O. REPRODUCTION WILL SEVERELY LIMIT MUTATION ABILITY. FAP 'S ETC, SPECIFIC TO REPRODUCTION CYCLE COULD BE DELINEATED BY ANY OF THE PCB METHODS MENTIONED PREVIOSLY, TECHNIQUES COULD BE USED TO TARGET A MATING APPENDAGE, FOR EXAMPLE OR TO CREATE A NUTRITIONALLY DEFICIENT ENVIRONMENT TO MINIMISE REPLICATION .ALTHOUGH MUCH OF THE DEBRIS FOLLOWING CELL DEATH MAY INHIBIT CUREATIVE PATHWAYS(EITHER BY CONSIDERING THE CHEMICAL REACTION FLOW MODEL WHERE CLEARANCE OF ENDPRODUCT MAINTAINS UNIDIRECTIONAL FLOW OF REACTION OR BY CONSIDERING THE HOST SYSTEMS FUNCTIONING BETTER IF NOT OVERLOADED WITH DIE-OFF DEBRIS AND POSSIBLE TOXINS), SOME OF THE CELL

NUTRITIONALLY AND OTHERWISE CHALLANGING ENVIRONMENT WILL OFTEN LEAD TO BACTERIAL PHAGE ACTIVATION. THESE PHAGES MAY ACT AS

LYSOSOMES DO IN ANIMAL CELLS, INITIATING AUTODESTRUCTION WHEN CELL HAS RECIEVED MAJOR INSULT . PHAGES AND PLASMIDS MAY CODE FOR ORGANISM DESTRUCTION AND UPON THEIR ACTIVATION AND RELEASE CAUSE THE DESTRUCTION OF MORE BACTERIA, HOWEVER, THEY ALSO FORM

MECHANISMS FOR ENSURING SURVIVAL OF AT LEAST SOME OF THE PARENT BACTERIA'S GENETIC CODE AS IN NATURE A BACTERIA IS UNLIKELY TO EXIST ALONE AND AS OTHER BACTERIA IN THE VICINITY WILL ALSO SHARE WHATEVER HARDSHIP; THE LARGESCALE RELEASE OF PHAGES, PLASMIDS AND OTHER MEANS OF SHARING GENETIC AND OTHER INFORMATION ENSURES EVOLUTION, DIVERSITY AND INCREASED POSSIBILITY OF SHARING SURVIVAL MECHANISMS SO THAT SOME MAY SURVIVE THE INSULT . EVEN IF THERE ARE NO BACTERIAL SURVIVORS, THE PLASMIDS AND PHAGES WILL FURTHER ENRICH THE GENE POOL.

IT IS IMPORTANT TO NOTE THAT PENICILLIN RESISTANCE HAS RISEN DRAMATICALLY OVER THE PAST FEW DECADES . SCIENTISTS AND DOCTORS ALIKE ACCREDIT THIS TO OVERUSE OF THE ANTIBIOTIC AND THEN TRY TO CHANGE ANTIBIOTICS OR DEVELOP ARTIFICIAL CHANGES IN PENICILLIN TO MAKE IT RESISTANT TO THE MUTATED BACTERIA. A FACT THAT SEEMS TO HAVE ESCAPED ALL THESE SCIENTISTS IS THAT THE PENICILLIUM MOULD HAS PREYED ON BACTERIA FOR UNTOLD MILLIONS OF YEARS PRIOR TO THE PURIFICATION OF PENICILLIN; THE SHARP RISE IN ANTIBIOTIC

RESISTANCE FOLLOWING PURIFICATION OF THE ANTIBIOTIC THEREFORE MUST INDICATE SIGNIFICANT DEVIATION FROM THE NATURAL PROCESS. WHEN A MOULD ENCROUCHES ON A BACTERIAL COLONY, IT IS NOT ONLY ITS ANTIBIOTIC THAT IT USES TO ATTACK, A COMPLEMENT OF OTHER FACTORS INCLUDING DIGESTIVE ENZYMES ARE ALSO USED. PLASMID AND PHAGE PHASES ARE ALLOWED TO OCCUR AND SHOULD RESISTANCE FORM, THE MOULD WILL OFTEN MODIFY ACCORDINGLY TO OVERCOME THE RESISTANCE . THIS PROCESS ENSURES THE SURVIVAL OF SOME BACTERIAL FRACTION AND THE CONTINIOUS EVOLUTION OF BOTH BACTERIA AND MOULD. IT IS UNLIKELY THAT ORGANISMS COULD DEVELOP RESISTANCE TO A CRUDE PENICILLIUM EXTRACT AS EASILY AS THEY CAN TO PURIFIED PENICILLIN-MUTATION TO OVERCOME ENZYMATIC AND OTHER CHANGES WOULD REQUIRE SEPARATE MUTATIONS TO ANTIBIOTIC RESISTANCE.

THIS PATENT COVERS THE USE OF CRUDE PENICILLIUM MOULD EXTRACT IN THE TREATMENT OF DISEASE . PATENT ACTUALLY COVERS

THE USE OF CRUDE MOULD EXTRACTS IN THE TREATMENT OF DI SEASE . THESE MAY BE

PREPARED BY DI SRUPTION AND FILTRATION PROCEDURES AND MAY BE FURTHER ENHANCED BY FEATURES OF THIS PATENT TO HAVE EFFECTIVE SPECIFIC ANTIDISEASE ACTIVITY AND MINIMAL S IDE EFFECTS .

CRUDE MOULD EXTRACTS MAY ACTUALLY HAVE LESS SIDE-EFFECTS THA PURIFIED COUNTERPARTS WHERE THEY MAY BE , UNDER THE GUIDELINES OF THIS PATENT HAVE COMPONENTS RELATED TO ALLERGY OR OTHER SIDEEFFECTS BE TESTED(EVEN AGAINST PATIENT'S OWN CELLS) AND REMOVED IN THE VARIOUS PHASES OF ACTIVITY AND SEQUALAE IN PRECURSOR/INTERMEDIATE/ENDPRODUCT CLASSIFICATION TO COVER ALL F/A/P'S ETC. AS THE COMPOUND CARRIES OUT THE DESIRED FUNCTION IN THE BODY.

IF WE NOW RETURN TO THE PREVIOUS RECOMMENDATION OF MAKING THE BACTERIA'S ENVIRONMENT NON-CODUSIVE TO REPLICATION; THIS APPEARS TO DIRECTLY CONTRADICT THE PREVIOUS RECOMMENDATION THAT MINIMAL CHANGE BE DONE TO THE BACTERIAL ENVIRONMENT SO AS NOT TO STIMULATE MUTATION, THESE TWO SEEMINGLY CONFLICTING REQUIREMENTS ONLY APPEAR TO BE SO AS THEY ARE BEING CONSIDERED IN THE SAME PHASE(PRECURSOR/INTERMEDIATE/ENDPRODUCT) IT IS A FEATURE OF THIS PATENT THAT WHEN SEEMINGLY CONFLICTING SITUATIONS ARE UNITED OUT OF PHASE THE UNITY CAN BE HARMONIOUS AND BENEFICIAL. CONSIDER FOR EXAMPLE, SOME FORCE CAUSING HEALTHY CELL DESTRUCTION. PRECURSOR PHASE INCLUDES THE DAMAGING AGENT, INTERMEDIATE PHASE INCLUDES THE DAMAGED CELL STRUCTURES, ENDSTAGE PHASE INCLUDES HEALTHY CELL DEBRIS. TO FASCILITATE HEALING, OPTIMAL CELL CONDITIONS SHOULD BE PROVIDED YET DIRECT ENDPRODUCTS OF THE HARMFUL INSULT MAY BE OF USE IN REVERSING THE DAMAGING AGENT AND ITS EFFECTS AS WOULD BREAKDOWN FRAGMENTS NOT RELATED TO THE INSULT. LET US CONSIDER THE EXAMPLE OF CHEMOTHERAPYCAUSING HEALTHY CELL BREAKDOWN ALONG WITH CANCER CELL DESTRUCTION; SLOWING THE ELIMINATION OF SOME DAMAGED HEALTHY CELLS MAY SLOW THE REACTION FLOW SUCH FRAGMENTS MAY ABSORB MORE OF THE TOXIC AGENT AND ALLOW HEALTHY CELL SURVIVAL.-ALTERNATIVELY, SLOWING THE REACTION FOR HEALTHY CELLS WILL ALSO ALLOW FOR MORE TIME SPENT IN INTERMEDIATE PHASE SO THAT DAMAGED HEALTHY CELLS CAN BE GIVEN A GREATER CHANCE TO ACQIRE RESISTANCE OR MUTATE. IDEALLY, BROKEN HEALTHY CELL FRAGMENTS FROM OTHER CAUSATIVE AGENTS (NON-TOXIC) SUCH AS LYSED BLOOD CELLS FROM PATIENT BROKEN SONICALLY OR HYPOTONICALLY OR CELLULAR STRUCTURE RELEASED AFTER HYPOOSMOTIC INTRAMUSCULAR INJECTION WITH OR WITHOUT PCR OR OTHER AMPLIFICATION PROVIDE FREE CELLULAR FRAGMENTS WHICH WOULD SLOW THE PRECURSOR TO ENDPOINT REACTION; FURTHERMORE SUCH FRAGMENTS MAY BIND THE TOXIC OR EVEN INFECTIVE OR OTHER AGENT CAUSING CELL DESTRUCTION AND LIMIT THAT EFFECT ON HEALTHY CELLS. IN THE CASE OF AIDS FO EXAMPLE, PROVIDING A LARGE AMOUNT OF CELLULAR RECEPTOR DECOUYS TO BIND IT MAY FREE MANY HEALTHY CELLS PARTICULARLY IF THE DECOYS HAD HIGHER AFFINITY(AGAIN RAISED BY FEATURES OF PATENT.)

IN PRECURSOR PHASE THEREFORE THE FOLLOWING ATTACKS ARE POSSIBLE.

SPECIFIC ANTIBIOTIC/CHEMOTHERAPY

DEVELOPMENT OF LIBRARY PERSONALISED THERAPY

INTRODUCTION

GREATLY ADVANCE MODERN MEDICINE.

1- LACK OF EFFICACY

2- LACK OF SPECIFICITY

3- SIDE-EFFECTS/ALLERGIES

FIELD OF PATENT

INVENTOR WILL DESCRIBE SEVERAL PROCESSES BY WHICH THERAPY MAY BE GIVEN INCREASED EFFICACY, SPECIFICITY AND DIMINISHED TOXICITY TO HEALTHY CELLS. INCLUDED WILL BE METHODS FOR DEVELOPMENT OF NEW IMPROVED THERAPIES FOR CONDITIONS BOTH CURRENTLY TREATABLE AND THOSE WITHOUT EFFECTIVE CURRENT THERAPY. IMPROVEMENTS WILL BE MADE ON CURRENT ANTIBIOTIC AND CHEMOTHERAPEUTIC AGENTS, AND A NEW CLASS OF MEDICATION WILL BE INTRODUCED, OVERLAPPING BUT DISTINCT FROM THERAPY INTRODUCED IN THE PRECURSOR/INTERMEDIATE./ENDPRODUCT PATENT BY SAME INVENTOR . GUIDELINES OF THIS PATENT HAVE BROAD APPLICATIONS AND SHOULD NOT BE RESTRICTED BY THE EXAMPLES USED.

A-IMPROVING ON CURRENT THERAPY

1-SPECIFICITY-

THE HIGH TOXICITY OF CHEMOTHERAPEUTIC AGENTS HAS LED TO MANY ATTEMPTS TO BIND THIS TREATMENT TO 'MAGIC BULLETS', THE ONLY AVENUE PURSUED WHICH OFFERED EXCITING AND EAGERLY ANTICIPATED BUT ULTIMATELY DISAPPOINTING RESULTS WAS THE USE OF MONOCLONAL ANTIBODIES . THESE ANTIBODIES WERE OFTEN RAISED IN ANIMAL MODELS THEN THE CELLS GENERATING THEM WOULD BE SPLICED ONTO MYELOMA CELLS OR UNDERGO OTHER GENETIC OR OTHER MANIPULATION TO ENSURE CONSTANT SUPPLY OF ANTIBODY FROM A SINGLE CLONE OF CELLS WHICH WILL SPECIFICALLY ATTATCH TO THE CANCER BEING TREATED.

DIFFICULTIES IN THIS PROCESS INCLUDE FINDING SPECIFIC CANCER ANTIGENS TO RAISE THE ANTIBODY AGAINST, AS WELL AS FRQUENT

DISSOSCIATION OF THE ANTIBODY-CHEMOTHERAPY UNIT WHEN APPLIED IN THE LIVING SYSTEMS .RADIOACTIVE PARTICLES BOUND TO MONOCLONAL ANTIBODIES FACE SIMILAR PROBLEMS AND DESPITE FEW ANECDOTAL SUCCESSES, ALL LARGE TRIALS TO DATE HAVE BEEN DISAPPOINTING. EVEN IF THE MONOCLONAL ANTIBODY IS APPROPRIATE, IT ALONE IS INCAPABLE OF CAUSING CANCER DESTRUCTION IN THE MAJORITY OF CASES. THIS PATENT COVERS OPTIONS OF TARGETING THE ANTIBODIES AT OTHER SOURCES SUCH AS THOSE WHICH CAUSE OR SYNERGISE WITH DISEASE. IT ALSO COVERS METHODS OF INCREASING THERAPEUTIC EFFICACY OF MONOCLONAL OR OTHER ANTIBODIES BY ALSO RAISING COMPLEMENT AND OTHER NON-CELLULAR AND/OR CELLULAR IMMUNE RESPONSES TO THE

TAGGING THERAPY PATENT BY AUTHOR.

TARGETING/DEVELOPMENT

ATTATCHMENT TO MEMBRANE/ANTIBODY/CLAS

USE OF PROTEIN AROUND CANCER/CELLMEMB TO TAG THERAPY

1- INHIBITION OF REPRODUCTION

2- INHIBITION OF INDUCTION OF RESISTANCE

3- STABILISATION OF GENETIC CODE.

4- INHIBITION/INTERFERANCE/PROTECTION AGAINST MUTATING AGENTS

6- USE OF MULTIPLE MODALITIES WITH DIFFERENT TARGETS TO DECREASE THE POSSIBILITY OF MUTATION OR INDUCTION OF RESISTANCE.

THE CONCEPT OF COMBINATION THERAPY IS NOT NEW; COMBINATION

ANTIBIOTICS AND COMINATION CHEMOTHERAPY HAVE OFTEN BEEN USED IN THE HOPE OF EFFECTING IMPROVEMENT WHILE DECREASING THE CHANCE OF RISING RESISTANCE.WITHOUT AN UNDERSTANDING OF CLASSIFICATION PATENT , HOWEVER, THERE EXISTS A REAL DANGER OF DAMAGING HEALTH- RELATED F/A/P'S ETC AND OVERLOOKING DRFAP'S ETC. NONDESCRIMINANT USE OPF SUCH POWERFUL AGENTS ESSENTIALLY PUSHES ALL EXPOSED FACTORS TO ATTEMPT TO OVERCOME THE DANGER. ORGANISMS PREVIOUSLY ANTAGONISTIC, FOR EXAMPLE, MAY SHARE RESISTANCE PLASMIDS IN ORDER TO SURVIVE. THERAPY THAT DOES NOT TAKE THE

CLASSIFICATION, EFFICACY AND SPECIFICITY PATENTS INTO

1-LACK OF SPECIFICITY

EVEN WHERE A TREATMENT IS CLAIMED TO BE OF NARROW

SPECTRUM, FAILURE TO RECOGNISE

CAUSATIVE/.SYNERGISTIC/INFECTIVE/NEUTRAL/ANTAGONISTIC F/A/P'S

ETC WILL OFTEN ACTUALLY MEAN POOR SPECIFICITY.

SYSTEMS OFTEN WILL CHANGE CLASSIFICATION AND SYNERGISE IN THE

FACE OF A COMMON ENEMY.

A SIMPLE EXAMPLE CAN BE GIVEN WHERE TWO STRAINS OF STAPHYLOCOCCI

ARE GROWING IN THE SAME CULTURE MEDIUM; AS THEY ARE SHARING THE

SAME NUTRIENTS AND WHERE THERE IS NO DIRECT CONTACT BETWEEN THE

COLONIES SUCH AS WHERE THEY ARE BEING GROWN ON AGAR PLATES OR

WHERE THEY HAVE BEEN IMPLANTED AT SEPARATE SITES ON A LIVING

SYSTEM AGAIN, THEY MAY BE SEEN TO BE IN COMPETITION FOR

NUTRIENTS/SUBSTRATES ETC- DEGREE OF ANTAGONISM WILL DEPEND ON

FACTORS INCLUDING RESPECTIVE GROWTH RATES AS WELL AS SUPPLY OF

LIMITING ESSENTIAL FACTOR.

WHEN THE SYSTEM IS TREATED WITH AN ANTIBIOTIC TO WHICH CULTURE A

IS SENSITIVE BUT CULTURE B IS RESISTANT THERE WILL BE INITIAL

DIEOFF OF A BUT, OFTEN A WILL DEVELOP RESISTANCE TO THE

ANTIBIOTIC, BY THE SAME SYSTEM THAT PROTECTS B. APPARENTLY

CULTURE B CHANGES FROM ANTAGONISTIC TO SYNERGISTIC AND DONATES PLASMIDS,PHAGES AND OTHER SYSTEMS/FRACTIONS TO ITS FORMER

OPPONENT. SUCH DONATION MAY BE TRACED BY RADIOACTIVE LABELLING. AN THIS MODEL CAN ALSO APPLY TO UNRELATED SPECIES.

A SIMPLE MODEL THAT MAY BE EASIER TO PICTURE AND WHICH IS ALSO BIOLOGICALLY VALID IS ONE WHERE TWO ANTAGONISTIC BACTERIA OR ITHER ORGANISMS,NOT NECESSARILY RELATED NOR EVEN OF THE SAME SPECIES ARE OPPOSED BY COMPETITION FOR NUTRIENTS/SECRETION OF INHIBITORY FACTORS OR BY SOME COMPLEX INTERPLAY WITH HOST AND/OR OTHER FACTORS. LET US NOW CONSIDER A SITUATION WHERE ONE IS RESISTANT TO PENICILLIN AND THE OTHER IS PENICILLIN SENSITIVE;AS THE PENICILLIN IS INTRODUCED INTO THE SYSTEM , THE PENICILLIN RESISTANT COMPONENT OF THE RESISTANT ORGANISM WILL BE ACTIVATED OR INDUCED(AS PENICILLIN USE TODAY IS NOT TARGETED OR SPECIFIED TO ANY SIGNIFICANT DEGREE WHEN COMPARED WITH SPECIFIC LIBRARY AND TECHNIQUES PRESENTED IN THIS PATENT) ; IF THE RESISTANT MODALITY IS ONE OF PENICILLINASE ACTIVITY(AN ENZYME WHICH INACTIVATES

PENICILLIN), ALTHOUGH THERE MAY BE DONATION OF THIS ABILITY FROM THE RESISTANT TO THE SENSITIVE ORGANISM, THIS IS NOT ESSENTIAL TO CAUSE ALTERATION IN THE CLASSIFICATION AND DYNAMICS OF THE ORGANISMS. CONSIDERING THAT A FINITE AMOUNT OF PENICILLIN WILL ENTER THE SYSTEM; AN ORGANISM CAPABLE OF BREAKING DOWN A QUANTITY OFG IT BY USE OF PENICILLINASE OR OTHER METHOD (EVEN IF SELFISH AND UNSHARED) IT WILL DECREASE THE TOTAL AMOUNT OF

ORGANISMS NEED NOT EVEN BE POSESSED OF RESISTANT ABILITY TO CHANGE CLASSIFICATION. E.COLI AND LACTOBACILLI MAY BE IN

ALTHOUGH ALL ABOVE MODELS MAY APPLY IN THIS SITUATION AS WELL, IT IS NOT ESSENTIAL THAT EITHER ORGANISM SPECIE/COLONY BE RESISTANT TO THE ANTIBIOTIC TO SYNERGISE. IF BOTH ARE SENSITIVE;THE PRESENCE OF ONE BEING KILLED BY THE ANTIBIOTIC EFFECTIVELY DECREASES THE FREE AVAILABLE CIRCULATING AMOUNT/CONCENTRATION OF THE

ANTIBIOTIC. THE LACK OF SPECIFICITY THEREFORE ENABLES SYNERGY AMONGST EVEN PREVIOUSLY OPPOSED ORGANISMS, F/A/P 'S ETC

DEVELOPMENT OF BIOLOGICAL THERAPEUTIC AGENTS PATENT.

INTRODUCTION

HISTORY

(DIGITALIS, PENICILLIN ETC) OR BY LARGESCALE SCREENING FOR

DESIRED QUALITIES(EG TOXICITY SCREENING HAS LED TO THE ISOLATION OF MANY CHEMOTHERAPEUTIC AGENTS) .WHE SUCH AGENTS NO LONGER

DEMONSTATE EFFICACY (EG. RESISTANCE DEVELOPING TO CHEMOTHERAPY OR ANTIBIOTICS), OTHER AGENTS , OFTEN UNRELATED, ARE SOUGHT.

ADAPTATION.

BIOLOGICAL ADAPTATION.

DEMONSTRATIONS WILL BE MADE IN THE USE OF SUCH TECHNOLOGY IN THE FIELDS OF ANTIBIOTIC THERAPY AS WELL AS CHEMOTHERAPY; ALTHOUGH THIS PATENT IS BY NO MEANS RESTRICTED TO THESE EMBODYMENTS .THREE OTHER CONSEQUENCES OF THERAPEUTIC SIGNIFICANCE WHICH MAY RESULT FROM FEATURES OF THIS PATENT INCLUDING FORCED COHABITATION

/INDUCED, PROMOTED/PERMITTED INTERRELATIONSHIPS INCLUDE

1-CANNIBALISM

2-EXPRESSION

3-TAGGING

IT IS ALSO IMPORTANT TO NOTE THAT IN MANY OF THE SITUATIONS ILLUSTRATED IN THIS PATENT, WE WILL BE CONSIDERING THE INTERPLAY OF 2 OR MORE ORGANISMS, IN MANY CASES THIS WILL ALSO LEAD TO EXPRESSION AND DEFINITION OF AN ORGANISMS REPRETOIRE OF

SURVIVAL MECHAN I SMS-THESE MAY BE CONSIDERED AS ;

1-OFFENSIVE

2-DEFENSIVE

3-ELUSIVE-THIS INCLUDES EVOLUTIONARY, EVOLVING TO BYPASS OR

OVERCOME THE CONSTRAINTS OF THE SITUATION . EVOLUTION MAY INCLUDE

PROGRESSION OR REGRESS ION; FEATURES WHICH MAY BE CONFUSED WITH

PLEOMORPHISM.

TRACKING AN ORGANISM AS IT DEALS WITH SUCH

VARIABLES/STRESSES, MAY, FOR EXAMPLE, LEED TO THE EXPRESSION OR EXPOSURE OF PREVIOUSLY HIDDEN OR DISGUISED F/A/P'S ETC. SUCH AS ANYIBODIES WHICH MAY ALLOW FOR EASIER AND MORE EFFECTIVE THBRAPY SUCH AS IMMUNOLOGICAL THERAPY TO BE DEVELOPED.SUCH THERAPY MAY BE INDUCED BY;

1-PRIMARY-ALTERATION/MODIFICATION OF ORGANISM W/P/E ETC.

2-SECONDARY-ALTERATION/MODIFICATION OF IMMUNOLOGICAL RESPONSE. 3-TERTIARY-ALTERATION/MODIFICATION OF BOTH ORGANISM/HOST RESPONSE /OTHER VARIABLES.

IT IS ALSO IMPORTANT TO REALISE THAT THIS PATENT EXAMINES THESE RELATIONSHIPS AND DESIGNS SOLUTIONS BASED ON THE THREE VARIABLES OF ORGANISM/THERAPY HOST/ AS WELL AS OTHER RELEVANT FACTORS IN

WHAT THE INVENTOR TERMS DYNAMIC FLOW. DYNAMIC FLOW STUDIES ENABLE

1-PROPHYLAVCTIC

2-ANTICIPATORY AND

3-RESPONSIVE THERAPIES

FURTHER EXPLANATIONS AND DEFINITIONS ARE NOW REQUIRED,

DEFINITIONS AND CLARIFICATION

1- FORCED COHABITATION/INDUCED, PROMOTED , PERMITTED

INTERRELATIONSHIPS

THIS TERMINOLOGY REFERS TO THE CONDITIONS STUDIED IN-VITRO AND

IN-VIVO,WHERE AT LEAST 2 ORGANISMS ARE FORCED TO EXIST FOR A TIME

PERIOD UNDER CONDITIONS WITH VARIABLE DEFINED MARGINS OF BIAS.

DURING THIS SET PERIOD , F/A/P ' S ETC . MAY MANIFEST , BE

GENERATED, PROMOTED OR INDUCED WHICH MAY PROVE USEFUL.

2-CANNIBALISM

THIS TERM REFERS TO THE EVENT WHICH TAKES PLACE WHEN AN ORGANISM FEEDS ON ANOTHER OR OTHERWISE INCORPORATES THE OTHER WHOLE OR PART (W/P/E/FAP'S ETC) INTO ITSELF OR INTO RELATED/ASSOSCIATED ORGANISM AND/OR F/A/P'S ETC.

3-EXPRESSION

EXPRESSION REFERS TO THE EXTERNAL OR INTERNAL CHANGES WHICH MANIFEST UNDER DEFINED CONDITIONS . EXPRESSION MAY FOLLOW

EXPRESSION REFERS TO CHANGES WHICH MAY BE SUPERFICIAL SUCH AS THE UNCLOAKING OF PREVIOUSLY 'HIDDEN' ANTIGENS; AS WELL AS TO CHANGES THROUGHOUT ANY OR ALL THE ORGANISM AND PRECIPITATED BY INTRINSIC OR EXTRINSIC F/A/P'S ETC.EXPRESSION MAY REFER TO GENETIC

ACTIVATION AND SUBSEQUENT CHANGES . AT ONE LEVEL , THIS MAY COVER THE CHANGES TAKING PLACE IN AN ORGANISM EXPOSED TO PENICILLIN WHERE RESISTANCE MECHANISMS ENGAGED AT THE GENETIC LEVEL MAY LEED TO THE EXPRESSION OF DEFENSE SYSTEMS AND THEIR AUGMENTATION, ONE SUCH SYSTEM WOULD INVOLVE THE EXPRESSION OF ENZYMES SUCH AS PENICILLINASE. ALTERNATIVELY, IN AN ORGANISM WITHOUT ADEQUATE ANTIBIOTIC RES I STANCE , EXPOSURE TO AN ORGANISM GENERATING

ANTIBIOTIC(S), EXPRESSION OF THE GENETIC 'ESCAPE POD' OR PHAGE MAY BE INITIATED . LYTIC PHAGES CAN ALSO BE COMPARED TO CELLULAR

LYSOSOMES OR AUTO-DESTRUCT MECHANISMS.

ALTERNATIVELY, IF THE COHABITATING ORGANISMS CAN SYNERGISE OR INTERACT AT SOME INTIMATE LEVEL,WE MAY SEE EXPRESSION OF

REPRODUCTION TUBULES, PLASMIDS ETC. IF THE MARGIN OF BIAS IS RAISED BY ADDING PENICILLIN TO THE CULTURE AND IF ONE OF THE ORGANISMS IS RESISTANT TO PENICILLIN, WE MAY SEE PLASMID

ALTHOUGH THE ABOVE EXAMPLES RELATE TO PENICILLIN, THIS IS ONLY BY EXAMPLE AND BY NO MEANS RESTRICTS THIS PATENT TO THIS AND OTHER ANTIBIOTICS. PATENT RELATES TO ANY RESPONSES TO DEFINED PARAMETERS AND SPECIFIC F/A/P'S ETC. WHICH MAY BE DEMONSTRATED BY PCB METHODS OF COMPARISON AND ISOLATION OF FACTIORS UNIQUE TO A PARTICULAR SITUATION BY COMPARING TO BASELINE IN THE ABSENCE OF SITUATION OR FACTOR TO WHICH SPECIFIC FACTORS ARE BEING SOUGHT.

ACQUISITION AND EXPRESSION OF RTESISTANCE INDICATES SEVERAL OTHER TARGETS FOR IMMUNOLOGICAL OR OTHER THERAPY.THESE INCLUDE

REPRODUCTIVE FEATURES, PLASMIDS,MEMBRANE AND OTHER CHANGES ETC.

EXPRESSION CAN ALSO EE CATEGORISED UNDER THE GUIDELINES OF PRECURSOR/INTERMEDIATE/ENDPRODUCT PATENT BY SAME INVENTOR.

THIS PHASE/SITUATION HAS GREAT SIGNIFICANCE IN

DIAGNOSIS/EVALUATION/THERAPY/PROGNOSIS ETC.

AN EXAMPLE OF THIS CAN BE SEEN WITH AIDS.

H.I.V. WILL ENTER THE BODY. ATTATCH TO SPECIFIC SITES ON T4 LYMPHOCYTES AND INSERT ITS GENETIC CONTENT INTO THAT OF THE LYMPHOCYTE BY VIRTUE OF MECHANISMS INCLUDING THOSE OF ITS REVERSE TRANSCRIPTASE ENZYME. ONCE ENSINUATED IN THE CELL'S GENETICS, THE VIRUS AND ITS MESSAGES ARE EXPRESSED BOTH INTRACELLULARLY,ON THE CELL SURFACE AND EXTRACELLULARLY.

WHEN SEARCHING FOR CURES OR THERAPIES; THE RESEARCH HAS LARGELY CENTERED ON DISABLING THE VIRUS VOR OVERCOMING ITS ENDPOINT DAMAGING EFFECTS. THE CELL EXPRESSING THE VIRUS .HOWEVER, FORMS AN ENTITY WORTHY OF MAJOR CONSIDERATION IN DESIGNING THERAPY. THE INFECTED CELL. EXPRESSING DISEASE AND, DISEASE F/A/P'S ETC MAY ITSELF BE CONSIDERED TO BE A DISEASE ENTITY.

F/A/P'S. AND OF WHICH AT LEAST SOME MAY BE SEEN AS EXPRESSION RELATED

USING CANCER THERAPY TO CLARIFY THE LATTER POINT.

THE BREAK IN LOGIC OF THERAPY RELATED TO CANCER OCCURS IN MANY STAGES OF THERAPY BUT CAN BE BEST EXAMPLIFIED BY ATTEMPTS TO COMBINE CHEMOTHERAPY/RADIOTHERAPY WITH IMMUNOTHERAPY. CANCER BIOPSIES ARE TAKE AND PROCESSED INTO SOME FORK FOR IMMUNISATION; THIS MAY INCLUDE CO-INCUBATION WITH MICRO-ORGANISMS OR OTHER PHYSICAL/CHEMICAL/BIOLOGICAL PROCESSES TO MODIFY PRESENTATION

AND/OR CAUSE EXPRESSION OF F/A/P'S ETC. WHICH MAY INCREASE

ANTIGENICITY OR OTHERWISE BE OF BENEFIT.

INNOCUOUS PRACTISES TO ALTER DIET/PH/VITAMIN AND OTHER

SUPPLEMENTS ETC. ALL THESE MAY BE ABLE TO CAUSE FURTHER CHANGES IN ORIGINAL CANCER CELLS. IT IS ALSO IMPORTANT TO NOTE THAT CHASNGES AND VARIATIONS IN EXPRESSION OF ASPECTS OF THE DISEASE MAY BE FEATURES OF THE NATURAL HISTORY OF THE DISEASE AND NEED TO BE CONSIDERED IN THERAPY /EVALUATION ETC.

AS AN EXAMPLE; VARIOUS TUMOURS INCLUDING THOSE OF THE BOWEL;

BREAST; OVARIES ETC. MAY SECRETB/EXPRESS PROTEINS/COMPLEXES SUCH AS CARCINOEMBRYONIC ANTIGEN (CEA) OR CA125 ETC. DURING SOME IF NOT ALL OF THE CYCLE OF MANY CANCER CELLS AND THEIR PROGENY .IT IS NOT UNCOMMON, HOWEVER , FOR THE DISEASE TO ALTER CHARACTERISTICS DURING ITS COURSE AS PART OF NATURAL PROGRESSION AND/OR OTHER FACTORS SUCH THERAPY ETC. CANCERS INITIALLY EXPRESSING CEA.CA125 AND/OR OTHER FACTORS MAY LOSE THE ABILITY TO EXPRESS THESE. OFTEN AS THEY UNDIFFERENTIATE TO A MORE AGGRESSIVE STAGE. THIS LEADS TO SOMETIMES CONFUSING SITUATION WHERE INCREASING LEVELS OF THESE CANCER 'MARKERS' INITIALLY INDICATE CANCER GROWTH AND DROPS IN THE LEVEL ARE USED TO INDICATE RESPONSE TO THERAPY, AS CELLS BECOME MORE AGGRESSIVE AND LESS DIFFERENTIATED , THEY LOSE THE ABILITY TO PRODUCE THESE MARKERS. AND AS THE CANCER GROWS AND ENTERS POSSIBLY ITS MOST DANGEROUS, RAPID GROWTH

PHASE, CHARACTERISTICALLY REFRACTILE TO CONVENTIONAL

THERAPIES . BLOOD TESTS SHOW A DROP IN THE TUMOUR MARKER AND MAY BE FALSELY INTERPRETED AS IMPROVEMENT.

POINT TO BE ILLUSTRATED HERE IS THAT THERE APPEAR TO BE 2

MISCONCEPTIONS IN BOTH CONVENTIONAL MEDICAL AS WELL AS ALTERNATIVE AND LAY THOUGHTS THAT CANCER IS AN IMMORTAL CELL THAT PROLIFERATES UNCHECKED AND UNCHANGING TILL DEATH OF HOST. THE OTHER IS THAT THE MALIGNANT CHANGE IS IRREVERSIBLE.

THERE ARE MANY DEMONSTRABLE FEATURES F/A/P'S ETC. THAT WOULD DISPROVE THE CONTENTION THAT CANCER DOES NOT CHANGE SIGNIGFICANTLY THROUGH ITS COURSE; NOT THE LEAST OF THESE BEING THE LOSS OF CELL MARKERS ; ANOTHER BEING DEVELOPMENT OF RESISTANCE TO THERAPY TO WHICH IT WAS PREVIOUSLY SENSITIVE. THE REASON I ACCUSE THE CONVENTIONAL MEDICAL PRACTITIONERS OF NOT APPRECIATING

/RECOGNISING/RESPONDING TO THE CHANGING CANCER CELL AS THERAPIES ARE USUALLY PLANNED AGAINST THE PRIMARY BIOPSY-AN EXAMPLE BEING THE PREPARATION OF VACCINES AGAINST TUMOUR CELLS THEN EXPOSING THE PATIENT TO RADIOTHERAPY/CHEMOTHERAPY ETC AND EXPECTING THE VACCINE TO EXERT SOME EFFICACY WHEN DISEASE PROGRESS AND THERAPY COULD HAVE ALTERED ITS ANTIGENS DRAMATICALLY. (INVENTOR COVERS A MORE EFFECTIVE AND RELEVANT TECHNOLOGY IN THE

PRECURSOR/INTERMEDIATE/ENDPRODUCT PATENT AS WELL AS CO-TEMPORAL AND DYNAMIC SECTIONS OF HIS PATENTS). THE OTHER WIDELY BELIEVED FALLACY IS THAT THE MALIGNANT CHANGE IS IRREVERSIBLE AND THAT REDEFFERENTIATION IS NOT A VIABLE THERAPEUTIC OPTION. OTHER THAN SOME CASES OF SPONTANEOUS

REMISSION, NO DEMONSTRATION OF THIS PHENOMENON HAS EVER BEEN REPRODUCED CLINICALLY AND THIS HAS ATTRACTED LITTLE INTEREST. THERE ARE COMPOUNDS WHICH HAVE BEEN SHOWN UNDER LABORATORY EXPERIMENTAL CONDITIONS TO BE CAPABLE OF CAUSING CANCER CELL DIFFERENTIATION; THESE INCLUDE INSULIN, METHOTREXATE AND COPPER 3, 5,DIISOPROPYL SALICYLATE . THE INVENTOR HAS BEEN DOCUMENTING AND DEVELOPING IMMUNOLOGICAL AND OTHER MECHANISMS WHICH HAVE LED TO THE DIFFERENTIATION OF CANCER CELLS TO LESS MALIGNANT AND MORE NORMAL FORMS.

THIS HAS BEEN EXPRESSED IN CASES WHERE UNDIFFERENTIATED BOWEL CANCER HAS BEEN MADE TO PRODUCE TUMOUR MARKERS OR WHERE THERE WAS A TRANSIENT RISE IN TUMOUR MARKERS ASSOSCIATED WITH MEASUREABLE CANCER REGRESSION. LEUKEMIA CELLS HAVE BEEN MADE TO ACQUIRE MORE 'NORMAL ' APPEARANCE BY INVENTOR'S THERAPIES INCLUDING THOSE OF THIS PATENT . NORMALISATION OF APPEARANCE WAS ACCOMPANIED BY

HOWEVER, IN TREATED PATIENTS THE ABNORMAL CELLS WILL POSE

4-TAGGING

ENABLE/ENHANCE THE LATTER'S VISIBILITY AND VULNERABILITY TO HOST SYSTEMS.

THIS TECHNIQUE CAN BEST BE EXAMPLIFIED WHEN ADDRESSING CANCER

CELLS.

CANCER CELLS BY INHERENT OR INDUCED MECHANISMS ARE ESSENTIALLY

IMMUNOLOGICALLY INVISIBLE, THAT IS, THE IMMUNE SYSTEM APPEARS

UNABLE TO SEE THEM AND/OR ADEQUATELY RESPOND TO THEM. IMMUNE CELLS

THAT KAY SOKETIMES BE SEEN AND/OR INDUCED TO ATTACK CANCER CELLS

ARE KNOWN AS NATURAL KILLER CELLS. THESE MAKE A VERY SMALL

PERCENTAGE OF THE IMMUNE SYSTEM AS A WHOLE.

BACTERIA,ON THE OTHER HAND, ATTRACT NEUTROPHILS AND OTHER CELLS

WHICH MAY MAKE UP 60-80% OF CIRCULATING IMMUNE CELLS UNDER

BACTERIAL CHALLENGE . THE ANTIBACTETRIAL EFFECT IS USUALLY RAPID

AND DRAMATICALLY EFFECTIVE.

ANTIVIRAL RESPONSE MAY INVOLVE LYMPHOCYTES WHICH MAKE UP ANOTHER

SIGNIFICANT PERCENTAGE OF THE CIRCULATING IMMUNE CELLS . AGAIN,

RESPONSE AGAINST THE COMMON VIRAL AGENTS SUCH AS COLDS OR FLUS IS

USUALLY RAPID AND DRAMATICALLY EFFECTIVE.

THE IDEA OF TAGGING GIVES RISE TO THAT POSSIBILITY.

SPONTANEOUS REMISSIONS THAT OCCUR WITH CANCER FOLLOWING INFECTIONB MAY INDICATE ORGANISMS WITH AFFINITY FOR CANCER CELLS. AFFINITY MAY EXPRESS IN THE FORM OF SPECIFIC BINDING OF ORGANISM(W/P/E/ F/A/P'S ETC) TO RECEPTORS ON THE SURFACE OF CANCER CELLS.

IN FACT, IT MAY BE POSSIBLE TO ATTATCH BIOLOGICAL OR OTHER

F/A/P'S TO SPECIFIC SITES ON AND/OR IN A CELL. SUCH A

PROCEDURE, PARTICULARLY WHERE IT LEADS TO RECOGNITION BY OR

TARGETING FOR ANOTHER SYSTEM IS TERMED TAGGING BY THE INVENTOR.

INHERENT OR REQUIRE DONATION OR INDUCTION BY THE GUIDELINES TO FOLLOW.

TAGGING THERAPY HAS PROVEN VERY EFFECTIVE AGAINST A BROAD RANGE OF DISEASES; BOTH CANCER AND AIDS RESPOND EXTREMELY WELL. THE PHENOMENON OF IMMUNE AND OTHER RESPONSE MODIFICATION WHICH FOLLOWS TAGGING WHERE TAGGING COMPLEX INDUCES A WIDE RANGE OF MODIFIED RESPONSE TO DISEASE. THE IMPORTANCE OF IMMUNOLOGICAL MODIFICATION IN AIDS IS WORTH HIGHLIGHTING.

H.I.V. IS BELIEVED TO BE THE CAUSATIVE AGENT BEHIND AIDS. IT WILL ENTER THE BODY AND ATTATCH TO CD4 RECEPTORS ON T4 LYMPHOCYTES THEN INSINUATE ITSELF INTO THE CELL GENETICS AND FURTHER THE DISEASE . AS HIV TAGS THE INFECTED CELLS WITH VIRAL PARTICLES THROUGHOUT IT AND ON ITS MEMBRANE SURFACE, OTHER T4 CEKLLS WITH THE APPROPRIATE CD4 RECEPTORS WILL ATTATCH AND BE SUBSEQUENTLY INFECTED. IT APPEARS THAT THE HIV WILL INDUCE 'ATTACK' BY THE VERY CELLS IT CAN INFECT AND DESTROY.

THERE ARE MANY APPLICATIONS TO THE TAGGING THEORY WHICH MAY BE HIGHLIGHTED BY APPLICATION IN AIDS.

THE PRECEDING DISCUSSION INDICATES THAT PATRT OF THE AIDS DISEASE PROCESS MAY INVOLVE THE EFFECTIVE TAGGING OF TARGET T4 CELLS BY THE HIV. THIS IMMEDIATELY SUGGESTS SEVERAL PATHWAYS OF DISRUPTING AT T.EAST THIS PATHWAY OF DISEASE.

ATTEMPTS TO BLOCK CD4 RECEPTORS SUCH THAT HIV CANNOT 'DOCK' AND SUBSEQUENTLY ENTER T4 CELLS MAY BE ACCOMPLISHED IN A VARIETY OF WAYS . CAUTION IS NEEDED HERE AS BLOCKADING THAT RECEPTOR MAY ITSELF LEED TO SEQUALAE OF AIDS AND/OR OTHER UNDESIREABLE

CHANGES. A DEFINITIVE MULTI-PRONGED PROTOCOL SHOULD BE EMPLOYED AT THIS STAGE; IE, THIS PATENT SUPPORTS TYEMPORARY BLOCKADING OF CD4 RECEPTORS ONLY IF OTHER THERAPY IS SIMULTANEOUSLY INITIATED AGAINST AIDS . THIS ADJUNCTIVE TREATMENT MAY VARY FROM HYPERTHERMIA TO THE APPLICATION OF OTHER NATURAL OR STRUCTURED RECEPTORS FOR HIV TO 'SWEEP' THE BLOOD FOR VIRAL FRAGMENTS. ALTERNATIVELY THERAPY COULD BE INITIATED TO ALTER CD4 RECEPTOR STRUCTURE SO THAT IT NO LONGER EASILY BINDS HIV. SUCH THERAPY COULD BE AS BASIC AS HYPERTHERMIA OR AS COMLICATED AS GENETICALLY OR OTHERWISE MODIFY RECEPTORS TO BE SIMILAR TO THOSE OF RESISTANT ANIMALS AND/OR HUMANS. INVENTOR HAS DEMONSTRATED THAT SEVERAL BIOLOGICAL ORGANISMS MAY COMPETE FOR RECEPTOR SITES AND DISPLACE HIV. HYPERTHERMIA HAS ALSO BEEN SHOWN BY THE INVENTOR TO BE

CD4 'DECOYS' ALONE OR ATTATCHED TO SOME DEFINITIVE THETRAPY HAVE ALSO FUNCTIONED WELL. CD4 RECEPTORS ARE COVERED BY THIS PATENT AS PERFECT 'MAGIC BULLETS' OR HOMING MECHANISMS FOR BINDING TO AND /OR SELECTIVELY DELIVERING THERAPY TO HIV. PATENT COVERS THE USE OF CD4 RECEPTORS AS CARRIERS OR DIRECT DELIVERY MECHANISMS OF THERAPY .WHETHER STANDARD SUCH AS AZT OR NEW. SPECIFICITY OF DELIVERY WOULD ENSURE INCREASED CONCENTRATION AT SITE OF ACTION AS WELL AS DECREASED SIDE-EFFECTS . DESPITE HIV'S NOTORIOUS

PENCHANT FOR MUTATION,ATTATCHMENT TO CD4 APPEARS TO REMAIN A CONSTANT FEATURE WHICH CAN BE EXPLOITED.

A SIMPLE MODEL COVERED BY THIS PATENT WOULD BE TO RAISE ANTIBODIES THAT WOULD ATTATCH NOT TO CD4 RECEPTORS AND BLOCK THEM NOR SIMPLY TO H.I.V. WHICH MAY , IF EFFECTIVE,WORK AGAINST FREE VIRUS,BUT TO RAISE HUMAN OR ANIMAL IMMUNE RESPONSE, FOR EXAMPLE ANTIBODIES AGAINST THE BOUND HIV-CD4 COMPLEX. CD4 RECEPTORS ATTATCHED TO HUMAN/ANIMAL/BACTERIAL OR OTHER FRAGMENTS MAY ENABLE ATTATCHMENT TO HIV AND INITIATION OF EFFECTIVE IMMUNE RESPONSE AGAINST HIV-CD4 COMPLEX AND/OR AGAINST THE ATTATCHED FRAGMENT WHICH MAY BE IMMUNO-ATTRACTING/STIMULATING/MODULATING.EVEN WHERE THE CD4 AND CELLULAR FRAGMENTS ARE MADE FROM CULTURES OF THE PATIENT'S OWN CELLS,TARGETING THE CD4-HIV COMPLEX IMMUNOLOGICALLY BY ENDOGENOUS AND/OR EXOGENOUS TECHNIQUES ENABLES THE DESTRUCTION OF BOUND CD4 DECOYS AS WELL AS T4 CELLS WHICH HIV HAS BOUND TO AND/OR INFECTED,WHERE THE CD4-HIV COMPLEX EXISTS. IT MAY ALSO BE LOGOCAL TO VACCINATE AGAINST OTHER FRAGMENTS/WHOLE COMPLEXES OF INFECTED CELLS-THIS WOULD BE COVERED UNDER INTERMEDIATE STAGE VACCINATION BY INVENTORS OTHER PATENT.

VACCINATING AGAINST HIV-T4 OR OTHER INVOLVED CELLULAR COMPLEXES ENABLES BOTH THE USE OF DECOY FRAGMENTS TO ATTATCH TO FREE HIV AND THEN BE ATTACKED BY ENDOGENOUS OR EXOGENOUSLY RAISED IMMUNE MECHANISMS; IT WOULD ALSO ALLOW FOR THE SPECIFIC TARGETING OF INFECTED CELLS. TAGGING THERAPY CAN ALSO BE USED IN COMPETATIVE MANNER. AS THE BINDING OF HIV TO CD4 RECEPTORS HAS BEEN DESCRIBED AS A FORM OF TAGGING; COMPETITION FOR THAT RECEPTOR AND/OR ALTERATION OF ITS SHAPE AND/OR CHARACTERISTICS MAY INTERFERE WITH THE DISEASE PROCESS.

CELLS WHICH HAVE BEEN TAGGED WITH HIV AND WHICH ARE INFECTED WITH THE VIRUS TEND TO BE MORE FRAGILE THAN THEIR HEALTHY COUNTERPARTS IN SEVERAL SITUATIONS. HYPERTHERMIA HAS BEEN DEMONSTRATED TO CAUSE INTERFERANCE WITH VIRAL BINDING TO CD4 RECEPTORS AS WELL AS LYSIS OF INFECTED CELLS WHICH APPEAR TO HAVE LOWER TOLERANCE TO PHYSICAL, CHEMICAL AND BIOLOGICAL AGENTS THAN THEIR HEALTH

COUNTERPARTS .

PH EXTREMES ALSO MAY CAUSE PREFERENTIAL DESTRUCTION OF DISEASED

CELLS.

CHEMOTHERAPY SUCH AS CYCLOSPORIN MAY ALSO CAUSE PREFERENTIAL

LYSIS OF DISEASED CELLS.

SEARCHING CASES OF SPONTANEOUS REMISSION (SR), UNUSUAL RESISTANCE OR HIGH RISK BUT HEALTHY INDIVIDUALS (HBH) OR SIMPLE BROAD SCREEN NORMAL/LABORATORY ENHANCED IMMUNE CELLS . SEARCHING HUMAN , ANIMAL AND/OR OTHER SYSTEMS FOR EFFECTIVE IMMUNE RESPONSES AGAINST THE DISEASE, 3 FORMATS CAN BE ENVISIONED.

1-EFFECTIVE,SPECIFIC HIV ANTISERA-

THESE MAY EXERT ACTIVITY AGAINST FREE CIRCULATING HIV AND MAY BE

OF USE PROPHYLACTICALLY, IMMEDIATELY AFTER EXPOSURE OR OF LIMITED

EFFICACY IN THERAPY.

CELLS ALREADY INFECTED MAY NOT RESPOND AS WELL AS FREE VIRUS.

2-EFFECTIVE ANTISERA AGAINST THE CD4-HIV COMPLEX . THIS WOULD ATTACK/NEUTRALISE/DEMONSTRATE AFFINITY FOR INFECTED CELLS. IN COMBINATION WITH THE ABOVE ANTISERA BOTH CELLULAR AND EXTRACELLULAR PHASES OF THE VIRUS MAY BE EFFECTED..

3-DECOY-NATURALLY OR ARTIFICIALLY GENERATED CD4 RECEPTORS

OR ANALOGUES CAN BB USED TO BIND FREE HIV. PARTICULARLY WHERE THE DECOY CAN BE GIVEN HIGHER AFFINITY THAN PATIENT'S OWN RECEPTORS. DECOYS MAY BE THEMSELVES TAGGED BY IMMUNOSTIMULATING/IMMUNOMODULATING F/A/P'S ETC.

ANTI-DECOY-HIV COMPLEX RESPONSES MAY BE RAISED AND/OR

ANTICIPATED-ANTICIPATION IS COVERED IN INVENTOR'S PATENTS

ON CO-TEMPORAL THERAPY AND PRECURSOR/INTERMEDIATE/ENDPRODUCT THERAPY

TAGGING THERAPY, WHERE BACTERIAL OR OTHER ORGANISM W/P/E FAP'S ETC ARE KADE TO ATTATCH TO VIRUS OR TO VIRALLY-INFECTED CELLS, HAS STRONG THERAPEUTIC POTENTIAL AS IT NOT ONLY ALERTS AND ACTIVATES IMMUNOLOGICAL AND/OR OTHER SYSTEMS BUT ALSO CAN MODULATE SUCH RESPONSES. IF IN THE ORDINARY COURCE OF THE DISEASE,HIV ATTACKS AND DESTROYS T4 CELLS; AS THE BODY ATTEMPTS TO FIGHT THE INFECTION BY MORE T4 LYMPHOCYTES, THESE TOO MAY BE INFECTED. GENERAL NON-SPECIFIC IMMUNOSTIMULATION THEREFORE MAY ACCELERATE THE PATIENT'S DETERIORATION. IF VIRUS AND INFECTED CELLS ARE TAGGED BY SAY BACTERIAL FRACTIONS. THE IMMUNE RESPONSE ATTRACTED TO THE COMPLEX IS LIKELY TO BE LARGELY NEUTROPHILIC. AS THESE CELLS APPEAR TO BE RESISTANT TO HIV INFECTION ; A SIGNIFICANT IMPROVEMENT IN THE HOST'S CHANCES OF BENEFICIAL RESPONSE MAY FOLLOW.

TAGGING MAY BE MADE SPECIFIC FOR DISEASE AND CAN TAGGING FAP'SA ETC MAY BE RAISED IF NOT NATURALLKY OCCURING., TAGGING AND CARRIER MECHANISMS ARE LARGELY DIVIDED BY SIZE OF ATTATCHED FAP'S ETC. THESE TECHNIQUES COMBINED WITH RESPONSE LIBRARIES OF ANTISERA, OTHER IMMUNE AGENTS INCLUDING TRANSFER FACTOR,ANTICIPATORY AND OTHER GUIDELINES MAY REVOLUTIONISE VACCINES AND OTHER MEDICAL THERAPIES.; SURVIVAL MECHANISMS

ACCORDING TO CLASSIFICATION PATENT, IDENTIFICATION OF

CAUSATIVE,SYNERGISTIC, INFECTIVE,NEUTRAL UNDER DEFINED CONDITIONS MAY INDICATE TARGETS FOR THERAPY.ORGANISMS THAT ASSIST DISEASE ORGANISMS UNDER CERTAIN CONDIOTIONS MAY NEED TO BE ADDRESSED OR NEUTRALISED IN THERAPY;ALTERNATIVELY,CONDITIONS MAY BE FOUND WHERE SYNERGY AND/OR OTHER ASSISTANCE DO NOT EXIST.SUCH

CONDITIONS SHOULD THEN BE DUPLICATED IF POSSIBLE IN THE PATIENT. WHEN TWO OR MOTE ORGANISMS ARE PLACED IN A SETTING WHERE THERE IS A DEFINED MARGIN OF BIAS AND WHERE THEY ARE MADE TO COMPETE FOR OPTIMAL SURVIVAL EITHER BY NATURE OR BY DESIGNED CONDITIONS SEVERAL SURVIVAL MECHANISMS MAY DEVELOP THESE MAY BE CATAGORISED AS;

1-OFFENSIVE

WHEN ORGANISMS PRODUCE F/A/P'S ETC. SPECIFICALLY TO

DESTROY/INHIBIT/INJURE/DAMAGE/NEUTRALISE OTHERS THEY ARE SAID BY AUTHOR TO BE EXERTING OFFENSIVE BEHAVIOUR. ALTHOUGH THE OFFENSIVE MECHANISMS MAY BE PHYSICAL(EG HEAT GENERATION) /CHEMICAL(EG

ALTERING PH OR OXYGEN CONCENTRATION) BIOLOGICAL OR ANY

2-DEFENSIVE

3-ELUSIVE/EVOLUTIONARY

THIS MECHANISM IS USUALLY MADE MORE POSSIBLE UNDER OPEN, IN-VIVO

CONDITIONS.BACTERIA MAY SURVIVE BY ELUDING THE PENICILLIN IN

AREAS OF THE BRAIN ,FOR EXAMPLE, WHERE THE BLOOD-BRAIN BARRIER

MAY LIMIT THE ABILITY OF PENICILLIUM OR ITS PRODUCTS) TO REACH

THE BACTERIA.

THE PENICILLIN-SENSITIVE BACTERIA MAY ACQUIRE GENETIC

INFORMATION, PERHAPS IN THE FORM OF PLASMID AND/OR PHAGE WHICH

WOULD CODE FOR SOME MECHANISM OF PENICILLIN RESISTANCE.

RADIOCELL TO NORMAL DYNAMIC FLOW

APPLICATION.

EXAMPLES OF DYNAMIC FLOW STUDIES CAN BEST BE DEMONSTRATED BY IN- VITRO AND IN-VIVO APPLICATION IN THE TREATMENT OF CANCER.

DYNAMIC FLOW STUDIES (DFS)CAN BE MADE IN LIMITED OR NARROW

SPECTRUM IN ISOLATED OR IN OPEN SYSTEM.DFS CAN ALSO BE MADE IN BANDS OF VARYING WIDTH UP TO 'UNLIMITED' OR BROAD-SPECTRUM

RADIOCELL TO NORMAL

RBC WBC

INTERFERANCE APHRODISIAC

DYNAMIC FLOW

THE TERM DYNAMIC FLOW REFERS TO STUDIES OF INTERACTIONS AND THEIR CONSEQUENSES WITH STAGES DEFINED AS THEIR F/A/P'S ETC .RELATE ON SEQUENTIAL FLOW AND TEMPORAL RELATIONSHIPS . DYNAMIC FLOW STUDIES ALSO ENABLE CO-TEMPORAL INVESTIGATION AND THERAPEUTIC

APPLICATION.

EXAMPLES OF DYNAMIC FLOW STUDIES CAN BEST BE DEMONSTRATED BY IN-VITRO AND IN-VIVO APPLICATION IN THE TREATMENT OF CANCER.

DYNAMIC FLOW STUDIES (DFS)CAN BE MADE IN LIMITED OR NARROW

IN HOST/INVITRO/IN-VIVO

SURVIVAL MECHANISMS

RADIOCELL TO NORMAL

RBC WBC

INTERFERANCE APHRODISIAC

ITSELF LEED TO SEQUALAE OF AIDS AND/OR OTHER UNDESIREABLE

CHANGES . A DEFINITIVE MULTI-PRONGED PROTOCOL SHOULD BE EMPLOYED AT THIS STAGE; IE, THIS PATENT SUPPORTS TYEMPORARY BLOCKADING OF CD4 RECEPTORS ONLY IF OTHER THERAPY IS SIMULTANEOUSLY INITIATED AGAINST AIDS . THIS ADJUNCTIVE TREATMENT MAY VARY FROM HYPERTHERMIA TO THE APPLICATION OF OTHER NATURAL OR STRUCTURED RECEPTORS FOR HIV TO 'SWEEP' THE BLOOD FOR VIRAL FRAGMENTS. ALTERNATIVELY THERAPY COULD BE INITIATED TO ALTER CD4 RECEPTOR STRUCTURE SO THAT IT NO LONGER EASILY BINDS HIV. SUCH THERAPY COULD BE AS BASIC AS HYPERTHERMIA OR AS COMLICATED AS GENETICALLY OR OTHERWISE MODIFY RECEPTORS TO BE SIMILAR TO THOSE OF RESISTANT ANIMALS AND/OR HUMANS. INVENTOR HAS DEMONSTRATED THAT SEVERAL BIOLOGICAL ORGANISMS MAY COMPETE FOR RECEPTOR SITES AND DISPLACE HIV. HYPERTHERMIA HAS ALSO BEEN SHOWN BY THE INVENTOR TO BE

CD4 'DECOYS' ALONE OR ATTATCHED TO SOME DEFINITIVE THETRAPY HAVE ALSO FUNCTIONED WELL. CD4 RECEPTORS ARE COVERED BY THIS PATENT AS PERFECT 'MAGIC BULLETS' OR HOMING MECHANISMS FOR BINDING TO AND/OR SELECTIVELY DELIVERING THERAPY TO HIV. PATENT COVERS THE USE OF CD4 RECEPTORS AS CARRIERS OR DIRECT DELIVERY MECHANISMS OF THERAPY .WHETHER STANDARD SUCH AS AZT OR NEW. SPECIFICITY OF DELIVERY WOULD ENSURE INCREASED CONCENTRATION AT SITE OF ACTION AS WELL AS DECREASED SIDE-EFFECTS . DESPITE HIV ' S NOTORIOUS

RADIOCELL TO NORMAL

RBC

WBC

INTERFERANCE

APHRODISIAC IN-VIVO TRIALS CAN INCLUDE MODELS SUCH AS NUDE MICE,SKID RATS AND OTHER IMMUNOLOGICALLY CHALLENGED AS WELL AS OTHER SYSTEMS.

VARIOUS PARAMETERS MAY BE DEFINED TO INDICATE POSITIONING OF SITUATION.AN EXAMPLE WOULD BE CHANGES IN A BACTERIUM AS IT

ACQUIRES PENICILLIN RESISTANCE STAGING DURING SUCH ACQUISITION COULD BE DEFINED BY DEGREE OF RESISTANCE AND/OR IMMUNOLOGICAL CHANGES DURING THAT TIME AND/OR METABOLIC CHANGES AS GROWTH RESUMES AND/OR LEVELS OF PENICILLINASE-DESTROYED PENICILLIN. THE LATTER FACTOR AND THOSE RELATED CAN NOT ONLY INDICATE STAGING BUT ALSO POSSIBILITY FOR DONATION OF RESISTANCE FROM AN OUTSIDE SOURCE OF RESISTANT ORGANISMS. IT MAY BE NECESSARY TO INTERPRET SEVERAL OF THESE FACTORS AND SYSTEMS(BOTH OPEN AND CLOSED)

DYNAMIC FLOW AND CO-TEMPORAL MODELS ALSO CAN ESTIMATE/INDICATE AND GIVE REFERANCE VALUES UNDER CERTAIN CONDITIONS FOR SUCH IMPORTANT PARAMETERS AS THERAPEAUTIC TEMPORAL INDEX VALUES MAY BE GENERAL LIBRARY DATA FOR SPECIFIC SITUATIONS AND/OR PATIENT SPECIFIC

IT IS POSSIBLE TO OUTLINE AND PREDICT DISEASE PATTERN FOR SPECIFIC PATIENT AS MANY DISEASES AS WELL AS NORMAL CELLS MAY BE ACCELERATED IN-VITRO OR IN CERTAIN ANIMAL MODELS. IT IS POSSIBLE THEREFORE TO DESIGN A PROTOCOL OF THERAPY AND TEST ITS EFFECTS ONSEVERAL GENERATIONS OF DISEASE AND NORMAL CELLS TO GAUGE EFFICACY, SPECIFICITY,TOXICITY AND TO OPTIMALLY DOSE-TITRATE.AGAIN STRESSING THAT FEATURES OF THIS PATENT ARE TO PROVIDE TIME AND BIOLOGICAL/OTHER MARKERS TO BEST INDICATE OPTIMAL DOSEAGE AND

PROVIDE INFORMATION FOR TEMPORAL DYNAMIC-FLOW

THERAPY . (TDT )

TDT THERAPY INVOLVES 3 SUBDIVISIONS;

1-PROPHYLACTIC/PREVENTATIVE

2-ANTICIPATORY

3-RESPONSIVE

EACH STAGE MAY BE ACTIVATED AT ANY TIME DURING CLINICAL MANAGEMENT IE. IN TDT THERE WILL CONSTANTLY BE FAP'S ETC. WHOSE PRESENCE OR INTERACTION MAY BB PREVENTED,ANTICIPATED AND/OR

RESPONDED TO . TDT THERAPY-PROPHYLACTIC/PREVENTATIVE

POSSIBLE APPLICATIONS ARE VERY BROAD,HOWEVER WE SHALL VARY

TEMPORAL DYNAMIC FLOW STUDIES (TDFS) MAY ALSO INDICATE RELATIVE TOLERANCE TO THERAPY OF HOST AND DISEASE SUGGESTING PULSES OF ALTERED DOSEAGE; MAXIMISING IT WHEN HOST TOLERANCE IS HIGH FOR EXAMPLE.

KNOWLEDGE OF THE TDFS OF ACQUISITION OF RESISTANCE MAY INDICATE MULTI-OR COMBINATION THERAPY.TDFS IS USED TO INDICATE HOW THE TARGET WILL RESPOND OVER TIME IN THE HOST ENVIRONMENT IN WHICH IT RESIDES AS WELL AS HOST RESPONSES OVER THE TIME PERIOD . THIS DIFFERS DRASTICALLY FROM CURRENT SCIENCE WHICH SIMPLY PLATES BACTERIA AND CHECKS FOR THEIR ANTIBIOTIC SENSITIVITY OVER A PERIOD OF DAYS AS THERAPY COMMENCES.TDFS WILL YEILD PERTINENT DATA OF THERAPY, HOST AS WELL AS DISEASE AND SUGGEST OPTIMAL THERAPIES,DOSEAGES AND TIMING.

FAVOURABLE RESULTS WOULD USUALLY FOLLOW WHERE THE IMMUNE SYSTEM IS RELATIVELY INTACT; IN ADVANCED IMMUNODEFICIENCY HOWEVER, INITIAL; RESPONSE WILL USUALLY BE SHORTLIVED.THIS WOULD BE

ANTICIPATORY

IF A PENICILLIN-SENSITIVE ORGANISM IS SHOWN AND/OR KNOWN BY TDFS TO BE LIKELY TO ACQUIRE PENICILLIN RESISTANCE BY PENICILLINASE MECHANISM ACQUIRED BY PLASMID DONATION FROM PENICILLIN RESISTANT, RELATED BACTERIA FOR EXAMPLE

ORGANISMS WHICH MAY BE USED TO RAISE ANTICIPATORY IMMUNE RESPONSE IN PATIENT OR USE ONE FROM LIBRARY. ANTICIPATORY VACCINATION, PARTICULARLY WHERE THE CHANGE BEING VACCINED AGAINST IS SPECIFIC AND IN LOW TO NO CONCENTRATION AT TIME OF VACCINATION IS LIKELY TO BE MUCH MORE EFFECTIVE THAN VACCINES PREPARED FROM ANTIGENS ALREADY SATURATING THE BODY BECAUSE OF THE IMMUNE SUPPRESSION CAUSED BY ANTIGENS RISING ABOVE A CERTAIN THRESHHOLD.

ANT I C I PATORY THERAPY HAS THIS ADVANTAGE THAT ONE CAN

USING CANCER AS AN EXAMPLE; VACCINES PREPARED AGAINST CANCER CELLS

USUALLY FAIL BECAUSE OF SEVERAL REASONS INCLUDING;

1-LACK OF IDENTIFIED , CANCER-SPECIFIC, IMMUNOSTIMULATING ANTIGENS .

2-CANCER MASS USUALLY GREATER THAN THAT REQUIRED FOR THRESHHOLD

INHIBITION OF IMMUNE SYSTEM.

3-LACK OF RELATIONSHIP BETWEEN VACCINE AND THE DISEASE

EMBODYMENT.

1-LACK OF IDENTIFIED EFFICIENT ANTIGENS.

THERE HAVE BEEN ATTEMPTS TO MODIFY CANCER CELL STRUCTURE TO ATTATCH ANTIGENIC MARKERS AND/OR IMMUNE STIMULATORS ,AND/OR TO PROCESS THE DISEASE IN A MANNER WHICH LEADS TO THE EXPRESSION OF HIDDEN OR SUPPRESSED COMPOUNDS OF ANTIGENIC AND/OR

IMMUNOSTIMULANT EFFECTS.

SECRETE/PRODUCE IMMUNE ATTRACTING/STIMULATING/MODULATING AGENTS IS DONE WITH THE HOPE THAT FACTORS COMMON TO THE CANCER AND ITS ENGINEERED COUNTERPART WILL CAUSE A VACCINE GENERATED REACTION TO INVOLVE THE DISEASE AS WELL.

THE USE OF SPECIFIC F/A/P'S ETC PARTICULARLY WHERE THESE ARE NOT IN ABUNDANT EXPRESSION BY THE DISEASE ENABLES THE FORMATION OF A VACCINE STRUCTURED OF MATTER WHICH IS NOT CAUSING THRESHOLD SUPPRESSION OF THE IMMUNE RESPONSE. WHERE SPECIFIC F/A/P'S ETC ARE HEAVILY EXPRESSED BY DISEASE THEN THE VACCINE IS LIKELY TO BE STRONGER AS A PREVENTATIVE THAN AS A THERAPY ONCE THE DISEASE IS ALREADY PRESENT.

ANTICIPATORY VACCINES MAY PROVIDE THE BEST OF BOTH WORLDS. DEFINED CONDITIONS WILL CAUSE CHANGES IN DISEASE. THESE CONDITIONS INCLUDE TEMPERATURE CHANGES, CHEMOTHERAPY, RADIOTHERAPY, FORCED COHABITATION ETC CHANGES MAY INCLUDE THE EXPRESSION OF, UNMASKING OF, GENERATION OF NEW AND/OR ALTERATION OF INITIAL F/A/P ' S ETC. TO POSSIBLY YEILD A DIFFERENT ANTIGENIC SIGNATURE AND/OR OTHER PROPERTIES . VACCINES PREPARED FROM INITIAL TISSUE BIOPSY OF CANCER OR THERAPY TAILORED AGAINST BACTERIA FROM INITIAL CULTURE MAY NO LONGER BE RELEVANT .HOWEVER , IF COTEMPORAL OR PRETEMPORAL MODELS (THOSE WHICH CAN PROCESS THE TARGET ORGANISM AND ALLOW IT TO EXPRESS ITS CHANGES PRIOR TEMPORALLY TO CHANGES OCCURRING IN PATIENT)COULD BE USED AND/OR IF THE CHANGES RESULTING CAN BE ANTICIPATED AND THERAPY OR VACCINES PREPARED AGAINST ANTICIPATED CHANGES THEN EFFECTIVE ANTICIPATORY THERAPY MAY BE USED TO GOOD EFFECT.

EXAMPLES OF APPLICATION IN VACCINE MANUFACTURE, CHEMOTHERAPY AND ANTIBIOTIC THERAPY- INCLUDING MULTIPHASIC THERAPY WILL FOLLOW IN LATE R SECTION OF PATENT.

TO CONCLUDE CLARIFICATION OF ANTICIPATORY BENEFITS AS OUTLINED;

2- CANCER MASS - IMMUNE THRESHOLD INHIBITION.

UNDER THE GUIDELINES OF THIS PATENT;

1- MATERIAL FROM WHICH VACCINE WILL BE GENERATED WILL BE

2- DISEASE IS EXPOSED TO SAME OR ANALOGOUS CONDITIONS USED IN VACCINE PREPARATION. IF THE BODY IS VACCINED AGAINST SPECIFIC F/A/P ' S ETC . RAISED BY INCUBATING TUMOUR CELLS WITH NEWCASTLE VIRUS ; THE TUMOUR CELLS IN THE PATIENT SHOULD BE EXPOSED TO THE VIRUS AS WELL ONCE VACCINE STIMULATION IS AT SIGNIFICANT TITRE, AND/OR EXOGENOUS IMMUNE SYSTEMS ARE READY.

APPEARANCE AN CHARACTERISTICS, AND/OR;

2-DISEASE IS EXPOSED TO SAME OR ANALOGOUS CONDITIONS USED IN

VACCINE PREPARATION. IF THE BODY IS VACCINED AGAINST SPECIFIC F/A/P ' S ETC. RAISED BY INCUBATING TUMOUR CELLS WITH NEWCASTLE VIRUS;THE TUMOUR CELLS IN THE PATIENT SHOULD BE EXPOSED TO THE VIRUS AS WELL ONCE VACCINE STIMULATION IS AT SIGNIFICANT TITRE , AND /OR EXOGENOUS IMMUNE SYSTEMS ARE READY.

RESPONSIVE

IN DEALING WITH LIVING SYSTEMS THERE ARE ADVANTAGES OVER NONLIVING DRUGS . ONE SUCH ADVANTAGE IS THAT WHEN A TARGET DEVELOPS RESISTANCE TO A PARTICULAR THERAPY DERIVED FROM A LIVING BIOLOGICAL SOURCE, FORCED COHABITATION/MUTATION CULTURE AND OTHER TECHNIQUES MAY BE USED TO GENERATE A NEW RESPONSE FROM THE ORGANISM OF ORIGIN OF THERAPY;THIS NEW IMPROVED RESPONSE MAY

OVERCOME TARGET RESISTANCE-APPL ICA TION EXAMPLES

INCLUDE CHEMOTHERAPY, ANTIBIOTIC THERAPY AS WELL AS VACCINE THERAPY- CASES OF APPLICATION WILL FOLLOW.

SURVIVAL MECHANISMS

1-OFFENSIVE

EXAMPLES OF THESE SUBDIVISIONS NOW FOLLOW:

INHERENT-AS WITH INHERENT ABILITY OF PENICILLIUM FOR PENICILLIN PRODUCTION.

MUTATED-AS WITH ORDINARY SYMBIOTIC FLORA OF HOST MUTATING UNDER PHYSICAL, CHEMICAL OR BIOLOGIC AGENTS TO BE PATHOGENIC

'DONATED' TO THE BACTERIA TO ENABLE IT TO MANUFACTURE TOXIN.

INDIRECTLY.DIRECT ACTION IS AS SPECIFIED ABOVE; INDIRECT ACTION MAY INVOLVE OTHER FAP'S ETC. SUCH AS FOR EXAMPLE A HOST OR HOST SYSTEM ACTING AS A THIRD PARTY AND BEING INDUCED TO EXERT EFFECT AGAINST ONE ORGANISM BY THE OTHER.

IT APPEARS , FOR EXAMPLE , THAT CERTAIN INFECTIONS MAY LEAD TO CANCER REGRESSION IF NOT REMISSION IN DOCUMENTED CASES OF SPONTANEOUS REGRESSIONS AND REMISSIONS. IN THESE CASES, IT APPEARS THAT AT LEAST PART OF THE RESPONSE IS SECONDARY TO IMMUNOLOGICAL AND OTHER HOST INTERACTION.

DEFENSIVE

DEFENSIVE MECHANISMS MAY ALSO BE ALLOTED THE SAME SUBDIVISIONS OF-INHERENT/INDUCED/MUTATED/DONATED/DIRECT/INDIRECT, AS CAN ALL THREE DIVISIONS; AS WITH OFFENSIVE AND ELUSIVE .DEFENSIVE

INHERENT-AS IN CASES OF BACTERIA WITH INHERENT PENICILLIN

RESISTANCE. INDUCED-AS WITH ALL DIVISIONS, APPLICATION MAY BE MADE TO SIMPLE OR COMPLEX ORGANISMS . A SIMPLE EXAMPLE OF THIS CLASSIFICATION INVOLVES A COMPLEX ORGANISM WHERE IMMUNE CELLS MULTIPLY AND OFFER DEFENSE AGAINST AN INVADING ORGANISM, SUCH A RESPONSE BEING

DIRECT-ALL Or THE ABOVE AND MANY OTHER DEFENSIVE F/A/P'S ETC. MAY SE DIRECT.

INDIRECT- AN EXAMPLE OF INDIRECT DEFENSIVE MECHANISMS WOULD INVOLVE A THIRD OR MORE PARTY; A COMPLEX EXAMPLE OF THIS IS

SUGGESTED BY THE LOW INCIDENCE OF 2 OR MORE PRIMARY TUMOURS IN THE ONE HOST. STUDIES HAVE SHOWN THAT THE PRESENCE OF ONE CANCER MAY CAUSE CHANGES IN THE HOST TO DEFEND AGAINST ANOTHER CANCER INVADING ITS TERRITORY.

ELUSIVE.

INHERENT-MANY BACTERIA/VIRUSES/CANCERS ETC APPEAR TO HAVE AN INHERENT ABILITY TO HIDE/ELUDE/EVADE EFFECTIVE IMMUNOLOGICAL ATTACK AT LEAST FOR A TIME PERIOD.

INDUCED-EXPERIMENTAL MODELS HAVE DEMONSTRATED THAT SOME VIRUSES AS WELL AS OTHER ORGANISMS ARE CAPABLE OF CANNIBALISING CELLS AND EXPRESSING THEIR ANTIGENS ON THEIR SURFACE . FORCED COHABITATION AND/OR IN THE PROGRESS OF AN ILLNESS SUCH A MECHANISM MAY ALLOW THE ORGANISM TO EVADE IMMUNOLOGICAL RESPONSE AS IT MAY BE RECOGNISED AS 'SAME' BY HOST BY VIRTUE OF CANNIBALISED ANTIGENS.

MUTATION-MAY LEAD TO ONGOING ELUSIVENESS AS IS THOUGHT TO BE THE MECHANISM WITH THE HIV VIRUSE'S ABILITY.

DIRECT-ALL ABOVE AND OTHERS MAY BE INCLUDED HERE

INDIRECT-CANCER CELLS MAY CAUSE INEFFICIENT IMMUNE RESPONSE YO PRODUCE BLOCKING/PROTECTING ANTIBODY WHICH MAY SHIELD/HIDE IT

SOME APPLICATIONS OF CURRENT PATENT

1-ANTIBIOTIC

2-CHEMOTHERAPEUTIC

3-IMMUNOLOGICAL

RELEVANT SUBCLASSIFICATIONS WILL

INCLUDE;

MODIFICATION

DE-NOVO GENERATION

PHASE THERAPY

INHIBITING THE GENERATION OF RESISTANCE

DEALING WITH RESISTANCE ONCE GENERATED

MULTIMODAL THERAPY.

ANTIBIOTIC

WITH THE UNDERSTANDING THAT PATENT MAY BE APPLIED TO ANY OF A NUMBER OF F/A/P'S ETC. WE WILL RESTRICT THIS DISCUSSION TO THE USE OF PENICILLIN IN THE TREATMENT OF STAPHYLOCOCCAL INFECTIONS.

A TEMPORAL AND CONDITION MATCHED INDEX MAY BE DELINEATED FOR

ORGANISMS AND CATALOGUED AS RESISTANCE POTENTIAL. RESISTANCE POTENTIAL WILL INDICATE HOW LIKELY AN ORGANISM/CELL

ETC. IS TO DEVELOP RESISTANCE TO

PARTICULAR THERAPY UNDER DEFINED CONDITIONS AND OVER WHAT TIME PERIOD.

UNDER THIS CLASSIFICATION WE WILL DISCUSS IT IS ALSO POSSIBLE TO DEFINE ABSOLUTE RESISTANCE POTENTIAL (ARP)AS WELL AS RESTRICTED RESISTANCE POTENTIAL JUST AS IT IS POSSIBLE TO DEFINE ABSOLUTE THERAPEUTIC POTENTIAL (ATP) AND

INDEXING SUCH POTENTIALS WILL ENABLE REALISTIC, ENHANCED

MECHANISMS OF ANTICIPATION .THERAPY AS WELL AS THE ABILITY TO

OBSERVE BIOLOGICAL AND OTHER SHIFTS . INDEXED

POTENT IALS OFFER A NEW METHOD OF EVALUATION AND PLANNING,-

AN EXAMPLE OF USE OF SUCH DATA WOULD BE THE DEFINITION OF PARAMETERS AND DOCUMENTATION OF RELATED FEATURES AGAINST A TEMPORAL AXIS. IF A TUMOUR IS KNOWN TO RESPOND IN A CERTASIN MANNER WHEN EXPRESSING CERTAIN CHARACTERISTICS AND IF TEMPORAL RESPONSE TO THERAPY AND/OR OTHER MARKER CAN BE USED TO CHART THE CELL STAGE THEN AN INDICATOR MAY BE OBTAINED AS TO THE STAGE THE CELL IS IN ASA RELATED TO ITS LIFECYCLE, GROWTH RATE , RESISTANCE TO THERAPY AND ANTICIPATED RESPONSE/RESISTANCE TO OTHER THERAPY.; HENCE MORE ACCURATE INDICATIONS CAN BE EVALUATED AS TO

CELLULAR STAGING , DIAGNOSIS , PROGNOSIS , ONSET OF

DISEASE, OPTIMAL THERAPY ETC MANY OF THESE INDICATORS WOULD BE FURTHER REFINED BY POTENTIAL DATA RELATING TO THE HOST/HOST SYSTEMS AS WELL AS POTENTIAL DATA RELATING TO OTHER INTERACTING

F/A/P'S ETC. WHICH MAY INFLUENCE THE SITUATION INCLUDING THERAPY AND OTHER F/A/P'S ETC. WHICH MAY BENEFIT HOST AND/OR DISEASE.

CELLULAR STAGING is A PRIMITIVE ART IN ITS CURRENT

STATE WHERE ESTIMATION OF 'AGGRESSIVENESS' OF DISEASE IS MADE BY NUMBER OF MITOTIC FIGURES INDICATING CELL DIVISION ACTIVITY: IT IS LARGELY DISEASE STAGING THAT DETERMINES THERAPY AND PROGNOSIS TODAY. DISEASE STAGING IS CURRENTLY LARGELY DETERMINED BY LOCATION AND EXTENT OF SPREAD OF DISEASE . CELLULAR STAGING IS ALONE AND/OR IN COMBINATION, A MUCH MORE RELEVANT AND USEFUL PARAMETER. CANCER CELL ACTIVITY IS A MAJOR FACTOR IN STAGING . KNOWING THE DEGREE OF ACTIVITY/AGGRESSION AS EVALUATED BY CELL

CHARACTERISTICS IN DEFINED PARAMETERS AS INDEX RELATED TO DISEASE STAGING/DATA ON CELL ACTIVITY AND CHARACTERISTICS DURING THE COURSE OF DISEASE . FOR EXAMPLE; ADENOCARCINOMA OF THE BOWEL MAY GROW AT A CERTAIN RATE AND DEGREE OF INVASIVENESS, THESE WILL VARY THROUGHOUT THE COURSE OF THE DISEASE, CERTAIN FEATURES OF DIFFERENTIATION MAY ALTER, CANCER CELL MARKERS SUCH AS CEA AND CAI25 MAY BE LOST AS THE CELLS BECOME MORE UNDIFFERENTIATED CELL AND BIOPSY APPEARANCE MAY EVEN CHANGE(REPORTED FREQUENTLY WHEN LYMPHOMA RECURRS/BECOMES MORE AGGRESSIVE , AS A NEW

CLASSIFICATION/TYPE OF LYMPHOMA).EVEN IN THE ABSENCE OF SUCH OVERTLY VISIBLE CHANGES; CHARACTERISTICS OF HOST AND DISEASE ALTER THROUGHOUT THE COURSE OF THE DISEASE. SUCH CHANGES MAY BE

DEPENDANT ON OR INDEPENDANT OF THERAPY. CELLULAR VSTAGING MAY BE ALONG NEW BASIC PARAMETERS SUCH GROWTH RATE IN VITRO/PERCENTAGE OF CELLS SURVIVING IN VITRO PLATING AND/OR SIMILAR PARAMETERS RELATING TO IN-VIVO TRANSPLANTATION . A CRUDE SUMMARY WOULD

DETERMINE THAT THE MORE CELLS SURVIVING AND THE GREATER THE GROWTH RATE IN CONDITIONS WITH GREATER MARGINS OF BIAS AGAINST THE TARGET CELL/ORGANISM,THE MORE RESISTANT, STURDY AND POSSIBLY MORE AGGRESSIVE/UNDIFFERENTIATED THEY ARE. CELLULAR AND ORGANISM STAGING AS SUGGESTED BY THIS PATENT ALSO OCCURS AT A MORE INTRICATE LEVEL.DATA BASE RELATING TO ACTIVITY/GROWTH/FUNCTION OF CELL /ORGANISM ETC UNDER INVESTIGATION UNDER CONDITIONS OF VARIOUS MARGINS OF BIAS, MEASURING SUCH VARIABLES AS GROWTH RATE, MUTATION RATE, RESISTANCE/SENSITIVITY TO VARIOUS F/A/P'S ETC INCLUDING THERAPY.ENABLES THE CHARTING OF CELL/ORGANISM ON

COMPOSITION(ABSOLUTE/RATIO)/METABOLISM ETCTHIS DATA CAN THEN BE USED TO INDICATE STRENGTHS/WEAKNESSES,THERAPY LIKELY TO IMPACT FAVOURABLY AND HOW LONG IT WILL BE BEFORE RESISTANCE DEVELOPS ETC. INDICATYION OF HOST STATUS ALONG SIMILAR PARAMETERS CAN ALSO BE OBTAINED.

IN THE CASE OF AIDS, FOR EXAMPLE, IT HAS TO DATE BEEN VERY

DIFFICULT TO EVALUATE STAGING AND PROGNOSIS.TOTAL T CELL COUNTS AND OTHER PARAMETERS HAVE BEEN INDICATORS BUT BY NO MEANS HAS THERE BEEN AN EFFECTIVE WAY TO PREDICT WHEN A DROP WAS LIKELY TO OCCUR NOR ACCURATELY PROGNOSTICATE .CONTROVERSY HAS ALSO EXISTED AS TO OPTIMAL TIMING OF THERAPY. KNOWLEDGE OF DATA PERTAINING TO SUCH ISSUES AS IMMUNOLOGICAL RESPONSE TO VARIOUS STIMULI SUCH AS BACTERIAL/VIRAL/PARASITE/.FUNGAL/CANCER/OTHER CHALLENGE AND GRAPHING THESE PROPERTIES AS THEY CHANGE IN TIME WITH EVOLUTION OF DISEASE WILL ENABLE ACCURATE STAGING OF DISEASE . DATABANKS REPRESENTING DIFFERENT TIMES OF .APPLICATION OF THERAPY AND

RESPONSES MAY ALSO OPTIMISE TREATMENT.

SIMPLE IN-VITRO CULTURES TO DETERMINE CELL SURVIVAL PERCENTAGE AND TIME UNDER CONDITIONS OF VARIOUS MARGINS OF BIAS INCLUDING PH CHANGES ETC AS WELL AS ABILITY TO RESPOND AND EXTENT OF RESPONSE TO IMMUNOSTIMULATING AGENTS SUCH AS (BY WAY OF EXAMPLE, BUT NOT LIMITED TO) INTERFERON, INTERLEUKIN, LEVAMISOLE ETC CAN ALL LEAD TO VALUABLE KNOWLEDGE.

BUILDING THE DATABASE.

ALTHOUGH THE MEDICASL MODEL, PARTICULARLY WITH REFERANCE TO AIDS, CANCER AND INFECTIONS , WILL BE USED, THE PATENT IS NOT RESTRICTED TO THESE DISORDERS NOR IS IT RESTRICTED TO THE MEDICAL MODEL. IN

CONJUNCTION WITH THE CLAS S I FI CAT I ON PATENT . BY SAME

INVENTOR,BROADER APPLICATION CAN BE EASILY ENVISIONED BOTH WITHIN AN WITHOUT THE MEDICAL HODEL (EVEN WHERE CAUSE OF DISEASE IS UNKNOWN, FOR

EXAMPLE , SYNERGISTIC , INFECTIVE , NEUTRAL , ANTAGONISTIC, NEMESIS

F/A/P'S ETC MAY BE KNOWN AND DATA OBTAINED FOR ANY/ALL OF THESE WOULD BE OF CLINICAL SIGNIFICANCE).

STRUCTURING OF DATABASE

1-TARGET DATA

2- INTERACTION DATA

3-HOST DATA

1-TARGET DATA.

TARGET HERE IS DEFINED AS ORGANISM/CELL/OTHER SUBJECT OF

INVESTIGATION.

TARGET DATA IS THAT UNIQUELY PERTAINING TO THE TARGET IN VARIOUS IN-VITRO/IN-VIVO SITUATIONS WITH VARIED MARGINS OF BIAS UNDER BOTH SET CONDITIONS AND THOSE WITH VARYING MARGINS OF BIAS(BOTH POSITIVE AND NEGATIVE BIAS ARE USED IN THESE SITUATIONS, SEPARATELY AND/OR, ALTERNATELY AND/OR IN VARIOUS

MANY OF THE PARAMETERS TO BE DISCUSSED CAN BE MEASURED IN TERMS OF TIME/TARGET CYCLES AND/OR GENERATIONS . DATA CAN THEREFORE BE PRESENTED WITH REFERANCE TO DEFINED CONDITIONS/PARAMETERS AND TARGET RESPONSE PER UNITS OF TIME/CYCLE AND/OR GENERATIONS. OPTIMAL GENERATION

OF MAXIMUM EMBODYMENTS.

A-NEED

T HE IMPORTANCE OF STRUCTURING DATA TO INCLUDE THIS PARAMETER MAY BE ILLUSTRATED IN MANY WAYS. ONE CURRENT SITUATION WHICH MAY BENEFIT CONSIDERABLY IS THE GENERATION OF A VACCINE FOR AIDS. EMMUNISING AGAINST HIV. IS VEXED BY THE PROBLEM OF VIRAL MUTATION. AT APPEARS THAT THE VIRUS MUTATES IN A FASHION AND AT A RATE THAT TENDERS MANY VACCINES INEFFECTIVE BY ALTERATION OF ANTIGENIC STRUCTURE AGAINST WHICH THE VACCINE WAS RAISED; IN OTHER WORDS, BY ALTERING ITS APPEARANCE , IT ESCAPES VACCINE EFFECTS GENERATED AGAINST ITS 'OLD SKIN'. SIMILARLY, MUTATION ALLOWS OTHER SYSTEMS TO ESCAPE THERAPY BY KNOWING A LARGE AMOUNT OF POSSIBLE MUTATION, COULD THERAPY NOT BE BETTER STRUCTURED?

FURTHERMORE;VACCINES RAISED AGAINST MANY; IF NOT ALL MUTATIONS OF VIRUS WOULD STAND A GREATER CHANCE OF SUCCESS THAN THOSE RAISED AGAINST ONE PRESENTATION AND WOULD SEEM TO BE EASIER TO PREPARE THAN SEARCHING FOR COMMON DENOMINATORS IN THE HIT AND MISS TECHNIQUES CURRENTLY EMPLOYED. (COMMKON FACTOR DOES EXIST, SEE PREVIOUS DISCUSSION RELATING TO CD4 RECEPTORS)

OBTAINING AN ADEQUATE POOL OF MULTIPLE EMBODYMENTS OF TARGET MAY BE DONE BY COLLECTING AND POOLING MULTIPLE SAMPLES FROM PATIENTS

(THESE MAY BE SUBDIVIDED BY OTHER FACTORS SUCH AS TREATMENT, TYPE AND LENGTH OF,T CELLS AT START ; UNTREATED ETC BUT THIS MAY NOT BE NECESSARY AS ULTIMATE GOAL IS THE COLLECTION OF AS LARGE A POOL OF VARIATIONS AS POSSIBLE . DIVISION OF POOL ACCORDING TO DEFINED COLLECTION CRITERIA SUCH AS TREATED/UNTREATED AND/OR OTHER CLINICAL/LABORATORY PARAMETERS MAY BE USEFUL IN DEFINING WHICH GROUP APPLIES BEST IN A GIVEN PATIENT/SITUATION BOTH

CURRENT AND ANTICIPATORY.)

ABSOLUTE POTENTIAL MAY BE EVALUATED IN SEVERAL WAYS;LET US

CONSIDER SOME OF THESE;

1-ENRICHED MEDIUM,

IN THIS SITUATION, THE TARGET IS PLACED IN SITUATION OF OPTIMAL GROWTH REQUIREMENT AND ALLOWED TO EXPRESS AS MANY EMBODYMENTS AS POSSIBLE OVER A PERIOD OF TIME. SOME ORGANISMS WILL MUTATE/DISPLAY SOME OF THEIR OTHER FORMS, OTHERS WILL BE CONTENT TO REMAIN

UNCHANGED AS THEY ARE UNCHALLENGED.

2-RESTRICTED MEDIUM

TARGET IS PLACED IN MINIMAL MEDIUM, AND/OR OTHER SITUATION WHERE SURVIVAL AND GROWTH ARE BARELY SUPPORTED . RESPONSE TO THIS

SITUATIOJN HAS VARIED FROM ORGANISMS WHICH MUTATE TO A MORE HARDY/AGGRESSIVE FORM TO OTHERS THAT REMAIN THE SAME, GROWING WITHIN THE CONFINES PERMITTED ANDF EVENTUALLY DYING OFF. IT MAY BE POSSIBLE TO INDUCE GENERATION OF DIFFERENT EMBODYMENTS OF TARGET BY CYCLING BETWEEN ENRICHED AND MINIMAL MEDIA.

3-INDUCTION/FASCILITATION OF CHANGE.

CONDITIONS MAY BE CREATED IN BOTH ENRICHED AND MINIMAL MEDIA AND ANY VARIETY OF BIASED MEDIA , COMBINATIONS/PERMUTATIONS , PULSING OF MEDIA AND CONDITIONS OVER VARIED DEFINED TIME PERIODS IN ORDER TO GENERATE MULTIPLE CHANGES.

SOME F/A/P'S ETC CAPABLE OF INDUCING CHANGE /MUTATION INCLUDE ; PHYSICAL/CHEMICAL AND BIOLOGICAL F/A/P'S ETC. CAPABLE OF CAUSING A CHANGE IN THE STRUCTURE/PRESENTATION/METABOLISM/FUNCTION AND/OR OTHER F/A/P/ 'S ETC. IN THE TARGET MAY DO SO DIRECTLY AND/OR INDIRECTLY .

PHYSICAL-RADIATION- GAMMA, UV . ETC,TEMPERATURE

CHEMICAL-OZONE/PEROXIDE/OTHER CHEMICALS CAUSING STRESS INCLUDING PH ETC BIOLOGICAL-ANTIBIOTICS , PLASMIDS .

1-TEMPORAL STUDIES

2-ENRICHED MEDIUM/GROWTH CONDITIONS

3-RESTRICTED MEDIUM/GROWTH CONDITIONS

4-MUTATION FACTORS

5-ORDINARY MEDIUM/ANIMAL

6-CURRENT GROWTH MEDIUM

simple culture profi le AND EVAL EFFICACY

THEMSELVES ; VARIOUS CHEMICAL AGENTS INCLUDING THOSE THAT CAN CAUSE DRAMATIC PH CHANGES CAN ALSO DO THIS AS CAN BIOLOGICAL AGENTS SUCH AS DIGESTIVE ENZYMES.MANY CHANGES INDUCED OR BROUGHT ABOUT BY F/A/P'S ETC. IN THIS CATEGORY REQUIRE THE CONTINUED PRESENCE OF THE F/A/P'S ETC.

CHANGES WHICH LAST EVEN AFTER CAUSE IS REMOVED OFTEN NEED TO INVOLVE THE ALTERATION OF SOME INTERNAL F/A/P'S ETC. IN THE TARGET BY THE CAUSE.THIS WOULD INVOLVE PHYSICAL/CHEMICAL/BIOLOGICAL F/A/P'S ETC. CAPABLE OF DIRECTLY EFFECTING AND/OR DAMAGING TARGET STRUCTURE . RADIATION(U .V. , X-RAY , OTHER ) CAPABLE OF DAMAGING NUCLEAR STRUCTURE MAY LEAD TO LASTING CHANGES IN TARGET AND ITS EFFECT MAY FOLLOW THROUGH SEVERAL GENERATIONS. CHEMICALS SUCH AS

BACTERIA,FOR EXAMPLE , MAY BE GIVEN GENETIC INFORMATION TO EXPRESS IN THE FORM OF PLASMIDS, PHAGES ETC.

PCB F/A/P'S ETC MAY BE COMBINED IN ANY COMBINATIONS OR

PERMUTATIONS FOR DESIRED EFFECT.

PLASHIDS CODING FOR ANTIBIOTIC RESISTANCE MAY EE INSERTED INTO TARGET BACTERIAL GENOME, THEN THE ANTIBIOTIC MAY BE INTRODUCED INTO THE ORGANISM' S ENVIRONMENT TO CAUSE EXPRESSION OF INSERTED INFORMATION(OTHER PROPERTIES OF TARGET ORGANISM EXPRESSING THAT GENETIC INFORMATION MAY BE EVIDENT INCLUDING ANTIGENIC PROPERTY CHANGES.)

ALL SUCH F/A/P'S ETC. MAY BE MADE TO ACT ON TARGET IN

AMPLE,ENRICHED/MINIMAL/RESTRICTED GROWTH ENVIRONMENT AND IN THOSE

OF VARIABLE BIAS; SINGLY AND OR IN VARIOUS COMBINATIONS OR

PERMUTATIONS.

MEDIA MAY BE CONSTANTLY STABILISED WITHIN DEFINED PARAMETERS OR ALLOWED TO DEPLETE ITSELF TO VARIOUS STAGES ± PCB F/A/P'S ETC TO CAUSE CHANGE(S)IN TARGET. DIRECT ACTION-THIS MAY BE BY DIRECT CAUSE -EXAMPLES OF THIS MAY BE PHYSICAL AGENTS SUCH AS HEAT . SOUND WAVES AND/OR OTHER

THEMSELVES; VARIOUS CHEMICAL AGENTS INCLUDING THOSE THAT CAN CAUSE DRAMATIC PH CHANGES CAN ALSO DO THIS AS CAN BIOLOGICAL AGENTS SUCH AS DIGESTIVE ENZYMES . MANY CHANGES INDUCED OR BROUGHT ABOUT BY F/A/P'S ETC IN THIS CATEGORY REQUIRE THE CONTINUED PRESENCE OF THE F/A/P'S ETC

CHANGES WHICH LAST EVEN AFTER CAUSE IS REMOVED OFTEN NEED TO INVOLVE THE ALTERATION OF SOME INTERNAL F/A/P'S ETC. IN THE TARGET BY THE CAUSE. THIS WOULD INVOLVE PHYSICAL/CHEMICAL/BIOLOGICAL F/A/P'S ETC CAPABLE OF DIRECTLY EFFECTING AND/OR DAMAGING TARGET STRUCTURE. RADIATION(U.V. , X-RAY , OTHER) CAPABLE OF DAMAGING NUCLEAR STRUCTURE MAY LEAD TO LASTING CHANGES IN TARGET AND ITS EFFECT MAY FOLLOW THROUGH SEVERAL GENERATIONS. CHEMICALS SUCH AS

BACTERIA, FOR EXAMPLE , MAY BE GIVEN GENETIC INFORMATION TO EXPRESS IN THE FORM OF PLASMIDS, PHAGES ETC

PCB F/A/P'S ETC MAY BE COMBINED IN ANY COMBINATIONS OR

PERMUTATIONS FOR DESIRED EFFECT.

PLASMIDS CODING FOR ANTIBIOTIC RESISTANCE MAY BE INSERTED INTO TARGET BACTERIAL GENOME, THEN THE ANTIBIOTIC MAY BE INTRODUCED INTO THE ORGANISM'S ENVIRONMENT TO CAUSE EXPRESSION OF INSERTED INFORMATION(OTHER PROPERTIES OF TARGET ORGANISM EXPRESSING THAT GENETIC INFORMATION MAY BE EVIDENT INCLUDING ANTIGENIC PROPERTY CHANGES. )

ALL SUCH F/A/P'S ETC. MAY BE MADE TO ACT ON TARGET IN

AMPLE, ENRICHED/MINIMAL/RESTRICTED GROWTH ENVIRONMENT AND IN THOSE

OF VARIABLE BIAS; SINGLY AND OR IN VARIOUS COMBINATIONS OR

PERMUTATIONS.

AMPLIFICATION OF DESIRED CHANGES MAY BE MADE BY ALLOWING SELECTED CHANGES TO GROW IN ENRICHED MEDIA, AND OR BY PCR OR OTHER METHOD TARGET DATA IN SUMMARY, THEREFORE AIMS TO IDENTIFY A LARGE AMOUNT OF POSSIBLE TARGET PRESENTATIONS BY PLACING IT IN A VARIETY OF CONDITIONS WHICH EITHER ALLOW IT TO PRESENT MULTIPLE EMBODYMENTS OR ACTUALLY CAUSE/INDUCE THE CHANGE. CHANGE/ALTERATION/MUTATION POTENTIAL MAY BE INDEXED AS ABSOLUTE IF UNRESTRICTED BY GROWTH CONDITIONS OR RESTRICTED IF WITHIN DEFINED GROWTH CONFINES USE OF MULTIPHASED ANTIBIOTIC THERAPY WITH BIOLOGICAL COMBINATION THERAPY.

DIRECT AND ANTICIPATORY.

DEFINITIONS

MULTIPHASIC ANTIBIOTIC THERAPY-

AS THE TARGET ORGANISM ACQUIRES RESISTANCE, THE PENICILLIUM WILL GENERATE COUNTERING MECHANISMS EITHER SPONTANEOUSLY OR UPON ASSISTANCE(VARIABLE BIAS/INDUCTION IN OPEN OR CLOSED SYSTEMS ETC )ANTIBIOTICS GENERATED AT THIS STAGE WILL DEMONSTRATE

EFFICACY AGAINST ORGANISMS RESISTANT TO THE PREVIOUS ANTIBIOTIC . THIS NEW FORM IS CALLED PHASE 2 ANTIBIOTIC

AGAINST PHASE 3 BUT PERHAPS LESS ACTIVE THAN PHASE 2.

STRUCTURE/CONFIGURATION/FUNCTION WHEN EXPOSED IN OPEN AND CLOSED SYSTEMS TO CERTAIN ANTIBIOTICS AND ANTIBIOTIC COMBINATIONS ETC TO PREDICT LIKELY RESISTANCE PATTERN;.THERAPY PROGRAM DESIGNED TO NEUTRALISE THAT COULD THEN BE INSTITUTED EG. ANTIBIOTICS) WHICH CAN EFFECTIVELY DEAL WITH THE ANTICIPATED RESISTANT GROUP OF ORGANISMS COULD BE INSTITUTED EARLY IN THERAPY.

A BASIC DEMONSTRATION INVOLVES E.COLI AND PENICILLIUM. STRAINS

WERE NOT IDENTIFIED FOR THIS TRIAL.

THE PENICILLIUM AND E.COLI WERE TESTED IN ANTIBIOTIC SENSITIVITY

ASSAY.

LESS THAN 10 PERCENT OF E.COLI COLONIES WERE RESISTANT TO THE

PHASE ONE PENICILLIN BEING GENERATED BY THE HOULD.

PENICILLIUM MOULD WAS PLACED INTO TRYPTICATED SOY BROTH AND

ALLOWED TO GROW FOR 3 WEEKS. AT THAT TIME TSB CONTAINED

SIGNIFICANT LEVELS OF PHASE ONE PENICILLIN, THIS WAS AGAIN TESTED

AND E.COLI CULTURES AGAIN DEMONSTRATED LESS THAN 10 PERCENT

RESISTANCE.

10 CC OF ECOLI ORGANISMS 10,000,000,000 ORGANISMS PER ML WERE

THEN INNOCULATED INTO THE BROTH.

WITHIN 3 DAYS THERE WAS CLOUDING OF THE MEDIUM, UPON

PLATING, E . COLI COLONIES WERE FOUND WITH 90% RESISTANCE TO PHASE

ONE PENICILLIN.

THIS CULTURE WAS THEN STORED

CULTURES WERE COLLECTED DAILY AND AT THE END OF THREE WEEKS , THE

BROTH CONTAINING THE MOULD HAD CLEARED. NO E.COLI REMAINED IN THE

MEDIUM.

TESTS ON THE TSB SHOWED INREASING ANTIBIOTIC EFFICACY WHICH

MAXIMISED AT ABOUT 2 WEEKS OF CC-INCUBATION.

PENICILLIUM HOULD REMOVED AT THAT TIME AND CULTURED ALONE

PRODUCED PHASE 2 PENICILLIN.

ATTEMPTS TO INCUBATE PHASE 2 E.COLI WITH PHASE 2 PENICILLIUM WERE

MET WITH SUCCESS 6 DAYS FOLLOWING INNOCULATION OF 10CC PHASE 2

E.COLI IN THE SAME MANNER AS WAS DONE IN PHASE 1 TRIALS.

AGAIN,REPEATING THE PROCESS GAVE RISE TO A PHASE 3 E COLI AND

PHASE 3 PENICILLIN.

THE TSB IN WHICH THE PENICILLIUM AND E.COLI WERE INCUBATED

DISPLAYED GRATER RESISTANCE TO E.COLI INFECTION THAN THE

PLAQUE FORMATION IN CULTURES CLOSE TO THE ANTIBIOTIC ZONE OF INHIBITION ON AGAR PLATE TESTING FOR ANTIBIOTIC SENSITIVITY WOULD SPREAD THROUGHOUT THE PLATE OVER A TWO DAY PERIOD, SUGGESTING THAT PHAGE LYSIS WAS ALSO PLAYING A ROLE.

WHEN CRUDE PENICILLIN(CP) WAS EXTRACTED FROM PURE CULTURES OF PHASE1, PHASE2 AND PHASE3 PENICILLIUM CULTURES ;(CP WAS EXTRACTED BY 0.2 MICRON FILTRATION OF PURE CULTURE MEDIUM-TSB AFTER 3 WEEKS OF INCUBATION.) AND TESTED AGAINST THE ORIGINAL E.COLI

CULTURE; THERE WERE NO E.COLI SURVIVORS. IT APPEARS THAT FOR THIS PARTICULAR BACTERIA, A COMBINATION OF 3 PHASES OF RESISTANT THERAPY WAS ENOUGH TO RAPIDLY OVERCOME THE BACTERIA PRIOR TO DEVELOPMENT OF RESISTANCE. OTHER BACTERIA MAY NEED THE PROCESS EXTENDED TO FURTHER PHASES HENCE THE TERM MULTIPHASED ANTIBIOTIC THERAPY.

CLASSIFICATION BY PHASE LEVEL CAN NOW BE DONE. CHARTS

PHASE LEVEL CLASS I FI CAT ION NEEDS TO BE RELATED

PHAGE /PLASMID INFLUENCE.

IT IS POSSIBLE FOR EXAMPLE, FOR PHASE 1 PENICILLIN TO EFFECTIVELY DESTROY BACTERIA OF 2ND, 3RD OR EVEN MORE ADVANCED PHASES , IF COMBINED WITH LYTIC PHAGES . OF 1ST AND/OR MORE ADVANCED PHAGES .

IN A LIVING SYSTEM, PHAGES MAY BE USED ALONE , HOWEVER, PHASE

MULTIPHASED PHAGE SYSTEM.

IN MUCH THE SAME WAY AS ANTIBIOTICS ENCOUNTER RESISTANCE. SO CAN

LYTIC PHAGES . LYTIC PHAGES ARE THOUGHT TO EXIST IN BACTERIAL CELLS

IN MUCH THE SAME WAY THAT LYSOSOMES EXIST IN NORMAL CELLS; WITH

THE CAPACITY TO CODE FOR THAT CELL'S DESTRUCTION.

WORK IN THE 1920'S UNTIL THE EARLY 1930'S ATTEMPTED TO MAKE USE

OF THESE PHAGES IN THE TREATMENT OF INFECTIONS WITH VARIOUS .OFTEN

POOR RESULTS.

THE PHAGES USED WERE OFTEN ISOLATED FROM FLIES, SEWERAGE WATER

ETC.

THIS PATENT DIFFERS IN THAT PHAGES USED MAY BE GENERATED FROM

OTHER SOURCES OR FROM WITHIN THE TARGET BACTERIA ITSELF.

CULTURE AND PURIFICATION FASCILITIES/TECHNIQUES TODAY MAKE FOR

PURER PRODUCT, .

PATENT ALSO COVERS MULTIPHASED PHAGE DEVELOPMENT

PATENT COVERS USE OF PHAGES IN COMBINATION WITH ANTIBIOTICS AND

/OR IMMUNE RESPONSES THEMSELVES IN EITHER NORMAL AND/OR PHASED

APPLICATION .

INTO LATTER PHASES AND RETURN , AMONGST OTHER THINGS, THEIR SENSITIVITY. PLASMIDS OF LATTER PHASES CAN ALSO BE IMMUNOLOGICALLY

TARGETED AS WI LL BE D I SCUSSED IN IMMUNOLOGI CAL PHASED THERAPY .

MRD IN BIOL ENHANCEMENT

INHIBITION OF PLASMIDS/ENZYMES ETC

CHANGES SUGGESTED BY OTHER MECHANISMS

INTERESTINGLY, WHEN THE CO-CULTURED MEDIUM WAS CHALLANGED-FASTER

THAN PURE PEN MORE IN 2 DAYS.

ALSO PHAGE/PLASMID RESISTANCE TRANSFER

ALSO ON LEUK/AIDS

PEN/PHAGE/ANTISERA TO R PLASMID/PHAGE/OTHER CHANGE

USE OF HYPERTHERMIA IN COMB INAT ION WI TH VACCINE THERAPY INDIVIDUALLY/AS PART OF PRECURSOR/ INTERMED IATE/ENDPRODUCT

THERAPY .

INTRODUCTION

TO OVERCOME THIS ONE OR ALL OF THREE MODIFICATIONS NEED TO TAKE PLACE

1 -MAKING THE VACCINE RESEMBLE THE

DI SEASE MORE CLOSELY .

2-MAKING THE DISEASE RESEMBLE THE

VACCINE MORE CLOSELY .

3 -MAKING THE HOST SYSTEM/ IMMUNE SYSTEM

RECOGNI SE VACCINE/DISEASE WI TH

IDENTICAL EFFECTIVE RESPONSES.

THI S POINT MAY BE DEALT WITH BY DIRECTING THE RESPONSE AGAINST PART OF THE DISEASE WHICH I S IN MINIMAL EXPRESSION AND/OR WHICH IS GRADUALLY MADE TO ATTATCH/EXPRESS AT A RATE WITH WHICH THE HOST SYSTEM MAY COPE.

1-MAKING THE VACCINE RESEMBLE THE

DISEASE MORE CLOSELY.

1-RAISING VIRUS IN TARGET AND/OR OTHER CELLS OF HOST TO BE

VACCINATED-THIS ENABLES SCREENING FOR AND REJECTION OF ANY

VARIANTS WHICH MAY BE GROSSLY PATHOLOGICAL TO THE RECIPIENT.

USE OF TEMPORAL EXTRAPOLATION PATENT CAN ALSO TEST

FOR SPECIFIC SYSTEMS/SITUATIONS/INTERACTIONS IN

NORMAL/REDUCED/ACCELERATED TIME FORMATS TO PREDICT FUTURE

EFFECTS. (CELL DIVISION MAY BE ACCELERATED IN VITRO/OTHER ANIMAL SYSTEMS TO STUDY FURTHER GENERATION IMPACT, SLOWED DOWN TO STUDY CELLULAR IMPACT; SIMILAR PROCEDURES WITH DISEASE PROCESS CAN ACCELERATE OR RETARD ITS GROWTH SO ITS INTERPLAY MAY BE STUDIED WITH OTHER FACTORS, CELLS , DISEASES ETC )

VARIABLES BUT IN-VITRO AND DEDICATYED ANIMAL TECHNOLOGY ALSO ENABLES THE VACCINE TO BEST RESEMBLE THE ACTUAL APPEARANCE OF INFECTION IN THIS PARTICULAR INDIVIDUAL AS WELL AS ALLOWING FOR THE RAISING OF IMMUNITY AGAINST INTERMEDIATE STAGES SUCH AS INFECTED CELLS AS WERLL AS PREPARING ENDPRODUCT IMMUNE RESPONSES TO ELIMINATE DISEASE.

2-MAKING THE DISEASE RESEMBLE THE

VACCINE MORE CLOSELY.

THIS IS THE MAIN POINT TO BE DEMONSTRATED AND EXPLOITED BY THIS

PATENT.

MAKING THE DISEASE RESEMBLE THE VACCINE MORE CLOSELY AT A GRADUAL

PACE CAN BE AVCCOMPLISHED IN SEVERAL WAYS, ONE WILL BE OUTLINED

BELOW;

THE CONCEPT IS TO TREAT THE DISEASE IN THE SAME MANNER USERD TO

GENERATE THE VACCINE AND THEN TO ALLOW AN IMMUNE SYSTEM HONED BY

PRIOR ADMINISTRATION OF VACCINE TO ATTACK THE DISEASE.

VACCINES PREPARED BY HEAT INACTIVATION WILL BE USED TO

DEMONSTRATE THE APPLICATION OF THESE GUIDELINES BUT ARE NOT

STEP ONE

PREPARE VACCINE BY CULTURING ORGANISM/TARGET THEN HEAT

INACTIVATION.

STEP2

USE VACCINE PREPARATION TO RAISE IMMUNE RESPONSE .

STEP 3

USE HYPERTHERMIA TO EXPOSE/ALTER DISEASE STRUCTURE TO FORMAT

CONFORMING TO THAT OF THE VACCINE USED TO GENERATE IMMUNE

RESPONSE.

AS THE HEAT CAUSES STRUCTURES TO ALTER AND THE EXPOSURE OF

PREVIOUSLY COATED AND/OR OTHERWISE DISGUISED; THE IMMUNE SYSTEM

ALREADY STIMULATED AGAINST THEM BY THE VACCINE WOULD BE ACTIVATED

DEVASTATINGLY.

WHAT THEN FOLLOWS IS THAT BY USING THIS NEW PATENT FIELD OF

ANTICIPATORY IMMUNOLOGY THE BODY WILL BE

3-THIS TECHNIQUE ALSO ENABLES EFFECTIVE ADJUNCTIVE IMMUNOTHERAPY WHICH AIMS TO ATTACK CELLS ALTERED AND POSSIBLY NOT DESTROYED BY THE THERAPY AS WELL AS RESISTANT CELLS WHICH SURVIVED THE THERAPY PROTOCOL IN THE MANUFACTURE OF THE VACCINE. THE FOLLOWING CASE DEKONSTRATES APPLICATION.

PATIENT N.B. PRESENTED WITH PRIMARY HEPATOMA WHICH HAD PERFORATED

HIS DIAPHRAGM AND ENCIRCLED HIS RIGHT LUNG. CANCER ADVANCED

DESPITE CHEMOTHERAPY, RADIOTHERAPY AND IMMUNOTHERAPY.

THE VACCINE WAS MANUFACTURED FROM BIOPSY TISSUE WHICH HAD BEEN

FRAGMENTED PHYSICALLY AND BOILED FOR 15 MINUTES EVERY DAY FOR 3

DAYS.

HYPERTHERMIA USING RADIOFREQUENCY ' MAGNETRODE ' EQUIPMENT WAS APPLIED FOR 3 SESSIONS OF 20 MINUTES EACH. ON CONSECUTIVE DAYS.

WHAT FOLLOWED WAS AS PREDICTED BY THEORY.

IN EACH OF THE HYPERTHERMIA SESSIONS THE BODY WAS HEATED TO 102 DEGREES .

THE FOLLOWING DAY AND FOR 1 WEEK SUBSEQUENTLY PATIENT

SPONTANEOUSLY DEVELOPED A CONTINUEOS FEVER RANGING FROM 100-104 DEGREES. PAIN RAPIDLY SUBSIDED.THERE WAS A MEASUREABLE

LYMPHOCYTOSIS AND LEUKOCUTOSIS BUT NO INFECTIVE FOCUS WAS FOUND AND REPEATED BLOOD CULTURES WERE NEGATIVE. IT WAS AS PREDICTED THAT HYPERTHERMIA EXPOSED STRUCTURES ON THE DISEASE MASS TO WHICH THE BODY HAD BEEN PREVIOUSLY IMMUNISED AND MASSIVE IMMUNE REJECTION THEN RESULTED.

INDUCED REMISSION THERAPY WAS PREVIOUSLY DISCUSSED UNDER

INDUCED REMISSION THERAPY PATENT BY SAME INVENTOR. TO BRIEFLY RECAP AND ILLUSTRATE THE APPLICATION OF SUCH PATENT UNDER THESE GUIDELINES; IT APPEARS THAT THERE ARE

BIOLOGICAL ORGANISMS-VIRUSES , BACTERIA, FUNGI , YEASTS ETC. WHICH CAN BE CLASSIFIED AS EITHER SYNERGISTIC OR ANTAGONISTIC TO THE DISEASE PROCESS.

WHEN VACCINATING AGAINST THE SYNERGISTIC ORGANISMS, INVENTOR HAS USED PHYSICAL ( SUCH AS SONICATION) , CHEMICAL (CHLORINE/PHENOL/OTHER) AND BIOLOGICAL MEANS (SUCH AS ENZYMATIC DEGRADATION) TO PREPARE VACCINES . LET US CONSIDER BY EXAMPLE ALTHOUGH IT SHOULD BE

CAUSATIVE AND SYNERGISTIC ORGANISMS WAY BE FOUND FROM PATIENT'S BLOOD, OTHER SECRETIONS AND DISEASE BIOPSY ONCE SAMPLE HAS BEEN PROPERLY PROCESSED OR CULTURED.

LET US CONSIDER THE DISEASE CANCER.

CANCER BIOPSIES CAN BE SHOWN TO DEMONSTRATE ORGANISMS OF VARIABLE MORPHOLOGY. (CANTWELL ET AL) IT IS INTERESTING THAT ORGANISMS HAVE LONG BEEN REPORTED IN ASSOSCIATION WITH CANCERS BUT HAVE BEEN IGNORED AS INFECTION AND/OR CONTAMINATION.YET SUCH ORGANISMS CAN BE DEMONSTRATED IN EVEN THE MOST STERILE OF BIOPSIES AND ARE NOT ASSOSACIATED WITH ANY LOCAL INFLAMMATORY PROCESS AS WOULD BE EXPECTED OF INFECTIONS.

SUCH ORGANISKS APPEAR INTEGRAL IN THE DISEASE PROCESS.AS

SIGNIFICANT NESTS EXIST WITHOUT ENTICING AN IMMUNE RESPONSE THEY ARE EITHER IMMUNOLOGICALLY INVISIBLE AND/OR PROTECTED BY SOME MECHANISK OF EITHER HOST, DISEASE AND/OR ORGANISK ITSELF.

WHEN THE SAMPLES ARE DISRUPTED BY PHYSICAL, CHEMICAL,BIOLOGICAL AND OR EVEN IMMUNOLOGICAL PATHWAYS SUCH AS BY SPECIFIC OR POOLED ANIMAL/HUMAN/OTHER SERUM, STAPHYLOCOCCAL -LIKE CULTURES MAY

FOLLOW.ACTUALLY, A VARIETY OF ORGANISMS INCLUDING E.COLI AND ACTINOMYCETES MAY BE CULTURED DEPENDING ON THE MEDIUM AND CONDITIONS USED AS WELL AS TIME.

DISCUSSED.

ORGANISM.CULTURE IS GROWN FOR 2-3 DAYS THEN BOILED FOR 15 MINUTES ON 3 CONSECUTIVE DAYS. PREPARATRION IS THEN REPLATED ON BLOOD AGAR AND REINNOCULATED IN TSB TO ENSURE NO GROWTH.

ANIMALS VACCINATED WITH THE HEAT-KILLED VERSION OF THE ORGANISMS WILL GENERATE BOTH LOCAL AND SYSTEMIC REACTIONS WHICH ARE DOSE- DEPENDANT. IN TESTING LIVING ORGANISM INNOCULATIONS INTO IDENTICAL ANIMALS.IT IS FOUND THAT THEY RARELY CAUSE AN ACUTE RESPONSE AT LOW DOSEAGE. SIMILAR LOW DOSEAGE OF THE HEAT-KILLED PREPARATIONS YEILDS

SIGNIFICANT LOCAL REDNESS AS WELL AS SYSTEMIC SIDE-EFFECTS SUCH AS HIGH TEMPERATURES . OBVIOUSLY, THEREFORE THE VACCINE DIFFERS IN IMMUNOLOGIC PROPERTIES TO THE ORGANISM.THE PROTECTIVE FACTORS AND/OR AGENTS APPEAR TO BE REMOVED AND/OR NEUTRALISED BY HEAT , STRONGLY IMMUNOGENIC FACTORS APPEAR TO BE GENERATED/EXPOSED BY HEAT . AS THESE ORGANISMS APPEAR RELATED TO THE CANCER

PROCESS ; WHETHER BELIEVED TO BE CAUSATIVE , SYNERGISTIC OR INFECTIVE OR NEUTRAL , THEY OBVIOUSLY DISPLAY AFFINITY FOR THE DISEASE

PROCESS AS THEY CAN CONSTANTLY BE CULTURED FROM PATIENTS AND ROUTINELY ARE RECOVERED FROM DISEASE BIOPSIES . AN IMMUNE RESPONSE AGAINST THESE ORGANISMS VILL THEREFORE IMPACT FAVOURABLY AGAINST DISEASE.

SEVERAL CASES HAVE DEMONSTRATED TEMPORARY BENEFICIAL TUMOUR SHRINKAGE FOLLOWING ADMINISTRATION OF HEAT-KILLED VACCINES . AGENTS USED TO GENERATE SYSTEMIC HEAT WHICH WOULD PREVIOUSLY ONLY LAST FOR LIMITED DURATION( PHYSICAL/CHEMICAL/BIOLOGICAL)WILL OFTEN GIVE RISE TO LONG LASTING AND GREATER TEMPERATURE RISES ONCE THE VACCINES HAVE GENERATED SIGNIFICANT IMMUNE RESPONSE;AT THAT POINT HYPEDRTHERMIA.EVEN FROM A HIGH DOSE VACCINE OR FROM

MICROWAVE/RADIFREQUENCY APPLIANCE EXPOSES IMMUNOGENIC KATERIAL OF THE TARGET AT A TIME THAT THE BODY CAN EFFECTIVELY DEAL WITH IT.

HYPERTHERMIA ALONE IS KNOWN TO SOMETIMES CAUSE EXCELLENT

RESPONSES , OTHER THAN HEAT ' S DESTRUCTIVE ABILITY, THIS EXPLANATION ALSO GIVES ANOTHER MECHANISM OF ALTERATION OF IMMUNOLOGICAL PRESENTATION OF TARGET ; UNFORTUNATELY, USE OF HYPERTHERMIA WITH VACCINE THERAPY IS VERY LIMITED.

HYPERTHERKIA IS USUALLY USED ALONE AND/OR IN COMBINATION WITH RADIOTHERAPY AND/OR CHEKOTHERAPY.UNDER THESE CIRCUMSTANCES IT IS VERY LIKELY THAT THE IMMUNE SYSTEM WILL BE FLOODED WITH ANTIGENIC MATERIAL AND MAY SUCCUMB TO THRESHOLD INHIBITION (AT WORST IF HYPERTHERMIA IS USED ALONE). IT IS THEORETICALLY MORE DAMAGING IMMUNOLOGICALLY IF THE HYPERTHERMIA IS USED SIMULTANEOUSLY WITH CHEMOTHERAPY AND/OR RADIOTHERAPY THEN ALTHOUGH SUCH SYSTEMS MAY SYNERGISE IN THEIR TUMOUR-DESTRUCTIVE ABILITY THE IMMUNE SYSTEK WILL ALSO BE WEAKENED BY THE COMBINATION THERAPY AND OVERWHELMED BY THE NEW ANTIGENIC INFORMATION . IT APPEARS PREFERABLE , THEREFORE

TO PRECEDE SUCH PROCEDURES WITH 2 WEEKS OF ANT I C I PATORY

IMMUNOTHERAPY WHERE THE BODY IS STIMULATED AGAINST

DISEASE PRESENTATION AFTER IT HAS BEEN TREATED OUTSIDE THE BODY BY SUGGESTED PROTOCOLS TO BE INSTITUTED 2 WEEKS LATER . THE 2 WEEK LAG PERIOD IS SELECTED TO ALLOW THE BODY TO GENERATE SIGNIFICANT SERUM IMMUNITY TO THE CHANGES ABOUT TO OCCUR. SOME DEMONSTRATIVE CASES NOW FOLLOW; MULTIPHASED PHAGE THERAPY

BROTH WAS THEN DIVIDED INTO 100 CC BOTTLES

IMMUNOSTIMULATION PARTICULARLY IN ANTICIPATORY

IMMUNOTHERAPY.

BOTTLE 1

PHASE ONE CRUDE PHAGE PREPARATION WAS ADDED AT DOSE OF 1CC PFU'S

WERE ABOUT 10 TO TH 5TH POWER.

CLEARING OF CLOUDINESS OCCURRED IN 48 HOURS

CULTURE NEGATIVE.

ANTIBIOTICS ARE ESSENTIALLY NON-LIVING PRODUCTS AND HENCE WILL NOT SIGNIFICANTLY ALTER IN BEHAVIOUR. PHAGES, ON THE OTHER HAND ARE LIVING AND MAY DO SO .TO DEKONSTRATE THIS .BOTTLES THAT WERE TREATED WITH MULTIPHASED ANTIBIOTIC THERAPY THAT HAD REMAINED CLEAR IN PREVIOUS SECTION AND NOT CULTURED ANY ORGANISMS SUBSEQUENT TO TREATMENT WERE RECHALLANGED . BY 10CC OF ORIGINAL STAPHYLOCOCCAL CULTURE.

TREATED CULTURES RESISTED AT LEAST 3 SUCH CHALLENGES.

BOTTLE-2

PURIFIED PHAGE PREPARATION-PHASE 1 ADDED ICC

CLEARING OF BROTH WITHIN 24 HOURS.

SURVIVED 3 RECHALLANGES BUT THEN APPEARED TO LOSE ACTIVITY.

BOTTLE THREE

CRUDE PHAGE PREPARATION PHASE 1 AND 2 ADDED 0.5CC OF EACH

CLEARING OF BROTH WITHIN 24 HOURS . CULTURE NEGATIVE

SURVIVED 4 RECHALLANGES BUT THEN APPEARED TO LOSE ACTIVITY

WITH NEW GROWTH

BOTTLE 4

PURIFIED PHAGE PREPARATION PHASES 1 AND 2 0.5CC OF EACH

CLEARING OF BOTTLE WITHIN 24 HOURS

SURVIVED 6 RECHALLANGES THEN REGROWTH. BOTTLE 5-

CRUDE PHAGE PREPARATION PHASE 1,2 AND 3

CLEARING OF BOTTLE WITHIN 24 HOURS CULTURE NEGATIVE

SURVIVED OVER 6 RECHALLANGES.

BOTTLE 6-

PURIFIED PHAGE PREPARATION PHASES 1 , 2 AND 3

CLEARING OF BOTTLE WITHIN 24 HOURS CULTURE NEGATIVE.

SURVIVED OVER 6 RECHALLANGES.

IT SHOULD BE NOTED THAT THE EFFECTS SHOWN ON SUCCESSFUL

RECHALLANGE MAY NOT BE SIKPLY DUE TO DECREASE IN THERAPEUTIC

DOSEAGE.

THE PHENOKENON OF ADAPTATION AND CO-SYNERGY MAY BE BEST

DEMONSTRATED BY PLEURIPOTENT PHAGES.

IT IS LIKELY THAT PHAGES DEVELOP SYNERGY WITH THEIR BACTERIAL

HOST.

IF SUCCESSFUL RECHALLANGE IS DUE TO WEAKENING DOSEAGE OF PHAGE

MIX THEN IT SHOULD ONLY BE A KATTER OF REESTABLISHING THE

DOSE, HOWEVER, PHAGE WHICH PREVIOUSLY CAUSED CLEARING OF BROTH

WOULD ONLY CAUSE PARTIAL IF ANY CLEARING AS PREDICTED FROK

REPEATED PASSAGE WORK IN ESTABLISHING PHAGE PHASE.

THIS WOULD HAPPEN WITH ORIGINAL BACTERIAL CULTURE AS WELL AS WITH

LATTER PHASE CULTURES INDICATING THAT THE ADAPTATION IS NOT ONLY

BACTERIAL BUT ALSO OF PHAGE.

PHASED IMMUNE THERAPY.

DIRECT/INDIRECT .

DIRECT

DIRECT IMMUNOTHERAPY INVOLVES THE RAISING OF AN IMMUNE RESPONSE

IN-VITRO OR IN-VIVO BY USE OF HUMAN AND/OR OTHER SYSTEM. DIRECT

RELATES TO RAISING OF A SYSTEM CELLULAR, HUMORAL, OR OTHER AGAINST

TARGET ORGANISMS.

ALLOWING THE TWO SYSTEMS TO INTERACT IN AN OPEN OR CLOSED SYSTEM

AND/OR INDUCING MULTIPLE MUTATIONS/PRESENTATIONS OF TARGET

ORGANISM(S) (AS DISCUSSED PREVIOUSLY) .

AS RESISTANT/ELUSIVE STRAINS EMERGE, NEW IMMUNE RESPONSES ARE RAISED TO COPE WITH THE CHANGES OF TARGET HENCE PHASED IMMUNE REPONSE IS ALSO POSSIBLE.

THE PHASED IMMUNE RESPONSE IN THIS DEMONSTRATION WILL BE SERUK RESPONSE AS INDUCED AND PURIFIED FROM HORSES.

PREPARATION OF HORSE SERUM

FOR PURPOSE OF THIS DEMONSTRATION, A HORSE WAS INJECTED WITH BACTERIAL PELLETS OF 3 × 10 TO THE 8TH POWER

INTRADERMALLY. INJECTION OF BACTERIAL FRAGMENTS AFTER BREAKDOWN BY OTHER MODALITY AND/OR IMMUNISATION CAN HELP GENERATE ANTICIPATORY IMMUNE RESPONSES WHICH CAN HELP COPE WITH ELIKINATION OF DISEASE BREAKDOWN PRODUCT.

INDIRECT

IT IS ALSO POSSIBLE TO USE ANTISERUM TO TARGET RESISTANCE- SPECIFIC FACTORS SUCH AS PLASKIDS CARRYING GENETIC MESSAGE FOR PENICILLIN RESISTANCE.

INJECTION ARE ALL VARIABLE FACTORS)

PURIFICATION OF SERUM FOR THE IN-VITRO TESTING WAS SIMPLY BY

CENTRIFUGATION TO SEPARATE CELLULAR FROM HUMORAL CONTENT.

IT SHOULD BE NOTED HERE THAT PURIFICATION MAY NOT BE A VERY

CRUCIAL FACTOR AS DOSEAGE TO PREVENT RESISTANT PHASE MAY NOT BE

VERY HIGH AS SAID PHASE IS NOT ALREADY IN EXISTANCE.

IN-VITRO TEST

BROTH WAS DIVIDED INTO 100 CC BOTTLES.

ϊd£ FOLLOWING EXPERIMENTS WERE THEN DONE AND REPEATED; BOTTLE ONE;

PROCAINE PENICILLIN 500,000 U WAS ADDED TO STAPHYLOCOCCUS

CULTURE .

SOME CLEARING OCCURRED WITH REGROWTH WITHIN 6 DAYS.

CULTURE THEN YEILDED PENICILLIN-RESISTANT STAPHYLOCOCCUC AUREUS.

THE BROTH WITH REGROWTH WAS INNOCULATED INTO A HORSE(50CCS WERE

SPUN DOWN AND BACTERIAL PELLET WAS IHPLANTED INTRACUTANEOUSLY

INTO A HORSE, 5 CCS OF SAME BROTH WAS INJECTED INTRADERMALLY

EVERY 3 DAYS FOR 3 WEEKS

50CC OF HORSE BLOOD WAS THEN COLLECTED , SPUN DOWN YEILDING SERUM.

AS THE HORSE WAS VACCINATED WITH BACTERIA AS WELL AS THE BROTH IN

WHICH RESISTANCE OCCURRED , IT IS LIKELY THAT THE HORSE WAS ALSO

INNOCULATED AGAINST PLASMIDS AND ENZYMES SUCH AS

PENICILLINASE(SUBSEQUENT TESTS IN WHICH BACTERIA WERE SONICALLY

LYSED PRIOR TO IMMUNISATION APPEARED TO INCREASE EFFICACY OF THIS

STEP.

BOTTLE2

ANTI-PHASE 2 BACTERIA ANTISERUM WAS ADDED 1CC DOSE TO 500,000

UNITS OF PENICILLIN.

BOTTLE CLEARED AND REMAINED CLEAR. UP TO I WEEK LATER , CUTURE

NEGATIVE.

BOTTLE THREE- ANTI-PHASE 2 ANTISERUM WAS ADDED 1CC DOSE.-NO

RESPONSE CULTURE-STAPH AUREUS -PENICILLIN SENSITIVE.

IT THEREFORE APPEARS THAT AT THIS DOSEAGE,THE MAJOR EFFECT OF ANIMAL SERUM IS TO- PREVENT THE RISE OF RESISTANCE.

ANIMAL SERUM ADDED TO PHAGES IN THE TREATMENT OF BACTERIAL CULTURES INHIBITED RISE OF RESISTANCE BOTH AS PHASE ONE (IN WHICHCASE PHASE ONE PHAGE AND PHASE ONE ANTISERUM HAVE ADDITIVE MULTIMODAL EFFECT) AND AS ANTISERUM TO PHAGE RESISTANT PHASE.

IT IS ALSO INTERESTING TO NOTE THAT INITIAL WORK INDICATES THAT EVEN WHEN PHAGE LOSES LYTIC ABILITY OVER PARTICULAR BACTERIA IT MAY STILL RETAIN AFFINITY TO IT IN WHICH CASE RAISING AN IMMUNE RESPONSE AGAINST THE PHAGE MAY SERVE AS A TAG AND ATTACK THERAPY. WHERE BACTERIA WERE ALLOWED TO BE TAGGED BY PHAGE THEN ANTISERUM OF ANIMAL IMMUNISED AGAINST PHAGE APPLIED , BACTERIAL LYSIS

FOLLOWED.

THERAPY AS PERTAINING TO CANCER.

DEVELOPMENT OF ANTICANCER ANTIBIOTICS/MULTIPHASIC CHEMOTHERAPY

INTRODUCTION

A LIMITING FEATURE OF CURRENT CHEMOTHERAPEUTIC THERAPY IS THE COMMON DEVELOPMENT OF RESISTANCE BY THE TARGET DISEASE. THE STANDARD RESPONSE AT THIS POINT IS TO EITHER INCREASE DOSEAGE AND/OR ADD TO OR TOTALLY ALTER THERAPEUTIC REGIMEN. IN MOST CASES OF CANCER IT IS LIKELY THAT CHEMOTHERAPEUTIC OPTIONS WILL BE EXHAUSTED PRIOR TO ELIMINATION OF DISEASE, THE CANCER WILL THEN PROGRESS TO DEATH OF PATIENT.

AS MANY CHEMOTHERAPEUTIC AGENTS ARISE FROM LIVING ORGANISMS. IT IS POSSIBLE TO ALLOW CO-INCUBATION METHODS AS PREVIOUSLY DISCUSSED TO YEILD NEW THERAPEUTIC PRODUCTS . IT IS ALSO LIKELY THAT SUCH MULTIPHASIC THERAPEUTICS KAY BE ACTIVE BOTH DIRECTLY AND INDIRECTLY AGAINST AGENTS DETERMINED BY CLASSIFICATION PATENT..

DEMONSTRATION OF CLASSIFICATION PATENT AS APPLIES TO MULTIPHASIC THERAPY.

INTRODUCTION

THE CLASSIFICATION PATENT STATES THAT FOR EVERY CONDITION

,ORGANISKS, FACTORS AND AGENTS CAN BE SUBDIVIDED INTO THOSE THAT PROMOTE, INHIBIT OR ARE NEUTRAL TO THE CONDITION.SOME MAY BE CAUSATIVE WHEREAS OTHERS ARE NEMESES OR CUREATIVE.

EPIDEMIOLOGY

THE SUGGESTION THAT INFECTIONS KAY BE ANTAGONISTIC TO DISEASES SUCH AS CANCER IS BORNE OF OBSERVATIONS THAT WHERE CERTAIN INFECTIONS DOKINATE ANN ATREA OR AN ERA,CANCER WAS SCARCE.CASES CAN BE MADE FOR TUBERCULOSIS ,MALARIA AND SYPHILLIS BEING SUCH AGENTS.IT IS ALSO TRUE THAT MANY OF THESE CONDITIONS WHICH

INHIBIT CANCER GROWTH IN ACUTE STATE MAY CAUSE OR PROKOTE IT IN CHRONIC STATE.

IT IS KNOWN , FOR EXAMPLE, THAT CHRONIC TUBERCULOUS FOCI MAY LEAD TO DEVELOPMENT OF LUNG CANCER,CHRONIC MALARIA TO LYKPHOMA AND

CHRONIC SYPHILLIS TO OTHER TYPES OF CANCER.

INTERESTINGLY AN OFTEN CITED INFECTION ASSOSCIATED WITH SPONTANEOUS REHISSION IS THAT OF ERYSIPELAS .THIS IS OFTEN CAUSED BY STAPHYLOCOCCAL OR STREPTOCOCCAL INFECTION. AS THESE INFECTIONS IN ACUTE FORM CAN ACT TO ELIMINATE DISEASE, IT IS PROBABLY MORE THAN COINCIDENCE THAT TUMOUR BIOPSIES APPEAR TO INDICATE AT TIMES SIMILAR INFECTIONS COEXISTING IN CHRONIC MANNER WITH THE . IN CHRONIC INFECTIONS, THERE IS USUALLY AN IMMUNE RESPONSE INCAPABLE OF ELIMINATING THE INFECTION. IN BACTERIAL AND OTHER INFECTIONS INTIMATELY ASSOSCIATED WITH CANCER THERE MAY BE ALMOST TOTAL ABSENCE OF VISIBLE IMMUNE RESPONSE-SEE PHOTOGRAPHS WITH

CAUSATIVE, SYNERGISTIC, NEUTRAL , INFECTIVE, ANTAGONISTIC AND NEMESIS ORGANISKS IS NOT RESTRICTED TO CANCER BUT VIRTUALLY TO ALL DISEASE AND OTHER CONDITIONS) SEE PHOTOS OF CANCER, AIDS, TISSUES ETC.

MANY OF THESE BACTERIA APPEAR STAPHYLOCOCCAL OR STREPTOCOCCAL IN ORIGIN.

ALTHOUGH CONVENTIONAL; MEDICAL THINKING DOES NOT CREDIT THESE ORGANISMS WITH ANYTHING MORE THAN NEUSANCE CONTAKINANT VALUE, IT WAS NOT ALWAYS THE CASE . AT THE TURN OF THE CENTURY, ORGANISKS ISOLATED FROM CANCER PATIENTS WERE THOUGHT DIRECTLY LINKED AND CAUSATIVE TO THE DISEASE PROCESS . THE WORK OF GLOVER, SCOTT, GREGORY AND LIVINGSTON LED TO THE IDENTIFICATION OF MANY ORGANISMS ASSOSCIATED WITH CANCER.LIVINGSTON AND OTHERS DESCRIBED AN

APPARENT PLEOMORPHIC ABILITY TO THESE ORGAN I SMS . VARIOUS VACCINES AND ANTIBIOTIC THERAPIES PROVED TO HAVE A VARIABLE DEGREE OF EFFICACY . IT IS NOT SURPRISING, THEREFORE, THAT MANY EFFECTIVE CHEMOTHERAPEUTIC REGIMENS ACTUALLY HAVE ANTIBACTERIAL ACTIVITY-IT IS POSSIBLE TO EVALUATE CHEMOTHERAPEUTIC EFFECTIVENESS BY TESTING IT AGAINST BACTERIAL AND OTHER ORGANISM CULTURES-BY SYSTEMS INTRODUCED BY INVENTOR.- KNOWING A LIBRARY OF ASSOSCIATED

ORGANISKS ALSO ENABLES PREDICTION OF SUSCEPTIBILITY AS WELL AS INCREASE ACCURACY OF DIAGNOSIS AND ESTIMATE DISEASE ACTIVITY. AS WELL AS DEVELOPING A RANGE OF NOVEL THERAPY.

IT IS ALSO KNOWN THAT ANTIBIOTIC THERAPY MAY CAUSE TEMPORARY IMPROVEMENT IN CANCER AND OTHER PATIENTS-MORE RECENTLY ALSO IN ARTHRITIS AND ULCERS,DISEASES UNTIL RECENTLY NOT THOUGHT RELATED TO BACTERIAL DISEASE. WHILE TEMPORARY IMPROVEMENT MAY BE DUE TO THE CLEARING OF A SUPERADDED INFECTION, IT IS HARD TO EXPLAIN THE OCCASSIONAL REMISSION OF CANCER FOLLOWING ANTIBIOTIC THERAPY BY THIS REASONING. IT IS HOWEVER ALSO LIKELY THAT THE INFECTION BEING TREATED WAS ITSELF THE CAUSE OF THE REMISSION.

IT IS ALSO CONVENTIONALLY RECOGNISED THAT MANY VIRUSES MAY BE IDENTIFIED IN CANCER CELLS . THESE HAVE BEEN NOTED AS OF DUBIOUS SIGNIFICANCE ALTHOUGH ANIMAL CANCERS MAY OFTEN-BE CAUSED IN A LABORATORY BY VIRUSES . BACTERIA, FUNGI I ETC WERE ALSO AT SOME TIME THOUGHT TO BE RELATED TO CANCER.MUCH WORK NOW SUGGESTS LINKS BETWEEN VIRUSES SUCH AS HEPATITIS, POLYOMA AND CANCER; FUNGII SUCH AS ASPERGILLUS FLAVUS, PARASITES SUCH AS SCHISTOCOMYCETES, ETC IT IS NOT THE OPBJECT OF THIS PATENT TO CLAIM CAUSATIVE FUNCTION OF MICROORGANISMS IN DISEASES OF UNKNOWN AETIOLOGY; BUT TO

MULTIPLE PHOTOS OF DR.CANTWELL DEMONSTRATING ORGANISMS SHOULD

INSERTED HERE.

IT SHOULD BE NOTED THAT THERE IS MUCH EVIDENCE LINKING THESE

ORGANISMS TO CANCER AND OTHER DISEASES; THEY ARE FREQUENTLY

ISOLATED FROM BIOPSIES , BLOOD , OTHER SPECIMENS ; THEY CAN BE

IDENTIFIED IN DISEASE FRAGMENTS; INJECTED INTO ANIMAL MODELS THEY

CAN CAUSE DISEASE AND THEN BE ISOLATED AGAIN FROM INDUCED

DISEASE. (LIVINGSTON AND ALEXANDER 1950-1970)

MORE RECENTLY, THE INVENTOR HAS FOUND THAT A WIDE RANGE OF

ORGANISMS RANGING FROM STREPTOCOCCAL-LIKE, STAPHYLOCOCCAL-LIKE

ORGANISMS,YEASTS, FUNGI I ETC. CAN BE ISOLATED FROM TUMOUR SAMPLES

AND FROM BLOOD AND OTHER PATIENT SAMPLES WHEN INJECTED INTO A

TUMOUR- BEARING ANIMAL, WILL SELECTIVELY LODGE IN TUMOUR

MASSES . THIS MAY BE SECONDARY TO MANY MECHANISMS BUT APPEARS TO

INDICATE AT LEAST AFFINITY FOR THE ORGANISMS AND CANCER.

THE INVENTOR HAS ALSO DEMONSTRATED THAT ANTISERA RAISED AGAINST

ORGANISMS ISOLATED FROM VARIOUS CANCERS WILL EXERT ACTIVITY

AGAINST THE CANCER CELLS THEKSELVES . THIS CAN BE DEMONSTRATED BOTH

WITH ORGANISMS ISOLATED FROM THE CANCER CELLS AND/OR FROM

ORGANISM LIBRARY OF SIMILAR/RELATED CANCERS EVEN AS BROAD A KATCH

AS CARCINOMAS AND SARCOMAS.

SEVERAL ORGANISM AND ORGANISM TYPES HAVE BEEN DEFINED BY AUTHOR

AS RELATE TO CANCER AETIOLOGY, SYNERGY AND THERAPY.THE OBSERVATION

OF SEVERAL ORGANISMS HAS LED MANY TO BELIEVE THAT THE CANCER

ORGANISM IS PLEOMORPHIC; IT HAS BEEN USED BY MORE TO SUPPORT THE

CONTENTION THAT THESE ORGANISMS ARE CONTAMINANTS .ALTHOUGH ABOVE

EVIDENCE TENDS TO SUGGEST OTHERWISE ,THE INVENTOR WISHES TO

INDICATE THAT EVEN IF SUCH INFECTIONS ARE CONTAMINANTS THAT ALONE

MAY INDICATE AFFINITY OF ORGANISMS FOR TUMOUR MASSES.

MULTIPHASIC THERAPY CAN BE APPLIED IN TERMS OF

CHEMOTHERAPY, IMMUNOTHERAPY, RADIOTHERAPY AND INTERPLAY OF THESE

AND OTHER THERAPIES.

ISOLATION OF ORGANISMS

THE MULTIPHASIC APPROACH IN TISSUE ANALYSIS AND TREATMENT YEILDS INTERESTING RESULTS . CONDIDERATION OF CANCER AS A SYSTEMIC DISEASE AS OPPOSED TO CANCER AS A BALL OF DISEASED CELLS,OBSERVATIONS CAN YEILD AN INTERESTING THEORY.

IN-VITRO THERAPIES MAY BE CAPABLE OF 100% CANCER CELL KILL

WHETHER BY CHEMICALS,RADIATION, IMMUNOMOLOGICAL AGENTS AND YET WOULD BE UNABLE TO ACHIEVE IN-VIVO REMISSION;M0RE

IMPORTANTLY, EVEN AFTER SUCH IN-VITRO ' INACTIVATION ' INJECTION OF IN-VITRO'KILLED' PREPARATION OF CANCER TISSUE WHERE CELLS HAVE BEEN DISRUPTED SONICALLY,CHEMICALLY, IMMUNOLOGICALLY ,OTHER

PHYSICAL MANNER THEN FILTERED SO THAT NO LIVING CELLS PASS THROUGH THE FILTER, FILTRATE INJECTED INTO AN ANIMAL SYSTEM WOULD OFTEN RESULT IN ANIMAL DISEASE OR DEATH . THIS STRONGLY SUGGESTS THAT THE LIVING CANCER CELL IS NOT NECESSARY TO PREPETUATE/INITIATE DISEASE CONDITION.

IT IS CURRENTLY STANDARD PRACTICE TO CULTURE VIRAL VACCINES ON

CONTINUEOUS CELL LINES

CONTINUEOUS CELL LINES ARE IMMORTAL CELL LINES , ESSENTIALLY CANCER

CELLS.RESEARCH WORK BY INVENTOR INDICATES THAT DAMAGED/DEGRADED

CANCER CELL PREPARATIONS, EVEN WHEN FILTERED TO REMOVE LIVING

CELLS, STILL MAY CONTAIN FACTORS/AGENTS/ORGANISMS WHICH MAY

INITIATE /AGGRAVATE DISEASE CONDITION.

THIS POINT IS STRESSED TO STATE LINK AND RELEVANCE WITH NEW

VACCINE MANUFACTURE PATENT.

MULTI PHAS I C SYSTEM APPROACH WOULD THEN AIM TO

ATTEMPT TO DEFINE OTHER LIVING SYSTEMS THAT MAY BE ACTIVE IN THE

DISEASE PROCESS.

THE SEARCH FOR LIVING SYSTEMS WAS CONDUCTED ON THE FOLLOWING

BASIS;

1-EVIDENCE FOR LIVING SYSTEMS BEING PRESENT WITH PROXIMITY TO

DISEASE AND DISSEMINATED THROUGH DISEASED BODY ON BIOPSY.

2-ABILITY TO REPEATEDLY CULTURE ORGANISMS FROM

BLOOD, SERUM, URINE, BIOPSIES AND OTHER SAMPLES FROM HOSTS OF CANCER

AND/OR OTHER DISEASES.

3-WORK BY DR . LIEDA MATTMAN DEMONSTRATING PRESENCE OF CELL-WALL -

DEFICIENT ORGANISMS IN DISEASES SUCH AS CANCER , AIDS , ARTHRITIS

ETC.

4-WORK BY INVENTOR DEKONSTRATING THE ABILITY TO CULTURE ORGANISKS

FROK PATIENT SAKPLES

5-PREVIOUS WORK BY LIVINGSTON, ALEXANDER, SCOTT AKONGST MANY OTHERS

INDICATING THAT A VARIETY OF ORGANISKS ISOLATED FROM DISEASES

SUCH AS CANCER CAN GENERATE DISEASE OFTEN SIMILAR IF NOT

IDENTICAL TO THE ORIGINAL AND FROM WHICH ORGANISMS MAY OFTEN BE

RECOVERED.

6-WORK BY INVENTOR DEMONSTRATING THE ABILITY OF ORGANISMS TO

CAUSE/INDUCE/ASSIST/ACCELERATE/AGGRAVATE DISEASES SUCH AS CANCER

AND THAT IMMUNOLOGICAL AS WELL AS OTHER THERAPIES TARGETING THESE

ORGANISMS WOULD OFTEN REFLECT WITH IMPROVEMENT IN DISEASE

CONDITION.

FOR THE PURPOSE OF ILLUSTRATION WE WILL CENTRE ON THE DISEASE CANCER, ALTHOUGH THIS IS BY NO MEANS INTENDED TO RESTRICT PATENT OR APPLICATIONS AS THE CLASSIFICATION PATENT AND EMERGENT THERAPIES ASPPKLY TO ALL DISEASE AND OTHER CONDITIONS.

THE MULTIPHASIC APPROACH WOULD ALLOW FOR THE FOLLOWING LOGIC;

DISEASE A IS RESPONSIVE TO DISEASE THERAPY ANTI-A, AS THE DISEASE DEVELOPS RESISTANCE TO AND/OR RECURRS AFTER TREATKENT IT IS LIKELY TO HAVE CHANGED IN SOME FORK OR TO HAVE ACTIVATED INTRINSIC/EXTRINSIC METHODS FOR COPING WITH THERTAPY. EXTRINSIC METHODS KAY INCLUDE ACTIVATION OF SOKE DEFENSIVE RELATIONSHIP WITH CAUSATIVE AND/OR SYNERGISTIC ORGANISM.

THE MULTIPHASIC APPROACH AS APPLIED TO CANCER CAN BE SUMMARISED SIMPLY;AS MANY CHEMOTHERAPEUTIC AGENTS ORIGINATE FROM LIVING ORGANISMS, (THESE MAY BE CLASSIFIED AS ANTAGONISTIC OR NEMESES DEPENDING ON EFFICACY)AND AS CERTAIN ORGANISMS APPEAR CAPABLE OF CO-EXISTING WITH CANCER AND SOMEHOW EXERT AN EFFECT FAVPOURABLR TO THE DISEASE; THESE MAY BE CATAGORISED AS CAUSATIVE OR

SYNERGISTIVC, THESE MAY ALSO HAVE DEFINED ANTAGONISTS AND

NEMESES , IN FACT, THEY MAY ALSO BE USEFUL TO PROVIDE AND/OR TEST PHAGES/PLASMIDS/OTHER GENETIC MANIPULATION TO EFFECT CHANGE OF CLASSIFICATION STATUS.

CO-INCUBATION MAY BE USED TO DEVELOP THERAPY DE-NOVO.

THE OBJECT OF THIS PATENT IS TO DEMONSTRATE

1-GENERATION OF THERAPY

2-MINIMISATION OF SIDE-EFFECTS

3-CRUDE/PURIFIED USE

4-CO-TEMPORAL UPGRADING OFD THERAPY

5-USE AS MULTIPHASIC THERAPY

6-INTERACTION WITH OTHER MULTIPHASIC THERAPIES

9-LINK WITH MACHINE THERAPY.

IMMUNOLOGICAL INC ASCITES

OPP REGENERATUON

ORGAN ORGANISM

BUG

RE INFORCE NORMAL FUNCTION

PEN AND OTHER UDSED DIRECT/VS Asstd inf

BUG

REINFORCE NORMAL FUNCTION

PEN AND OTHER UDSED DIRECT/VS Asstd inf

INDUCED REMISSION THERAPY

INTRODUCTION

INDUCED REMISSION THERAPY COMBINES SEVERAL TREATMENT PROTOCOLS AS

INVENTED AND IMPLEMENTED BY DR. SAM CHACHOUA.

THIS THERAPY IS BASED ON OBSERVATIONS ON

1-SPONTANEOUS REMISSION

2-ORGAN RESISTANCE

3-ORGANISM RESISTANCE

WHEN SUCH DATA IS INCORPORATED WITH

1-CATEGORISATION PATENT

2-PRECURSOR/INTERMEDIATE/ENDPRODUCT THERAPY

3-MULTIPHASIC THERAPY

4-BIOLOGICAL ENHANCEMENT PATENT

5-EXTERNAL MACHINE/OTHER INTERVENTION

6-APPLICATION AND INDUCTION OF NEW WHITE AND RED BLOOD CELL

MECHANISMS.

INTERMEDIATE SUPPLEMENTS

SPONTANEOUS REMISSION OBSERVATIONS UNIQUE TO PATENT.

OBSERVATIONS OF SPONTANEOUS REMISSIONS FROM CANCER AND OTHER

DISEASES HAVE INDICATED THAT THESE HAVE OFTEN FOLLOWED AND/OR

BEEN CONCURRENT WITH INFECTIONS.

IT IS UNIQUE TO PATENT THAT THESE OBSERVATIONS HAVE BEEN COMPARED

AND CONTRASTED WITH CASES OF CANCER DETERIORATION AND/OR SUDDEN

AGGRAVATION/DETERIORATION IN CANCER CONDITION. IT WAS FOUND THAT

THERE WERE REPORTS OF THIS PHENOMENON ALSO OCCURING CONCURRENTLY

OR SUBSEQUENT TO INFECTIONS.

INFECTIONS REPORTED IN CASES OF IMPROVEMENT HAVE FALLEN UNDER A

WIDE CLASSIFICATION OF

MICROORGANISMS; VIRAL, BACTERIAL, FUNGAL, , YEAST, PARASITE ETC.

INTERESTINGLY, CASES OF DETERIORATION ALSO OFTEN OCCURRED AFTER

EXPOSURE TO ORGANISMS THAT MAY FALL ANYWHERE WITHIN SUCH A BROAD

SPECTRUM.

IT APPEARS THEREFORE THAT ORGANISMS MAY EXERT DIRECT OR INDIRECT

EFFECTS THAT MAY;

1-BENEFIT THE HOST(BIOLOGICAL ENHANCEMENT).

2-BENEFIT THE DISEASE

3-INHIBIT THE DISEASE

BENEFIT/INHIBITION OF DISEASE MAY BE ON DIRECT ACTIVITY ON

DISEASE/DISEASE-RELATED FACTORS, AND /OR INDIRECTLY SUCH AS BY

INHIBITION OR AUGMENTATION OF ANTI-DISEASE RESPONSE OF HOST.

PATENT DIFFERS FROM PRIOR ART IN THE USE OF MICROBIAL ORGANISMS

IN DEVELOPMENT OF CANCER THERAPIES IN THAT THIS PATENT SEEKS TO

DEFINE A FORMAT AND RELATIONSHIPS BETWEEN ORGANISMS AND DISEASE

IN ORDER TO ACHIEVE A LOGICAL BASIS FOR IMPROVED

NATURAL ORGANISMS MAY BE SELECTED, OTHERS MAY BE

MODIFIED, CREATED, BRED, ENGINEERED TO FULFIL, POTENTIATE, MIMIC

AMPLIFY OR COPY BENEFICIAL CHARACTERISTICS AND

OPPOSE, NEUTRALISE, ELIMINATE HARMFUL FACTORS THAT ASSIST DISEASE. .

TO DATE THE USE OF MICROORGANISMS IN THE TREATMENT OF CANCER HAS BEEN RESTRICTED TO HAPHAZARD ATTEMPTS TO IMMUNOSTIMULATE AND/OR CAUSE DAMAGE TO THE DISEASE DIRECTLY OR BY GENERATION OF CHEMOTHERAPEUTIC AGENTS . TECHIQUES TO BE DEMONSTRATED WHICH

OUTLINE THE CLASSIFICATION, DEVELOPMENT AND PURIFICATION OF

PRECURSOR /INTERMEDIATE/ ENDPRODUCT

THERAPY.

AS WITH THE CLASSIFICATION PATENT , A MORE EXTENSIVE DISCUSSION IS INCLUDED, THE AIM OF THE FOLLOWING IS TO INDICATE PRACTICAL

APPLICATION.

LIVING BIOLOGICAL SYSTEMS ARE DISCUSSED IN THE 2MEA-CU DIPSAL- BHT-PATENT . AS MENTIONED THIS PATENT REFERS TO IMMUNE-MODULATING FUNCTION AS WELL AS CELL-PROTECTIVE EFFECTS OF THE COMBINED FURMULA.

LIVING BIOLOGICAL SYSTEMS REFERS TO A COMBINATION OF BACTERIA, VIRUSES, YEASTS AND FUNGII WHICH AS AWHOLE AND/OR IN PART CAPABLE OF CONFERRING HEALTH BENEFITS TO HIGHER ORGANISMS .

BENEFITS MAY BE DIRECT OR INDIRECT . BY SUPPLEMENTATION, BIOLOGICAL ENHANCEMENT AND/OR ANTIDISEASE THE FOLLOWING MECHANISMS ARE PROVIDED AS EXAMPLES AND ARE NOT RESTRICTIVE OF PATENT.

.EXAMPLES OF LIVING BIOLOGICAL SYSTEM EFFICACY SOLELY AND AS PART OF OTHER THERAPY ARE INCLUDED AS WELL AS EXAMPLES OF THEIR USE IN PRECURSOR/INTERMEDIATE /'ENDPRODUCT THERAPY AND APPLICATIONS AS THERAPY. PREVENTION, AND BIOLOGICALLY ENHANCED FOODS , CELLS OF TARGET OR OTHER SPECIE(S) MAY ALSO BE INCLUDED IN THE LIVING BIOLOGICAL SYSTEM.

SUPPLEMENTATION

BACTERIA SUCH AS LACTOBACILLI CAN PROVIDE MANY USEFUL NUTRIENTS AS WELL AS SUPPLEMENTS . THE CONCEPT OF LIVING BIOLOGICAL SYSTEMS DIFFERS FROM ORDINARY SUPPLEMENTATION IN THAT LIVING BIOLOGICAL SYSTEMS ARE LIVING IN WHOLE ORGASNISM SENSE OR IN REPLICATING UNIT SENSE

EXAMPLES OF LIVING BIOLOGICAL SYSTEMS(LBS)ACTING AS REPLICATING SUPPLEMENTATION INCLUDE LACTOBACILLI THAT GENERATE FOLIC ACID, VITAKIN B12-SUCH AS LACTOBACILLUS LACTIS, MANY ORGANISMS CAPABLE OF GENERATING THESE AND OTHER ESSENTIAL AND NON-ESSENTIAL BUT BENEFICIAL SUPPLEMENTS AND NUTRIENTS, WHEN PRESENTED TO THE BODY IN THE FORM OF LIVING BIOLOGICAL SYSTEMS , DESIGNED TO

GROW/REPLICATE IN HARMONY WITH THE BODY'S INTESTINAL OR OTHER FLORA (LBS HAVE SO FAR BEEN DEVELOPED FOR FOOD, SUPPLEMENT, TOPICAL AND COSMETIC APPLICATIONS AS WELL AS INHALATION BOTH AS SIMPLE AND MULTIPHASED .

A BASIC LBS CONSISTS OF FOOD-DERIVED ORGANISMS SUCH AS

LACTOBACILLI , YEASTS , FUNGII ETC. SELECTED FOR THEIR INHERENT SAFETY AND BENEFICIAL PRODUCTS/EFFECTS-IF A SUPPLEMENT SUCH AS B12 IS TAKEN, IT WILL ONLY LAST THE DURATION OF ABSORPTION AND

SUPPLEMENTATION WITH A LIVING BIOLOGICAL SYSTEM CAPABLE OF PRODUCING REQUIRED ANTIBIOTIC WILL CONSTANTLY DELIVER SMALL DOSES INTO THE SYSTEM AFTER INITIAL APPLICATION/ADMINISTRATION , A

SPECIFICALLY DESIGNED AND/OR

MULTIPHASIC SYSTEM WILL CONFER HIGHER PROTECTIVE EFFICACY.

LBS MAY THEREFORE PROVIDE USEFUL SUPPLEMENTARY

FUNCTIONS, ANTIBIOTIC

ABILITY, ENZYMES(ASPERGILLI , YEASTS , LACTOBACILLI CAN CONTRIBUTE

DIGESTIVE AS WELL AS MANY OTHER ENZYMES) PROTECTION TO HOST

ORGANISM MAY BE DIRECTLY OR INDIRECTLY GIVEN

LACTOBACILLI-ACIDOPHILUS

THERMOPHILUS

CREMORIS

LACTIS

BIFIDUS

BULGARICUS( INCLUDING LACTOBACILLUS BULGARICUS 51)

PLANTARUM

FAECIUM

KEFIR CULTURE

RHIZOPII

ASPERGILLUS ORYZAE

BACILLUS SUBTILIS

FORMULA CONTAINS APPROX 300 MILLION ORGANISMS PER GRAM OF EACH

STRAIN AND SPECIE.

THESE ARE BASIC FOOD EXTRACTS AND CAPABLE OF BROAD SPECTRUM

NUTRITIONAL, ANTIBIOTIC, IMMUNOSTIMULATING, DIGESTIVE AND OTHER

FUNCTIONS.

IT IS POSSIBLE TO ADJUST FORMULATION FOR SPECIFIC FUNCTION , TO

PASS IT THROUGH KULTIPHASIC SYSTEM AND TO ADD SPECIFIC OTHER

ORGANISKS SUCH AS SACCAROMYCES CEREVISEAE

TORULA YEASTS

ASPERGILLUS ORYZAE

PENICILLIUM NOTATUM

CAUTION IS NEEDED WITH SPECIFIC FORMULATIONS WITH ACTIVE

PENICILLIUM/YEAST/ASPERGILLI ETC BECAUSE OF PROBLEMS OF

ALLERGY, FERMENTATION, GAS ETC.

LIVING BIOLOGICAL SYSTEMS MAY BE PHASED-THIS COULD BE IN THE FORM OF RESAISTANT FLORA REPLACEMENT AFTER BEING PASSAGED WITH THE ANTIBIOTIC TO BE USED FOR DISEASE TREATMENT . HENCE A SUPPLEMENT OF LBS PHASE ONE OR MORE POST PENICILLIN PASSAGE WOULD FORM A MORE EFFICIENT BOWEL REPLACEMENT THAN UNPHASED ORGANISM SUPPLEMENT.

LBS AND TS (TARGET SYSTEM) AS WELL AS

NTS ( NON-TARGET SYSTEMS ) ARE ESSENTIAL IN

PRECURSOR/INTERMEDIATE/ENDPRODUCT THERAPY. IN INCREASING

SPECIFICITY,EFFICACY AND DECREASING SIDE-EFFECTS.

DEFINING THESE SYSTEMS IS ALSO ESSENTIAL IN BIOLOGICAL ENHANCEMENT PATENT.

KULTIPHASIC THERAPY-CONTINUED

ALTHOUGH DEKONSTRATED CASES SPEAK OF KULTIPHASIC THERAPIES BEING DEVELOPED IN LINEAR SEQUENCE; IT IS ALSO POSSIBLE TO DEVELOP MULTIPHASIC THERAPY NON-SEQUENTIALLY AND BY CLONAL OR OTHER CELL/TARGET POPULATION EXPANSION, IN WHICH CA8E TARGET MAY BE EXPOSED TO VARIOUS MUTATING AGENTS AND CONDITIONS, WHICH MAY INCLUDE THERAPEUTIC ORGANISM EXTRACT IN DOSES AND CONDITIONS WHICH ENABLE DEVELOPMENT OF RESISTANCE. THERAPEUTIC

ORGANISM/EXTRACTS MAY EVEN BE PROVIDED IN MULTIPLE PHASES SUCH THAT THE THERAPY TO BE DEVELOPED BY CO-CULTURING OF MULTIPLE-RESISTANCE TARGET WITH THERAPEUTIC ORGANISK WILL BE HIGHLY EFFECTIVE AND SUPERIOR TO SINGLE AND/OR LIMITED COMBINATIONS OF MULTI-PHASED THERAPY. PRELIMINARY CULTURE EXPERIMENTS HAVE

INDICATED THIS.

SENSITIVITY, THIS MAY NOT BE COVERED BY LATTER PHASE THERAPY.

THERE ATRE THEORETICAL DANGERS IN THIS APPROACH;

1-CREATING RESISTANCE IN TARGET ORGANISMS COULD NOT ONLY POSE SERIOUS RISK IF IT EVER ESCAPED THE TEST TUBE SCENARIO BUT ALSO IT OPENS THE BASIC PHASE ONE POOL SO THAT EACH VARIATION NOW HAS THE POTENTIAL OF NECESSITATING NEW .DIFFERENT PHASE THERAPY. 2-IT APPEARS TO BE MORE LOGICAL TO ALLOW PHASE THERAPY TO MIMIC OR DUPLICATE BODY HOST CHANGES SO THAT SUBSEQUENT PHASES BEAR RELATIONSHIP TO WHAT WILL ARISE IN THE BODY IN THE FORM OF RESISTANCE. CO- CULTURING THE ORGANISMS IN FRESH BLOOD AND/OR OTHER RELEVANT PATIENT SAKPLE. BY PRODUCING CHANGES AS WILL OCCUR IN THE BODY AND/OR REFERRING TO A LIBRARY WITH PREDICTED CHANGE IN TARGET AND REQUIRED COMPENSATION BY THERAPY AS INDICATED BY PRELIMINARY TESTING THAT PLACES TARGET ON ANTICIPATED CHANGE CURVES.

3-USING BLOOD, TISSUE, OTHER PATIENT SAMPLES, DUPLICATION OF

IDENTICAL CONDITIONS PREVIOUSLY EXPERIENCED BY PATIENT.

ANTIBIOTICS, CHEMOTHERAPY, RADIOTHERAPY ETC. IN COMBINATION PERHAPS WITH A CULTURE MEDIUM WHICH CONTAINS PATIENT BLOOD AND/OR OTHER PATIENT-SPECIFIC FACTORS.

LIMITED OR CLOSED CULTURE PROCESSING ALONG WITH RELEVANT OPEN-CULTURE AS RELATES TO PATIENT.

AN EXAMPLE OF AN OPEN-CULTURE TECHNIQUE THAT MAY BE OF BENEFIT INCLUDES THE CO-CULTURING OF TARGET ORGANISM WITH THERAPEUTIC ANTIBIOTIC ALONG WITH ANTIBIOTIC-RESISTANT ORGANISMS ISOLATED FROM PATIENT (STOOL, SKIN, MOUTH, SPUTUM ETC ) SUCH THAT DONATION OF RESISTANCE(FOR EXAMPLE BY PHAGE OR PLASMID)MAY BE ANTICIPATED AND THERAPY DEVELOPED ACCORDINGLY. DEFINING LIVING BIOLOGICAL SYSTEMS

LBS MAY BE DEFINED FOR VARIOUS SITUATIONS AND CONDITIONS.

USE OF LBS MAY BE ACTIVE(EG IN DEVELOPMENT OF THERAPY)OR PASSIVE

EG. IN EXPRESSION OF INTERMEDIATE AND ENDPRODUCT . LBS MAY BE A

CONGLOMERATE OF THERAPEUTIC ORGANISMS OF SIMILAR OR DIFFERENT

SPECIES OR MAY BE TARGET ORGANISM CONGLOMERATE.

AN EXAMPLE OF THERAPEUTIC ORGANISMS OF THE SAME SPECIES BEING

COMBINED IN A LIVING BIOLOGICAL SYSTEM WOULD BE A MIXTURE OF

PENICILLIA BEING COMBINED AS THERAPEUTIC LBS; EVEN THE SAME

PENICILLIUM MAY BE DEFINED AS A LBS IF COMBINED WITH OTHER

PHASES . LBS CAN BE DEFINED BY ORGANISMS CO-EXISTING IN CERTAIN

SAMPLES EG STOOL,SOIL BACTERIA ETC., IN DEFINED ENTITIES EG.KEFIR

CULTURE . SUCH LBS POOLS MAY BE TAPPED IN WIDE SEARCH FOR THERAPY

OR OTHER FACTOR.

LBS THERAPEUTIC MAY REPRESENT NATURALLY OCURRING ENTITIES AND/OR

THOSE ARTIFICIALLY OR OTHERWISE COMBINED OR MODIFIED . AN EXAMPLE

WOULD BE THE COMBINATION OF ANTIBIOTIC SYSTEM WITH PHAGE SYSTEM

AND/OR IMMUNE SYSTEM AS A MULTIFACTORIAL LBS THERAPEUTIC ENTITY.

LBS AS A THERAPEUTIC ENTITY MAY ALSO BE DEFINED AS A MIXTURE OF

ANTAGONISTIC AND NEMESIS FACTORS AS DEFINED IN CLASSIFICATION

PATENT.

TARGETED LIVING BIOLOGICAL SYSTEMS MAY INCLUDE DISEASE CAUSATIVE

ORGANISM ALONG WITH DISEASE SYNERGISTIC ORGANISM ALONG WITH

DISEASE -MODIFIED TISSUE-AN EXAMPLE IN AIDS WOULD BE A LBS

COMBINING HIV.PNEUMOCYSTIS CARINNI AND INFECTED T CELLS.

COMBINED THERAPEUTIC LBS MAY BE DRAMATICALLY MORE EFFECTIVE THAN

ANY SINGLE COMPONENT.

TARGET MAY BE CO-INCUBATED WITH LBS EMPIRICALLY,EG STAPHYLOCOCCUS

AUREUS MAY BE INCUBATED WITH PENICILLIUM, STAPHYLOCOCCUS PHAGE AND

ANTI-STAPHYLOCOICCUS AUREUS ANTISERUM .

THE IDEA OF SUCH EMPIRICAL METHOD IS THAT ANY ORGANISM MUTATION

RESISTANT TO ONE MODALITY MAY SUCCUMB TO ANOTHER ORGANISM IN THE

LBS , THIS TECHNIQUE MAY BE USEFUL IN REACHING FAST THERAPIES BUT

IS NOT ONLY INEFFICIENT-EG IT MAY BE IMPOSSIBLE TO RAISE PHAGE

SPECIFICALLY FOR ORGANISM IF ANTIBIOTIC OR ANTISERUM RAPIDLY

DESTROYS IT. IT IS ALSO POSSIBLE THAT THE VARIOUS INGREDIENTS OF

THE LBS MAY INTERFERE WITH EACH OTHER AND THEIR

ACTIVITY, PARTICULARLY IF THE LBS IS AN ARTIFICIAL ONE. IT IS

POSSIBLE, FOR EXAMPLE THAT THE ANTISERUM CAUSES BACTERIAL CLUMPING

AND THAT ANTIBIOTICS CANNOT THEN ADEQUATELY PERMEATE THE MASS . IT

IS ALSO POSSIBLE THAT CONDITIONS FOR OPTIMAL SURVIVAL AND

FUNCTION OF THE VARIOUS LBS COMPONENTS MAY DIFFER PARTICULARLY

WHERE THE LBS IS COMPRISED OF DIFFERENT SPECIES ARTIFICIALLY

COMBINED.

MUTATIONS RESISTANT TO L ; BS , ALTHOUGH LESS LIKELY TO OCCUR THAN

AGAINST ANY SINGLE MODALITY OF LBS SEPARATELY MAY BE HARDER TO

DEAL WITH. EXPANDING THE RESISTANCE POOL TO MULTIPLE MODALITIES

MAY NOT BE AS PRUDENT AS EXPOSING THE TARGET TO SINGULAR

MODALITIES IN ISOLATION . OPTIMISING THEM AND THEN USING THEM AS

MULTIMODAL/MULTIPHASIC THERAPY.

USING A LIVING SYSTEM/PATIENT TO DEVELOP MULTIPHASIC/MULTIMODAL

PATIENT TREATED WITH PARTICULAR PHAGE OR ANTIBIOTIC FOR EXAMPLE MAY DEVELOP RESISTANCE TO THAT THERAPY; REISOLATING THE TARGET ORGANISM THEN COINCUBATING IT WITH THE THERAPEUTIC ORGANISM ALLOWS FOR DEVELOPMENT OF SPECIFIC PHASE TWO THERAPY ETC THIS DATA ALLOWS FOR ACCUMULATION OF IN-VIVO MULTIPHASIC LIBRARY DATA WHICH MAY BE EFFECTIVELY APPLIED TO SUBSEQUENT PATIENTS.IT IS ALSO NOT NECESSARY TOWAIT FOR PHASE ONE FAILURE IN-VIVO TO SEARCH FOR PHASE TWO AS WITHIN HOURS TO DAYS OF PRELIMINARY APPLICATION OF THERAPY, RESISTANT TARGET FORMS MAY BE ISOLATED FROM PATIENT BEFORE BECOMING CLINICALLY SIGNIFICANT. IT MAY

GLUTATHIONE PEROXIDASE AS WELL AS CARRYING OUT SYSTEMIC ANTIOXIDANT FUNCTIONS. CELLS SUCH AS HEPATIC CELLS AND OTHERS WHICH MAY BE TARGETED FOR OPTIMAL PRODUCTION OF ACTIVE INTERMEDIATES AND ENDPRODUCTS. IF HEPATIC CELLS AND/OR BLOOD CELLS FROM PATIENT OR OTHER CELLS FROM PATIENT OR FROM OTHER COMPATIBLE SOURCE INCLUDING ANIMAL CELLS AND/OR ORGANISMS/SYSTEMS CAPABLE OF

THE MOST VALID INGREDIENT IN A LIVING BIOLOGICAL THEREFORE WOULD BE CELL TYPE OF THE SAME AS TARGET CELL TYPE PREFERABLY FROM PATIENT PROVIDED THAT THE DESIRED ENDPOINT AND INTERMEDIATE PRODUCTS ARE BEST MANUFACTURED BY TARGET CELLS.WE WILL NOW EXPAND ON ALL THESE POINTS.

DESIGNING LBS AS PROCESSING INTERMEDIATES.

1-AMPLIFICATION OF INTRINSIC SYSTEM

WHERE INTRINSIC ANTIOXIDANT SYSTEM SUCH AS SOD IS STIMULATED.

2-AKPLIFICATION OF THERAPY

3-INHIBITION OF TOXICITY

BY PRODUCTION OF DESIRED ENDPOINTS AND CO-FACTORS, THESE MAY BE

SEPARATED PRIOR TO ADMINISTRATION.

THERAPIES/AGENTS MAY BE PROCESSED THROUGH LBS SIMPLY TO BE

PASSAGED THROUGH LIVING SYSTEMS THAT MAY NEUTRALISE SIDE-EFFECTS.

OR TOXIC FRAGMENTS INHERENT OR RELEASED DURING SOME PATHWAY OF

METABOLISM OF AGENT.

A SIMPLE EXAMPLE OF LIVING BIOLOGICAL SYSTEMS BEING USED TO PREPROCESS FACTORS WHICH MAY COMPROMISE A RECIPIENT INCLUDES THE USE OF LACTOBACILLI, AND RELEVANT ASPERGILLI AND OTHER SAFE ORGANISMS CONTAINING LACTASE ENZYMES TO PROCESS MILK PRODUCTS FOR LACTOSE INTOLERANT INDIVIDUALS . NEW INVENTION DIFFERS FROM PRIOR ART IS THAT PRIOR ART NECESSITATES ADMINISTRATION OF PURIFIED LACTASE ENZYME ALONG WITH LACTOSE CONTAINING FOODS IN ORDER TO ADEQUATELY DIGEST THE FOOD. THIS PATENT AIMS TO INTRODUCE LACTOSE-DIGESTING ORGANISMS INTO BOWEL FLORA AS A LONGLASTING SOLUTION, IT IS ALSO POSSIBLE TO MODIFY AND ENHANCE INTRINSIC BOWEL ORGANISMS SO THAT THEY DEVELOP LACTASE ABILITY BY SIMPLE CO-INCUBATION WITH ORGANISMS WITH THAT ABILITY, WITH COMPLICATED GENETIC MANIPULATION TECHNIQUES OR BY SIMPLE ADDITION OF APPROPRIATE LBS INTO BOWEL FLORA.

LET US NOW CONSIDER A SPECIFIC EXAMPLE OF LBS USE WITH

SUPPLEMENTS AS RELATED TO 2 -MEA, COPPER2

3, 5DIISOPROPYL SALICYLATE PATENT.

LIVING BIOLOGICAL SYSTEM TESTED WAS COMPOSED OF;

LACTOBACILLI-STRAINS OF THE FOLLOWING;

ACIDOPHILUS

BIFIDUS

THERMOPHILUS

BULGARICUS

LACTIS

CREMORIS

FAECIUM

PLANTARUM

KEFIR

RHIZOPII

SACCHROMYCES CERVESEAE

EACH ORGANISM CONCENTRATION-50 MILLION VIABLE UNITS PER GRAM

MANY PAPERS HAVE BEEN WRITTEN REPORTING IMMIUNOSTIMULATING

PROPERTIES AS WELL AS ANTIBIOTIC, ANTIFUNGAL , ANTICANCER, AS WELL AS

A PLETHORA OF OTHER ATTRIBUTES.

ALL SUCH BENEFITS ARE OF USE, HOWEVER IN APPLICATION AS

INTERMEDIATE AND ENDPRODUCT GENERATION, THIS SAMPLE FORMULA AS

WELL AS OTHERS CONTAINING ORGANISMS WITH ABILITIES RANGING FROM

ANTIOXIDANT TO ANTIBIOTIC AND ANTIVIRAL WAS ADDED TO THE

FORMULATION OF THE 2-MEA AND CU DIPSAL.

IT WAS FOUND THAT PATIENTS TREATED NOTED A MORE RAPID INCREASE

AND VITALITY THAN WITH THE CHEMICAL FORMULATION ALONE.

AN EXPLANATION FOR THIS MAY RELATE TO THE LBS ABILITY TO GENERATE

SUPEROXIDE DISMUTASE AS WELL AS HAVING ITS OWN BENEFICIAL

INHERENT PROPERTIES . THE CHEMICAL PART OF THE FORMULATION WAS

THEREFORE ABLE TO INTERACT WITH MICROBIAL MECHANISMS TO BOOST AND

ENHANCE LBS ANTIOXIDANT ENZYME GENERATION. THE LBS WOULD IN TURN

PROVIDE INCREASED ENDPRODUCT LEVELS OF THE ANTIOXIDANT ENZYMES TO

THE BODY AS WELL AS COMPLEMENTS OF CO-FACTORS AND INTERMEDIATES

REQUIRED IN THE PATHWAYS OF GENERATION OF ENDPOINT.

PRELIMINARY TRIALS HAVE INDICATED THAT PHASE 2 LBS, IE. THAT WHICH

HAS BEEN PREVIOUSLY CULTURED WITH 2-MEA AND CUDIPBAL PROVIDED

APPROACH

THAT IS TO SAY THAT VARIOUS MODES MAY BE USED TO AUGMENT EACH

OTHER'S FUNCTION.

PHAGES RAISED AGAINST OR WITH ACTIVITY AGAINST PENICILLIN

RESISTANT ORGANISMS WILL AUGMENT THE FUNCTION OF SAID ANTIBIOTIC

FUNCTION IS EVEN AUGMENTED AGAINST PENICILLIN SENSITIVE ORGANISMS

AN EXAMPLE OF THIS IS THE PLATING ON BLOOD AGAR OF STREPTOCOCCAL

CULTURE WITH PENICILLIN SENSITIVITY.

STREPTOCOCCUS WAS ISOLATED FROK SKIN SAMPLE AND POSESSED

PENICILLIN SENSITIVITY (TEST WAS REPEATED ON 6EVERAL OCCASSIONS

USING PENICILLIN AS WELL AS OTHER TYPES OF ANTIBIOTICS AND

STREPTOCOCCAL, STAPHYLOCOCCAL AND OTHER HOST ORGANISMS AS WELL AS

THEIR PHAGES AS SUPPLIED BY ATCC AND/OR RAISED INDEPENDANTLY.WITH

SIKILAR RESULTS)AFTER PLATING AND CULTURING FOR 3 DAYS AT ROOK

TEMPERATURE,THE PLATE WAS COVERED WITH MANY PURELY STREPTOCOCCAL

COLONIES . ON THE THIRD DAY, A DISC SATURATED WITH PROCAINE

PENICILLIN WAS PLACED IN THE CENTRE OF THE AGAR PLATE. WITHIN 24

HOURS A ZONE OF CLEARANCE WAS EVIDENT AROUND THE DISK AS A HALO

MEASURING 2MM IN DEPTH. THE FOLLOWING DAY THE ZONE MEASURED

3MM,THERE WAS NO FURTHER ENLAGEMENT OF ZONE WITH FURTHER

INCUBATION.

SREPTOCOCCAL PHAGE WAS ADDED TO THE PENICILLIN-SATURATED

DISCPHAGE WAS EITHER ONE OBTAINED FROM ATCC WHICH HAD

DEMONSTRATED EFFICACY IN LYSIS OF THIS PARTICULAR STREPTOCOCCUS

OR ONE RAISED FROM THE BACTERIA BY TECHNIQUES PREVIOUSLY NOTED.

SOLUTION OF PHAGE ESTIMATED AT 10 TO THE NINTH POWER OF PLAQUE

FORMING UNITS 0.5CC OF PHAGE TSB SUSPENSION WAS ADDED TO DISC

SATURATED WITH PROCAINE PENICILLIN,

ZONE OF CLEARANCE FORMED AS IN PREVIOUS TEST; ZONE OF CLEARANCE

WAS MARGINALLY LARGER 0.5 MM, MORE IMPORTANTLY, WITHIN 24 HOURS

PLAQUE FORMATION WAS EVIDENT THROUGHOUT MANY OF THE COLONIES-AGAR

PLATE CONTAINED NO VIABLE COLONIES WITHIN 48 HOURS.

IN OTHER TEST SYSTEMS WHERE TOTAL COLONY CLEARANCE DID NOT

OCCUR, MULT I PHASED (USUALLY NO MORE THAN 3)WERE REQUIRED TO ACHIEVE

TOTAL BACTERIAL LYSIS.

THIS IN-VITRO DATA DOES NOT EASILY TRANSLATE IN IN-VIVO DATA AS

PHAGE OF SINGLE PHASE IS USUALLY UNABLE TO ERADICATE INFECTION

FROM A LIVING BODY; NOT ONLY IS A LIVING OPEN SYSTEM CONDUSIVE TO

THE BACTERIAL TARGET'S DEVELOPMENT OF RESISTANCE BUT THERE IS

ALSO THE PROBLEM OF THERAPY REACHING TARGET, MUCH OF THE PHAGE

LOAD MAY BE INTERCEPTED BY THE HOST'S IMMUNE RESPONSE AND

ELIMINATED PRIOR TO REACHING THE BACTERIA. PRIOR MECHANISMS AND

EXAMPLES DESCRIBED SHOW THE ABILITY OF MULTIPHASED PHAGES AND IMMUNE RESPONSES TO AUGMENT EACH OTHERS ABILITY AS WELL AS OTHER

PATHWAYS OF THERAPY SUCH AS ANTIBIOTIC THERAPY..

MULTIPHASIC THERAPY IN MULTIPLE MODES CAN ENHANCE EACH OTHERS

FUNCTION AS WELL AS OFFER PREVENTION AGAINST THE DEVELOPMENT OF

RESISTANCE

PHAGES CAN BE RAISED SPECIFICALLY AGAINST ANTIBIOTIC -RESISTANT

STRAINS OF TARGET ORGANISM.

IMMUNE RESPONSE SUCH AS ANTISERUM MAY BE RAISED AGAINST ORGANISMS OTHER TECHNIQUES INCLUDING SELECTIVE FILTRATION, ELECTROPHORESIS AND OTHER TECHNOLOGIES INCLUDING ISOLATION AND GENETIC AMPLIFICATION TECHNOLOGY INCLUDING MONOCLONAL ANTIBODY PRODUCTION AND OTHER MECHANISMS INVOLVING HYBRID AND OTHER CELL LINES.

THE PATENT COVERS THE USE OF ANTISERA/WHITE BLOOD CELL

EXTRACT/IMMUNOSTIMULATION AS ADJUNCT TO ANTIBIOTIC THERAPY BOTH DIRECTLY AND BY RAISING RESPONSE AGAINST TARGET PREVIOUSLY TREATED WITH ANTIBIOTIC SO THAT THERE IS A PASSIVE AS WELL AS A LATTER ACTIVE IMMUNE RESPONSE AGAINST THERAPY RESISTANT ORGANISMS. IT IS POSSIBLE TO INCUBATE PATIENT CELLS WITH TRANSFER FACTOR FROM IMMUNISED CELLS OF OTHER SOURCE, TO INDUCE THEIR

ACTIVITY AGAINS TARGET ORGANISM.TO RECOGNISE ISOLATE AND AMPLIFY USING INTERFERON, INTERLEUKIN AND/OR OTHER MODALITIES PATIENT CELLS WITH ACTIVITY AGAINST TARGET.

0.3CC OF SERUM IS INJECTED INTRADERMALLY. DOSES UP TO 5CC HAVE BEEN USED INTRADERMALLY/SUBCUTANEOUSLY/INTRAMUSCULARLY WITHOUT HARMFUL RESULTS . THE LOW DOSE IS USED AS IN THEORY, THE TARGET RESISTANT POPULATION EXISTS IN EITHER LOW DOSE OR HAVE NOT YET BEEN GENERATED . FURTHERMORE WE CAN USE THE ANTISERA TO INHIBIT DONASTION OF PLASMIDS OR OTHER RESISTANCE-DONATING FACTORS.

EVEN WHERE RESISTANT STRAINS EXIST IN SIGNIFICANT AMOUNTS ;IT IS UNLIKELY THAT THEY WILL SURVIVE BOTH ANTIBIOTIC AND PHAGE ATTACK,AGAIN LEAVING RELATIVELY LITTLE FOR THE ANTISERA TO

OVERCOME .

THERAPY

1 MILLION UNITS OF PROCAINE PENICILLIN

0.6CC OF PHAGE LYSATE (10 TO THE NINETH POWER PLAQUE FORMING

UNITS)

0.3CC HORSE SERUK. (ANECDOTAL CASES HAVE SUGGESTED THAT HUMAN AND

OR ANIMAL IMMUNOGLOBULINS INCLUDING THE COMMONLY AVAILABLE FORMS

SUCH AS POOLED IMMUNOGLOBULINS EVEN IF NOT SPECIFICALLY RAISED

AGAINST TARGET MAY BE OF BENEFIT BUT TEND TO NOT BE AS EFFECTIVE;

CURRENT RISK OF HEPATITIS AND AIDS CONTAMINATION OF HUMAN STOCK

MAY MAKE ANIMAL SERA MORE APPEALING.

TECHNIQUE

1 MILLION UNITS OF PROCAINE PENICILLIN WERE INJECTED

INTRAMUSCULARLY.

0.6CC OF PHAGE LYSATE WAS INJECTED INTRADERMALLY AT THE SAME

TIME.

0.3CC OF ANTISERUM WAS INJECTED INTRADERMALLY 6 HOURS LATER.THE

REASON FOR THE DELAY IS THE THEORETICAL POSSIBILITY THAT

ANTISERUM MAY BIND AND NEUTRALISE PHAGE LYSATE PRIOR TO ITS

CIRCULATION AND REACHING TARGETS.

THE PHAGE INJECTION IN ALL THREE PATIENTS GAVE RED MARKS 1-4

INCHES IN DIAMETER AND WAS ITCHY FOR SEVERAL MINUTES . ONE REPORTED A MILD HEADACHE AND TEMPERATURE OF 100 DEGREES CELSIUS THAT LASTED FOR 6 HOURS.

TONSILLITIS RESOLVED IN ALL PATIENTS WITHIN 48 HOURS OF TREATMENT

RESISTANT TO ANTIBIOTIC AND/OR PHAGE. THESE MODALITIES, INTERTWINED MAY BE PASSAGED THROUGH SEVERAL PHASES.

USE OF INTERTWINED MODALITIES

PATENT COVERS THE USE OF MULTIPHASIC THERAPY AS WELL AS THE USE

OF PHAGES AND/OR ANTISERA AS ADJUNCTS TO ANTIBIOTIC

THERAPY, ANTICANCER AND ANTI-AIDS THERAPY.

IT IS ALSO TO BE STRESSED THAT ALTHOUGH CURRENT APPLICATIONS MAY

APPEAR CRUDE, PATENT COVERS THE APPLICATION OF MORE REFINED

TARGETING OF THE VARIOUS MODALITIES SUCH AS THE RAISING OF

SPECIFIC IMMUNE RESPONSES AGAINST PLASMIDS WHICH MAY CODE FOR

ANTIBIOTIC RESISTANCE

EXAMPLES OF ANTIBIOTIC ENHANCEMENT.

STAPHYLOCOCCAL TONSILITIS USUALLY REQUIRES 7-10 DAYS OF

ANTIBIOTIC THERAPY FOR ADEQUATE RESOLUTION.

3 PATIENTS AGE 15-19 SUFFERING FROM RECURRING BOUTS OF

TONSILLITIS HAD PREVIOUSLY BEEN TREATED WITH AMOXIL 250 MG TDS

FOR 10 DAYS ON THREE OCCASSIONS . EACH PRESENTATION YIELDED

STAPHYLOCOCCUS AUREUS CULTURE . WITH SENSITIVITY TO AMOXIL BUT NOT

TO PENICILLIN PHAGE WAS RAISED AGAINST THE CULTURE BY CULTURING

THE ISOLATED STAPHYLOCOCCUS IN 500CC OF TRYPTICATED SOY BROTH

,0.05CC OF 1%HYDROGEN PEROXIDE SOLUTION WERE ADDED ON THE THIRD

DAY OF CULTURE WHEN BACTERIAL GROWTH WAS RICH.BACTERIAL LYSIS

OCCURRED 2DAYS LATER. 0.1CC OF BROTH WAS THEN DRAWN FOR TESTING.

AND CAUSED LYSIS OF ESTABLISHED COLONIES OF THE BACTERIA ON AGAR

PLATE INDICATED PHAGE PRESENCE

BROTH WAS AGITATED AND FILTERED THROUGH 0.2 MICRONS.

HORSE ANTISERUM WAS RAISED BY INTRADERMAL INJECTION OF 0.5CC OF

TSB CONTAINING ONE MILLION ORGANISMS PER ML.

INTRADERMAL INNOCULATION WAS REPEATED EVERY THREE DAYS FOR 2

WEEKS.

3 CC OF BACTERIAL CULTURE WERE THEN TREATED WITH 100,000 U OF

PROCAINE PENICILLIN(CULTURE OT THIS SAMPLE INDICATED BACTERIAL

SURVIVAL)CULTURE WAS CONTINUED FOR A 12 HOUR PERIOD; ORGANISMS

WERE THEN LYSED BY 15 MINUTES OF SONICATION.

THE THEORY HERE IS THAT CHANGES IN BACTERIAL STRUCTURE AND

CONTENT WILL ALTER AS PENICILLIN-RESIBTANCE SYSTEMS VARE

INDUCED, HORSE IMMUNE RESPONSE WILL THEN BE ABLE TO TARGET THESE

AS WELL AS BACTERIAL STRUCTURE IN UNCHALLANGED STATE.

IT SHOULD BE NOTED HERE THAT COMPARIBON OF SERUM ELECTROPHORESIS

FROK ANIMALS VACCINATED WITH BACTERIA/BACTERIAL FRAGMENTS IN

UNCHALLANGED STATE AND THOSE CHALLANGED WITH THE ANTIBIOTICS

ENABLES DEFINITION OF IMMUNE RESPONSE RAISED AGAINST INDUCEABLE

RESISTANCE FACTORS.

100 CC OF HORSE BLOOD IS DRAINED TWO WEEKS FOLLOWING THE FINAL HORSE IMMUNISATION AND CENTRIFUGED TO YEILD SERUM, SERUM IS STORED AT 3 DEGREES CELSIUS FOR 9 MONTHS. THIS IS AN OLD TECHNIQUE THAT REMOVES MUCH OF ALLERGIC COMPONENT OF SERUM. IT IS WITHIN THIS PATENT PARAMETERS TO INCLUDE ANY MORE SOPHISTICATED PURIFICATION TECHNOLOGY INCLUDING 'WASHING' OF SERUM AGAINST HUMAN/AND/OR PATIENT'S OWN RED BLOOD OR OTHER CELLS/CELL FRAGMENTS AS WELL AS CANCER WILL BE USED HERE AS AN EXAMPLE TO DEMONSTRATE APPLICATION

OF TECHNOLOGY; IT IS NOT TO RESTRICT THIS PATENT WHICH APPLIES TO

MANY, IF NOT ALL DISEASE AND OTHER CONDITIONS.

1-RAISING OF REPONSE AGAINST CANCER-SPECIFIC FACTORS.

THIS INVOLVES PREPARATION OF SUCH ENTITIES AND/OR REFERRING TO

LIBRARY SAMPLES .CANCER TISSUE. IN CERTAIN CASES OF NATURE OR AFTER

SPECIFIC CULTURE/PREPARATION TECHNIQUES, OCCURS IN HIGHLY

UNDIFFERENTIATED (OFTEN ASSOSCIATED WITH CLINICAL AGGRESSIVENESS)

FORM. INTERESTINGLY, THE GREATER THE DIFFERENTIATION.THE LESS

AGGRESSIVE THE DISEASE, SUGGESTING THAT REDIFFERENTIATIN EVEN

PARTIAL OF TARGET CANCER CELLS MAY PROMOTE GREATER

SURVIVAL. (SEE REDIFFERENTIATION SECTION OF BIOLOGICAL ENHANCEMENT-ALSO TIE IN OF LBS WITH INTERFERANCE PHENOMENON IN CANCER,ULCERS ETC.)

(ACTUALLY SYSTEM ALSO WORKS WELL WITH GENERAL POOLED ANTIHUMAN

ANTISERA(CONTRAST WITH MULTIPHASIC

HORSE IS VACCINATED WITH NORMAL HUMAN BLOOD CELLS WHICH HAVE BEEN

EXPOSED TO 10,000DB FOR 1 MINUTE. BLOOD FROM POOL IS INJECTED INTO

THE ANIMAL INTRADERMALLY AT 0.5 CC EVERY 3 DAYS FOR 3

WEEKS . ANIMAL SERUM AT THAT TIME CONTAINED SIGNIFICANT AMOUNTS OF

ANTI-HUMAN ANTISERUM.

LEUKEMIA CELLS WERE SUSPENDED IN SALINE(CML 150,000 X 10 TO THE

NINETH POWER PER CC FROM PATIENT MENTIONED PREVIOUSLY)AND TREATED

WITH ANTI-HUMAN ANTISERUM.

1CC OF LEUKEMIA SALINE SUSPENSION WAS ADDED TO 0.5CC OF ANTISERUM

AND INCUBATED FOR 6 HOURS . WHOLE CELLS WERE THEN SPUN DOWN AND

WASHED 3 TIMES WITH SALINE THEN RESUSPENDED IN 2CC OF

SALINE . AGAIN ALTHOUGH PATENT DETAILS USE OF ANTIHUMAN

ANTISERUM, ANY ANTI-HUMAN IMMUNOLOGICAL RESPONSE INCLUDING CELL

MEDIATED , ENZYMATIC, ORGANISM , CHEMICAL, PHYSICAL OR BIOLOGICAQL

AND/OR COMBINATIONS MAY BE USED THE PATENTED CONCEPT OF THIS

PATENT IS TO RAISE AN ANTI-NORMAL RESPONSE TO EFFECTIVELY TREAT

DISEASE AND REMOVE FROM IT ANY NORMAL FACTORS,HENCE FASCILITATING

THE AIMING OF THERAPY WITH HIGH PRECISION AT THE RESIDUAL

FASCTORS WHICH WE WILL TERK CANCER-SPECIFIC OR DISEASE-SPECIFIC

FRACTION(DSF)

SIKILARLY TECHNIQUES PHYSICAL , CHEMICAL/BIOLOGICAL ( INCLUDING THAT

OUTLINED ABOVE )CAN BE USED TO RAISE AN ANTI-DSE RESPONSE, UPON

TREATING HEALTHY CELLS WITH THE ANTI-DSE WE ARE LEFT WITH HEALTHY-CELL SPECIFIC EXTRACT(HCSE). IT IS A VALID ASSUMPTION THAT

HCSE MAY BE AUGMENTED WITHOUT ENHANCING DISEASE PROCESS(SEE

BIOLOGICAL ENHANCEMENT SECTION)

ANOTHER CRUDE BUT USEFUL PROCEDURE IS THE IMPLANTING OF TUMOUR

BIOPSIES INTO ANIMAL VACCINED AGAINST NORMAL HUMAN FACTORS AND

RECOVERING IMPLANT 3-6 DAYS LATER WHEN ANIMAL SYSTEMS WOULD HAVE

ATTACKED, RE MOVED OR DENATURED MUCH OF THE NORMAL HUMAN

COMPONENTS OF THE BIOPSY. EVEN NORMAL ANIMAL IMPLANTATION WITHOUT

ANY PRIOR ANTIHUMAN IMMUNISATION WOULD STILL REMOVE MUCH OF THE

NORMAL HUMAN COMPONENT OF DISEASED HUMAN CELLS BUT PERHAPS NOT AS

EFFICIENTLY.

THERAPEUTIC ORGANISM CAN THEN BE CULTURED WITH VARIBLE DEGREES OF

BIAS WITH THE SPECIFIC DISEASE FRACTIONS AS WELL AS WHOLE CVELLS

WHICH HAVE BEEN 'DEHUMANISED'.

SEVERAL STRAINS OF PENICILLIUM WERE INCUBATED WITH LEUKEMIA CELLS

THAT HAD SURVIVED THE 'DEHUMANISING' PROCEDURE FOR THREE WEEKS.

OTHER TECHNIQUES

AS PREVIOUSLY MENTIONED, IT IS POSSIBLE TO DEFINE LIVING

BIOLOGICAL SYSTEMS TO CERTAIN PROCEDURES; BY EXPOSING TARGET TO

LIVING BIOLOGICAL SYSTEMS TO TARGETS IT IS POSSIBLE TO ISOLATE

ORGANISMS WITH SPECIFIC AFFINITY

LIVING BIOLOGICAL SYSTEM MAY BE BROAD(SUCH AS SOIL ORGANISMS)

NARROW (WITH VARIOUS DEGREES OF DEFINITION EG BY

SPECIE/SUBSPECIE)

DEFINED FOR FUNCTION/OTHER; EXAMPLE -CHEMOTHERAPY GENERATING

ORGANISMS.

EXPANDED;NATURALLY BY ADDITION OF LIVING/NON-LIVING COMPONENTS.

EXPANDED ARTIFICIALLY BY EXPOSURE OF LBS TO MUTATING AGENTS.

A NARROW,DEFINED LBS WAS CHOSEN WHERE THE COMPOSITION WAS

PENICILLIUM SPECIES ISOLATED FROM VARIOUS FOOD SOURCES;

GRAPE JUICE , MOULDY BREAD, PENICILLIUM NOTATUM STOCK ATCC

CULTURES; ALL WERE CO-INCUBATED WITH CANCER CELLS AND CELL

FRAGMENTS THAT WERE 'HUMANISED'FOR A PERIOD OF THREE WEEKS

TERMEDADAPTATION PHASE.

THE SECOND PHASE OF THE PROCESS IS THE SELECTIVE

ISOLATION PHASE DURING THIS PHASE THE LBS OF POOLED

PENICILLIUM ORGANISMS, HAVING BEEN CO-INCUBATED IN 500CC OF

TRYPTICATED SOY BROTH WITH DEHUMANISED LEUKEMIA CELLS (10CC OF SALINE SUSPENSION AT 150,000 CELLSX 10 TO THE NINETH POWER)FOR THREE WEEKS IN THE ADAPTATION PHASE;ARE NOW 'CHALLANGED WITH THREE LYMPH NODE BIOPSIES, EACH MEASURING ICMM DIAMETER

APPROXIMATELY WITH ATTATCHED PIN MARKERS OF DIFFERENT COLOURS. RED-NORMAL -HISTOLOGICALLY DISEASE-FREE LYMPH NODE FROM LEUKEMIA PATIENT.

GREEN-NORMAL LYMPH NODE REMOVED FROM HEALTHY VOLUNTEER AXILLA. (IN OTHER CASES THE THIRD CONTROL LYMPH NODE WAS REMOVED FROM AUTOPSIES AND/OR ANIMAL LYMPH NODES) EACH OF THE THREE BIOPSY TYPES ARE REPRESENTED BY THREE BIOPSIES OF ICM DIAMETER WERE PLACED INTO THE BROTH CONTAINING THE PENICILLIUM LBS AFTER THE ADAPTATION PHASE OF 3 WEEKS.

SAMPLES ARE IMMERSED IN BROTH FOR THREE DAYS, 6 DAYS AND THREE WEEKS . AT EACH TIME ONE OF THE BIOPSY SAMPLES WAS WITHDRAWN HALF WAS INSERTED INTO 200CC OF TRYPTIC SOY BROTH,THE OTHER HALF WAS RINSED WITH 30 CC OF SALINE AND THEN PLACED INTO 200CC OF TSB HALF IS RINSED TO DIMINISH THE CHANCE OF CULTURING SUPERFICIAL. NON-SPECIFIC ORGANIBMS FLOATING IN THE TSB AND SIMPLY WERE REMOVED ALONG WITH THE BIOPSIES WITHOUT HAVING ANY REAL AFFINITY FOR THEM .

(THIS MODEL IS AN EXAKPLE MODEL AIMED TO INDICATE HOW TO CREATE AND EXTRACT EFFICIENT, UNI AND/OR MULTIPHASIC THERAPY , ENHANCING CURRENT CHEMOTHERAPY PROTOCOLS, THE TIME PERIODS ARE DEPENDANT ON ORGANISM ACTIVITY, IF DEALING WITH PAST VIRUSES OR BACTERIA.THE IUMMERSION OF BIOPSIES MAY BE MEASURED IN MINUTES OR HOURS, FOR EXAMPLE, SLOWER ORGANISMS MAY REQUIRE MORE TIME. TUMOUR BIOPSIES ARE ABLE TO REMAIN STRUCTURALLY COHESIVE UP TO SEVERAL WEEKS, ORGANISM WITH THE HIGHEST AFFINITY MAY BE SLOWER THAN OTHERS IN THE LBS AND TAKE TIME TO ESTABLISH ITSELF AND DISPLACE OTHER ORGANISMS FROM THE BIOPSY. THE BEST LIVING MATCH WILL BE OBTAINED IF CANCER CELLS ARE STILL VIABLE AT THE TIME OF ORGANISM INVASION AND/OR IF THE BIOPSY SPECIMEN IS REPRESENTATIVE OF THE DISEASE AS IT EXISTS IN-VIVO. PATENT ALSO COVERS IN-VIVO MATCHING TECHNIQUES USING ANIMAL MODELS THAT CAN SUSTAIN LIVING CANCER CELLS AND LIVING LBS CULTURES OVER A DEFINED PERIOD AND ALTHOUGH SUCH A SYSTEM WAS TESTED OUT IN SHEEP, ONE WOULD REQUIRE EITHER ABSENCE OF IMMUNOLOGICAL RESPONSE OR ANIMAL MODEL WITH ITS OWN 'HUMAN EQUIVALENT' CANCER IN ORDER TO MAINTAIN CANCER EXPOSURE OVER A TIME PERIOD OF SEVERAL WEEKS. THERE ARE DIFFICULTIES IN FACTORING FOR ANIMAL-SPECIFIC CONDITIONS AND ALTHOUGH THE RESULTS CAN BE DRAMATIC(ANIMAL IMPLANTED WITH SOLID TUMOUR ON ONE

BUTTOCK, INJECTED WITH LBS IN OTHER BUTTOCK WILL WITHIN DAYS TO WEEKS DEVELOP PUS COLLECTION AT BOTH SITES, CULTURE OF THE LBS SITE WILL REVEAL MIXED ORGANISM8 DOMINATED THE MOST HARDY/IMMUNE RESISTANT, THE CULTURE OF ABSCESS WHERE TUMOUR WAS INJECTED WILL OFTEN YEILD A PURE CULTURE OF ORGANISM. EITHER FROM THE LBS(IF SHORT TIME PERIOD, INDICATING THAT WITH HIGHEST AFFINITY, BUT OCCASSIONALLY OTHER ORGANISMS WOULD BE CULTURED AS WELL; THESE WERE ASSUMED TO BE FROM OTHER LBS IN THE ANIMAL MODEL BUT MAY HAVE BEEN OTHER DISEASE-RELATED ORGANISMS FROM WITHIN THE

BIOPSY.), ANIMAL MODELS WERE NOT EXTENSIVELY USED FOR THIS TESTING AS A CLOSED SYSTEM SEEMED EASIER, MORE PRACTICAL AND MORE HUMANE).

THE BIOPSY FRAGMENT WERE THEN CULTURED INDIVIDUALLY IN SEPARATE

STERTILE MEDIA, MANY TYPES OF MEDIA COULD BE USED ,TSB IS CHOSEN

TO ILLUSTRATE PATENT.

WITHIN 2 WEEKS PURE CULTURES OF PENICILLIUM COULD BE ISOLATED

FROM FROM THE SIX DAY AND 3 WEEK SPECIMENS, MACROSCOPIC AND

MICROSCOPIC EXAMINATION REVEALED INFILTRATION OF BIOP8IES BY

PENICILLIUM MOULD.

EARLIER SAMPLES WERE VARIABLY POSITIVE BUT AT THREE WEEKS,GROWTH

EVEN IN THE SALINE-WASHED BIOPSY WAS DEFINITE. EACH OF THE BIOPSY PREPARATIONS SERVES A PURPOSE , SAMPLES REMOVED EARLY WILL CONTAIN ORGANISMS AND ORGANISM PRODUCTS CAPABLE OF FAST ATTATCHMENT AND SUPERFICIAL COATING. OPTIMAL DATA MAY BE OBTAINED IF CULTURE MEDIUM INCLUDES FRACTIONS OF OR IS LARGELY COMPRISED OF PATIENT' S BLOOD, ALTERNATIVELY, BIOPSY SAMPLES MAY BE TESTED ON SELECTED CULTURES GROWN ON HUMAN AND/OR PATIENT'S BLOOD AS A SECOND CHECK. USE OF BLOOD AND/OR OTHER SAMPLES OF HUMAN AND/OR ANIMAL ORIGIN DEPEND LARGELY ON LOCATION OF CANCER AND THERAPY TYPE BEING DEVELOPED.

ORGANISMS/AGENTS THAT ADHERE TO NORMAL TISSUE BIOPSY MAY BE USED TO IMMUNISE ANIMALS SO THAT ANTISERA OR OTHER IMKUNE RESPONSE COULD BE DEVELOPED TO INHIBIT THE DEVELOPMENT OF SUCH CHARACTERISTICS IN FURTHER CULTURES.

ORGANISMS THAT ATTATCH TO CANCER CELL/CANCER MASS SELECTIVELY MAY

BE USED TO DEVELOP TAGGING AND TARGETING

THERAPIES. TO BE COVERED LATER.

IN COMPLICATED LBS'S ORGANISMS/PRODUCTES AND OTHER FACTORS WILL BE FOUND THAT WILL PENETRATE TO VARIOUS DEPTHS AND ACT AT VARIOUS LEVEL(EG BACTERIALO COMPONENTS OF LBS MAY ATTATCH TO NECROTIC CENTRE OF MASS WHEREAS VIRAL COMPONENT OF LBS MAY ACT ON CELLULAR LEVEL.

AS WITH PREVIOUS PHASE, ORGANISMS FROM WASHED DISEASE BIOPSIES WILL BE PLACED ALONG WITH NORMAL AND PATHOLOGIC TISSUE UNTIL GROWTH ON PATHOLOGIC TISSUE IS FASTER AND MORE LUXURIOUS ON THE DISEASED AS OPPOSED TO THE NORMAL BIOPSY.

ORGANISKS CAN BE ISOLATED AND REINCUBATED REPEATEDLY UNTIL OBVIOUS AFFINITY FOR DISEASED TISSUE IS EXPRESSED, THIS MAY BE AIDED BY THE ANTISERA RAISED AGAINST ORGANISMS WITH AFFINITY FOR HEALTHY TISSUE AND/OR OTHER MECHANISMS AND FACTORS RAISING

CULTURE BIAS AGAINST THEM(ONCE THESE STRAINS ANDF TYPES ARE DEFINED AS EXPRESSING PREFERANCE TO HEALTHY OR DISEASED TISSUE; THE HEALTH- PREFERRED ORGANISM TYPES MAY BE

INHIBITED, REMOVED OR NEUTRALISED AND THOSE WITH DISEASE

PREFERANCE PROMOTED.

FOLLOWING THREE SUCH PASSAGES , THE PENICILLIUM ISOLATED FROM THE LEUKEMIC LYMPH NODE WAS PLACED INTO 500CC TSB AND CULTURED FOR THREE WEEKS THE MEDIUM WAS THEN PASSED THROUGH A 0.2 MICRON FILTER. 0.1CC OF THIS PRODUCT WAS ADDED TO PATIENT'S BLOOD, SAME PATIENT WHO HAD DONATED THE DISEASED NODE BIOPSIES . WHITE CELLS WERE CENTRIFUGED DOWN AND RESUSPENDED IN SALINE LEUKEMIA COUNT AT THIS TIME WA8 220,000 X 10 TO THE NINETH POWER PER CC. ICC OF SALINE SUSPENSION WAS USED.

RESUSPENDED IN SALINE AT 210,000 CELLS PER CC.

2 HOURS LATER COUNT WAS 200,000.

ORAL/INTRAMUSCULAR/INTRADERMAL/SUBCUTANEOUS DOSING ROUTES.

PATIENT WAS INJECTED WITH 3CC OF SCPE(SPECIFIC CRUDE PENICILLIN EXTRACT)INTRAMUSCULARLY . WBC COUNT BASELINE 220,000,24 HOURS LATER COUNT 180,000 REPEATED DOSE OF SCPE DROPPED COUNT TO

150.000 24 HOURS LATER. REPEATED DOSEAGE DROPPED LEVEL TO 120,000 THE WHITE BLOOD CELL COUNT REMAINED AT THAT LEVEL WITH VARIATIONS OF NO MORE THAN 20,000 FOR 6 WEEKS WITH DAILY DOSEAGE OF 3CC SCPE INTRAMUSCULAR THERE WAS NO FURTHER DROP DESPITE CONTINUED DOSEAGE. IN VITRO TESTING DEMONSTRATED LOSE OF EFFICACY OF SCPE. IN LEUKEMIA CELL KILL.

THIS SITUATION WOULD BE ANALAGOUS TO THE DEVELOPMENT OF

CHEMOTHERAPY RESISTANCE.

TO GENERATE NEW, EFFECTIVE THERAPY FROM THE SAME INITIAL

SOURCE, ANY NUMBER OF COINCUBATION METHODS WITH VARIOUS DEGREES OF

BIAS FOR THE PURPOSE OF THIS DEMONSTRATION, THE FOLLOWING WAS

DONE;

WHITE BLOOD CELLS FROM PATIENT WERE SPUN DOWN, RESUSPENDED IN

SALINE THEN SPUN DOWN AGAIN(IN THEORY, THIS PROCESS ALLOWS REMOVAL

OF OTHER BLOOD CELLS AND OTHER NORMAL BLOOD COMPONENT SO THAT

THESE ARE NOT ALSO TARGETED BY THE PENICILLIUM OR OTHER

THERAPEUTIC ORGANISM) .WHITE BLOOD CELLS ARE SPUN DOWN INTO A

PASTE AND THE ORGANISM IS INNOCULATED INTO THIS

PASTE. ESSENTIALLY, THEREFORE, THE LEUKEMIC CELLS FORM ALL OF THE

SOURCES OF NUTRITION FOR THE FUNGUS . THE PENICILLIUM MOULD GREW

RAPIDLY AND WITHIN 3 WEEKS THE 10 CM BY ONE CM CANCER PASTE WAS

TOTALLY REPLACED BY MOULD MACROSCOPICALLY.THIS MOULD WA8 THE

TNNOCULATED INTO 500CC OF TSB AND FOLLOWING 3 WEEKS OF CULTURE,

SCPE WAS AGAIN PREPARED AND TESTED AGAINST LEUKEMIA CELLS FROM

THE PATIENT. THIS SEC0ND GENERATION OF SCPE PROVED HIGHLY

EFFECTIVE. SALINE LEUKEMIA SUSPENSIONS OF 200,000 COUNT PER CC

WERE REDUCED TO 80,000 WITHIN THREE HOURS OF INCUBATION OF 1CC OF

SUSPENSION WITH 0.1CC OF SCPE SECOND GENERATION.

THIS PROCESS CAN AGAIN BE REPEATED WHEN RESISTANCE DEVELOPS TO

SECOND GENERATION SCPE.THE COMBINATION OF MULTIPLE

PHASES/GENERATIONS OF SCPE PROVES MORE EFFECTIVE AND LONGLASTING

THAN SINGLE PHASESTECHNIQUES PREVIOUSLY MENTIONED TO INCREASE

SPECIFICITY SUCH AS TESTING AGAINST NORMAL TISSUE, RAISING

ANTISERA TO FEATURES WITH ANTI-NORMAL EFFECTS AS WELL AS USING

BROAD OR EXPANDED LBS TO HAVE A LARGE SAMPLE GROUP FROM WHICH TO

CHOOSE.

PATET ALSO INCLUDES DESIGNING OF LBS FOR SELECTIVE TARGETING OF

CONDITIONS AS WELL AS CELL TYPES IT IS POSSIBLE TO CULTURE LBS

WITH ANAEROBICOR MICROAEROPHILIC CHARACTERISTIC8 FOR EXAMPLE

WHICH THEY MAY ENCOUNTER IN THE ANAEROBIC CENTRE OF TUMOUR MASSES

THE OBJECTIVE OF THIS AREA OF THE PATENT, HOWEVER , IS TO TEACH A PRINCIPLE THAT PRODUCTS OF ORGANISM A MAY BE MADE SPECIFIC FOR TARGET B AND SHOULD THAT TARGET DEVELOP RESISTANCE THEN CO-INCUBATION MAY ENABLE THE MODIFICATION OR EXPANSION OF THE ORGANISM'S ABILITY SO THAT IT IS AGAIN EFFECTIVELY ANTAGONISTIC TO TARGET.

SIMILAR EXPERIMENTS WERE CONDUCTED WITH ACTINOMYCETE AND STREPTOMYCETE SPECIES WHICH WERE ISOLATED BY LEAVING CANCER BIOPSIES OPEN TO AIRBORNE CONTAMINATION. AGAIN. AS RESISTANCE DEVELOPED , RE-COINCUBATION PRODUCED NEW EFFECTIVE PATHWAYS.

THIS PATENT APPLIED TO MODERN CANCER THERAPY ESSENTIALLY PRESENTS THE ABILITY TO CONSTANTLY DEVELOP NEW SAFE THERAPIES AND AS PREVIOUSLY SEEN. MULTIPHASIC THERAPY PROVES MORE EFFECTIVE THAN SINGLE GENERATION. COMPOUND MULTIPHASIC( WHERE 2 OR MORE

AT ITS SIKPLEST APPLICATION,WHERE THERAPEUTIC ORGANISMS ARE CULTURED IN MEDIUK PURELY OF TARGET AS IT EXISTS IN PATIENT OR IN EXPANDED FORM(EXPOSED TO PRIOR THERAPY OR MUTATING AGENTS TO EXPAND CELL CLONE NUMBER TO ANTICIPATE MUTATION) THERAPEUTIC PRODUCTS WHICH ARE HIGHLY EFFECTIVE MAY BE OBTAINED . WHEN THE ORGANISM EXTRACT AND DISEASE ARE CO-INCUBATED WHERE THE DISEASE MAY DEVELOP RESISTANCE; INCUBATION OF THERAPEUTIC ORGANISM ON CULTURE MEDIUM COMPOSED WHOLLY OF RESISTANT CELLS WILL ALLOW FOR THE DEVELOPMENT OF NEW AGENTS FROM THE THERAPEUTIC ORGANISM TO DEAL WITH RESISTANT CELLS.

PATENT GENERATION OF THERAPY BY INCUBATION OF MICROORGANISMS IN CULTURE MEDIA MOSTLY IF NOT WHOLLY COMPRISED OF TARGET.

ORGANISM CAN BE SIMILARLY PROCESSED TO YEILD NEW THERAPIES) CULTURE MEDIA WHOLLY OR MOSTLY COMPRISED OF TARGET TEND TO CONFER STRONG ACTIVITY AND SPECIFICITY TO THE THERAPEUTIC ORGANISM. OTHER TECHNIQUES SUCH AS DE-HUMANISING THE CANCER CELLS OR WHATEVER TARGET AS MAY ALLOW FOR DISEASE-SPECIFIC MEDIA WHICH WOULD, IN TURN FURTHER INCREASE SPECIFICITY AND EFFICACY. IN PRACTISE, WITH CANCER,THIS OFTEN LEADS TO MICROBIOLOGICAL COMPLICATIONS AS DEHUMANISING THE CELLS OFTEN STIMULATES THE EXPRESSION OF SYNERGISTIC OR CAUSATIVE ORGANISMS.

THE PRECEDING ARM OF INDUCED REMISSION THERAPY EXPLAINED THE USE PATENT TECHNOLOGY TO IMPROVE AND EXPAND CHEMOTHERAPY TO THE POINT WHERE AN ENDLESS ARMY OF SAFE. SPECIFIC CHEMOTHERAPEUTIC AGENTS COULD BE GENERATED.

IT ALSO HAS BEEN PROVEN THAT KANY ORGANISKS SUCH AS PENICILLIUM MOULD CAN EXERT POWERFUL ANTICANCER PROPERTIES . THIS PATENT COVERS THE USE OF CRUDE AND PURIFIED SPECIFIC EXTRACTS OF PENICILLIN IN THE TREATKENT OF CANCER AND AIDS

TESTS FOR BOTH CANCER AND AIDS WERE CONDUCTED WITH PENICILLIUM, STREPTOMYCETES, KAMBUCHA, ACTINOMYCETES , ASPERGILLI AS WELL AS OTHER UNIDENTIFIED MOULDS, IN EACH CASE, EVEN WHERE THERE WAS NO PREVIOUS ANTIDISEAE ACTIVITY OR SPECIFICITY, THESE WERE ENABLED BY THE PRECEDING TECHNOLOGY.

THE ABOVE SECTION RELATED TO TARGETING OF DISEASED CELLS AND CANCER MASSES BY FUNGII AND WAS DESIGNED TO ILLUSTRATE HOW STANDARD CHEMOTHERAPY TECHNIQUES COULD BE IMPROVED, TAILORED AND EXTENDED .

USE OF VIRAL /BACTERIAL AND OTHER

B IOLOG I CAL AGENTS TO ATTACK D I SEASED CELLS - ( THIS IS DIFFERENT TO TAGGING AND TARGETING THERAPY

ALTHOUGH OVERLAPPING MECHANISMS MAY EXIST)

VIRUSES AND BACTERIA MAY BE PROCESSED IN MUCH THE SAME WAY AS THE PENICI LLIUM WAS PROCESSED , HOWEVER , THERE ARE DISTINCTIVE FACTORS

ALSO IN BIOLOGICAL MECHANISMS AS WELL AS SPEED OF CO-CULTURE.

VIRAL USE

CHOOSING AND DEVELOPING SPECIFICITY

EPIDEMIOLOGICAL, LOGICAL AND OTHER SEARCH TECHNIQUES WERE

PREVIOUSLY COVERED.

DIRECT INFECTION-VIRAL

VIRUSES TO BE USED AS EXAMPLES IN DEMONSTRATION OF USE OF VIRUSES

AS THERAPEUTIC AGENTS ARE LISTED BELOW BUT NOT INTENDED TO

RESTRICT PATENT, THESE AND ALL OTHERS ARE COVERED UNDER THE

GUIDELINES OF THIS PATENT.

FELINE PANLEUKOPENIA VIRUS

CANINE DISTEMPER VIRUS

NEWCASTLE VIRUS

PIDGEON POX

MEASLES VIRUS

MUMPS VIRUS

THE8E WERE USED BECAUSE OF READY AVAILABILITY AND BECAUSE OF

RELATIVE HUMAN SAFETY.

FELINE PANLEUKOPENIA VIRUS AND CANINE DISTEMPER VIRUS WERE CHOSEN

FOR THE LEUKEMIA MODEL .

BLOOD WAS COLLECTED FROM PATIENT WITH CHRONIC LYMPHOCYTIC

LEUKEMIA COUNT 88,000.

FELINE PANLEUKOPENIA VIRUS WAS CHOSEN AS IT LOGICALLY APPEARED A

GOOD AGENT FOR INFECTING ROGUE WHITE BLOOD CELLS.

PREVIOUS STUDIES CIRCA THE MID 50'S DEMONSTRATED THE ABILITY OF

VACCINATION WITH FELINE PANLEUKOPENIA VIRUS TO CAUSE TEMPORARY

REMISSIONS OF LEUKEMIA, LASTING SEVERAL WEEKS AFTER SINGLE DOSE. THERE ARE SEVERAL MODIFICATIONS PRESENTED BY THIS PATENT.FPLV WAS PREVIOUSLY ADMINISTERED IN SINGLE DOSE AND OCCASSIONALLY CORTICOSTEROIDS TO ALLOW MAXIMUM TIME FOR INFECTION TO ATTACK TARGET BEFORE IMMUNE REJECTION TAKES PLACE . SUCH TECHNIQUES SELDOM IMPACTED FAVOURABLY ON THE DISEASE, LEUKEMIA INVARIABLY RECURRED WITH RAPID DEATH WITHIN WEEKS TO MONTHS.

IT SEEMED THAT AS A UNIMODAL THERAPY VIRAL INFECTION OF LEUKEMIA CELLS WAS INEFFECTIVE LONGTERM, YET, OBVIOUSLY THE THERAPY WAS EFFECTIVE IN THE SHORTERM, POSSIBLE HYPOTHESES FROM THIS

OBSERVATION FOLLOW;

1-DISEASE MUTATES TO RESIST VIRUS

3-VIRUS CHANGES IN SOME WAY SO THAT IT IS NO LONGER DAMAGING TO DISEASE, IN MANY CASES REPORTED,THE RECURRENCE OF DISEASE AFTER INITIAL RESPONSE WAS EVEN MORE AGGRESSIVE THAN BEFORE, IT IS POSSIBLE THAT THE VIRUS EITHER STRENGTHENS THE DISEASE OR WEAKENS THE HOST IN THE LONGTERM.

THE ANSWER APPPEARS TO LIE IN A MIXTURE OF 1 AND THREE

LARGELY; ALTHOUGH IMMUNE ELIMINATION OF VIRUS MAY BE A FACTOR IT DOES NOT APPEAR TO BE MAJOR.THIS IS STATED FOLLOWING OBSERVATIONS THAT CORTICOSTEROID AND OTHER INHIBITION OF IMMUNE RESPONSE DOES NOT SEEM TO FAVOURABLY EFFECT OUTCOME ; FURTHERMORE , IF THE IMMUNE RESPONSE DOES ATTACK THE VIRUS IT SHOULD ALSO ATTACK THE VIRALLY

-INFECTED CANCER CELLS.

VIRAL MUTATION TO LESS AGGRESSIVE FORM ALSO D0E8 NOT SEEK TO BE A MAJOR FACTOR AS INFECTED CELLS , WHEN REMOVED FROM PATIENT SEVERAL WEEK8 INTO THERAPY WILL EXHIBIT INFECTION AND RAPID LYSIS OF LEUKEMIA CELLS WHICH HAVE NOT BEEN PREVIOUSLY EXPOSED TO IT.

IT APPEARS THAT THE MAJOR FACTOR AT PLAY IS THE ADAPTION AND/OR MUTATION OF CANCER CELLS TO SURVIVE AND FUNCTION WHILE CO-EXISTING WITH VIRAL INFECTION( ANOTHER FEATURE WHICH APPEARS TO INDICATE THAT VIRUS MAINTAINS ACTIVITY AND THAT IMMUNE RESPONSE DOES NOT PROTECT CANCER CELLS FROM THE VIRUS IN THE LONGTERM IS THAT THE CYTOPLASMIC VACUOLATION WHICH MARKS VIRAL ACTIVITY CASN BE SEEN IN THE MAJORITY OF CANCER CELLS EVEN AFTER RECURRENCE OF DISEASE. THESE CELLS ARE CAPABLE OF INFECTING OTHERS THAT HAVE NEVER BEEN EXPOSED TO THE VIRUS . ) ATTEMPTS TO DEVELOP VIRUSES WITH GREATER ANTICANCER VIRULENCE HAVE INVOLVED REPEATED PASSAGES OF VIRUS THRUGH CANCER CELL GENERATIONS; AS SEEN FROM THE ABOVE, IT APPEARS THAT VIRUS AND CANCER DEVELOP A SYNERGISTIC RELATIONSHIP AFTER THE INITIAL THERAPEUTIC RESPONSE HENCE ATTEMPTS TO DEVELOP GREATER VIRULENCE THROUGH REPEATED PASSAGING WAS, NOT

SURPRISINGLY, OFTEN MET WITH FAILURE.

A CASE DESCRIBING THESE FEATURES WILL NOW BE DESCRIBED.

FEMALE 50, WITH 6 YEAR HISTORY OF CHRONIC LYMPHOCYTIC LEUKEMIA PRESENTS WITH RISING WHITE BLOOD CELL COUNT -30,000 AT

PRESENTATION AND 87% LYMPHOCYTES. PATIENT WAS UNRESPONSIVE TO CHEMOTHERAPY. IT WAS DECIDED TO ATTEMPT RAPID LEUKEMIA SATURATION WITH VIRUS AND RAISE MINIMAL IMMUNB RESPONSE WITHOUT USING IMMUNOSUPPRESSIVE TECHNIQUES (AS NOTED STEROIDS HAD PROVEN OF NO USE IN PRIOR EXPERIMENTS.)WHITE BLOOD CELLS OF PATIENT WERE SPUN DOWN AND SEPARATED, THEY WERE THEN RESUSPENDED AT 100 , 000 X 10 TO THE NINETH POWER PER CC IN 5CC OF SALINE . FELINE PANLEUKOPENIA VIRUS 1 CC AS PRESENTED FOR VETERINARY USE WAS INCUBATED WITH THE LEUKEMIA CELLS FOR 24 HOURS THE CELLS WERE THEN WASHED WITH 10 CC OF SALINE THREE TIME8 (CELLS WERE SPUN DOWN THEN RESUSPENDED IN 10CC OF SALINE THREE TIMES). THE POINT OF THIS PROCEDURE IS TO INTRODUCE AS MUCH OF THE VIRUS INTRACELLULARLY AS POSSTBLE, MINIMISING FREE VIRUS INJECTION AND INCREASING DELIVERY DOSE . PATIENT ' S INFECTED CELLS DEMONSTRATED CYTOPLASMIC

INCLUSIONS . THEY WERE PLACED INTO 500CC OF SALINE AND INJECTED INTRAVENOUSLY INTO THE PATIENT (APPROXIMATELY 500,000 X 10 TO THE NINETH POWER INFECTED CELLS) INTRAVENOUS DRIP INJECTED OVER A SIX HOUR PERIOD. PATIENT WAS OBSERVED FOR SIGNS OF A REACTION, NONE WAS NOTED.

PROCEDURE WAS REPEATED DAILY FOR SIX DAYS.SLIGHT TEMPERATURE (100 DEGREES CELSIUS)WAS NOTED BUT ONLY LASTED FOR A FEW HOURS ON DAY THREE. NO OTHER SIDE EFFECTS WERE NOTED. BY THE SECOND DAY WBC COUNT HAD DROPPED TO 25, 000; AND PERHAPS MORE SIGNIFICANTLY, LYMPHOCYTE PERCENTAGE DROPPED TO 65% OVER 24 HOURS,BLOOD SMEAR SHOWED 30% OF WHITE BLOOD CELLS WITH CYTOPLASMIC INCLUSIONS . BY THE SECOND TEST(48 HOURS AFTER FIRST INJECTION) WBC COUNT HAD DROPPED TO 15,000 AND 80% OF WBC DEMONSTRATED CYTOPLASMIC

INCLUSIONS . LYMPHOCYTE PERCENTAGE DROPPED TO 50%. IT IS NOTED HERE THAT, ALTHOUGH THE PRACTISE OF INJECTING INFECTED CANCER CELLS INTO THE PATIENT IS AN ADVANCED FORM OF GENE THERAPY, SUPERIOR SEPARATION TECHNIQUES, WHERE LEUKEMIC CELLS CAN BE SEPARATED FROM NORMAL WHITE BLOOD CELLS AND OTHER NORMAL CELLS VIRUS MAY BE

RESTRICTED TO INFECTION OF LEUKEMIA CELLS SEE ALSO

SPECIFICATION TECHNOLOGY TO BE DISCUSSED LATER.

IMPROVEMENT CONTINUED,THE NIGHT SWEATS WHICH HAD PLAGUED THE PATIENT FOR THREE YEARS STOPPED AFTER THIRD TREATMENT. WBC AND PERCENTAGE LYMPHOCYTES WILL NOW BE DISPLAYED FOR SUBSEQUENT DAYS DAY3-11,000 - 50%

DAY4- 9,800- 54%

DAY5- 7,200- 48%

DAY 6- 5,600- 34%

AT THE END OF 1 WEEK, ALL WBC'S STILL DISPLAYED CYTOPLASMIC

VACUOLATION, DAY 12 PATIENT SPIKED A FEVE OF 104 CELSIUS WHICH LASTED FOR THREE HOURS . WBC COUNT 3 , 200-20%LYMPHOCYTES . DAY 15 SHOWED A DROP IN PERCENTAGE OF WBC'S WITH INCLUSION

BODIES; NEUTROPHILS AND OTHER NORMAL CELLS REGAINED NORMAL

MORPHOLOGY. A PERCENTAGE OF LYMPHOCYTES (15%)CONTINUED TO DISPLAY INCLUSION BODIES ALTHOUGH NO BIZARRE NUCLEAR CHANGES OR HEAVY CHROMATIN STAINING SUGGESTIVE OF MALIGNANCY WERE PRESENT.

PATIENT REMAINED IN REMISSION FOR 6 WEEKS,FOLLOWING WHICH THE COUNTS OF WBC AS WELL AS % OF LYMPHOCYTES BEGAN TO RISE. BY WEEK 8 COUTS WERE 20, 000-B4%.ALMOST ALL LEUKEMIC CELLS DEMONSTRATED CYTOPLASMIC INCLUSION BODIES SUGGESTIVE OF CONTINUED VIRAL ACTIVITY IN THE LEUKEMIC CELLS.CO-INCUBATING THESE CELLS WITH NORMAL AND/OR LEUKEMIC WBC FROM ANOTHER SOURCE RESULTED IN

INCLUSION BODIES AND CELL LYSIS OF THE NEW CELLS HENCE PROVING THAT VIRUS WAS STILL ACTIVE . ELEVATION OF INTERFERON AND

INTERLEUKIN LEVELS WAS NOTED AT START OF THERAPY . THESE REMAINED ELEVATED; THE IMMUNE SYSTEM WAS , HOWEVER , APPARENTLY AS BLIND TO THE VIRUS AS IT WAS TO THE CANCER CELLS.

STAGE 2 VIRAL THERAPY

THE SECOND STAGE OF VIRAL THERAPY ATTEMPTED INVOLVED THE INTRODUCTION OF ANOTHER VIRUS WITH AFFINITY FOR LEUKEMIA IN ITS MODE OF APPLICATION.CANINE DISTEMPER VIRUS WAS NOTED IN IN-VITRO STUDIES TO CAUSE NUCLEAR VACUOLATION AND CELL DESTRUCTION IN LEUKEMIA CELLS(OTHER STUDIES ALSO DEMONSTRATED THAT CULTURING MANY FORMS OF VIRUSES IN LEUKEMIA CELLS THEN INJECTING INFECTED LEUKEMIA CELLS INTO THE BODY WOULD LEAD TO THE

PREFERRENTIAL, ACCELERATED INFECTION OF OTHER LEUKEMIA CELLS. EVEN IN CASE DISCUSSED ABOVE IT CAN BE 8EEN THAT MASSIVE IMPROVEMENT OCCURRED BEFORE MAXIMUM VIRAEMIA ON DAY 12,PRIOR USE OF VIRAL; VACCINES WOULD NECEBSITATE DAYS TO WEEKS PRIOR TO MARKED IMPROVEMENT BEING EVIDENT ; IT IS AS IF LEUKEMIC CELLS/CELL

FRAGMENTS FORM OPTIMAL VECTORS FOR THE DELIVERY OF VIRAL AGENT TO OTHER LEUKEMIC CELLS . THE INTRACELLULAR VIRAL REPLICATION AND HENCE AMPLIFICATION OF ADMINIBTERED DOSEAGE IS ALSO A FEATURE OF THIS PATENT.

CANINE DISTEMPER VIRUS WAS INCUBATED WITH THE RECURRED LEUKEMIA CELLS FOR 24 HOURS AS PER PREVIOUS TECHNIQUE DESCRIBED FOR FELNE PANLEUKOPENIA VIRUS . NUCLEAR VACUOLATION WAS APPARENT WITHIN 24 HOURS. PROTOCOL DESCRIBED ABOVE WAS REPEATED.

IT APPEARED THAT THE SAME PROCESS TOOK PLACE WHEREBY THE LEUKEMIA CELLS BECAME RAPIDLY INFECTED AND WBC DROPPED INTO NORMAL RANGE WITHIN 10 DAYS.LEUKEMIA CELLS ONLY APPEARED TO BE INFECTED IN THIS SECOND STAGE OF VIRAL; INFECTION AND DISPLAYED BOTH THE CYTOPLASMIC INCLU8IONS OF THE FPLV AND NUCLEAR VACUOLATION OF THE CDTV. PRESUMABLY, THE VIRAL INTERFERANCE PHENOMENON PROTECTED NORMAL CELLS BUT WAS NOT AS PROTECTIVE FOR LEUKEMIA CELLS.COUNT8 REMAINED WITHIN NORMAL RANGE FOR A PERIOD OF 4 WEEKS THE DISEASE RECURRED; DEMONSTRATING BOTH NUCLEAR VACUOLATION AND CYTOPLASMIC INCLUSIONS.CELLS RETAINED INFECTIVE CAPACITY FOR CDTV AND FPLV. OTHER IN-VITRO; ANIMAL AND HUMAN STUDIES WERRE CONDUCTED WHERE A THIRD STAGE THERAPY WITH FOWL POX VIRUS WAS ADDED AS WELL AS THE USE OF 2 OR MORE VIRUSES TOGETHER IN INFECTING AND DESTROYING LEUKEMIA CELLS. IT APPEARED THAT THE COMBINATION OF CDTV AND FPLV DESTROYED MORE LEUKLEMIA CELLS IN-VITRO THAN EITHER ONE ALONE;YET IN THE LIVING SYSTEM, ALTHOUGH BOTH INFECTED THE LEUKEMIC CELL AND CAUSED REMISSION, THAT WAS AS SHORT LASTING AS USING ONLY ONE AGENT. IN THESE LIMITED TRIALS, THE SEQUENTIAL USE OF VIRAL AGENTS COULD REPEATEDLY CAUSE

CARRY HUMAN ANTIGENS ON V

TARGETING OF CAUSATIVE AND SYNERGISTIC

ORGANISMS.

ASCITESD/EFFUSIONS HAVE ORGS

IDENTIFY, ANTIBIOTIC, TAG , PHAGE, INTERFERANCE , CARRIER OF ORGS/TARGET CELLS

INDUCED REMISSION THERAPY INCLUDING LBS ROLE IN MINIMISING SUPRADDED INF, OTHER DISEASE, PHAGE./PLASMID DONORS.

GENETIC/OTHER IMBALANCE EVIDENT BY ATTACK

;IF THE SEARCH FOR AGENTS AND ORGANISMS THAT 'STICK ' TO CANCER CELLS AND/OR CELL MASSES IS MADE WITH THE PURPOSE OF TAGGING SUCH TARGETS

TO SURFACE LIGHT AMPLIFYING X-RAYS.

BROAD , DEFINED , SPECIFIC, EXPANDED NATURAL , /ARTIFICIAL

(FPLV, CDV, FOWL POX VIRUS) DID NOT EXTEND REMISSION TIME ACHIEVED BY FPLV ALONE(UNLESS THEY WERE APPLIED IN SEQUENCE RATHER THAN SIMULTANEOUSLY).

IT APPEARS THAT ANTIVIRAL IMMUNOLOGICAL RESPONSE IS HAMPERED WHEN THE VIRUS IS INTRACELLULAR IN LEUKEMIA CELLS. TWO OBERVATIONS ARE IMPORTANT, THE LEUKEMIA CELLS DISPLAY VIRAL ACTIVITY YET THERE ARE NO SYSTEMIC MANIFESTATIONS OF THE VIRUS UPON LEUKEMIA RECURRENCE; FURTHERMORE , RE-ACTIVATION OF VIRUS APPEARS RESTRICTED AND LIMITED, THE LONGER IT IS ASSOSCIATED WITH THE LEUKEMIA; IT IS AS IF THE VIRUS INCORPORATES AND SYNERGISES, WITH THE LEUKEMIC CELL MECHANISM, VIRAL RECOVERY AND INFECTION OF OTHER CELLS

DECREASES.

VIRAL SOURCE SHOULD ALSO BE CONSIDERED.MOST VACCINES ARE CULTURED ON EMBRYONIC CELLS OR ON CONTINUOUS CELL LINES(CANCER CELLS) A CHANCE OF VIRAL ADAPTATION ALREADY THEREFORE MAY HAVE TAKEN PLACE . MANY VIRUSES ARE ABLE TO CANNIBALISE FRACTIONS OF CELLS IN WHICH THEY ARE CULTURED AND EXPRESS THEM. SPONTANEOUS REMISSION FOLLOWING VIRAL INFECTION AND/OR TRIALS USING VIRUSES TO INFECT CANCER CELLS HAVE DEMONSTRATED MAXIMAL EFFECTS AFTER INITIAL INCUBATION PERIOD OF SEVERAL DAYS . TO THREE WEEKS;THIS TIME PERIOD ALLOWS FOR MAXIMUM VIRAL CELL LYSIS AS WELL AS ANTIVIRAL IMMUNOLOGICAL RESPONSE.

AS SPONTANEOUSLY CONTRACTED VIRUSES ARE LIKELY TO BE MORE VIRULENT AS WELL AS CARRY OTHER ANTIGENS RELATED TO THE PERSON OR SPECIE FROM WHICH THEY ORIGINATED, BOTH THE VIRAL DESTRUCTIVE EFFECT AS WELL AS ANTIVIRAL IMMUNE RESPONSE ARE LIKELY TO BE STRONGER THAN RESPONSE AND EFFECT CAUSED BY THE ATTENUATED FORMS AVAILABLE FOR VACCINES WHICH BY CULTURE IN CANCER CELL LINES NOT ONLY RISK CARRYING HARMFUL FACTORS, BUT ALSO ARE THUS ATTENHUATED IN THEIR ANTICANCER ABILITY AS WELL..

THE RECURRENCE OF CANCER FOLLOWING VIRAL-INDUCED REMISSION IS OFTEN MOPRE AGGRESSIVE THAN PREVIOUS CANCER ACTIVITY; THIS MAY BE DUE TO HOST FACTOR DEPLETION BY VIRAL INFECTION, E .G.BY DIRECT VIRAL ACTIVITY . BY ALLOWING SUPERADDED INFECTION OR OPPURTUNISTIC INFECTION TO ENTER THE SYSTEM. OR BY THRESHOLD INHIBITION OF IMMUNE RESPONSE; IF VIRUS REACHES ADEQUATE LEVELS , AND EXPRESSES ITSELF ON THE CANCER CELL SURFACE IT MAY BY THRESHOLD EFFECT LEAD TO FURTHER IMMUNE RESISTANCE OF CANCER CELLS.

WHEREAS CANCER CELLS ARE ABLE TO ADAPT TO AND INCORPORATE THEIR VIRAL INVADERS TO A POINT WHERE DIRECT VIRAL ACTIVITY IS NO LONGER A VIABLE PROBLEM FOR THE DISEASE, WHEREAS SOME OF THE ANTIDISEASE PROPERTIES OF THE VIRUS MAY BE

NEUTRALISED, MAINTENANCE OF CELL INTEGRITY IN THE FACE OF FURTHER CHALLANGE MAY BE COMPROMISED; INITIAL STUDIES APPEAR TO INDICATE THAT SENSITIVITY TO OTHER CHEMICAL OR PHYSICAL THERAPIES RISES DEPENDING ON THE NUMBER OF VIRAL STAGES USED.

THE AGGRESSIVENESS OF THE TUMOUR UPON ITS RECURRENCE MAY BE DUE TO A PROCESS OF CLONE SELECTION; WHERE THE CANCER CELLS SURVIVING ARE THOSE THAT DIVIDE RAPIDLY, PRIOR TO VIRUS REACHING DEADLY LOAD, THE DIVISION TIME OF CELL AND VIRUS MAY EVEN SYNCHRONISE IN

SOME WAY; THE PRESENCE OF THE VIRUS MAY EVEN CHOOSE FOR OR CAUSE

THE REVERSION OF CELLS TO MORE PRIMITIVE , UNDIFFERENTIATED

LEVELS(THIS RAISES THE INTERESTING HYPOTHESIS THAT AS CANCER CELL

DIVIUSION RATES MAY SYNCHRONISE WITH INVADING VIRUS THAT SLOW

VIRUSES OR VIRUSES INBERTED THEN INHIBITED IN SOME WAY MAY SLOW

CANCER REPLICATION.

THERE APPEARS TO BE A LIMIT IN CANCER CELL'S COPING ABILITY WITH

SUPERADDED INFECTIONS TO THE POINT WHERE A SPECIFIC OR MULTIPLE

INFECTIONS CAN TAX THE CANCER CELLS ABILITY TO COPE WITH FURTHER INSULTS , EVEN WHERE SUCH INSULTS WERE PREVIOUSLY INEFFECTIVE.

THERE APPEAR TO BE THREE TIMES AT WHICH FURTHER INTERVENTION MAY

OPTIKISE RESULTS;

1-INITIAL VIRAL SATURATION

2-POINT OF OPTIKAL EXPRESSION

3-TIKE OF ADAPTATION/RECURRENCE

INITIAL VIRAL SATURATION

OPTIMAL, RAPID TUMOUR LOAD DECREASE CAN BE ACCOMPLISHED BY THE

GUIDELINES OF THIS PATENT WHEREBY TARGET CELLS ARE INCUBATED WITH

VIRUS PRIOR TO REINSERTION INTO THE SYSTEM. SLOW INTRAVENOUS

INSERTION OF VIRUS AND VIRALLY TAGGED CELLS SEEK TO SATURATE

DISEASED CELLS .USE OF CORTISONE TO FASCILITATE DISEASED CE4LL

SATURATION(IE EXTEND UNOPPOSED PERIOD OF VIRAEMIA),THIS IS NOT

RECOMMENDED AS NORMAL CELLS THEN ALSO BECOME AT INCREASED RISK OF

VIRAL INFECTION.

IF MULTIPLE VIRUSES ARE TO BE USED SIMULTANEOUSLY, THEIR

COMPATIBILITRY IN CULTURE AND MECHANISMS SHOULD FIRST BE

DEMONSTRASTED SO THAT INTERFERANCE DOES NOT OCCUR BETWEEN

THEM. OPTIMISING THE VIRAL VECTOR CAN BE ACCOMPLISHED BY SEVERAL

PROCESSES.

1-INCREASING AFFINITY OF VIRUS FOR CANCER CELLS.

SELECTIVE CULTURE AND 'WASHING' PROCEDURES MAY BE DONE TO ISOLATE

MOST SPECIFIC STRAINS. AS WITH THE PENICILLIUM EXAMPLE PREVIOUSLY

DESCRIBED LBS OF THE VARIOUS CLASSIFICATIONS MAY BE INCLUDED IN

SALINE.WASHING RELATES TO THE REPEATED ADDITION OF NORMAL CELLS

TO THE SOLUTION AND, ALLOWING 30 MINUTES FOR ADSORPTION AND THEN

SPINNING DOWN AND REMOVING CELLS SEVERAL TIMES UNTIL THE FINAL

BATCH OF SPUN DOWN CELLS SHOW MINIMAL TO NO VIRAL INFECTION AFTER

24 HOUR CULTURE. THE REMAINING PORTION OF THE LBS IS LIKELY TO

THEREFORE HAVE LITTLE AFFINITY FOR THE HEALTHY CELLS TESTED.

IN SELECTING FRACTIONS OF LBS WITH PARTICULAR AFFINITY FOR CANCER

CELLS.THEY CAN BE ADDED ALONG WITH COMPLIMENTARY NORMAL CELLS TO

THE SOLUTION AND ADSORPTION ALLOWED TO OCCUR OVER,SAY 30

MINUTES , SUBSEQUENT SEPARATION AND INCUBATION OF CANCER CELLS ONLY

WILL IN THEORY YEILD VIRUS WITH PREFERRED AFFINITY FOR CANCER

CELLS.THESE CELLS ARE CULTURED TO LYSIS.VIRUS RESUSPENDED AND

EXPOSURE TO NORMAL AND HEALTHY CELLS AGAIN

UNDERTAKEN . ADSORPTION, CULTURE , SEPARATION PROCEDURE IS REPEATED

UNTIL ONLY CANCER CELLS APPEAR INFECTED, VIRUS THEN MAY BE SAID TO

HAVE PARTICULAR AFFINITY FOR TUMOUR CELLS.

MANY VIRUSES WILL DEVERLOP TUMOUR CELL AFFINITY; CANCER CELLS HAVE

OFTEN BEEN REPORTED TO HAVE VIRAL STRUCTURES AND IT IS BELIEVED

THAT CANCER CELLS HAVE RESTRICTED RESISTANCE TO VIRAL INFECTION

AS COKPARED TO NORMAL CELLS . AS THESE CELLS ARE ABLE TO SURVIVE WITH KULTIPLE INFECTIONS IT CAN BE SEEN WHY SUCH CELLS APPEAR TO SUIRVIVE IN A CHAOS DEADLY TO NORMAL CELLS . HENCE DO NOT NEED OTHER DEFENSE HECHANISMS AS ADVANCED AS THOSE OF NORMAL CELLS.. IN-VITRO TESTING , HOWEVER SHOWS TOTAL CELL LYSIS OF PERIPHERAL CIRCULATING LEUKEMIA CELLS, IT IS LIKELY THAT RESISTANCE BEGINS IN THE BONE MARROW OR WHEREVER STEM CELLS MAY BE. INCUBATION OF BONE MARROW LEUKEMIA CELLS WITH VIRUS , SEARCHING FOR OPTIMAL LYTIC FRACTION.

DURING THIS TIME IT HAS BEEN SHOWN THAT ANIMAL OR HUMAN ANTISERA TO THE

WITH MULTIPLE INFECTIONS IT CAN BE SEEN WHY SUCH CELLS APPEAR TO SUIRVIVE IN A CHAOS DEADLY TO NORMAL CELLS, HENCE DO NOT NEED OTHER DEFENSE MECHANISMS AS ADVANCED AS THOSE OF NORMAL CELLS..

IN-VITRO TESTING, HOWEVER SHOWS TOTAL CELL LYSIS OF PERIPHERAL CIRCULATING LEUKEMIA CELLS, IT IS LIKELY THAT RESISTANCE BEGINS IN THE BONE MARROW OR WHEREVER STEM CELLS MAY BE. INCUBATION OF BONE MARROW LEUKEMIA CELLS WITH VIRUS, SEARCHING FOR OPTIMAL LYTIC FRACTION.

OPTIMISING VIRAL SATURATION INVOLVES IDENTIFICATION OF TARGET IN WHATEVER MANIFESTATION (STEM CELL, CIRCULATING PERIPHERAL CELL ETC.), INCUBATING ALL CELL FORMS POSSIBLE WITH VIRUS, USE OF VIRUS CULTURED FOR SPECIFICITY IN FREE FORM AS WELL TO SATURATE ALL TARGET CELLS.

VIRUS AS CARRIER

MANY SPONTANEOUS REMISSIONS HAVE BEEN REPORTED SUBSEQUENT TO INFECTION WITH ANIMAL VIRUS OR VIRUS FROM OTHER HUMKAN CARRIER,IN BOTH CASES IT IS LIKELY THAT VIRUS MAY HAVE CANNIBALISED CELLULAR STRUCTURES FROM PREVIOUS HOST WHICH MAY SIGNIFICANTLY FIGURE ANTIGENICALLY.

IT IS THEREFORE A FEATURE OF THIS PATENT THAT VIRUSES TO BE USED IN THE THERAPY OF CANCER SHOULD BE INITIALLY CULTURED ON IMMUNOGENIC MEDIA .SUCH AS ADULT, PERHAPS EVEN NON-HUMAN SOURCES. IN THEORY, ALLOWING THE VIRUS TO CANNIBALISE ANTIGENIC STRUCTURES AND/OR GENETICS THAT EXPRESS ANTIGENIC STRUCTURES, ENABLES THEIR EXPRESSION TO MARK CANCER CELLS MORE STRONGLY, IE TO GIVE NON-SELF ANTIGENS AS WELL AS VIRAL ANTIGENS FOR THE IMMUNE SY8TEM TO

RESPOND AGAINST.

IT APPEARS THAT THE ABILITY OF CANCER TO MUTATE SO READILY IS AT

LEAST IN PART DUE TO ITS EXISTANCE IN AN OPEN SYSTEM WHERE IT CAN

READILY ABSORB AND INCORPORATE OTHER ORGANISMS; THESE ORGANISMS

MAY, IN TURN, ABSORB AND INCORPORATE CANCER-REL; ATED INFORMATION

WHICH MAY ALLOW THEM TO BE USED AS A VECTOR IN ITS PREPETUATION

AND/OR SPREAD. NUMEROUS STUDIES HAVE SHOWN THAT ORGANISMS ISOLATED

FROM CANCERS, WHEN INJECTED INTO ANIMALS,CAUSE GENERATION OF

CANCER IN ANIMAL (ALEXANDER, LIVINGSTON, SCOTT)

IN RESPONSE TO MANY INFECTIONS AT LEAST ONE AND USUALLY ALL THREE

OF THE FOLLOWING PHASES WILL BE DESCRIBED;

1-CANCER SHRINKAGE/LOSS OF DENSITY

2-CANCER SPREAD/ACCELLERATION OF GROWTH (ORGANISM OF INFECTION

STILL IDENTIFIABLE/CULTUREABLE)

3-AGGRAVATION OF DISEASE CONDITION/FAILURE OF HOST SYSTEM/DEATH.

FOR EVERY INFECTIOUS/OTHER ORGANISM TIME AND POTENTIALS MAY BE

ESTIMATED FOR ANTIDISEASE ACTIVITY/DISEASE SYNERGY.

INTERNAL OR EXTERNAL INTERVENTION ALONG ANY OF THESE PHASES MAY

DRASTICALLY EFFECT OUTCOME.

AS PREVIOUSLY DEFINED, THERE IS AN INITIAL PERIOD OF VIRAL SATURATION WHERE THE THERAPEUTIC OBJECTIVE IS TO ACCOMPLISH AS COMPLETE A SATURATION OF DISEASE AS POSSIBLE; HOPEFULLY WITH .AN ORGANISM WHICH HAS BEEN MADE HIGHLY SPECIFIC AND AGGRESSIVE.

IMMUNOLOGICAL OR OTHER THERAPY.

HOWEVER,USUALLY BE A MORE AGGRESSIVE DISEASE UPON ITS RECURRENCE. DEPENDING ON WHETHER OR NOT THE ORGANISM HAS SURVIVED IN ACTIVE FORM,THE CANCER CELL MAY STILL PROVE TO BE SENSITIVE TO OTHER THERAPY ( IF ORGANISM/S ARE STILL ACTIVE, THEY MAY BE TAXING THE CANCER CELL'S ABILITY TO COMPENSATE FOR FURTHER INSULTS SUCH AS CHEMOTHERAPY OR RADIOTHERAPY.

USING VIRUSES AS ADJUNCTS TO CONVENTIONAL THERAPY.

SITE. INTRAMUSCULAR/INTRADERMAL AND SUBCUTANEOUS ROUTES WERE ALL TRIED.

PATENT COVERS THE USE OF THIS FAMILY OF VIRUSES IN THE TREATMENT OF CANCER ALONE, AND/OR IN COMBINATION WITH OTHER THERAPY.

VIRUSES KAY BE PASSAGED THROUGH TUMOUR CELLS AND TESTED FOR EFFICACY AND SPECIFICITY AS WELL AS AUGMENTING THESE CHARACTERISTICS.

PATIENT, 38 PRESENTED WITH GRAPEFRUIT SIZED BREAST CANCER WITH ATTATCHMENT TO PECTORAL MUSCLES SDIMPLE SURGERY WAS NOT POSSIBLE AND CANCER HAD GROWN DESPITE CHEMOTHERAPY AND LOCALISED RADIATION. FOR THREE DAYS.DAILY INTRATUMOURAL APPLICATION OF THE PIGEON-POX VIRUS WAS DONE AT 3 SEPARATE SITES SURROUNDING THE TUMOUR PATIENT DEVELOPE AN AREA OF ERYTHEMA ABOUT 2CC DIAMETER AT SITE OF EACH INJECTION (MADE AT 3 CM DEPTH INTO TUMOUR WHICH WAS ATTATCHED TO SKIN)THE END OF THE THIRD DAY OF APPLICATION COULD BE NOTED AS OPTIMAL EXOGENOES SATURATION AS DEFINED IN THIS EXPERIMENT.12 ON DAY 12 PATIENT DEMONSTRATED A GENERAL REDDENING OF DISEASED BREAST AND A TEMPERATURE OF 104,THESE FEATURES MARK THE PERIOD OF OPTIMAL EXPRESSION; AT THIS TIME TUMOUR WAS

RADIOGRAPHICALLY PROVEN TO HAVE SHRUNK BY 35% AND WAS NO LONGER

ATTATCHED TO MUSCLE OR TO SKIN. IT WAS EASILY REMOVED SURGICALLY. VIRUSES CAN THEREFORE BE USED AS DIRECT KILLING/NEUTRALISING AGENTS WHICH , APPEAR USEFUL IN CAUSING AT LEAST A TEMPORARY REDUCTION IN TUMOUR BULK. IT ALSO APPEARS THAT EVEN UPON

RECURRENCE, CANCER CELLS WOULD OFTEN BE MORE SENSITIVE TO

THERAPIES THAT THEY WERE INITIALLY RESISTANT TO.

USE OF VIRUS AS THERAPY MAY BE DIRECT AND IN THREE PHASES

1-MAXIMUM SATURATION WHERE ACTION IS LARGELY BY DIRECT VIRAL

LYSIS THIS OCCURS WITHIN A FEW DAYS OF INFECTION

2-MAXIMUM EXPRESSION -THIS OCCURS WITHIN 1-3 WEEKS OF INFECTION

WITH THE VIRUSES MENTIONED AND VARIES WITH INCUBATION

PERIOD. MAXIMUM EXPRESSION OCCURS WHEN VIRUS EXPRESSES BEYOND

SATURATION AND OFTEN INVOLVES SIGNIFICANT VIRAEMIA.

THIS STAGE INVOLVES BOTH DIRECT VIRAL ACTIVITY AS WELL AS MAJOR

IMMUNOLOGICAL INVOLVEMENT; BY THIS TIME NOT ONLY ARE CELLULAR

IMMUNE MECHANISMS ALERTED BUT ANTIVIRAL ANTISERUM SHOULD ALSO BE

AT HIGH TITRE. ALL IMMUNOSTIMULATING AND/OR IMMUNE AUGMENTING

MECHANISKS CAN COME HEAVILY INTO PLAY HERE . PATENT THEREFORE

COVERS PRIOR VACCINATIONS, INTERFERON, INTERLEUKIN AND OTHER

LYMPHOKINES , IMMUNOSTIMULANTS AS WELL AS PASSIVE IMMUNISATION OF

HUMAN OR NON-HUMAN ORIGIN.

THIS RAISES THE TWO FIELDS OF TAGGING AND TASRGETIONG WHICH WILL

BE DISCUSSED LATER.

IT SHOULD BE NOTED THAT THE VIRUSES MENTIONED WILL CAUSE MARKED

RISE IN INTERFERON/INTERLEUKIN LEVELS.

3-REGRESSION/DEVELOPMENT OF SYNERGY /COEXISTANCE BETWEEN CANCER AND VIRUS.

THESE CELLS ARE OFTEN MORE VULNEREABLE TO

CHEMOTHERAPY/RADIOTHERAPY THAN THEIR PREDECESSORS AND ARE

PROBABLY BEING DEPLETED IN THEIR ABILITY TO COPE WITH FURTHER INSULT BY THE PRESENCE OF VIRAL LOAD.

FEATURES OF PATENT AS RELATE TO ABOVE CLASSIFICATION.

1-MAXIMUM SATURATION.

IN THEORY, THE MORE RAPID AND COMPLETE THE SATURATION, THE LESS THE

CHANCE OF DEVELOPING OF RESISTANCE AND THE GREATER THE

POSSIBILITY OF LONGTERM REMISSION.

PATENT FEATURES IN DEVELOPMENT OF THERAPY;

1-DEVELOPMENT OF VIRAL VECTOR/VECTORS

A UNIQUE FEATURE OF THE PATENT IS THE DEVELOPMENT OF A VIRAL

THERAPY PROTOCOL INVOLVING MORE THAN ONE VIRUS; IN-VITRO DATA CAN INDICATE WHICH VIRUS IS BEST SUITED IN WHICH ORDER; GENERALLY IT IS THE VIRUS CAPABLE OF CAUSING THE GREATEST TUMOUR CELL

DESTRUCTION AS WELL AS CAPABLE OF SYNERGISING WITH SUBSEQUENT

VIRAL INFECTIONS. IT WOULD NOT BE WISE, FOR EXAMPLE, TO FIRST INFECT

WITH AN ORGANISM WHICH WILL IMMUNIBE OR INTERFERE WITH SUBSEQUENT

THERAPEUTIC ORGANISMS.

IT IS A FEATURE OF THE PATENT TO SELECT FOR AND BREAD VIRUSES TO

BE HIGHLY ACTIVE AS WELL AS HIGHLY SPECIFIC FOR CANCER CELLS. THIS

CAN BE ACCOMPLISHED BY CO-CULTURE AND SELECTIVE WASHING . SOME SUCH MECHANISMS WILL NOW BE OUTLINED;

1-INCREASlNG VIRAL POOL-THIS MAY REFER TO SINGLE VIRUS AND/OR

VIRAL MIXTURE.

VIRUS IS PASSAGED THROUGH VARIOUS CELL TYPES IN ORDER TO CREATE A

LIBRARY

THE FELINE PANLEUKOPENIA VIRUS , FOR EXAMPLE COULD BE INCUBATED IN

VARIOUS CANCER CELL LINES AS WELL AS NORMAL CELL LINES AS WELL AS

VARIOUS FRESH TISSUE AND CELL BIOPSIES. THIS WOULD THEN INDICATE

NOT ONLY WHICH TISSUES FORM TARGETS FOR THE VIRUS BUT ALSO THE

AGGRESSIVENESS AND RATE OF GROWTH IN EACH. TESTING CANCER CELL LINES AND BIOPSIES IS IMPORTANT AS REGARDLESS OF WHAT IS KNOWN OF VIRAL BEHAVIOUR AND FAVOURED TARGET CELL TYPE; IT IS LIKELY THAT CANCER CELLS OF VASTLY DIFFERENT TYPES MAY ALSO BE VULNEREABLE.

TESTING THE AFFINITY OF THESE FOR THE CANCER TO BE TARGETED MAY

BE ACHIEVED IN VITRO OR IN-VIVO. IN-VIVO TESTING MAY BE

ACCOMPLISHED IN MUCH THE SAME WAY AS THERAPEUTIC ORGANISM SCREEN

IN PREVIOUS EXAMPLE OF PENICILLIUM LBS.

A VIRUS WHICH IS MADE INTO AN EXPANDED TEST LBS EITHER BY

PASSAGING THROUGH VARIOUS CELL TYPES OR BY

PHYSICAL/CHEMICAL/BIOLOGICAL MANIPULATION, ALONE OR AS PART OF LBS

CONTAINING OTHER VIRUSES (THESE ALSO PERHAPS EXPANDED) CAN BE

INJECTED OR OTHERWISE ADMINISTERED TO ANIMALS BEARING AN IMPLANT

OF THE TARGET TISSUE TO BE ASESSED . ANIMAL CHOSEN WOULD BE TESTED

TO DEMONSTRATE NO PRIOR EXPOSURE/INHERENT RESISTANCE TO VIRUSES

BEING TESTED (AS WITH PENICILLIUM LBS ) ; SAMPLES OF THE TUMOUR

IMPLANT ARE REMOVED AT VARIOUS INTERVALS OVER A TWO WEEK PERIOD

(IT IS POSSIBLE TO USE NUDE MICE AND/OR SKID RATS FOR TESTING

WITHOUT THE INCUMBERENCE OF THE IMMUNE SYSTEM,THIS

WILL,HOWEVER,OFTEN RESULT IN ANIMAL DEATH.)

A PROTOCOL WOULD BE AT 6 HOURS, 12 HOURS THEN DAILY FOLLOWING

ORAL , RECTAL , SUBLINGUAL , INTRADERMAL , SUBCUTASNEOUS , INTRAMUSCULAR

ADMINISTRATION. FOLLOWING INTRAVENOUS APPLICATION, SAMPLES MAY BE

TAKEN EARLIER, PERHAPS AT 30 MINUTES THEN AT DAILY INTERVALS.

INFORMATION GAINEDBY CULTURING THESE BIOPSIES IN VIRAL CULTURE

WILL INDICATE WHICH VIRUSES HAVE HIGH INHERENT ABILITY TO ATTATCH

TO CANCER. CULTURES OF THE EARLY BIOPSIES WILL SHOW WHICH OF THE

VIRAL LBS HAS THE GREATEST EARLY AFFINITY FOR THE

CANCER. SUBSEQUENT BIOPSIES WILL INDICATE WHICH OF THE LBS ATTATCH

TO AND INFECT THE CANCER CELLS IN THE LONGTERM. THIS IS ALSO A

SYSTEM FOR INDICATING WHICH OF THE VIRUSES CAN COMBINE WELL AS

MIXED THERAPY.

THE TEST CAN BE REPEATED FOR EACH STAGE OF VIRAL INFECTION; AS IN

FOLLOWING FPLV INFECTION, OTHER VIRUSES CAN THEN BE TESTED IN THE

SAME AS ABOVE MANNER AGAINST THE INFECTED CANCER CELLS TO INDICATE OPTIMAL SECOND STAGE VIRUS TO BE USED. TEST CELLS COULD

BE FROM IN-VITRO OR IN-VIVO CULTURES , FROM PATIENT SAMPLES POST

TREATMENT.

IN VITRO TESTING FOR AFFINITY COULD BE ACCOMPLISHED BY IMMERSING

TARGET CELLS/TISSUES INTO SOLUTIONS CONTAINING VIRAL LBS'S OF

VARIABLE CONCENTRATIONS.

VIRAL AFFINITY CAN BE DELINEATED IN TERMS OF TIME NEEDED TO INFECT A SAMPLE WITH RELATION TO CONCENTRATION, ALONE OR WHEN IN LBS OF COMPARABLE OR OTHER CONCENTRATIONS.

VIRAL AFFINITY FOR TARGET TISSUE MAY BE GIVEN AND/OR

AMPLIFIED/AUGMENTED BY REPEATED PASSAGE THROUGH A TARGET . PASSAGE OF VIRUS THROUGH TARGET CELLS IS A COMMONLY USED METHOD IN VIRAL RESEARCH; EXPANDING THE VIRAL LBS AND THE USE OF MULTIPLE VIRUSES IN THERAPY ARE UNIQUE IN THIS PATENT. A FURTHER PROBLEM WITH ATTEMPTS TO REPEATEDLY PASSAGE VIRUS THROUGH CANCER CELLS INVOLVES THE PREVIOUSLY DESCRIBED PHENOMENON OF VIRAL/CANCER ADAPTATION WHERE FOLLOWING A SHORT REMISSION, LEUKEMIA CELLS RECURRED WITH VACUOLATION SUGGESTING VIRAL ACTIVITY PRESENT; VIRUS COULD BE RECOVERED FROM LKEUKEMIA CELLS RECURRING AFTER INITIAL REMISSION.THIS SUGGESTS THAT REPEATED PASSAGING IN-VITRO MAY ALSO RESULT IN LOSS OF VIRULENCE AND EFFECTIVENESS.

IT IS ALSO TRUE THAT TWO UNIQUE PHENOMENON HAVE BEEN OBSERVED BY THE INVENTOR; VIRUS (S ) CO-EXISTING IN CANCER CELLS MAY BE

REACTIVATED INTO VIRULENT STATE AND CELLS MAY BE REINFECTED BY THE SAME VIRUS . FPLV, UPON REPEAT CHALLANGE OF LEUKEMIA CELLS CARRYING FPLV MAY REINFECT THE CANCER, ALTERNATIVELY, REACTIVATION MAY OCCUR. REACTIVATION OF VIRAL VIRULANCE MAY ALSO BE

ACCOMPLISHED BY HEAT-KILLED VACCINE PREPARATIONS OF THE SAME VIRUS . FOLLOWING THE PHASE OF TUMOUR RECURRENCE THEREFORE, AT LEAST PARTIAL INHIBITION OF DISEASE MAY BE ACCOMPLISHED BY REACTIVATION OF VIRAL AGENT INFECTING THE CELL.

ANOTHER UNIQUE FEATURE OF THIS PATENT THEREFORE IS THE REACTIVATION OF VIRAL AGENT. A CASE OF CHRONIC MYELOID LEUKEMIA IN A 38 YEAR OLD MAN WAS PUT INTO REMISSION BY IDENTICAL PROTOCOL TO THAT USED IN THE CASE OF CHRONIC LYMPHOCYTIC LEUKEMIA PREVIOUSLY DESCRIBED, PATIENT HAD BEEN SUFFERING FROM THE DISEASE FOR THREE YEARS AND WAS NO LONGER RESPONDING TO CHEMOTHERAPY . WBC COUNT 53 , 000 AT BASELINE, -FOLLOWING FPLV INNOCULATION, PATIENT WAS IN REMISSION THREE WEEKS LATER, LEUKEMIA RECURRED WITHIN TWO

MONTHS.CYTOPLASMIC INCLUSION BODIES CHARACTERISTIC OF FPLV COULD BE SEEN IN ALL LEUKEMIA CELLS UPON RECURRENCE OF DISEASE; COINCUBATION OF RECURRED LEUKEMIA CELL LYSATES WITH OTHER LEUKEMIA CELLS/WHITE BLOOD CELLS SHOWED LITTLE TO NO VIRALACTIVITY. ADMINISTRATIONDAILY BY INTRADERMAL INJECTION OF HEAT-KILLED FPLV, CAUSED REACTIVATION OF VIRUS AND MARKED DROP IN LEUKEMIC CELL COUNT. (COUNT PRIOR TO THERAPY BY HEAT-KILLED

PREPARATION; 38 ,000 , COUNT DROPPED WITHIN 24 HOURS TO 35 , 000, THEN 28,000 WITHIN 48 HOURS; AT THE END OF 1 WEEK OF INJECTING ICC OF HEAT-KILLED FPLV, COUNT DROPPED TO 18,000. IT REMAINED STABLE FOR SEVERAL DAYS BUT THEN BEGAN TO RISE AGAIN FOLLOWING TWO WEEKS OF THERAPY WITH HEAT KILLED FPLV-(PREPARATION WAS VETERINARY AND INJECTED AS ICC AMPOULE).

RECHALLANGE AT THIS POINT WITH FPLV LIVE VIRUS ASGAIN CAUSED DROP IN COUNT. IN VITRO ASSAY DEMONSTRATED THAT FPLV LYTIC ACTIVITY COULD STILL BE DETECTED DESPITE SYNERGY ARISING WITH PRIOR VACCINATION, AGAIN THERAPEUTIC EFFECT WAS SHORT-LIVED. AT A CUNT OF 60,000WBC 4 MONTHS AFTER COMMENCING THERAPY; HYDROXYUREA WAS ADKINISTERED(PRIOR DOSEAGE OF 6 TABLETS DAILY FOR THREE DAYS A WEEK WAS INEFFECTIVE AT PRESENTATION BUT NOW DISPLAYED SOME ACTIVITY); COUNT WAS STABLE AT 45,000 6 WEEKS LATER; HYDROXYUREA WAS DISCONTINUED FOR A WEEK (TO ALLOW FOR SOME AUGMENTATION OF IMMUNOLOGICAL RESPONSE. PATIENT WAS THEN TREATED WITH CANINE DISTEMPER VIRUS AS PER PRIOR PROTOCOL; REMISSI ON FOLLOWED WITHIN TWO WEEKS AND LASTED FOR EIGHT WEEKS . AT THE TIME OF

RECURRANCE, LEUKEMIA CELLS DISPLAYED BOTH THE CYTOPLASMIC

INCLUSION BODIES CHARACTERISTIC OF FPLV AS WELL AS INTRANUCLEAR VACUOLATION CHARACTERISTIC OF CDTV, CELL LYSATES SHOWED LITTLE TO NO ACTIVITY OF VIRAL PARTICLES WHEN TESTED AGAINST UNINFECTED LEUKEMIA CELLS . THE RECURRENCE OF LEUKEMIA WAS MARKED BY GREATER LEUKEMIA GROWTH RATE. WBC COUNT ROSE FROM 50,000 TO 145,000 WITHIN TWO WEEKS. INTERESTINGLY, HEAT KILLED FPLV VACCINE ADMINISTERED AS PREVIOUSLY WAS CAPABLE OF RESTORING BOTH FPLV AND CDTV VIRULENCE AND FOLLOWING A WEEK OF VACCINATION, COUNT DROPPED TO 80, 000.

PATIENT REFUSED CHEMOTHERAPY OFFERS AT THIS STAGE AND WISHED TO CONTINUE VIRAL THERAPY. THIRD STAGE VIRAL THERAPY INVOLVED THE USE OF THE FOWL POX VACCINE. VACCINE WAS APPLIED AS PER PREVIOUS PROTOCOLS; THERE WAS NO FURTHER DROP IN WHITE CELL COUNTS.

COUNT REMAINED 80-90,000 FOR 4 WEEKS

PERIOD.FOLLOWUP FOR A FURTHER 4 MONTHS SHOWED GOOD DISEASE

CONTROL AT THIS DOSE.

THIS CASE CARRIED OUT AT AN EXPERIMENTAL RESEARCH INSTITUTE WITH FULL PATIENT AUTHORISATION, DEMONSTRATED A THREE STAGE THRESHOLD PRIOR TO DRAMATIC RETURN TO LEUKEMIA SENSITIVITY TO THERAPY. IT ALSO DEMONSTRATED THE ABILITY TO REACTIVATE TWO UNRELATED VIRUSES WITH HEAT-KILLED FRACTIONS OF ONE; THIS SUGGESTS A COMMON

MECHANISM OF TUMOUR SYNERGY WHICH MAY BE REVERSED BY A HEAT- KILLED FRACTION OF ONE

ABILITIES.

IT SHOULD ALSO BE NOTED THAT IMMUNE RESPONSES WHICH PROTECT NORMAL CELLS FROM VIRAL INFECTION(PARTICULARLY, MULTIPLE VIRAL INFECTIONS) DO NOT SEEM TO FUNCTION IN CANCER CELLS. THIS IS USEFUL KNOWLEDGE AS IT MAY BE POSSIBLE TO CHOOSE SPECIFICITY BY USING A VIRUS TO WHICH THE BODY IS ALREADY IMMUNE; SUCH AS MEASLES OR MUMPS. ANTI SERA AS WELL AS OTHER SYSTEMS WOULD PREVENT NORMAL CELLS FROM BEING REINFECTED, WHEREAS CANCER CELLS WOULD BE EASIER TO INFECT.

80 YEAR OLD PATIENT SUFFERING FROM CHRONIC LYMPHOCYTIC LEUKEMIA WAS VACCINATED WITH THE MUMPS VACCINE AFTER IT HAD BEEN INCUBATED WITH HIS CELLS IN THE MANNER PREVIOUSLY DESCRIBED. WBC COUNT AT START OF THERAPY WAS 86 ,000; PATIENT ACHIEVED REMISSION WITHIN 2 WEEKS, STILL DISEASE-FREE AT 2 YEAR FOLLOWUP.

INJECTION OF MEASLES VACCINES AND MUMPS VACCINES INTO PATIENTS SUFFERING FROM VARIOUS CANCERS RANGING FROM BTRAIN, BREAST AND BOWEL TO LEUKEMIA, LYMPHOMA AND OTHERS RESAULKTED IN MINIMAL TO NO EFFICACY. IT IS UNLIKELY THAT MAXIMUM SATURATION WAS EVER ACHIEVED AS IMMUNE RESPONSE MEMORY WOULD ELIMINATE VIRUS PRIOR TO REACHING ITS TARGET . EVEN DIRECT INTRATUMOUR INJECTION MET WITH LITTLE EFFICACY. THIS COULD ALSO HAVE BEEN DUE TO THE ATTENUATED FORM OF VIRUS AVAILABLE IN COMMERCIAL VACCINES(PRIOR STUDIES IN THE EARLY SEVENTIES SHOWED MARKED SOLID TUMOUR, SHRINKAGE FOLLOWING

INNOCULATICN OF VIRULENT FORM OF MUMPS INTO THE TUMOURS.

IN THE CASES TESTED BY INVENTOR, THERE NEVER APPEARED TO BE A STAGE OF MAXIMUM EXPRESSION FOLLOWING DIRECT INNOCULATION OF VACCINE. THE LEUKEMIA CASE, HOWEVER, WAS TREATED WITH PATIENTS LEUKEMIA CELLS WHICH HAD ABSORBED THE VIRUS VAS PER THE TEACHINGS OF THIS PATENT. VIRAL LOAD WAS THEREFORE AMPLIFIED; THIS PROCESS ALSO APPEARS TO BE MORE EFFICIENT IN SPREADING THERAPY AMONGST DISEASED CELLS THAN SIMPLE APPLICATION OF VIRUS.

2-MAXIMAL EXPRESSION.

ADMIN-TAGGED CELLS ETC

PROTECT OTHER , NORMAL CELLS BYVACC INE/OTHER V, ANTISERA

TAILOR FOR PATIENT BLOOD AND IMMUNITY

IT SHOULD BE NOTED HERE THAT SOME VIRAL AGENTS MAY NOT EVEN NEED SUCH CONSIDERATION AS

REACTIVATION USING DEAD V

MASS WAS 12 INCHES IN DIAMETER, WITH MARKED SKIN ATTACHMENT AIDS PATIENTS REVIEWED CNTINUED THERAPY OVER SEVERAL MONTHS(6 MONTHS MIN

AS CARRIER

AS INHIB/DIRECT ATTACK

AS TAG

TARGET1

STAGE OF MAXIMUM EXPRESSION FOLLOWING DIRECT INNOCULATION OF VACCINE .THE LEUKEMIA CASE, HOWEVER, WAS TREATED WITH PATIENTS LEUKEMIA CELLS WHICH HAD ABSORBED THE VIRUS VAS PER THE TEACHINGS OF THIS PATENT . VIRAL LOAD WAS THEREFORE AMPLIFIED; THIS PROCESS ALSO APPEARS TO BE MORE EFFICIENT IN BPREADING THERAPY AMONGST DISEASED CELLS THAN SIMPLE APPLICATION OF VIRUS.

PATENT TEACHINGS FOR MAXIMAL SATURATION

1-SELECT VIRUS/GROUP OF VIRUSES WITH HIGH AFFINITY FOR TARGET

CELL.

2-CULTURE TO DEVELOP AFFINITY BUT NOT ADAPTATION.

IN MULTIPHASIC THERAPY INVENTOR SPEAKS OF REPEATED CHALLANGE OF

THERAPEUTIC ORGANISM WITH RESISTANT TARGET . WE HAVE SPOKEN HERE OF

THERAPY WITH VARIOUS STAGES CORRESPONDING TO THE USE OF VARIOUS

VIRAL AGENTS . THE PROBLEM WITH USING MULTIPHASIC THERAPY HERE IS

THAT THE TARGET HAS NOT REALLY DEVELOPED RESISTANCE

BUT, RATHER, SYNERGY WITH THERAPEUTIC AGENT . THERE IS THE FURTHER

RISK THAT CO-INCUBATION WILL MORE LIKELY RESULT IN ATTENUATION

AND ADAPTATION OF VIRUS.

IN CASES WHERE THE CANCER RECURRS WITHOUT PRESENCE OF VIRUS, PHASE

THERAPY IS EASY AS ONE WOULD THEN SEARCH FOR VIRAL MUTATION OR

OTHER VARIATION OF THE SAME VIRUS WHICH COULD RE-INFECT THE

TARGET CELL, ALTERNATIVELY ONE CAN TRY TO TRIGGER REACTIVATION OF

ATTENUATED VIRUS OR SEARCH FOR VIRAL VARIANT WHICH CAN REINFECT

OR INFECT RESISTANT CELL CLONES. DIFFICULTY HERE ARISES AS,UNLIKE

WITH MANY HIGHER ORGANISMS SUCH AS BACTERIA AND FUNGII,VIRAL CO- INCUBATION WITH CANCER CELLS TENDS TO RESULT IN ATTENUATION AND

ADAPTATION OF VIRUS AND TARGET CELLS

CROSS BREEDING OF VIRUSES MAY RE-ESTABLISH VIRULENCE AS MAY

PASSAGE OF VIRUS THROUGH ORIGINAL TARGET(IN THIS CASE

ANIMAL)TISSUE. THEREFORE WE HAVE TWO SEPARATE SITUATIONS IN

DEVELOPMENT OF MULTIPHASED THERAPY; ONE INVOLVES EXPOSING CANCER

CELLS TO A VIRUS WHERE THE VIRUS DOES NOT ACHIEVE TOTAL CELL

DESTRUCTION, IE WHERE RESISTANT CELLS ARE PRESENT AND/OR WHERE DI

KILL VIRUS THEN REINFECT 2-MAXIMAL EXPRESSION.

THE PREVIOUSLY DISCUSSED CASE OF CLL,FOR EXAMPLE HAS BEEN

AS WITH THE PREPARATION OF MULTIMODAL CHEMOTHERAPY, ATTEMPTS TO DEVELOP MULTIMODAL VIRAL THERAPY IN SITUATIONS WHERE VIRUS WAS INCUBATED WITH CANCER CELLS IN TSB; DESPITE STRICT STERILE

MULTIPLE BIOPSY WORK BY DR. ALAN CANTWELL AND OTHERS DEMONSTRATE SIMILAR COCCAL ORGANISMS IN THE VICINITY OF TUMOUR MASSES. THESE MAY BE CLASSIFIED BY CLASSIFICATION PATENT AND DEALT WITH ACCORDINGLY.

AS CANCER CELLS PASS THROUGH THE VARIOUS PHASES OF THERAPY, THEY ARE VACCINATED INTPO ANIMALS

n

p

ANTIGENICALLY ATTRACTED TO THESE AND HENCE ATTACK THE CANCER

CELL.

THE ABILITY OF THESE ANTIGENS TO HIGHLIGHT PREVIOUSLY NON-IMMUNE

ATTRACTING SYSTEMS AND/OR SYSTEMS SUCH AS CANCER OR AIDS INFECTED

CELLS WHICH ATTRACT INAPPROPRIATE AND/OR INSUFFICIENT IMMUNE

RESPONSE. THIS PHENOMENON IS CALLED TAGGING BY THE INVENTOR.

VIRAL ANTIGENS ATTATCHED TO CANCER CELLS MAY MAKE THEM MORE

ANTIGENIC; VIRAL EXPRESSION MAY CARRY EVEN GREATER ANTIGENIC

POTENTIAL; IF VIRUS IS DERIVED FROM ANIMAL SOURCE, OR HUMAN OR

OTHER SOURCE WHERE IT IS ABLE TO TRANSFER AND EXPRESS ANTIGENS

RELATED TO PRIOR CULTURE HOST/MEDIUM.I.E. IT IS KNOWN THAT

CANCERS TRANSPLANTED FROM ONE SPECIE INTO ANOTHER, ARE OFTEN

DESTROYED DUE REJECTION OF ANTIGENS OF OTHER SPECIE . VIRAL TAGGING

MAY BE ACCENTUATED BY THE CANNIBALIUSATION AND SUBSEQUENT

EXPRESSION OF ANTIGENS FROM ANOTHER SPECIE/ANTIGENICALLY

DIFFERENT SOURCE.

TARGETING INVOLVES THE FURTHER STEP OF RAISING AN IMMUNE RESPONSE

TO THE EXPRESSED ANTIGENS AND/OR CATERING FOR PRE-EXISTING IMMUNE

RESPONSE.

TAGGING AND TARGETING WILL BE DISCUSSED IN GREATER DETAIL.

UNDER THEIR OWN TITLE AND CAN BE APPLIED TO

VIRUSES, BACTERIA, FUNGII AS WELL AS ANTIBODIES AS WILL BE

DISCUSSED LATER.

BACTERIA

THGERE ARE BACTERIA WHICH CAN BE USED IN THE DEVELOPMENT OF

SPECIFIC DIRECT THERAPY AND/OR VACCINES AGAINST CANCER AND OTHER

DISEASES.

BY USE OF THE PREVIOUSLY DESCRIBED TECHNIQUES OF CO-INCUBATION

WITH VARIABLE BIAS,BACTERIA CAN BE SELECTED AND GROEN TO

SPECIFICALLY ATTATCK TARGET.

THERE ARE , AS WITH ALL LIVING THERAPIES TO BE CONSIDERED, THREE

FACTOR8 TO BE CONSIDERED;

1-AFFINITY

2-EFFECACY

3-ANTIGENICITY.

SEARCH FOR AFFINITY/DEVELOPMENT OF

AFFINITY.

THE OBJECTIVE HERE IS TO DEMONSTRATE, ISOLATE AND UTILISE

BIOPSY. THESE WILL BE COVERED LATER UNDER INDUCED

REMI SS ION THERAPY SUMMARY . WE WILL NOW DESCRIBE

HOW BACTERIA MAY BE ISOLATED/SEPARATED/DEFINED BY OR GRANTED

AFFINITY. THE MECHANISM IS SIMILAR TO THAT USED FOR VIRUSES AND

FUNGII AS PREVIOUSLY DESCRIBED.

STEP1-DEFINE A LIVING BIOLOGICAL BYSTEM FOR TESTING

STEP2-DEFINE MEDIUM

STEP3-DEFINE TARGET

STEP 1-DEFINING THE LIVING BIOLOGICAL SYSTEM.

THE SCOPE HERE MAY BE NARROW, AS IN TESTING 2 OR 3 STRAINS OF A SINGLE ORGANISM OR MAY BE AS EXPANDED AS A LARGE RANGE OF STRAINS, ORGANISMS, SPECIES AS THEY EXIST IN A NATURAL CONDITION (AN EXAMPLE BEING KEFIR, KAMBUCHA MUSHROOM, VARIOUS FERMENTED FOODS) OR ANY COMBINATION OF THESE, LBS MAY BE EXPANDED BY

ADDITION OF OTHER ORGANISMS,EXPOSURE OF MUTATING AGENTS TO EXPAND

POOL.ETC.

DEFINING MEDIUM

IT IS UNLIKELY THAT ANY SINGLE MEDIUM WOULD BE NEUTRAL/NOT

FAVOURING THERAPEUTIC OR TARGET ORGANISM UNLESS THEY ARE BOTH RELATED- (CANCER VS CANCER-TO BE DISCUSSED LATER) .TRYPTICATED SOY BROTH IS USED IN MOST EXAMPLES,THIS PATENT IS,HOWEVER NOT

RESTRICTED TO IT; IF IT IS INTENDED TO BIAS FOR THERAPEUTIC

BACTERIA EXAMPLIFIED HERE BY HAEMOLYTIC STAPHYLOCOCCI VS.TARGET CANCER CELLS, BLOOD AGAR PLATE WOULD FAVOUR THE BACTERIA. IF ONE WISHED TO FAVOUR THE TARGET TO ALLOW IT TO EXPRESS SOME RESISTANC MECHANISMS; CELL NUTRIENT BROTH FORTIFIED WITH ANTIBIOTICS WOULD FORM THE OTHER END OF THE SPECTRUM, DECREASING ANTIBIOTIC DOSE TO SUBLETHAL LEVELS FOR TARGET BACTERIA DECREASES THE DEGREE OF BIAS, INTERMEDIATE FORMULATIONS ALLOW FOR THE VARYING DEGREES OF BIAS.

DEFINING TARGET

TARGET TO BE USED AS EXAMPLE HERE IS A CANCER CELL . THIS TARGET MAY BE RESTRICTED OR PURE (AS SIMPLE CELL-LINE,FOR EXAMPLE) OR MORE COMPLEX SUCH AS BY MULTIPLE PHASES FOLLOWING TREATMENT/OTHER MUTATION OR MODIFICATION, RESTRICTED TO SINGLE LINE OR TO SINGLE BIOPSY OR REPRESENTED BY POOLED BIOPSY OF PARTICULAR CANCER TYPE. AS ULTIMATELY CANCER THE DISEASE IS WHAT IS BEING ATTACKED , OTHER TARGETS NEED TO BE ASSOSCIATED ORGANISMS; CAUSATIVE, SYNERGISTIC ETC.

EVEN NEUTRAL OR ANTAGONISTIC ORGANISMS MAY BE

AN EXAMPLE WILL NOW BE MADE OF/ LEUKEMIA CELLS/SOLID TUMOURS- AND BACTERIAL THERAPEUTIC ORGANISMS.

1-CUSTOMISING PRE-EXISTING THERAPY

THE COLEY VACCINES,DEVELOPED FROM STREPTOCOCCUS PYOGENES AND SERRATIA MARASCESENS AS A HEAT-KILLED PREPARATION WAS PUBLISHED TO HAVE SHOWN GOOD PROMISE IN THE THERAPY OF CANCER, PARTICULARLY SARCOMA.WITH FIGURES EXCEEDING 30% REMISSION RATE IN SOKE TRIALS. THE COLEY VACCINES WERE ASSOSCIATED WITH INTENSE TEMPERATURES AS WELL AS WITH SEVERE SHAKING,HYPOTENSION AND OTHER FEATURES OF ANAPHYLAXIS.

THIS SHOCK REACTION IS BOTH TRAUMATIC AND APPARENTLY VITAL TO

GOOD RESPONSE.

IT IS ASSUMED BY THE INVENTOR THAT AT LEAST SOME OF THE SIDE

EFFECTS OF THIS THERAPY ARE DUE TO THE NON-SPECIFICITY OF THE

BACTERIAL EXTRACTS.

THE FOLLOWING WILL ILLUSTRATE APPLICATION OF PATENT.

24 YEAR OLD MALE PRESENTS WITH RECURRENCE OF OSTEOGENIC SARCOMA

.3 LESIONS IN THE RIGHT LUNG MEASURE 1.5-2 CM DIAMETER EACH, ONE 3

CM LESION IS PRESENT IN LEFT LUNG WITH LEFT LOWER ZONE PLEURAL

EFFUSION. ON PRIOR PLEURAL ASPIRATE CELLS OF OSTEOGENIC SARCOMA

WERE DEMONSTRATED IN THE FLUID.

PATIENT, HAVING FAILED PRIOR CHEMOTHERAPY AND RADIOTHERAPY

UNDERWENT COLEY VACCINE THERAPY.STANDARD THERAPY ADMINISTERED TO

HIM WAS FORMULATED AS FOLLOWS;

6 CULTURES OF STREPTOCOCCUS PYOGENES WERE INCUBATED FOR 24 HOURS

WITH 3 SEPARATE CULTURES OF SERRATIA MARASCESENS.EACH BACTERIA

WAS ISOLATED FROM PATIENT SAMPLES AND WERE NOT OTHERWISE DEFINED.

THE STREPTOCOCCI AND SERRATIA WERE CO-INCUBATED FOR TWO DAYS IN

TRYPTICATED SOY BROTH 500CCTHE SOLUTION WAS THEN BOILED FOR 15

MINUTES ON THREE CONSECUTIVE DAYS.

APPLICATION WAS INTRADERMAL (ALTHOUGH USUAL COLEY THERAPY IS

INTRAVENOUS OR INTRATUMOURAL , INTRADERMAL USE WAS APPLIED AS IT

WAS FELT THAT THE REACTION MAY BE LESS SEVERE AND PATIENT WAS

VERY NERVOUS)

DAY1-0.1CC

DAY2-0.2CC

DAY3-0.3CC

THEN 0.6CC WERE APPLIED EVERY 3RD DAY FOR 6 WEEKS

EVALUATION AT THAT POINT BY CT SCAN SHOWED INCREASE OF MASSES BY AN AVERAGE OF 60%,2 NEW MASSES OF 1CM DIAMETER WERE IDENTIFIED IN THE LEFT LUNG AND FLUID WAS TO MIDZONE BILATERALLY.

ALTHOUGH THE DESIRED REACTIONS MANIFESTED, THEY APPEARED TO HAVE NO SPECIFICITY FOR THE DISEASE.

TESTING FOR AND EXPANDING AFFINITY AND MAXIMISING SPECIFICITY.

TECHNIQUE IS AS PREVIOUSLY DESCRIBED,

REMOVAL OF ORGANISMS WITH HIGH AFFINITY FOR NORMAL TISSUE.

THIS PROCESS MAY BE DONE AT ANY STAGE(S) DURING AND/OR FOLLOWING PREPARATION OF THERAPY,

AS THE AIM IS TO MINIMISE THE CHANCE OF PRODUCING COMPOUNDS WITH ANTI-NORMAL TISSUE ABILITY THE ORIGINAL ORGANISMS ARE WASHED TO REMOVE ANY (OR AT LEAST TO REDUCE THE NUMBER)OF ORGANISMS WITH AFFINITY FOR HEALTHY TISSUE. IN ORDER TO DO THIS, THE BACTERIA ARE CULTURED , SAY IN TSB, FOR 24 HOURS THEN THE HEALTHY TISSUE WE WISH TO PROTECT IS WASHED AGAINST THE CULTURE.LET US USE, FOR EXAMPLE , THE PATIENT ' S BLOOD; BLOOD ( 5 CC) IS ADDED TO 10 CC OF CULTURE AND ALLOWED TO SETTLE/COAGULATE . SUPERTNATANT IS REMOVED AND INNOCULATED INTO 500CC OF TSB. FOLLOWING A 24 HOUR CULTURE A TEN CC VOLUME OF THE MIXED CULTURE IS REMOVED AND AGAIN WASHED AGAINST 5CC OF WHOLE BLOOD(THIS PROCESS IS DEMONSTRATED IN

EXAMPLES,VOLUMES MAY BE ALTERED; PATENT COVERS OTHER METHODS OF WASHING INCLUDING CENTRIFUGE, OTHER PHYSICAL/CHEMICAL/BIOLOGICAL METHODS OF EXTRACTION, INCLUDING REFINED METHODS OF

IMMUNOLOGICALLY REMOVING ORGASNISMS WITH AFFINITY FOR NORMAL RECEPTORS PRESENT IN HEALTHY CELLS BUT NOT IN DISEASE, OR FOR EVEN GREATER PROTECTION, REMOVING ORGANISMS WITH AFFINITY FOR ANY NORMAL RECEPTORS/OTHER NORMAL CELLULAR COMPONENTS INCLUDING THOSE THAT MAY BE SHARED BY CANCER OR OTHER TARGET CELL-THE KEY FEATURE OF THIS PART OF THE PATENT IS THE WASHING OF VACCINES TO REMOVE ANY PART THAT MAY EFFECT NORMAL CELLS) THE WASHING AGAINST

PATIENT ' S BLOOD WAS REPEATED THREE TIMES . (OTHER METHODS OF ELIMINATING ORGANISMS WITH AFFINITY FOR HEALTHY TISSUE INCLUDE THE SATURATION OF CELLS WITH ANTIBIOTICS TO INHIBIT ORKILL ORGANISMS THAT ATTATCH TO THEM OR TO DEVISE AN IMMUNOLOGICAL SYSTEM TO ATTACK AND ELIMINATE SUCH ORGANISMS INCLUDING THE RAISING OF AN ANTKISERUM AGAINST ORGANISMS ATTATCHED TO THE HEALTHY CELLS FOLLOWING WASHING; IN TURN,WASHING THE SERUM AGAINST REQUIRED ORGANISMS WITH ANTI-DISEASE ACTIVITY WILL LEAVE ONLY THE PART OF THE SERUM WITH SPECIFIC ACTIVITY AGAIANST ORGANISMS THAT ATTATCH TO HEALTHY CELLS)

FOLLOWING THE THIRD WASH,CULTURES STILL DEMONSTRATED SERRATIA AND STREPTOCOCCI . THESE WERE INCUBATED FOR 24 HOURS IN TSB; IN THEORY THESE ORGANISMS HAD LITTLE AFFINIKTY FOR HEALTHY CELLS; IN ORDER TO SELECT THOSE WITH SPECIFIC ACTIVITY AGAINST DISEASED CELLS;THE ORGANISMS WERE WASHED AGAINST SARCOMA CELLS ISOLATED FROM THE PLEURAL EFFUSION. (SARCOMA CELLS WERE FIRST SPUN FROM EFFUSION SAMPLE TAKEN A WEEK BEFORE TERMINATION OF STANDARD COLEY THERAPY; AND WERE RESUSPENDED IN 10CC OF SALINE AT 10,000 BY TEN TO THE FIFTH CELL CONCENTRATION PER CC ) TO THE TEN CC ,IOO CC OF 48 HOUR CULTURES WAS ADDED;THE CELLS WERE SPUN DOWN AND THEN RESUSPENDED IN 10CC OF SALINE;ICC WAS ADDED TO TSB FOR

CULTURE; THE CELLS WERE THEN AGAIN SPUN DOWN AND RESUSPENDED IN SALINE 10CC-ICC SAMPLE WAS REMOVED FOR CULTURE AND THE PROCESS WAS REPEATED.

MULTIPLE PHASES MAY BE ESTABLISHED FOR BOTH THE SELECTION AGAINST AND THE SELECTION FOR CERTAIN ORGANISMS,THE WASHING PROCEDURE TO REMOVE ORGANISMS WITH ANTI-NORMAL CELL ABILITY CAN BE FOLLOWED THROUGH MANY PHASES WHERE REMAINING ORGANISMS ARE CULTURED AND REWASHED UNTIL, IN THEORY THE AMOUNT OF RECOVERSABLE ORGANISMS FROM NORMASL-CELL WASAHINGS WILL BE MINIMAL.SIMILARLY, IN

THEORY, THE MORE TIMES THE MIXED CULTURE IS WASHED AGAINST TARGET

CELLS SUCH ASD CANCER CELLS, THE GREATER THE AFFINITY AND THE HIGHER PERCENTAGE OF CULTURE WITH AFFINITY WILL DEVELOP. BOTH BACTERIAL TYPES WERE RECOVERED FROM CENTRIFUGED CANCER CELL PELLET AFTER THREE WASHINGS AGAINST THE SARCOMA CELLS.

THESE CULTURES WERE THEN USED IN THE PREPARATION OF THE VACCINE . THE METHOD WAS IDENTICAL TO THAT DESCRIBED FOR THE

VACCINES WHICH WERE PREVIOUSLY USED.

IN ADDITION, THE MIXED CULTURE WAS ALSO GROWN FOR 48 HOURS WITH SARCOMA CELLS IN THE MEDIA ( 10 CC OF SUSPENSION AS PREVIOUSLY DESCRIBED WAS ADDED TO 100CC OF TSB CULTURE)THIS WAS DONE TO MAKE ADVANTAGE OF TAGGING AND TARGETING POTENTIAL.

A THIRD PREPARATION WAS DESIGNED TO RAISE ANTICANCER ACTIVITY IN THE ORGANISMS . THE BACTERIAL MIX WAS CULTURED IN A PELLET OF SARCOMA CELLS; UTILIZING JUST THE CANCER FOR NUTRITION, IT WAS HOPED THAT THE ORGANISMS WOULD DEVELOP SPECIFIC ENZYMES AND OTHER ANTI-CANCER MECHANISMS. (IT IS POSSIBLE TO DO THESE CULTURES INTERSPERSED WITH TSB CULTURES WITH OR WITHOUT TARGET TO MAINTAIN FULL BACTERIAL ACTIVITY)

THE VACCIE WAS THEREFORE COMPRISED OF THREE COMPONENTS ONCE THE

ANTI-NORMAL CELL FACTORS WERE REMOVED.

THE SARCOMA CELLS WERE SPUN INTO A PELLET INTO WHICH

CELLS

BACILLUS SUBTILIS ANTIBIOTIC ETC EVEN NOABIOTICS.

BILATERAL PLEURAL CANCER EFFUSIONS WERE PRESENT TO MIDZONE

COLEY, OTHER CANCERS . . .

CANCER VS CANCER

USE OF PROTECTIUE PROTEIN TO TARGET

USE OF ANTISERUM AGAINST CANCER WTHOUT ANTIGENS/UNDIFFERENTIATED.

USE MULTIPHASE OTHER SPECIE/PERSON ANTIGENS

SEQUENTIAL MULTIVIRAL THERAPY

TAGGING

TARGETING

BACTERIA-COLEY ETC

MULTIPHASIC CARRIER / TARGETING

YEAST IRT

NORMAL GENE AMPLIFICATION

IMMUNE/MULTIPHASIC ETC.

TISSUES OF SPECIES OF TARGET CELLS DEBULKING

INDUCED REMISSION THERAPY-OVERVIEW

FEATURES OF PATENT CLASSIFICATION PATENT ORGANISM/ORGAN RESISTANCE

MULTIPHASIC/MULTIMODAL THERAPY

LIBRARY MATCHING

-IMPROVED GRTH RATE/ANTIBODS

TAGGING THERAPY CARRIER THERAPY

STUDIES OF SPONTANEOUS REMISSION HAVE LED MANY TO SEE THE RELATIONSHIP BETWEEN INFECTIONS AND CANCER REGRESSION (COLEY- EARLY INVESTIGATION OF CANCER ALSO LED TO THE ISOLATION OF MANY MICROORGANISMS THAT WERE THOUGHT RELATED TO THE DISEASE PROCESS,WORK BY SCOTT, ALEXANDER AND LIVINGSTON AS WELL AS MANY OTHERS EARLIER THIS CENTURY SUGGESTED AN INTIMATE IF NOT CAUSAL RELATIONSHIP OF THE ORGANISMS WITH THE DISEASE. IT HAS ALSO BEEN OBSERVED THAT CERTAIN INFECTIONS MAY CAUSE PROLONGATION OF CHEMOTHERAPY-INDUCED REMISSION, OR CAUSE PARTIAL REGRESSION OF DISEASE(OBSERVATIONS WITH MEASLES AND MUMPS INFECTIONS AND THEIR IMPACT ON THE DISEASE PROCESS OF LEUKEMIA HAS INDICATED THIS); AS YET OTHER INFECTIONS WHICH MAY OR MAY NOT BE RELATED DIRECTYLY TO THE DISEASE PROCESS, ARE CAPABLE OF ACCELERATING THE DISEASE PROCESS, CMV INFECTION, OTHER VIRAL/BACTERIAL PNEUMONIA,FOR

EXAMPLE, ARE CAPABLE OF FURTHER IMMUNOSUPPRESSION OF

PATIENT, ACCELERATING HIS DEATH OR DEBILITY EITHER BY DIRECT ACTION OR BY ALLOWING FOR ACCELERATION OF THE CANCER PROCESS. IT APPEARS , THEREFORE, THAT ORGANISMS MAY CAUSER OR PREPETUATE A DISEASE CONDITION OR CAUSE DUSEASE RESOLUTION OR INHIBITION; AS MICROORGANISMS THAT ASSIST AND MICROORGANISMS THAT INHIBIT DISEASE MAY BELONG TO THE SAME SPECIES OR BE OTHERWISE RELATED, THIS OBSERVATION CAN LEED TO SOME CONFUSION, FOR THIS REASON, THE CLASSIFICATION SEGMENT OF THE PATENT WAS

DEVELOPED.THIS OBSERVATION IS NOT LIMITED TO THE CANCER PROCESS; ANY DISEASE PROCESS CAN HAVE A SET OF ORGANISMS/FACTORS ETC DEFINED WHICH WILL EITHER ASSIST THE SDISEASER PROCESS OR ASSIST THE KAOST IN ELIMINATING OR REDUCING THE DISEASE.

PNEUMOCYSTIS AMONGST OTHERS;STAPHYLOCOCCAL ERYSIPELAS HAS BEEN NOTED BY AUTHOR, HOWEVER, TO CAUSE A RAISE IN T CELL COUNTS IN PATIENTS SUFFERING FROM AIDS.

EVEN LESS DRASTIC CONDITIONS DEMONSTRATE SIMILAR RELATIONSHIPS. HERPES. FOR EXAMPLE IS A VIRAL DISEASE THAT LAYS DORMANT UNTIL ACTIVATED BY A WEAKENED HOST CONDITION OR BY SYNERGISTIC ORGANISMS; SUCH ACTIVATION CAN OCCUR FOLLOWING VIRAL INFECTION SUCH AS WITH AIDS AND/OR THE FLU VIRUS; HERPES OUTBREAKS CAN BE SIGNIFICANTLY INHIBITED BY PHAGE THERAPY/MULTIPHASIC IMMUNE RESPONSES.

AS IN TYHE CASE OF CANCER, PSORIASIS, AIDS, MS, ARTRHRITIB AND

MULTIPLE OTHER DISEASES PREVIOUSLY THOUGHT UNRELATED TO MICROBIAL ORGANISMS INCLUDING CARDIOVASCULAR, CHRONIC DEGENERATIVE,ACUTE AS WELL AS ALL OTHER DISEASE AND OTHER CONDITIONS;RELATED FACTORS AND ORGANISMS MAY BE ENCOUNTERED AND CLASSIFIED ACCORDING TO CLASSIFICATION SECTION OF PATENT; THIS IS IMPORTANT AS ORGANISMS AND FACTORS WHICH ASSIST THE DISEASE SHOULD BE NEUTRALISED WHEREAS THOSE THAT OPPOSE THE DISEASE MAY BE INCORPORATED INTO OR USED TO EXTRACT THERAPY.

IDENTIFYING TARGETS

THERE ARE 3 MAIN TARGETS FOR INDUCED REMISSION THERAPY.

1-DISEASE MANIFESTATION (EG. CANCER CELL)

2-DISEASE CAUSE

3-SYNERGISTIC ORGANISMS/FACTORS

2-CAUSE-DISCUSSION HERE WILL BE INCLUDE CAUSATIVE ORGANISMS WHETHER SUCH A RELATIONSHIP IS PROVEN OR HYPOTHESISED BY INVENTOR.

3-RELATED ORGANISMS-

SYNERGISTIC, ANTAGONISTIC, NEUTRAL, INFECTIVE, NEMESIS, INCLUDING

THEIR APPLICATION IN TAGGING AND CARRIER VACCINES.

INDUCED REMISSION THERAPY IS THEREFORE MULTI-TARGETED,

MULTIPHASIC AND MULTI-MODAL.

TARGET-SELECTION

-ORGANISMS OF HIGH DISEASE AFFINITY

ISOLATION OF ORGANISMS RELATED TO TARGET DISEASE MAY BE POSSIBLE VIA PROCESSING OF PATIENT SAMPLES INCLUDING BUT NOT RESTRICTED TO URINE, BLOOD, STOOL, SPUTUM, EAR SWAB, THROAT SWAB, BIOPSY. ORGANISMS MAY BE READILY EVIDENT OR DETECTED BY COMPARISON WITH NORMAL ORGANISM PARAMETERS IN HEALTHY CONTROLS AND/OR BY COMPARISON WITH SAMPLES TAKEN PRIOR TO ONSET OF DISEASE.

STRAIGHTFORWARD CULTURE PRACTISE MAY DETECT THESE ORGANISMS; IN DEALING WITH BIOPSIES AND BLOOD, IN PARTICULAR, AFFINITY MAY BE SO HIGH THAT 8EVERE TISSUE DISRUPTION IS NEEDED TO RELEASE THE ORGANISMS AND ALLOW THEIR CULTURE.

HIGH AFFINITY ORGANISMS CAN BE SEEN IN TISSUE BIOPSIES OF CANCER, FOR EXAMPLE. TWO FEATURES DISTINGUISH THESE ORGANISMS FROM OTHERS. FIRSTLY, THEY APPEAR RESTRICTED TO WELL-DEFINED

NESTS, SECONDLY AND PARADOXICALLY, THEY ARE NOT SURROUNDED BY ANY SIGNIFICANT IMMUNOLOGICAL RESPONSE.ORDINARY INFECTIONS WOULD BE EXPECTED TO ATTRACT SIGNIFICANT IMMUNOLOGICAL RESPONSE AND IN THE ABSENCE OF ADEQUATE RESPONSE WOULD OVERRUN THE AREA IN WHICH THEY ARE LOCATED YET THE ORGANISMS IDENTIFIED FROM TISSUE BIOPSIES OF DISEASE (CANCER, FOR EXAMPLE), IN THE ABSENCE OF AN IMMUNE

CHALLANGE, REMAIN IN WELL-CIRCUMSCRIBED NESTS. SUCH ORGANISMS MAY BE ISOLATED FROM SPECIMENS AND BIOPSY SAMPLES AS WELL AS FROM BIOPSIES (AS SEEN IN POST-MORTEMS)OF SEEMINGLY NORMAL TISSUE NOT OVERTLY INVOLVED WITH DISEASE . -SEE DIAGRAMS OF BIOPSIES FROM CANCER AND AIDS PATIENTS.

ISOLATION OF ORGANISMS FROM TUMOUR BIOPSIES AND/OR LEUKEMIA CELLS/BIOPSIES/BLOOD AND OTHER SAMPLES OF VARIOUS DISEASES MAY RERQUIRE TISSUE/CELLULAR FRAGMENTATION TO ALLOW RELEASE AND GROWTH OF ORGANISMS (AGAIN, IT SHOULD BE NOTED THAT GROWTH OF THESE ORGANISMS APPEARS RESTRICTED TO WELL-DEFINED NESTS IN-VIVO; AND MAY NOT EXPRESS GROWTH WITHOUT CELLULAR DISRUPTION VIA PHYSICAL,CHEMICAL OR BIOLOGICAL MEANS.

SIMPLE CULTURE ISOLATION TECHNIQUES.

TUMOUR BIOPSY IS REMOVED UNDER STERILE PRECAUTIONS; IT IS THEN DISSECTED USING STERILE PROCEDURE AND A SECTION OF 'HEALTHY' TUMOUR TISSUE IS REMOVED-THIS IS ONE WHICH IS NOT ULCERATED AND CONTAINS NO GROSS EVIDENCE OF INFECTION(INFECTED 8ECTIONS ALSO SERVE A PURPOSE AS THEY INDICATE INFECTING ORGANISMS WITH HIGH AFFINITY FOR CANCER TISSUE,UPON CLASSIFICATION.THEY TOO CAN BE PROCESSED AND USED).THESE 'STERILE' SAMPLES ARE FURTHER CUT INTO BECTIONS OF ABOUT HALF A CM IN DIAMETER.

ONE SUCH SAMPLE IS SMEARED ALONG AN AGAR PLATE, ANOTHER ACROSS A BLOOD AGAR PLATE.SAMPLES ARE SMEARED AND ALSO PLACED WHOLE ON VARIOUS SOLID MEDIA INCLUDING LOWENSTEIN-JENNSEN MEDIUM AS WELL AS OTHERS.AVAILABLE MEDIA IS USED BOTH IN SOLID AND LIQUID FORM SUCH AS TRYPTICATED 80Y BROTH ETC.TO COVER AS LARGE A RANGE AS POSSIBLE TO SEARCH FOR ANY ORGANISMS; VIRAL, BACTERIAL, FUNGAL, YEAST ETC.

TRYPTICATED SOY BROTH WILL DEVELOP CLOUDINESS OVER THE SAME TIME PERIOD.

OTHER TISSUE BIOPSIES ARE PLACED INTO CULTURE MEDIA COMPRISED OF OR ALONG WITH SELECTED/DEFINED LIVING BIOLOGICAL SYSTEMS. BIOPSY SEGMENT OF ABOUT 1CM DIAMETER IS ALSO IMPLANTED INTO LABORATORY ANIMALS SUCH AS SHEEP GOATS OR HORSES.

SOLID CARCINOMA BIOPSIES WILL OFTEN YEILD BIOLOGICAL CULTURES; SARCOMA BIOPSIES MAY NOT AS READILY GROW ORGANISMS, LEUKEMIA CELL COLLECTIONS HAVE ALSO PROVEN DIFFICULT TO YEILD ORGANISMS ON ROUTINE CULTURE PROCESSES.

BACTERIA SEEN IN TUMOUR HISTOLOGY OFTEN APPEAR COCCAL IN NATURE. CULTURE WILL OFTEN REVEAL ORGANISMS WHICH MAY BE STAPHYLOCOCCAL IN MORPHOLOGY. BACILLI (GRAM POSITIVE AND NEGATIVE, ACID FAST ETC. ) AS WELL AS MANY OTHERS MAY ALSO BE REVEALED.

COMPLEX CULTURE TECHNIQUES

WHEN ORGANISMS ARE INTIMATELY ENCLOSED IN CELLULAR OR TISSUE STRUCTURES THEY MAY NOT BE EASILY REVEALED BY ORDINARY CULTURE TECHNIQUES; TISSUE AND/OR CELLULAR DISRUPTION MAY BE NEEDED PRIOR TO ORGANISM GROWTH. DISRUPT ION MAY BE ACCOMPLISHED PHYSICALLY AND/OR CHEMICALLY AND/OR BIOLOGICALLY AND THIS MAY ACCOUNT FOR THE INCREASED INCIDENCE OF INFECTIONS POST RADIOTHERAPY AND CHEMOTHERAPY(ESPECIALLY IN COMBINATION WITH IMMUNOSUPPRESSION THAT ALSO FOLLOWS THESE THERAPIES) . INTERESTINGLY, ONE OF THE MOST PROBLEMATIC INFECTIONS FOLLOWING BONE MARROW ABLATION IS MULTI- RESISTANT STRAIN STAPHYLOCOCCUS AUREUS; THIS ORGANISM OFTEN IS YEILDED FROM COMPLEX CULTURE TECHNIQUES OF CANCER TISSUE OR CANCER PATIENT SAMPLE.

PHYSICAL

PHYSICAL DISRUPTION OF CANCER TISSUE MAY BE ACHIEVED BY EXTREME HEAT (PASTEURISATION, EVEN BOILING FOR 10-15 MINUTES) , FREEZING AND SUBSEQUENT THAWING OF SAMPLE MAY ALSO BE ADEQUATE TO ALLOW FOR THE SUBSEQUENT CULTURING OF ORGANISMS MAY BE MADE POSSIBLE.IT MAY BE ARGUED HERE THAT FREEZING AND BOILING SIMPLY PREPARE A MORE FERTILE SOIL FOR CONTAMINANT INFECTION, THIS IS STILL RELEVANT AS INFECTIONS THAT REPEATEDLY CONTAMINATE TUMOUR SAMPLES MUST HAVE AFFINITY FOR THEM.

FREEZING OF A TUMOUR BIOPSY OR A COLLECTION OF CANCER CELLS SUCK AS IN LEUKEMIC BLOOD , SUBSEQUENT THAWING AND CULTURE IN THE

INVENTOR'S EXPERIENCE HAS A GREATER CHANCE OF YEILDING BACTERIAL GROWTH THAN EXTREME HEAT, FURTHERMORE, RESULT ANT CULTURES FROM THE SAME SAMPLE MAY DIFFER FOLLOWING HEAT THAN FOLLOWING COLD TREATMENT. THIS MAY BE DUE TO INAPPROPRIATE EXTREMES SELECTING FOR RESISTANT ORGANISMS . SOME BACTERIA MAY SURVIVE FREEZING AND

OTHER PHYSICAL DISRUPTION SUCH AS BONIFICATION, ELECTRICAL AND OTHER DISRUPTIVE PHYSICAL MECHANISMS HAVE BEEN EMPLOYED BY INVENTOR WITH VARYING DEGREES OF SUCCESS IN ELLICITING CULTURES WHERE WHOLE SAMPLES OR SPECIMENS HAVE FAILED TO PROVIDE ORGANISM GROWTH BY DIRECT CULTURE PROCESSES. CHEMICAL

VARIOUS CHEMICAL AGENTS HAVE BEEN USED BY AUTHOR IN DISSOLVING

TISSUE STRUCTURES TO ALLOW FOR ORGANI8M EXPRESSION. SUCH

TECHNIQUES HAVE INCLUDED THE EXPOSURE OF CANCER SAMPLES TO PH

FLUCTUATIONS OR SIMPLY TO EXTREMES WHICH ALLOW FOR TISSUE AND OR

CELLULAR BREAKDOWN.

VARIOUS LEVELS OF HYDROXYUREA ADDED TO LEUKEMIA CELLS ALLOWED FOR

BREAKDOWN AND BACTERIAL GROWTH SIMILAR IN MORPHOLOGY AND

CHARACTERISTICS TO STAPHYLOCOCCUS AUREUS.THIS BUGGEBTS THAT

TREATMENT OF SAMPLE WITH CHEMOTHERAPY MAY FASCILITATE ORGANISM

CULTURE.

BIOLOGICAL

INCUBATION OF CANCER BIOPSY/CANCER CELL SUSPENSION WITH VARIED FRAGMENTS OF ANIMAL BLOOD (TESTED FOR STERILITY) ,WILL OFTEN YEILD POSITIVE CULTURE.ANIMALS MAY BE OF A LARGE VARIETY OF NON-HUMAN CREATURES INCLUDING HORSES GOATS AND SHEEP. ANIMAL BLOOD MAY ORIGINATE FROM UNVACCINATED ANIMALS AND/OR FROM THOSE WHICH HAVE BEEN PREVIOUSLY CHALLANGED BY THE CANCER (OR A RELATED ONE) OR THOSE PREVIOUSLY CHALLANGED WITH HUMAN TISSUE. BOTH CELLULAR AND HUMOURAL ANTI-HUMAN AND/OR ANTICANCER RESPONSE CAN DISRUPT SAMPLE STRUCTURE AND ALLOW FOR BACTERIAL GROWTH. INVENTOR HAS FOUND THAT ENZYMATIC DIGESTION OF CANCER CELLS MAY ALSO FASCILITATE ORGANISM CULTURE

PHYSICAL/CHEMICAL/BIOLOGICAL METHODS MAY BE USED SEPARATELY OR IN ANY COMBINATION.THE ORGANISMS YEILDED MAY VARY BY TECHNIQUE AND ART OFTEN NOT RESTRICTED TO PURE COLONIES.

DETERMINATION OF CLASSIFICATION.

PLEASE REFER TO CLASSIFICATION SECTION.

-MANY ORGANISMS RECOVERED FROM DISEASE BIOPSIES OR FROM BLOOD OR OTHER SAMPLES OF PATIENTS, PARTICULARLY WHERE DISEASE IS

PROCEEDING UNCHECKED; WILL REPRESENT CAUSATIVE OR SYNERGISTIC ORGANISMS.NEMESIS OR ANTAGONISTIC ORGANISMS MAY BE RECOVERED IF THE PATIENT IS UNDERGOING (OR IN THE TIME PERIOD IMMEDIATELY PRIOR OR SUBSEQUENT TO)REGRESSION OR REMISSION.

DISEASES OTHER THAN CANCER WILL ALSO YEILD ORGANISMS ON POST-DISRUPTION CULTURE TECHNIQUES. ARTHRITIS AND OTHER AUTO-IMMUNE DISEASES MAY YEILD BACTERIA RESEMBLING STAPHYLOCOCCUS AUREUS AS MAY CULTURES OF AIDS BLOOD. SUCH ORGANISMS MAY ALSO BB ISOLATED FROM A VARIETY OF DISEASES AND PATIENT SAMPLES INCLUDING PSORIASIS,CARDIOVASCULAR DISEASE AND VIRTUALLY ANY DISEASE

CONDITION INVESTIGATED BY INVENTOR TO DATE INCLUDING GENETIC DISEASES SUCH AS DOWNS SYNDROME.BACTERIAL APPEARANCE MAY RESEMBLE STAPHYLOCOCCI , STREPTOCOCCI , BACILLI COLI FORMS , PROTEUS ETC . A LARGE LIBRARY OF DISEASE AND RELATED CULTURES WILL BETTER DELINEATE,DEFINE AND ASSOSCIATE DISEASE WITH RELEVANT ISOLATED ORGANISMS.,

INVENTOR HAS FOUND THAT ISOLATED ORGANISMS MAY VARY IN MORPHOLOGY AND CHARACTERISTICS DURING VARIOUS STAGES OF DISEASE AND THERAPY. IT APPEARS THAT THE CANCER OR OTHER DISEASE STATE MAY BE PROTECTIVE OF SUCH ORGANISMS . AS ADMINISTRATION OF APPROPRIATE CONVENTIONAL ANTIBIOTIC, PARTICULARLY WHERE ORGANISM WAS ISOLATED FROM CANCER PATIENT WILL HARDLY IF EVER ELIMINATE THE ORGANISM. IT CAN USUALLY BE ISOLATED SOON AFTER AND SOMETIMES EVEN DURING ANTIBIOTIC THERAPY; OFTEN WITH ALTERED ANTIBIOTIC RESISTANCE PATTERN; IT MAY BE THAT THE CANCER CONDITION SOMEHOW SHIELDS THE ORGANISM(EG ORGANISMS DEEP WITHIN A LARGE TUMOUR MASS MAY ESCAPE THERAPEUTIC ANTIBIOTIC DOSES, THIS MAY ALLOW FOR PROTECTION AND TIME TO DEVELOP AND/OR SELECT FOR RESISTANT STRAINS.) IT IS ALSO HYPOTHESISED BY AUTHOR THAT CANCER CELLS MAY THEMSELVES DONATE RESISTANCE DIRECTLY TO THESE ORGANISM (AS IN CASES OF

CREATING A LIBRARY AND MATCHING

A LIBRARY IS GENERATED AND CLASSIFIED ACCORDING TO CLASSIFICATION

PATENT . LIBRARY CLASSIFIES THE FOLLOWING

ORGANISMS ISOLATED FROM BIOPSIES

ORGANISMS ISOLATED FROM PATIENT SPECIMENS

ORGANISMS WITH AFFINITY AS NOTED EPIDEMIOLOGICALLY, CLINICAL

HISTORY, LIVING BIOLOGICAL SYSTEM TESTS, OR AS GENERATED/INDUCED

IN LABORATORY SITUATION.

ORGANISMS ARE THEN CLASSIFIED ACCORDING TO CLASSIFICATION PATENT.

1-

DISEASED CELLS , WHERE AVAILABLE, ARE PREPARED INTO VACCINES SUCH

AS ONCOLYSATES AS WELL AS BEING PLACED THROUGH ALL THE PROCESSES

OF MULTIPHASIC/MULTIMODAL THERAPY AS WELL AS USING TAGGING AND

TARGETING MECHANISMS.

2-

DISEASE-RELATED ORGANISMS/FACTORS ARE TARGETED IF THEY CAU6E OR

ASSIST THE DISEASE PROCESS -A LIBRARY OF HEAT-KILLED VACCINES AS

WELL AS OTHERS ARE PREPARED AS WELL AS A RANGE OF THERAPIES BASED

ON TAGGING,CARRIER,MULTIPHASIC/MULTIMODAL TECHNIQUES.

3-

ORGANISMS/FACTORS OPPOSING THE DISEASE PROCESS OR OPPOSING

DISEASE-RELATED SYNERGISTIC/CAUSATIVE ORGANISMS ARE

AUGMENTED/USED FOR THE CREATION OF THERAPY AND ARE AMPLIFIED/HADE

MORE SPECIFIC BY INCREASED EFFICACY AND SPECIFICITY GUIDELINES OF

PATENT.

AN EXAMPLE OF LIBRARY USE AND MATCHING WILL FOLLOW;THIS COMPRISES A FRACTION OT INDUCED REMISSION THERAPY PROTOCOLS;ALONG WITH SPECIFIC PROTOCOLS AND NON-SPECIFIC MODALITIES SUCH AS THE USE OF LIVING BIOLOGICAL SYSTEMS TO CREATE AND STABILISE AN ENVIRONMENT IN THE PATIENT CONDUSIVE TO HEALTH

SPECIFIC PROTOCOLS

THIS TITLE REFERS TO MATCHING OF THERAPIES TO PATIENT AND DISEASE . RAISING THE THERAPY FROM AND AGAINST PATIENT BIOPSY AND SPECIFIC ORGANISMS FROM PATIENT AS PER CLASSIFICATION PATENT. BIOLOGICVALLY ENHANCED FOODS.

INTRODUCTION

A NUMBER OF MODERN AND ANCIENT FOODS AND DRINKS ARE PREPARED BY

BACTERIAL FERMENTATION OF SUBSTRATE-

SUBSTRATE PRODUCT

MILK CHEESE, YOGHURT, BUTTER, ETC

VEGETABLES PICKLES, SAURKRAUT

FRUIT WINE

MANUFACTURE.

PATENT INTRODUCES FOODS MADE FROM/ENFORCED WITH LIVING BIOLOGICAL SYSTEMS WITH THERAPEUTIC/PREVENTATIVE/REGENERATIVE AS WELL AS OTHER BENEFICIAL PROPERTIES . ARRANGEMENT OF LBS MAY BE DESIGNED FOR SPECIFIC PURPOSE OR AS BROAD SPECTRUM. HIGH ORGANISM VIABILITY IS PREFERRED BUT NOT ESSENTIAL.

CHOOSING THE LIVING BIOLOGICAL SYSTEM

ORGANISMS USED IN PRIOR ART OFTEN BELONGED TO A RESTRICTED GROUP

OR SPECIE, EG YEASTS/ACIDOPHILUS ETC

DIFFERENCES FROM PRIOR ART INCLUDE;

1-LBS FORMULATION

2-ORGANISM DOSEAGE

3-NEW FOOD TYPES GENERATION

AND SUPPLEMENTATION.

SUPPLEMENTATION

GENERAL VS SPECIFIC.

GENERAL SUPPLEMENTATION INVOLVES USE OF PREVIOUSLY DEFINED LIVING

BIOLOGICAL SYSTEM FORMULA ADDED TO FOODSTUFF AND DRINKS AT ANY

DOSES DETERMINED BY PRODUCT. ,

BACTERIAL POWDER, FOR EXAMPLE, CANNOT BE ADDED IN LARGE DOSES

TO SOFT DRINKS ALTHOUGH DOSES OF SEVERAL MILLION UNITS DO NOT

USUALLY INTERFERE SIGNIFICANTLY WITH FLAVOUR OR

TEXTURE. SUPPLEMENTATION OF DAIRY FOOD, HOWEVER CAN EASILY SUPPORT

BILLIONS OF ORGANISMS MORE WITHOUT SIGNIFICANT CHANGE IN FLAVOUR

OR TEXTURE. THIS TERM REFERS TO A NEW RANGE OF FOODS WHICH HAVE BEEN EITHER MANUFACTURED BY AND/OR REINFORCED WITH LIVING BIOLOGICAL SYSTEMS AS PREVIOUSLY DEFINED.

INTRODUCTION

BACTERIAL FERMENTATION OF SUBSTRATE-

SUBSTRATE PRODUCT

MILK CHEESE, YOGHURT, BUTTER, ETC

VEGETABLES PICKLES, SAURKRAUT

FRUIT WINE

MANY OF THESE FERMENTED FOODS CONTAIN RELATIVELY LOW LEVELS OF LIVING ORGANISMS/CELLULAR STRUCTURES AS THE USUAL FERMENTATION PROCESS CULMINATES IN CHANGES (SUCH AS LACTIC ACID BUILD UP, BACTERIAL ENDPRODUCT ACCUMULATION, PH CHANGES ETC.) WHICH ARE INHIBITORY/LETHAL TO THE ORGANISMS USED IN FOOD/DRINK

MANUFACTURE.

CHOOSING THE LIVING BIOLOGICAL SYSTEM

ORGANISMS USED IN PRIOR ART OFTEN BELONGED TO A RESTRICTED GROUP

OR SPECIE, EG YEASTS/ACIDOPHILUS ETC

DIFFERENCES FROM PRIOR ART INCLUDE;

1-LBS FORMULATION

2-ORGANISM DOSEAGE

3-NEW FOOD TYPES GENERATION

AND SUPPLEMENTATION.

SUPPLEMENTATION

GENERAL VS SPECIFIC.

BACTERIAL POWDER, FOR EXAMPLE,CANNOT BE ADDED IN LARGE DOSES

JUST MENTION LBS EGSAMOL LACTOSE INTOLERANT CHOLESTEROL IMMUNITY SPECIFIC PROTOCOLS MAY THEORETICALLY BE MORE APPROPRIATE AND MEET WITH GREATER CHANCE OF SUCCESS BUT WOULD TAKE A FINITE PERIOD OF TIME TO DEVELOP PARTICULARLY WHERE MULTIPHASIC/MULTIMODAL THERAPY IS INVOLVED; IN MANY CASES THEREFORE, THE INVENTOR HAS OPTED TO FIRST MATCH AND EMPLOY LIBRARY THERAPY UNTIL THERAPY DEVELOPED FROM PATIENT'S OWN SAMPLES CAN BE DEVELOPED AND EMPLOYED.

GENERAL-/NON-SPECIFIC THERAPY

STANDARDISING THERAPY IS BETTER ACHIEVED IF CERTAIN CONDITIONS CAN BE CONTROLLED IN ALL PATIENTS. SUPPLEMENTATION WITH A COMPLEX LIVING BIOLOGICAL SYSTEM SUCH AS THAT PREVIOUSLY DESCRIBED ENABLES NOT ONLY THE ESTABLISHMENT OF BENEFICIAL BOWEL FLORA WHICH MAY PROVIDE NUTRITION, IMMUNOSTIMULATION AS WELL AS

ANTIDISEASE ACTIVITY. SUPPLEMENTATION WITH 5 GRAMS TDS MAY

DISPLACE PATHOGENIC ORGANISMS SUCH AS CANDIDA ALBICANS AND MAY, BY PROVIDING A STABLE, MODIFYING INFLUENCE(REPRODUCIBLE BY SIMILAR ADMINISTRATION IN OTHER PATIENTS) ALLOW FOR ANTICIPATION OF BOWEL FLORA INVOLVEMENT IN DISEASE AND HOST STATE AS WELL AS INTERPLAY WITH THERAPY. IN THEORY, CONTROLLING BOWEL FLORA AS WELL AS SKIN FLORA(APPLICATION OF LIVING BIOLOGICAL SYSTEM IN COSMETIC FORM) ALONG WITH RESPIRATORY AND OLFACTORY FLORA CONTROL (SKIN AND BOWEL MODIFICATION IS BY SIMILAR FORMULATION TO THAT DISCUSSED PREVIOUSLY, INVENTOR BELIEVES THAT IN THE FORMULATION OF LBS FOR THE RESPIRATORY AND OLFACTORY TRACTS, BACTERIA (EVEN THOSE WHICH APPEAR BENEFICIAL)SHOULD NOT BE USED . DEPENDING ON SPUTUM AND SWAB CULTURES,PHAGE LBS CAN BE FORMULATED TO REMOVE ANY PATHOGENIC ORGANISM FROM ANY AREA BUT PARTICULARLY RESPIRATORY PASSAGES . BY USE OF LBS SUPPLEMENTATION, SYNERGISTIC ORGANISMS MAY BE

MINIMISED.BY CONTROLLING THESE FLORA, ORGANISMS WHICH MAY DONATE RESISTANCE TO TARGET OR OTHERWISE SYNERGISE WITH IT MAY BE MINIMISED. PHAGE AND ANTIBIOTIC ORGANISMS MAY BE ADDED TO THE LBS, HOWEVER, PHAGE OPTIMAL USE IS IN RELATIVELY STERILE AREAS SUCH AS THE LUNGS.

ABILITY OF SYNNERGISTIC ORGANISMS TO ASSIST DISEASE PROCESS AS WELL AS PERHAPS INFLUENCING THE CAUSATIVE ORTGANISMS AS WELL. MORE EXTENSIVE TECHNIQUES OF FLORA REPLACEMENT SUCH AS COLONIC/FLUSHING WITH OR WITHOUT ANTIBIOTIC/ANTISERA/IMMUNE RESPONSE/PHAGE SYSTEM TO ELIMINATE DISEASE-ASSOSCIATED FLORA PRIOR TO OR SIMULTANEOUSLY WITH ADDITION/RESEEDING WITH KNOWN FLORA.

BIOLOGICALLY ENHANCED FOODS FORMAT. AND CHARACTERISTICS DURING VARIOUS STAGES OF DISEASE AND THERAPY. IT APPEARS THAT THE CANCER OR OTHER DISEASE STATE MAY BE PROTECTIVE OF SUCH ORGANISMS. AS ADMINISTRATION OF APPROPRIATE CONVENTIONAL ANTIBIOTIC, PARTICULARLY WHERE ORGANISM WAS ISOLATED FROM CANCER PATIENT WILL HARDLY IF EVER ELIMINATE THE ORGANISM. IT CAN USUALLY BE ISOLATED SOON AFTER AND SOMETIMES EVEN DURING ANTIBIOTIC THERAPY; OFTEN WITH ALTERED ANTIBIOTIC RESISTANCE

PATTERN; IT MAY BE THAT THE CANCER CONDITION SOMEHOW 8HIELDS THE ORGANISM(EG ORGANISMS DEEP WITHIN A LARGE TUMOUR MASS MAY ESCAPE THERAPEUTIC ANTIBIOTIC DOSES, THIS MAY ALLOW FOR PROTECTION AND TIME TO DEVELOP AND/OR SELECT FOR RESISTANT STRAINS.) IT IS ALSO HYPOTHESISED BY AUTHOR THAT CANCER CELLS MAY THEMSELVES DONATE RESISTANCE DIRECTLY TO THESE ORGANISM (AS IN CASES OF

AIMING CELLS DEFINE LIBRARY DEFINE MECHANISMS

VIRAL/UINF ALSO INTRFERANCE

AS WITH THE UNDERLYING THEORY OF HYERTHERMIA PATENT, CHANGES PHYSICAL, CHEMICAL OR BIOLOGICAL USED IN PREPARATION OF VACCINES OR IN ANY OTHER THERAPY SHOULD BE USED TO PREPARE THE TARGET AS WELL FOR OPTIMUM RESPONSE TO THERAPY . OTHER EXAMPLES OF THIS HYPOTHESIS WILL NOW FOLLOW.

BREAST CANCER 42 YEAR OLD FEMALE- ADENOCARCINOMA OF LEFT BREAST-

MAMMOGRAPHY AND BIOPSY PERFORMED AS BASELINE.

TUMOUR HAD INCREASED IN SIZE FROM 3CM DIAMETER TO 15 CM BY 8 CM

OVER A THREE MONTH PERIOD.

VACCINE WAS PREPARED BY ENZYMATIC DIGESTION WITH PROPRIETARY

PREPARATION OF DIGESTIVE ENZYMES CALLED GADITAL(PRECISE

COMPOSITION IN GLOSSARY)

THIS LED TO GENERATION OF CELLULAR(AND POSSIBLE RELATED ORGANISM

EXTRACTS WHICH WERE USED TO GENERATE MULTIMODAL THERAPY BOTH

AGAINST CELLS AND RELATED ORGANISMS AS EXPLAINED IN INDUCED

REMISSION THERAPY PATENT.

VACCINES MADE AS PER IRT PATENT DETAILS WERE USED TO TREAT THE

PATIENT.

CANCER GROWTH WAS ARRESTED AS SHOWN IN THE FOLLOWING FILMS;

AFTER 4 WEEKS THERE WAS EVIDENCE OF NECROSIS BUT NO OVERT

SHRINKAGE

ON THE 6TH WEEK,DIRECT INTRATUMOURAL INJECTION OF GADITAL WAS

ATTEMPTED AND RAPID SHRINKAGE FOLLOWED AS SHOWN IN THE FOLLOWING

FILMS.

IT SHOULD BE NOTED HERE THAT A SMALL 2CM LESION IN THE OTHERT

BREAST WAS PREVIOUSLY(PRIOR TO VACCINE THERAPY) INJECTED WITH THE

DIGESTIVE ENZYMES WITH NO RESULTING CHANGE.)

MOST DIGESTIVE ENZYMATIC CHANGES IN CELLULAR OR TISSUE STRUCTURE

WOULD PROBABLY RESOLVE WITHIN A DEFINED PERIOD OF TIME (SUCH AS

ONE CELL CYCLE)IN THE BODY, HENCE PRIOR TREATMENT WITH ENZYME

DIGESTION A LONG TIME PRIOR TO VACCINE THERAPY IS UNLIKELY TO BE

VERY USEFUL IN THIS SETTING; AS OPPOSED TO ENZYME TREATMENT

IMMEDIATELY PRIOR TO, AND/OR DURING AND/OR FOLLOWING THE

VACCINATION PROGRAM.

AS THE BODY WAS FIRST VACCINATED AGAINST DIGESTED STRUCTURES AND

WAS ABLE TO BUILD A STRONG , RESPONSE AGAINST THESE; SUBSEQUENT

TREATMENT WITH THE SAME DIGESTIVE ENZYME (BY DIRECT INTRATUMOURAL

INJECTION) ALLOWS FOR THE EXPOSURE OF DISEASE STRUCTURES AGAINST

WHICH THE BODY HAS BEEN VACCINATED BY EXPOSING THE DISEASE IN

VIVO TO PART OR ALL OF THE PROCESBES USED IN PREPARING THE

VACCINE. THIS ALLOWS FOR DRAMATIC IMPROVEMENT IN RESPONSE TO

VACCINE AND ACCOUNTS FOR THE DRAMATIC IMPROVEMENT IN PATIENT.

VACCINATION WITH CERTAIN PREPARATIONS OF DISEASE WILL BE FAR MORE

EFFECTIVE IF THE DISEASE PRESENTATION CAN BE MADE TO MIMIC THE

STRUCTURES AGAINST WHICH THE RESPONSES WERE RAISED. THIS CAN BE

ACCOMPLISHED BY TREATING THE DISEASE WITH THE SAME PROTOCOLS BY

WHICH THE VACCINE WAS PREPARED AND/OR BY USING OTHER MEANS WHICH

LIBERATE IDENTICAL OR SIMILAR STRUCTURES FROM THE TARGET DISEASE

IN-VIVO.

WITH THE MYFERTHERMIA AND HEPATOMA AND THE EXAMPLE OF ENZYME DIGESTION WITH THE BREAST CANCER WE HAVE COVERED THE IMPROVEMENT

OF VACCINATION PROGRAMS WITH PHYSICAL AS WELL AS BIOLOGICAL

PROCESSING OF BOTH VACCINE AND DISEASE IN ORDER TO ALLOW FOR

PROXIMITY OF THERAPY AND TARGET FORM.

ANOTHER EXAMPLE OF PHYSICAL CHANGES BEING EMPLOYED BOTH IN THE

MANUFACTURE OF THERAPY AS WELL AS THE IN-VIVO, IN-SITU

PROXIMISATION OF STRUCTURE PRESENTATION TO THAT OF VACCINE AFTER

BUILD UP OF IMMUNE REPONSE TO VACCINE MAY BE DEMONSTRATED BY THE

USE OF SPECIFIC FREQUENCY GENERATORS.

AS AN EXAMPLE, LEUKEMIA CELLS FROM A CASE OF ACUTE MYELOCYTIC

LEUKEMIA WERE DISRUPTED BY PROLONGED EXPOSURE TO 300 HZ PULSED

OUT AT 150 WATTS FOR 48 HOURS.

THE LEUKEMIA CELLS WERE SEPARATED BY CENTRIFUGATION FROM BLOOD

SAMPLE AND SUSPENDED IN NORMAL SALINE AT CONCENTRATION OF 100,000

CELLS BY 10 TO THE 9TH POWER PER CC.

THIS SUSPENSION WAS EXPOSED TO THE PULSED FREQUENCIES AS

TRANSMITTED THROUGH A 150 WATT PLASMA GLOBE(CATHODE AND ANODE

ARRANGEMENT THROUGH HELIUM GAS. SIMILAR TRIALS WERE ALSO DONE

THROUGH OTHER TRANSMISSION MODALITIES SUCH AS 80LID ANTENNAE AND

USING VARIOUS CARRIER WAVES WITH SIMILAR RESULTS)

AFTER 3 DAYS OF CONTINUEOS EXPOSURE TO PULSED FREQUENCIES AT ROOM

TEMPERATURE; THE LEUKEMIA CELL SUSPENSION WAS FILTERED THROUGH 0.2

MICRONS TO REMOVE LIVING CELLS.

PATIENT WAS VACCINATED WITH THE FREQUENCY-ALTERED CELLS AT 3CC

EVERY 3RD DAY.

PATIENT'S WHITE BLOOD CELL COUNT REMAINED LARGELY UNCHANGED OVER

THE VACCINATION PERIOD. PATIENT WAS EXPOSED DAILY TO PULSED

FREQUENCY OF 300 HZ AT 150 WATTS. FOR 15 MINUTE SESSIONS.

WHITE BLOOD CELL COUNT AT START OF VACCINATION 154000,PRIOR TO

PULSED FREQUENCY 157,000; 24 HOURS POST PULSED FREQUENCY-72,000

FOLLOWING ONE WEEK OF THERAPY COUNT REDUCED TO 24, 000.COUNT

REMAINED AT 15-30,000 FOR 8 WEEKS; PATIENT THEN RELAPSED AND

SUBSEQUENTLY DIED OF PNEUMONIA.

IT IS BELIEVED THAT MULTIPHASIC/MULTIMODAL THERAPY WOULD OBTAIN

BETTER RESULTS.

MANY PHYSICAL/CHEMICAL/BIOLOGICAL PROCESSES MAY RELEASE

ASSOSCIATED ORGANISMS/ORGANISM STRUCTURES WHICH MAY ENHANCE

ERFGFICACY OF PREPARATION PROVIDED THAT SUCH ORGANISMS DO NOT

SURVIVE IN LIVING FORM, THIS WOULD JEOPARDISE RESPONSE

PARTICULARLY IF ORGANISM IS CAUSATIVE OR SYNERGISTIC IN WHICH

CASE AGGRAVATION OF DISEASE CONDITION MAY RESULT.

LINK WITH MACHINERY PATENT ( S )

42 YEAR OLD FEMALE SUFFERING FROM BREAST CANCER; ADENOCARCINOMA,

WITH LIVER SECONDARY DISEASE (SINGLE LESION OF 10 CM DIAMETER IN

R LOBE OF

LIVER). PATIENT WAS ABOUT TO UNDERGO ADRIAMYCIN

CHEMOTHERAPY. BIOPSY SAMPLE WAS TAKEN AND SUSPENDED IN 10 CC OF

THE PATIENT'S BLOOD BIOPSY MEASURED 1 CM DIAMETER AND WAS PLACED

WHOLE INTO THE BLOOD. HALF A MG OF ADRIAMYCIN WAS ADDED TO THE

BLOOD . INCUBATION WAS ALLOWED FOR 3 HOURS. BIOPSY SAMPLE WAS RECOVERED THEN THE PROCESS REPEATED 3 TIMES. THE BIOPSY SAMLE WAS THEN RECOVERED, MANUALLY GROUND, RESUSPENDED AND SHAKEN IN 25CC OF NORMAL SALINE. BROAD SPECTRUM STAPHYLOCOCCAL PHAGES(10 TO THE 9TH POWER PLAQUE FORMING UNITS PER CC) 25CCWERE ADDED TO THE MIXTURE AND EVERYTHING THEN PASSED THROUGH A 0.2 MICRON FILTER. PATIENT WAS VACCINATED WITH 3CC EVERY 3RD

DAY. ULTRASOUND REVEALED LITTLE CHANGE IN TUMOUR SIZE AFTER 3 WEEKS OF THIS. ADRIAMYCIN SINGLE STANDARD DOSE WAS ADMINISTERED AT THIS POINT AND LIVER TUMOUR DISAPPEARED WITHIN 2 WEEKS.

PHAGES OF MIXED CULTURES OF STAPHYLOCOCCUS AUREUS WERE USED HERE AS IMMUNE ADJUVANTS. IDENTICAL PHAGE PREPARATIONS ALONE HAD NEVER PREVIOUSLY EFFECTED TUMOUR SIZE IN BREAST LIVER SECONDARIES ACCORDING TO INVENTOR'S EXPERIENCE. IT IS FELT THAT PRIOR EXPOSURE TO ADRIAMYCIN ALLOWED THE IMMUNE SYSTEM TO REACT AGAINST TUMOUR COMPONENTS DAMAGED BY CHEMOTHERAPY PRIOR TO ITS APPLICATION, HENCE A MAJOR IMMUNE REACTION FOLLOWED THE IN-VIVO CHANGES.

PATIENT REMAINED IN REMISSION FOR 4 MONTHS THEN DEVELOPED LIVER AND BONE RECURRENCE. SHE REFUSED FURTHER CHEMOTHERAPY AND DIED 6 MONTHS LATER.

AIDS PATIENT 28 YEAR OLD MALE.4 YEAR HISTORY

DIAGNOSIS. ASYMPTOMATIC, T-CELL COUNT 350,T4/T8 RATIO

0.05 CC GOAT BLOOD WAS INJECTED INTRADERMALLY. DAY

DAY 3-T-CELL TOTAL- 250, RATIO 0.8

DAY 10-T-CELL TOTAL-450 RATIO 0.9

AIDS PATIENT-45 YEAR OLD MALE,2 YEARS SINCE DIAGNOSIS .

T-CELL TOTAL -240, T4/T8 RATIO 0.5

HORSE BLOOD 0.1CC CRUDE LYSED INJECTED SUBDERHALLY DAY 1

DAY 3-T CELL TOTAL 248 T4/T8 RATIO 0.5

DAY 10-T CELL COUNT 330 T4/T8 RASTIO 0.6

AIDS PATIENT -50 YEAR OLD FEMALE- 6 MONTHS SINCE DIAGNOSIS.

T CELL TOTAL COUNT 150 T4/T8 RATIO 0.4

GOAT SERUM- 0.1 CC INJECTED INTRADERMALLY

DAY 3- TOTAL T CELLS-90 T4/T80.3

DAY 10- TOTAL T CELL 210 T4/T80.6

THERE IS DATA TO SUGGEST THAT THE EFFECT OF DECREASE AND SUBSEQUENT AUGMENTASTION OF IMMUNE RESPONSE MAY BE MORE DRAMATIC WHEN THE ANIMAL HAS BEEN IMMUNISED AGAINST THE HIV/DISEASED CELLS/BLOOD OF PATIENT. AGAIN, THE TWO PHENOMENON ARE THOUGHT TO BE AT LEAST PARTIALLY RESPONSIBLE.

REMOVING ANTIHUMAN COMPONENT

TECHNIQUES FOR THIS RANGE FROM SIMPLE TO COMPLICATED.

SERUM IS STORED AT 3'CELSIUS FOR 9 MONTHS.

IN THI8 INVENTOR'S FIELD OF EXPERIENCE , BOTH IMMUNISED AND NON- IMMUNISED BLOOD WAS STUDIED; THE DISADVANTAGE OF THE ABOVE

DEHUMANISING METHOD IS THE LONG TIME NEEDED TO MANUFACTURE SPECIFIC VACCINES.THE IDEA OF USING A LIVING RESISTANT EXTRANEOUS SYSTEM TO COMBAT HIV IS TO BE ABLE TO MODIFY THERAPY(AS IN

RAISING NEW ANTISERUM FOR EXAMPLE)AS THE VIRUS MUTATES INTO A FORM THAT CAN INHIBIT/ELUDE/OTHERWISE SURVIVE PREVIOUS IMMUNE RESPONSE . PREPARATION OF BROAD SPECTRUM ANTISERA AGAINST A LARGE VARIETY OF HIV SAMPLES AS COLLECTED OR RAISED AND USE OF TYHAT OR THE SPECIFIC FRACTION OF IT 8H0WN TO ACT SPECIFICALLY AGAINST THE PATIENT'S VIRAL LOAD(AS PREVIOUSLY DISCUSSED,THIS WOULD BE THE FRACTION ALTETRED ELECTROPHORETICALLY AFTER EXPOSURE TO HIV; IT CAN THEN BE IDENTIFIED BY ITS PHYSICAL

CHARACTERISTI CS; OTHER METHODS OF PRECIPITATING IT OUT. WITH TARGET CELL OR VIRUS THEN RECONSTITUTING IT MAY ALSO APPLY )MAY OVERCOME THIS PROBLEM AS WOULD THE USE OF MORE RAPID

'DEHUMANISING' TECHNIQUES SUCH AS WASHING SERUM AGAINST NORMAL BLOOD CELLS ETC.

PERHAPS THE GREATEST SUCCESS WAS NOTED WHEN THE ANTISERA WERE USED IAS PART OF MULTIMODAL/MULTIPHASIC APPLICATION.SEVERAL CASES WERE TREATED WITH ANTISERA ALONE TO DEMONSTRATE EFFICACY OF THIS SIMPLE PATHWAY AS SOLE THERTAPY AS WELL.

USE OF NON-IMMUNISED ANTISERA IN THE TREATMENT OF AIDS.

THE PREPARATIONS USED WERE CRUDE BY MODERN STANDARDS.

I YEAR OLD HORSE WAS BLED AND 100 CC OF SERUM WERE REMOVED

FOLLOWING CENTRIFUGATION OF BLOOD . SERUM WAS STORED AT 3'C FOR

NINE MONTHS AS WERE SERA FROM SHEEP AND GOAT.

PRECIPITATES WERE MARKED BY 3 MONTHS AND ALL PRECIPITATE WAS

REMOVED BY 0.2 MICRON FILTRATION AT THE END OF NINE MONTHS.

USE OF HORSE SERUM

23 YEAR OLD FEMALE.18 MONTHS SINCE DIAGNOSIS.T CELL COUNT 320,

T4/T8 RATIO 0.8

0.6CC ANTISERUM ADMINISTERED INTRADERMALLY

DAY3-T CELL COUNT 280 T4/T8 RATIO 0.6

DAY 10-T CELL COUNT 420 T4/T8 RATIO 1.0

DAY 30-T CELL COUNT 380 T4/TB RATIO 0.9

45 YEAR OLD MALE 1 YEAR SINCE DIAGNOSIS T CELL COUNT 140;T4/T8

RATIO 0.5

0.1 CC GOAT ANTISERUM INJECTED INTRADERMALLY

DAY 3- T CELL COUNT 90 ;T4/T8 RATIO 0.3

DAY 10 -T CELL COUNT 210;T4/T8 RATIO 0.8

DAY 30- T CELL COUNT 340;T4/T8 RATIO 1.0

18 YEAR OLD MALE 8 MONTHS SINCE DIAGNOSIS.T CELL COUNT 200;T4/T8

RATIO 0.8

0.1 CC SHEEP ANTISERUM USED INTRADERMALLY

DAY 3- T CELL COUNT 210 T4/T8 RATIO 0.8

DAY 10 -T CELL COUNT 310 T4/T8 RATIO 0.8

DAY 30 -T CELL COUNT 280 T4/T8 RATIO 0.7

USE OF IMMUNISED ANIMAL ANTISERUM

1 CC OF SUPERNATANT WAS USED TO VACCINATE HORSE INTRADERMALLY 3 TIMES A WEEK FOR THREE WEEKS.100CC OF ANIMAL BLOOD WERE THEN DRAWN AND SERUM SEPARATED AND STORED FOR 9 MONTHS TO ALLOW FOR ANTIHUMAN FRAGMENT SEPARATION. PREPARATION OF ANTIHUMAN ANTISERUM

ANIMAL(HORSE)WAS INJECTED WITH 0.5CC OF HUMAN BLOOD POOLED FROM

HEALTHY DONORS EVERY THREE DAYS FOR THREE WEEKS.

SERUM WAS EXTRACTED ON FOURTH WEEK AND LABELLED ANTIHUMAN SERUM.

THIS WAS USED TREAT BLOOD ISOLATED FROM SEVERAL DISEASES IN ORDER

TO REMOVE NORMAL COMPONENTS AND LEAVE DISEASE-RELATED

ORGANISMS/FACTORS.

USE OF ANTISERA RAISED AGAINST THIS DISEASE-SPECIFIC FRAGMENT

RAISES A THEORETICALLY MUCH MORE SPECIFIC ANTISERUM.

MULTIPHASIC WOULD INVOLVE A SCENARIO EXAMPLED BY THE FOLLOWING; MULTIPHASIC GENERAL,RAISED BY REPETITION OF THE ABOVE PROCESSES OF MANUFACTURE SO THAT EVERY WEEK, BLOOD DRAWN FROM AIDS PATIENTS UNDER TREATMENT 3 TIMES A WEEK WITH ANTISERUM AT DOSEAGE OF 0.6 CC INTRADERMAL ; WOULD BE USED TO VACCINATE ANIMALS WHICH YEILDED PREVIOUS ANTISERA OR NEW ONES. POOLED BLOOD MAY BE USED DIRECTLY AND/OR FIRST PREPARED BY TREATMENT WITH ANTIHUMAN ANTISERUM.

USE OF MODERN PURIFICATION OF SERUM TECHNIQUES SUCH AS THOSE PREVIOUSLY MENTIONED IN PATENT COULD ACCELERATE THE PRODUCTION OF SAFE PATIENT-SPECIFIC MULTIPHASIC SERA.

EFFICACY IS AMPLIFIED WHEN ANTISERUM IS USED AS PART OF MULTIPHASIC/MULTIMODAL THERAPY AND NEW PATHWAYS/MECHANISMS ARE ALSO GENERATED. IT IS POSSIBLE, FOR EXAMPLE TO TAG DISEASED CELLS WITH FRACTIONS AND THEN VACCINATE ANIMALS AGAINST EITHER THE TAGGING AGENT ALONE OR AGAINST THE TAGGING AGENT-DISEASE COMPLEX.THIS IS OF PARTICULAR IMPORTANCE IN THE TREATMENT OF CANCER BUT IS MENTIONED HERE TO COVER THE USE OF ANTISERA BY THIS MECHANISM IN AIDS.

EVERY PHASE OF THE USE OF EXOGENOUS ANIMAL ANTISERA CAN

DEMONSTRATE BENEFITS OF PREPARATIONS RANGING FROM THE CRUDEST USE

OF WHOLE BLOOD TO EXTRACT8 CELLULAR/NON-CELLULAR TO THE USE OF

CRUDE AND PURIFIED ANTISERA.

AN EXAMPLE WILL BE GIVEN OF THE USE OF PURIFIED ANTISERA RAISED

AGAINST A GENERAL POOL OF AIDS BLOOD TREATED WITH ANTIHUMAN

ANTISERUM.

PATIENT 45 YEAR OLD MALE;5 YEAR HISTORY SINCE DIAGNOSIS. T CELL

COUNT STABLE AT 900-1000 FOR THAT TIME . PRESENTS WITH INCREASING FATIGUE AND RAPIDLY DECREASING T CELL COUNT. READINGS TAKEN OVER

THE PREVIOUS MONTHS HAD SHOWN A MONTHLY DROP IN T CELL COUNTS BY

150-200 PER MONTH. AT PRESENTATION T CELL COUNT TOTAL 350,T4/T8

RATIO 0.8.

SPECIFIC ANTISERUM (RAISED AGAINST POOLED AIDS BLOOD TREATED WITH

ANTIHUMAN ANTISERUM)

0.6CC WERE ADMINISTERED INTRADERMALLY 3 TIMES A WEEK

DAY 3-T CELL COUNT 340 T4/T8 RATIO 0.8

DAY 10- T CELL COUNT 310 T4/T8 RATIO 0.7

DAY 30- T CELL COUNT 400 T4/T8 RATIO 0.9

DAY 50- T CELL COUNT 510 T4/T8 RATIO 1.0

DAY 60- T CELL COUNT 480 T4/T8 RATIO 1.0

DAY 90- T CELL COUNT 550 T4/T8 RATIO 1.0

DAY 120 T CELL COUNT 515 T4/T8 RATIO 1.0

USE OF MULTIPHASIC ANTISERA

POOLED AIDS BLOOD WAS TREATED WITH ANTIHUMAN ANTISERA AND USED TO

VACCINATE HORSE AS PER ABOVE METHOD.

HORSE SERUM WAS ALLOWED TO STAND AT 3ºC FOR 9 MONTHS

PATIENTS (3) WERE INJECTED WITH 0.6 CC OF ANTISERUM 3 TIMES A

WEEK FOR THREE WEEKS; THEIR BLOOD WAS THEN POOLED AND PREPARED AS

PER PREVIOUS PROTOCOL TO REVACCINATE HORSE AS WELL AS VACCINATING

NEW ANIMALS. THE ANTISERUM RAISED AS PER PREVIOUS PROTOCOL WAS

THEN PROCESSED. ANTI SERUM RAISED FROM PREVIOUSLY IMMUNISED ANIMAL

WAS LABELLED SECOND CHALLANGE ANTISERUM; ANIMALS VACCINATED DE¬

NOVO GENERATE A PURELY SECOND GENERATION ANTISERUM.

THIS PROCESS MAY BE REPEATED INDEFINITELY. ORIGINAL ANIMAL WILL BE

IN ITS THIRD YEAR BY THE TIME THE THIRD PHASE IS READY(AS THIS

TECHNIQUE REQUIRES 9 MONTHS FOR DEHUMANISING) .OTHER TECHNIQUES

OF PREPARING ANIMAL SERA FOR HUMAN USE ;SUCH AS PLASMAPHARESIS

AND/OR WASHING AGAINST HUMAN BLOOD ETC. CAN GREATLY SPEED

MULTIPHASIC ANTISERA GENERATION.

PATIENTS TREATED WITH MULTIPHASIC ANTISERA ARE EXAMPLIFIED BY THE

FOLLOWING CASE;

MALE 52, 3YEAR HISTORY SINCE DIAGNOSIS-T CELL COUNT 220 T4/T8

RATIO 0.6.

TREATED BY 0.6 CC ANTISERA INTRADERMAL EVERY 3 DAYS.

DAY 3- T CELL COUNT 280 T4/T8 RATIO 0.8

DAY10- T CELL COUNT 350 T4/T8 RATIO 0.8

DAY 30 TCELL COUNT 418 T4/T8 RATIO 0,8

DAY 60 T CELL COUNT 410 T4/T8 RATIO 1.0

DAY 120 T CELL COUNT 400 T4/T8 RATIO 1.0

IN MOST OF THE ABOVE CASES PATIENTS WERE EITHER ASYMPTOMATIC OR SUFFERED FROM FATIGUE WHICH READILY RESOLVED WITHIN THE FIRST 24 HOURS.

WHERE PATIENTS PRESENTED WITH SPECIFIC INFECTIONS, WHICH RECURRED

FREQUENTLY OR WERE RESISTANT TO ANTIBIOTIC THERAPY, ANIMAL

SERA(BOTH GENERAL AND SPECIFIC) WAS USEFUL IN ELIMINATING THESE

DISEASES.

USING THE CULTURE TECHNIQUES PREVIOUSLY DESCRIBED IN THE INDUCED REMISSION THERAPY PATENT, ORGANISMS MAY BE ISOLATED FROM SAMPLES OF AIDS BLOOD; BIOPSIES OF KAPOSI'S LESIONS ETC OFTEN REVEALS A STAPHYLOCOCCUS AUREUS-TYPE ORGANISM AMONGST OTHERS. MANY SUCH ORGANISMS HAVE BEEN DEMONSTRATED BY DR ALAN CANTWELL IN BIOPSIES FROM AIDS PATIENTS POST MORTEM. IN FACT,SIMILAR ORGANISMS MAY BE SEEN IN MANY DISEASE CONDITIONS INCLUDING CARDIOVASCULAR AS WELL AS ACUTE AND CHRONIC DEGENERATIVE DISEASES.

WHETHER THE ORGANISMS ISOLATED FROM AIDS BLOOD PLAY A ROLE IN CAUSE OR SIMPLY SYNERGISE WITH THE DISEASE. RAISING VACCINES AND ANTISERA AGAINST THEM APPEAR BENEFICIAL,EVEN IN ABSENCE OF ANTI- HIV ANTISERA IN THERAPY.

500 CC OF TSB ARE INNOCULATED AND CULTURED FOR 3 DAYS. BACTERIAL GROWTH IS CENTRIFUGED AND RESUSPENDED IN 30 CC OF NORMAL SALINE. SUSPENSION IS BOILED FOR 15 MINUTES EVERY THREE DAYS THEN USED TO IMMUNISE AN ANIMAL (HORSE)BY INJECTIONS INTRADERMALLY OF 1CC EVERY 3 DAYS . ANIMALS CAN ALSO BE INJECTED WITH LIVING ORGANISMS OR THOSE PREPARED IN ACCORDANCE WITH HYPERTHERMIA/VIBRATIONAL THERAPY PATENT . A REVIEW OF THOSE RESULTS CAN BE SEEN BY REFERANCE TO RELEVANT PATENTS.

ANTISERA RAISED AGAINST THE HEAT KILLED ORGANISMS AS DESCRIBED

ABOVE IS COMBINED WITH ANTISERA RAISED AGAINST THE LIVING

BACTERIλ(SAME PREPARATION TECHNIQUE WITHOUT THE HEAT KILLING

AFTER RESUSPENSION IN SALINE)VACCINATION IS INTRADERMAL 0.5 CC

THREE TIMES A WEEK FOR THREE WEEKS, FOLLOWED BY ANTISERUM

PREPARATION AS PREVIOUSLY DESCRIBED.

ANTISERA RAISED AGAINST THESE ORGANISMS APPEAR CAPABLE OF

MAINTAINING IMMUNE STATUS AND AT LEAST PREVENTING DETERIORATION

IN THE CASES STUDIED.

PATIENT AGE 42 DIAGNOSED FOR 3 YEARS.T CELL COUNT DROPPING 80-IOO

POINTS PER MONTH OVER PAST 4 MONTHS.T CELL COUNT 311 T4/T8 RATIO

0.2.

PATIENT WAS TREATED WITH ANTISERUM(0.6 CC INTRADERMAL 3 TIMES A

WEEK)RAISED AGAINST ORGANISMS ISOLATED FROM HIS BLOOD AS PER

PREVIOUS DISCUSSION.

DAY 3- T CELL COUNT 330 T4/T8 RATIO 0.2

DAY 10 - TCELL COUNT 318 T4/T8 RATIO 0.2

DAY 60 -T CELL COUNT 350 T4/T8 RATIO 0.3

DAY 120 -T CELL COUNT 300 T4/T8 RATIO 0.3

DAY 180 - T CELL COUNT 315 T4/T8 RATIO 0.3

DAY 210- T CELL COUNT 322 T4/T8 RATIO 0.4

AS COVERED BY PATENT,MULTIPHASE ANTISERA MAY BE RAISED AGAINST THESE ORGANISMS FROM THE 8AME OR/AND NEW ANIMALS PATENT IS NOT RESTRICTED TO PARTICULAR ANIMAL/(S) IT IS POSSIBLE THAT SOME ANIMALS ARE MORE SUITED TO DEVELOPPMENT OFCERTAIN DISEASE THERAPYU THAN OTHERS BY BEING MORE ABLE TO MOUNT EFFICIENT EFFECTIVE, RESPONSE . DIFFERENT ANIMALS MAY BE ABLE TO GENERATE SUCH THERAPY OVER DIFFERING TIME PERIODS. MIXTURES OF ANTISERA FROM VARIOUS ANIMALS MAY ALSO BE USED TOGETHER .D

ELIMINATE ALONE;BY TARGETING CELLS, INTERMEDIATES,CAUSATIVE AND SYNERGISTIC ORGANISMS.USE IS COVERED BY PATENT IN ALL FORMS FROM CRUDE ,GENERAL TO REFINED AND SPECIFIC,ALONE AND/OR IN

COMBINATION WITH ANY OF THE OTHER MULTIPHASIC/MULTIMODAL ARMS OF THERAPY .

SPECIFIC PROTOCOLS MAY THEORETICALLY BE MORE APPROPRIATE AND MEET WITH GREATER CHANCE OF SUCCESS BUT WOULD TAKE A FINITE PERIOD OF TIME TO DEVELOP PARTICULARLY WHERE MULTIPHASIC/MULTIMODAL THERAPY IS INVOLVED; IN MANY CASES THEREFORE, THE INVENTOR HAS OPTED TO FIRST MATCH AND EMPLOY LIBRARY THERAPY UNTIL THERAPY DEVELOPED FROM PATIENT'S OWN SAMPLES CAN BE DEVELOPED AND EMPLOYED.

GENERAL-/NON-SPECIFIC THERAPY

ANTIDISEASE ACTIVITY. SUPPLEMENTATION WITH 5 GRAMS TDS MAY

DISPLACE PATHOGENIC ORGANISMS SUCH AS CANDIDA ALBICANS AND MAY, BY PROVIDING A STABLE, MODIFYING INFLUENCE(REPRODUCIBLE BY SIMILAR ADMINISTRATION IN OTHER PATIENTS) ALLOW FOR ANTICIPATION OF BOWEL FLORA INVOLVEMENT IN DISEASE AND HOST STATE AS WELL AS INTERPLAY WITH THERAPY. IN THEORY, CONTROLLING BOWEL FLORA AS WELL AS SKIN FLORA(APPLICATION OF LIVING BIOLOGICAL SYSTEM IN COSMETIC FORM) ALONG WITH RESPIRATORY AND OLFACTORY FLORA CONTROL (SKIN AND BOWEL MODIFICATION IS BY SIMILAR FORMULATION TO THAT DISCUSSED PREVIOUSLY, INVENTOR BELIEVES THAT IN THE FORMULATION OF LBS FOR THE RESPIRATORY AND OLFACTORY TRACTS, BACTERIA (EVEN THOSE WHICH APPEAR BENEFICIAL)SHOULD NOT BE USED. DEPENDING ON SPUTUM AND SWAB CULTURES, PHAGE LBS CAN BE FORMULATED TO REMOVE ANY PATHOGENIC ORGANISM FROM ANY AREA BUT PARTICULARLY RESPIRATORY PASSAGES . BY USE OF LBS SUPPLEMENTATION, SYNERGISTIC ORGANISMS MAY BB

MINIMISED. BY CONTROLLING THESE FLORA, ORGANISMS WHICH MAY DONATE RESISTANCE TO TARGET OR OTHERWISE SYNERGISE WITH IT MAY BE MINIMISED. PHAGE AND ANTIBIOTIC ORGANISMS MAY BE ADDED TO THE LBS, HOWEVER, PHAGE OPTIMAL U6E IS IN RELATIVELY STERILE AREAS SUCH AS THE LUNGS.

ABILITY OF BYNNERGISTIC ORGANISMS TO ASSIST DISEASE PROCESS AS WELL AS PERHAPS INFLUENCING THE CAUSATIVE ORTGANISMS AS WELL.MORE EXTENSIVE TECHNIQUES OF FLORA REPLACEMENT SUCH AS COLONIC/FLUSHING WITH OR WITHOUT ANTIBIOTIC/ANTISERA/IMMUNE RESPONSE/PHAGE SYSTEM TO ELIMINATE DI8EASE-ASSOSCIATED FLORA PRIOR TO OR SIMULTANEOUSLY WITH ADDITION/RESEEDING WITH KNOWN FLORA.

BOWEL FLORS

METHOD FOR THE IDENTIFICATION AND THERAPEUTIC USE OF

DISEASE-ASSOCIATED AGENTS

by

Sam Chachoua, M.D. FIELD OF THE INVENTION

This Invention relates to a method for disease prevention, diagnosis, treatment, prognosis and monitoring. More particularly, this invention relates to the Identification and use of disease-associated organisms, elements and forces which may be used, whole or in part, In the diagnoses, therapy and prevention of a targeted disease or other unwanted bodily condition. Although a large portion of the attendant discussion Is related to the treatment of human organisms, the Instant Invention Is also intended for use In application to both other animals, plant life forms, insects and lower life-forms.

BACKGROUND

The present invention includes a general method for identifying potential disease-associated agents, and preparing from such agents various therapeutic agents; and therefore, concerns many areas of the medicinal arts, some of which are Included In the ensuing discussion.

A wide variety of chemically based treatments for cancer and other tumorous conditions have been developed and are well known, Including various forme of chemotherapy, photodynamic therapy, radiotherapy. immunotherapy and other therapies, such as combinations of various remedies. Although It is desirable that such treatments be generally toxic to only cells of a targeted disease, It has been difficult to Identify agents having such specificity. To the contrary, the use of known therapeutic agents is typically made with only the hope that the agent being used is more toxic to cells of the targeted disease than It is to normal cells of the body. In fact, many of such agents and therapies rely almost solely on an Increased rate of cell division or other mitotic activity In cancer cells, leading to Increased absorption and the subsequent toxic efficacy of said agents and techniques. Unfortunately, there are also normal cells In the body which have high mitotic activity, such as cells of the bone marrow and Intestines, which often suffer from such therapeutic agents and therapies. Indeed, many chemically based therapies for tumorous conditions involve the use of antimitotic drugs such as adriamycin, vincristine, cisplatin, daunomycin and methotrexate, which all demonstrate strong undesirable side-effects on the normal cells of the patient. Such adverse side effects Include hair loss, extreme nausea, vomiting, fatigue, weakness, sterility, and damage to the kidneys and heart. Because such side effects can impact severely the ability of a body's Immune system to focus on the original pathogenic agents, and therefore ofthe body to rebound from both the targeted disease and the therapy, there is a need for anticancer agents having greater specificity In their targeting capability. Such conventional chemotherapeutic treatments furthermore are not often able to circumvent the protective barriers built by most cancers against a host immune system. Indeed, most cancers are able to develop resistance to specific chemotherapeutic agents before such agents are able to completely penetrate such protective barriers.

In addition to such conventional therapies which target the destruction of diseased tissue through the absorption of toxic agents, more recently It has been tried to activate the patient's own Immune system for preventing the formation of micrometastages or eliminating metastases already formed, Such recent attempts have generally stimulated the formation of tumor specific T- killer cells by immunizing the patient with oncolysates, or lysates from tumor cells. In doing this, the problem arises that such cell lysates tend not to be sufficiently Immunogenic, and therefore fail to Induce sufficient stimulation of the patient's Immune system as to effectively prevent the formation of metastases. It is generally assumed that tumor specific T-lymphocytes, when they are present, occur only at low frequency among the lymphocytes, because the antigenlclty and immunogenicity of such anti-tumor agents la generally only weak. These tumor specific cells are usually not fully activated in tumor-bearing animals, and need additional activation signals. Furthermore, immuno-deficient diseases in general are thought to be caused by microbes so well camouflaged that the immune system has difficulty distinguishing said microbes from normal tissue components which such diseases attack. For example, in a patient infected with AIDS, an Infected T-cell will ordinarily be attacked only by another T-cell, which itselfwill become subsequently infected. Indeed, some physicians have attempted to overcorne the body's

MULTI PHASED PHAGE THERAPY

BROTH WAS THEN DIVIDED INTO 100 CC BOTTLES

PHAGES WERE RAISED BY ALLOWING BACTERIAL CULTURE IN TSB TILL NUTRIENT DEPLETION AND LYSIS . BROTH WAS THEN CHECKED FOR PLAQUE- FORMING ABILITY IE PRESENCE OF PHAGES.THE INITIAL BROTH IS

CONSIDERED CRUDE PHAGE PREPARATION WAS PURIFIED BY DIALYSIS AND CONCENTRATED BY ELECTROPHORESIS TO 10 TO THE NINTH POWER PFU'S PER CC OF SALINE IN WHICH THEY WERE RESUSPENDED . THIS WAS THEN CALLED PURIFIED PHAGE EXTRACT.THE BACTERIAL; DEBRIS WAS LABELLED CRUDE BACTERIAL LYSATE CBL AND PROVED EFFECTIVE IN

IMMUNOSTIMULATION PARTICULARLY IN ANTICIPATORY

IMMUNOTHERAPY .

BOTTLE 1

PHASE ONE CRUDE PHAGE PREPARATION WAS ADDED AT DOSE OF 1CC PFU'S

WERE ABOUT 10 TO TH 5TH POWER.

CLEARING OF CLOUDINESS OCCURRED IN 48 HOURS

CULTURE NEGATIVE.

AN IMPORTANT DIFFERENCE SHOULD BE POI NTED OUT HERE BETWEEN ANTIB IOTI C AND PHAGE THERAPY .

ANTIBIOTICS ARE ESSENTIALLY NON-LIVING PRODUCTS AND HENCE WILL NOT SIGNIFICANTLY ALTER IN BEHAVIOUR. PHAGES , ON THE OTHER HAND ARE LIVING AND MAY DO SO .TO DEMONSTRATE THIS .BOTTLES THAT WERE TREATED WITH MULTIPHASED ANTIBIOTIC THERAPY THAT HAD REMAINED CLEAR IN PREVIOUS SECTION AND NOT CULTURED ANY ORGANISMS SUBSEQUENT TO TREATMENT WERE RECHALLANGED. BY 10CC OF ORIGINAL STAPHYLOCOCCAL CULTURE.

TREATED CULTURES RESISTED AT LEAST 3 SUCH CHALLENGES.

BOTTLE-2

PURIFIED PHAGE PREPARATION-PHASE 1 ADDED ICC

CLEARING OF BROTH WITHIN 24 HOURS.

SURVIVED 3 RECHALLANGES BUT THEN APPEARED TO LOSE ACTIVITY.

BOTTLE THREE

CRUDE PHAGE PREPARATION PHASE 1 AND 2 ADDED 0.5CC OF EACH

CLEARING OF BROTH WITHIN 24 HOURS . CULTURE NEGATIVE

SURVIVED 4 RECHALLANGES BUT THEN APPEARED TO LOSE ACTIVITY

WITH NEW GROWTH

BOTTLE 4

PURIFIED PHAGE PREPARATION PHASES 1 AND 2 0.5CC OF EACH

CLEARING OF BOTTLE WITHIN 24 HOURS

SURVIVED 6 RECHALLANGES THEN REGROWTH. BOTTLE 5-

CRUDE PHAGE PREPARATION PHASE 1,2 AND 3

CLEARING OF BOTTLE WITHIN 24 HOURS CULTURE NEGATIVE

SURVIVED OVER 6 RECHALLANGES.

BOTTLE 6-

PURIFIED PHAGE PREPARATION PHASES 1 , 2 AND 3

CLEARING OF BOTTLE WITHIN 24 HOURS CULTURE NEGATIVE.

SURVIVED OVER 6 RECHALLANGES.

IT SHOULD BE NOTED THAT THE EFFECTS SHOWN ON SUCCESSFUL

RECHALLANGE MAY NOT BE SIMPLY DUE TO DECREASE IN THERAPEUTIC

DOSEAGE.

THE PHENOMENON OF ADAPTATION AND CO-SYNERGY MAY BE BEST

DEMONSTRATED BY PLEURIPOTENT PHAGES.

IT IS LIKELY THAT PHAGES DEVELOP SYNERGY WITH THEIR BACTERIAL

HOST.

IF SUCCESSFUL RECHALLANGE IS DUE TO WEAKENING DOSEAGE OF PHAGE

MIX THEN IT SHOULD ONLY BE A MATTER OF REESTABLISHING THE

DOSE, HOWEVER, PHAGE WHICH PREVIOUSLY CAUSED CLEARING OF BROTH

WOULD ONLY CAUSE PARTIAL IF ANY CLEARING AS PREDICTED FROM

REPEATED PASSAGE WORK IN ESTABLISHING PHAGE PHASE.

THIS WOULD HAPPEN WITH ORIGINAL BACTERIAL CULTURE AS WELL AS WITH

LATTER PHASE CULTURES INDICATING THAT THE ADAPTATION IS NOT ONLY

BACTERIAL BUT ALSO OF PHAGE.

PHASED IMMUNE THERAPY.

DIRECT/INDIRECT.

DIRECT

DIRECT IMMUNOTHERAPY INVOLVES THE RAISING OF AN IMMUNE RESPONSE

IN-VITRO OR IN-VIVO BY USE OF HUMAN AND/OR OTHER SYSTEM. DIRECT

RELATES TO RAISING OF A SYSTEM CELLULAR , HUMORAL , OR OTHER AGAINST

TARGET ORGANISMS.

ALLOWING THE TWO SYSTEMS TO INTERACT IN AN OPEN OR CLOSED SYSTEM

AND/OR INDUCING MULTIPLE MUTATIONS/PRESENTATIONS OF TARGET

ORGANISM(S) (AS DISCUSSED PREVIOUSLY).

PREPARATION OF HORSE SERUM

INDIRECT

INJECTION ARE ALL VARIABLE FACTORS)

IN-VITRO TEST

BROTH WAS DIVIDED INTO 100 CC BOTTLES.

THE FOLLOWING EXPERIMENTS WERE THEN DONE AND REPEATED; BOTTLE ONE;

PROCAINE PENICILLIN 500,000 U WAS ADDED TO STAPHYLOCOCCUS

CULTURE.

SOME CLEARING OCCURRED WITH REGROWTH WITHIN 6 DAYS.

CULTURE THEN YEILDED PENICILLIN-RESISTANT STAPHYLOCOCCUC AUREUS.

THE BROTH WITH REGROWTH WAS INNOCULATED INTO A HORSE(50CCS WERE

SPUN DOWN AND BACTERIAL PELLET WAS IMPLANTED INTRACUTANEOUSLY

INTO A HORSE, 5 CCS OF SAME BROTH WAS INJECTED INTRADERMALLY

EVERY 3 DAYS FOR 3 WEEKS

50CC OF HORSE BLOOD WAS THEN COLLECTED , SPUN DOWN YEILDING SERUM.

AS THE HORSE WAS VACCINATED WITH BACTERIA AS WELL AS THE BROTH IN

WHICH RESISTANCE OCCURRED , IT IS LIKELY THAT THE HORSE WAS ALSO

INNOCULATED AGAINST PLASMIDS AND ENZYMES SUCH AS

PENICILLINASE(SUBSEQUENT TESTS IN WHICH BACTERIA WERE SONICALLY

LYSED PRIOR TO IMMUNISATION APPEARED TO INCREASE EFFICACY OF THIS

STEP.

BOTTLE2

ANTI-PHASE 2 BACTERIA ANTISERUM WAS ADDED 1CC DOSE TO 500,000

UNITS OF PENICILLIN.

BOTTLE CLEARED AND REMAINED CLEAR. UP TO I WEEK LATER, CUTURE

NEGATIVE.

BOTTLE THREE- ANTI-PHASE 2 ANTISERUM WAS ADDED 1CC DOSE. -NO

RESPONSE CULTURE-STAPH AUREUS -PENICILLIN SENSITIVE.

IT THEREFORE APPEARS THAT AT THIS DOSEAGE, THE MAJOR EFFECT OF

ANIMAL SERUM IS TO PREVENT THE RISE OF RESISTANCE .

AT HIGHER DOSEAGES SOME DIRECT ANTIBACTERIAL EFFECTS WERE

OBSERVED; THESE WERE EVEN MORE MARKED IF WHOLE BLOOD WAS USED.

IN VIVO-CRUDE TO REFINED IMMUNE RESPONSES ELLICITED EXCELLENT

RESPONSE.

IT IS ALSO INTERESTING TO NOTE THAT INITIAL WORK INDICATES THAT EVEN WHEN PHAGE LOSES LYTIC ABILITY OVER PARTICULAR BACTERIA IT MAY STILL RETAIN AFFINITY TO IT IN WHICH CASE RAISING AN IMMUNE RESPONSE AGAINST THE PHAGE MAY SERVE AS A TAG AND ATTACK THERAPY. WHERE BACTERIA WERE ALLOWED TO BE TAGGED BY PHAGE THEN ANTISERUM OF ANIMAL IMMUNISED AGAINST PHAGE APPLIED, BACTERIAL LYSIS

FOLLOWED.

COMPONENTS OF IMMUNISED ANIMAL'S BLOOD.

NEW MECHANISMS WILL BE PRESENTED FOR

IMMUNE ACTIVITY. EFFICACY OF MULTIMODAL/MULTIPHASED

THERAPY AS PERTAINING TO CANCER.

DEVELOPMENT OF ANTICANCER ANTIBIOTICS/MULTIPHASIC CHEMOTHERAPY

INTRODUCTION

DEMONSTRATION OF CLASSIFICATION PATENT AS APPLIES TO MULTIPHASIC THERAPY.

INTRODUCTION

THE CLASSIFICATION PATENT STATES THAT FOR EVERY CONDITION

, ORGANISMS , FACTORS AND AGENTS CAN BE SUBDIVIDED INTO THOSE THAT

PROMOTE, INHIBIT OR ARE NEUTRAL TO THE CONDITION. SOME MAY BE

CAUSATIVE WHEREAS OTHERS ARE NEMESES OR CUREATIVE.

EPIDEMIOLOGY

THE SUGGESTION THAT INFECTIONS MAY BE ANTAGONISTIC TO DISEASES

SUCH AS CANCER IS BORNE OF OBSERVATIONS THAT WHERE CERTAIN

INFECTIONS DOMINATE ANN ATREA OR AN ERA,CANCER WAS SCARCE.CASES

CAN BE MADE FOR TUBERCULOSIS,MALARIA AND SYPHILLIS BEING SUCH

AGENTS. IT IS ALSO TRUE THAT, MANY OF THESE CONDITIONS WHICH

INHIBIT CANCER GROWTH IN ACUTE STATE MAY CAUSE OR PROMOTE IT IN

CHRONIC STATE.

IT IS KNOWN , FOR EXAMPLE, THAT CHRONIC TUBERCULOUS FOCI MAY LEAD

TO DEVELOPMENT OF LUNG CANCER,CHRONIC MALARIA TO LYMPHOMA AND

CHRONIC SYPHILLIS TO OTHER TYPES OF CANCER.

OTHER INFECTIONS SUCH AS SCHISTOMYCETES HAVE BEEN LINKED DIRECTLY

TO BLADDER CANCER.

INTERESTINGLY AN OFTEN CITED INFECTION ASSOSCIATED WITH

SPONTANEOUS REMISSION IS THAT OF ERYSIPELAS.THIS IS OFTEN CAUSED

BY STAPHYLOCOCCAL OR STREPTOCOCCAL INFECTION. AS THESE INFECTIONS

IN ACUTE FORM CAN ACT TO ELIMINATE DISEASE, IT IS PROBABLY MORE

THAN COINCIDENCE THAT TUMOUR BIOPSIES APPEAR TO INDICATE AT TIMES SIMILAR INFECTIONS COEXISTING IN CHRONIC MANNER WITH THE . IN CHRONIC INFECTIONS, THERE IS USUALLY AN IMMUNE RESPONSE INCAPABLE OF ELIMINATING THE INFECTION. IN BACTERIAL AND OTHER INFECTIONS INTIMATELY ASSOSCIATED WITH CANCER THERE MAY BE ALMOST TOTAL ABSENCE OF VISIBLE IMMUNE RESPONSE-SEE PHOTOGRAPHS WITH

CONSPICIOUS ABSENCE OF LOCAL INFLAMMATORY CELLS IN AREAS OF BACTERIA OR OTHER ORGANISMS IN CLOSE PROXIMITY TO CANCER CELLS. THIS MAY SUGGEST THAT THESE ORGANISMS ARE EITHER INHERENTLYT ELUSIVE/RESISTANT TO IMMUNOLOGICAL RESPONSES AND/OR ARE USING THE CANCER MASS TO ELUDE SAID RESPONSE. IT IS ALSO LIKELY THAT THE SAME MECHANISM BY WHICH CANCER ELUDES SAID RE8PONSE AS THE

ORGANISMS ARE OFTEN CULTUREABLE FROM BLOOD AS WELL AS FROM MANY TISSUES IN PATIENTS WITH DISEASE. (THE PRESENCE OF

CAUSATIVE, SYNERGISTIC, NEUTRAL , INFECTIVE , ANTAGONISTIC AND NEMESIS ORGANISMS IS NOT RESTRICTED TO CANCER BUT VIRTUALLY TO ALL DISEASE AND OTHER CONDITIONS)SEE PHOTOS OF CANCER, AIDS, TISSUES ETC.

MANY OF THESE BACTERIA APPEAR STAPHYLOCOCCAL OR STREPTOCOCCAL IN ORIGIN.

ALTHOUGH CONVENTIONAL; MEDICAL THINKING DOES NOT CREDIT THESE ORGANISMS WITH ANYTHING MORE THAN NEUSANCE CONTAMINANT VALUE, IT WAS NOT ALWAYS THE CASE . AT THE TURN OF THE CENTURY, ORGANISMS ISOLATED FROM CANCER PATIENTS WERE THOUGHT DIRECTLY LINKED AND CAUSATIVE TO THE DISEASE PROCESS.THE WORK OF GLOVER, SCOTT, GREGORY AND LIVINGSTON LED TO THE IDENTIFICATION OF MANY ORGANISMS ASSOSCIATED WITH CANCER. LIVINGSTON AND OTHERS DESCRIBED AN

IT IS ALSO KNOWN THAT ANTIBIOTIC THERAPY MAY CAUSE TEMPORARY IMPROVEMENT IN CANCER AND OTHER PATIENTS-MORE RECENTLY ALSO IN ARTHRITIS AND ULCERS, DISEASES UNTIL RECENTLY NOT THOUGHT RELATED TO BACTERIAL DISEASE. WHILE TEMPORARY IMPROVEMENT MAY BE DUE TO THE CLEARING OF A SUPERADDED INFECTION, IT IS HARD TO EXPLAIN THE OCCASSIONAL REMISSION OF CANCER FOLLOWING ANTIBIOTIC THERAPY BY THIS REASONING.IT IS HOWEVER ALSO LIKELY THAT THE INFECTION BEING TREATED WAS ITSELF THE CAUSE OF THE REMISSION.

IT IS ALSO CONVENTIONALLY RECOGNISED THAT MANY VIRUSES MAY BE IDENTIFIED IN CANCER CELLS.THESE HAVE BEEN NOTED AS OF DUBIOUS SIGNIFICANCE ALTHOUGH ANIMAL CANCERS MAY OFTEN BE CAUSED IN A LABORATORY BY VIRUSES . BACTERIA, FUNGII ETC WERE ALSO AT SOME TIME THOUGHT TO BE RELATED TO CANCER. MUCH WORK NOW SUGGESTS LINKS BETWEEN VIRUSES SUCH AS HEPATITIS, POLYOMA AND CANCER;FUNGII SUCH AS ASPERGILLUS FLAVUS, PARASITES SUCH AS SCHISTOCOMYCETES.ETC. IT IS NOT THE OPBJECT OF THIS PATENT TO CLAIM CAUSATIVE FUNCTION OF MICROORGANISMS IN DISEASES OF UNKNOWN AETIOLOGY; BUT TO

MULTIPLE PHOTOS OF DR. CANTWELL DEMONSTRATING ORGANISMS SHOULD BE

INSERTED HERE.

IT SHOULD BE NOTED THAT THERE IS MUCH EVIDENCE LINKING THESE

ORGANISMS TO CANCER AND OTHER DISEASES; THEY ARE FREQUENTLY

ISOLATED FROM BIOPSIES , BLOOD , OTHER SPECIMENS; THEY CAN BE

IDENTIFIED IN DISEASE FRAGMENTS; INJECTED INTO ANIMAL MODELS THEY

CAN CAUSE DISEASE AND THEN BE ISOLATED AGAIN FROM INDUCED

DISEASE. (LIVINGSTON AND ALEXANDER 1950-1970)

MORE RECENTLY,THE INVENTOR HAS FOUND THAT A WIDE RANGE OF

ORGANISMS RANGING FROM STREPTOCOCCAL-LIKE, STAPHYLOCOCCAL-LIKE

ORGANISMS , YEASTS , FUNGII ETC. CAN BE ISOLATED FROM TUMOUR SAMPLES

AND FROM BLOOD AND OTHER PATIENT SAMPLES WHEN INJECTED INTO A

TUMOUR- BEARING ANIMAL , WILL SELECTIVELY LODGE IN TUMOUR

MASSES.THIS MAY BE SECONDARY TO MANY MECHANISMS BUT APPEARS TO

INDICATE AT LEAST AFFINITY FOR THE ORGANISMS AND CANCER.

THE INVENTOR HAS ALSO DEMONSTRATED THAT ANTISERA RAISED AGAINST

ORGANISMS ISOLATED FROM VARIOUS CANCERS WILL EXERT ACTIVITY

AGAINST THE CANCER CELLS THEMSELVES.THIS CAN BE DEMONSTRATED BOTH

WITH ORGANISMS ISOLATED FROM THE CANCER CELLS AND/OR FROM

ORGANISM LIBRARY OF SIMILAR/RELATED CANCERS EVEN AS BROAD A MATCH

AS CARCINOMAS AND SARCOMAS.

SEVERAL ORGANISM AND ORGANISM TYPES HAVE BEEN DEFINED BY AUTHOR

AS RELATE TO CANCER AETIOLOGY. SYNERGY AND THERAPY . THE OBSERVATION

OF SEVERAL ORGANISMS HAS LED MANY TO BELIEVE THAT THE CANCER

ORGANISM IS PLEOMORPHIC; IT HAS BEEN USED BY MORE TO SUPPORT THE

CONTENTION THAT THESE ORGANISMS ARE CONTAMINANTS . ALTHOUGH ABOVE

EVIDENCE TENDS TO SUGGEST OTHERWISE , THE INVENTOR WISHES TO

INDICATE THAT EVEN IF SUCH INFECTIONS ARE CONTAMINANTS THAT ALONE

MAY INDICATE AFFINITY OF ORGANISMS FOR TUMOUR MASSES.

MULTIPHASIC THERAPY CAN BE APPLIED IN TERMS OF

CHEMOTHERAPY , IMMUNOTHERAPY, RADIOTHERAPY AND INTERPLAY OF THESE

AND OTHER THERAPIES.

ISOLATION OF ORGANISMS

THE MULTIPHASIC APPROACH IN TISSUE ANALYSIS AND TREATMENT YEILDS

INTERESTING RESULTS.CONDIDERATION OF CANCER AS A SYSTEMIC DISEASE

AS OPPOSED TO CANCER AS A BALL OF DISEASED CELLS , OBSERVATIONS CAN

YEILD AN INTERESTING THEORY.

IN-VITRO THERAPIES MAY BE CAPABLE OF 100% CANCER CELL KILL

WHETHER BY CHEMICALS , RADIATION, IMMUNOMOLOGICAL AGENTS AND YET

WOULD BE UNABLE TO ACHIEVE IN-VIVO REMISSION; MORE

IMPORTANTLY, EVEN AFTER SUCH IN-VITRO ' INACTIVATION ' INJECTION OF

IN-VITRO ' KILLED ' PREPARATION OF CANCER TISSUE WHERE CELLS HAVE

BEEN DISRUPTED SONICALLY, CHEMICALLY, IMMUNOLOGICALLY , OTHER

PHYSICAL MANNER THEN FILTERED SO THAT NO LIVING CELLS PASS

THROUGH THE FILTER, FILTRATE INJECTED INTO AN ANIMAL SYSTEM WOULD

OFTEN RESULT IN ANIMAL DISEASE OR DEATH . THIS STRONGLY SUGGESTS

THAT THE LIVING CANCER CELL IS NOT NECESSARY TO

PREPETUATE/INITIATE DISEASE CONDITION.

IT IS CURRENTLY STANDARD PRACTICE TO CULTURE VIRAL VACCINES ON

CONTINUEOUS CELL LINES .

CONTINUEOUS CELL LINES ARE IMMORTAL CELL LINES , ESSENTIALLY CANCER

CELLS . RESEARCH WORK BY INVENTOR INDICATES THAT DAMAGED/DEGRADED

CANCER CELL PREPARATIONS , EVEN WHEN FILTERED TO REMOVE LIVING

CELLS, STILL MAY CONTAIN FACTORS/AGENTS/ORGANISMS WHICH MAY

INITIATE /AGGRAVATE DISEASE CONDITION.

THIS POINT IS STRESSED TO STATE LINK AND RELEVANCE WITH NEW

VACCINE MANUFACTURE PATENT.

MULTI PHAS IC SYSTEM APPROACH WOULD THEN AIM TO

ATTEMPT TO DEFINE OTHER LIVING SYSTEMS THAT MAY BE ACTIVE IN THE

DISEASE PROCESS.

THE SEARCH FOR LIVING SYSTEMS WAS CONDUCTED ON THE FOLLOWING

BASIS;

1-EVIDENCE FOR LIVING SYSTEMS BEING PRESENT WITH PROXIMITY TO

DISEASE AND DISSEMINATED THROUGH DISEASED BODY ON BIOPSY.

2-ABILITY TO REPEATEDLY CULTURE ORGANISMS FROM

BLOOD, SERUM, URINE , BIOPSIES AND OTHER SAMPLES FROM HOSTS OF CANCER

AND/OR OTHER DISEASES.

3-WORK BY DR.LIEDA MATTMAN DEMONSTRATING PRESENCE OF CELL-WALL - DEFICIENT ORGANISMS IN DISEASES SUCH AS CANCER, AIDS , ARTHRITIS

ETC.

4-WORK BY INVENTOR DEMONSTRATING THE ABILITY TO CULTURE ORGANISMS

FROM PATIENT SAMPLES

5-PREVIOUS WORK BY LIVINGSTON, ALEXANDER , SCOTT AMONGST MANY OTHERS

INDICATING THAT A VARIETY OF ORGANISMS ISOLATED FROM DISEASES

SUCH AS CANCER CAN GENERATE DISEASE OFTEN SIMILAR IF NOT

IDENTICAL TO THE ORIGINAL AND FROM WHICH ORGANISMS MAY OFTEN BE

RECOVERED.

6-WORK BY INVENTOR DEMONSTRATING THE ABILITY OF ORGANISMS TO

CAUSE/INDUCE/ASSIST/ACCELERATE/AGGRAVATE DISEASES SUCH AS CANCER

AND THAT IMMUNOLOGICAL AS WELL AS OTHER THERAPIES TARGETING THESE

ORGANISMS WOULD OFTEN REFLECT/WITH IMPROVEMENT IN DISEASE

CONDITION.

THE MULTIPHASIC APPROACH WOULD ALLOW FOR THE FOLLOWING LOGIC; DISEASE A IS RESPONSIVE TO DISEASE THERAPY ANTI-A, AS THE DISEASE DEVELOPS RESISTANCE TO AND/OR RECURRS AFTER TREATMENT IT IS LIKELY TO HAVE CHANGED IN SOME FORM OR TO HAVE ACTIVATED INTRINSIC/EXTRINSIC METHODS FOR COPING WITH THERTAPY. EXTRINSIC METHODS MAY INCLUDE ACTIVATION OF SOME DEFENSIVE RELATIONSHIP WITH CAUSATIVE AND/OR SYNERGISTIC ORGANISM.

THE MULTIPHASIC APPROACH AS APPLIED TO CANCER CAN BE SUMMARISED SIMPLY; AS MANY CHEMOTHERAPEUTIC AGENTS ORIGINATE FROM LIVING ORGANISMS, (THESE MAY BE CLASSIFIED AS ANTAGONISTIC OR NEMESES DEPENDING ON EFFICACY)AND AS CERTAIN ORGANISMS APPEAR CAPABLE OF CO-EXISTING WITH CANCER AND SOMEHOW EXERT AN EFFECT FAVPOURABLR TO THE DISEASE;THESE MAY BE CATAGORISED AS CAUSATIVE OR

SYNERGISTIVC , THESE MAY ALSO HAVE DEFINED ANTAGONISTS AND

NEMESES, IN FACT, THEY MAY ALSO BE USEFUL TO PROVIDE AND/OR TEST PHAGES/PLASMIDS/OTHER GENETIC MANIPULATION TO EFFECT CHANGE OF CLASSIFICATION STATUS.

AS CANCER CELLS DEVELOP RESISTANCE TO A PARTICULAR THERAPY ; CO-INCUBATION AND BIASSED CULTURES ALLOW DEVELOPMENT OF MORE EFFECTIVE THERAPY.

CO-INCUBATION MAY BE USED TO DEVELOP THERAPY DE-NOVO.

THE OBJECT OF THIS PATENT IS TO DEMONSTRATE

1-GENERATION OF THERAPY

2-MINIMISATION OF SIDE-EFFECTS

3-CRUDE/PURIFIED USE

4-CO-TEMPORAL UPGRADING OFD THERAPY

5-USE AS MULTIPHASIC THERAPY

6-INTERACTION WITH OTHER MULTIPHASIC THERAPIES

9-LINK WITH MACHINE THERAPY.

INDUCED REMISSION THERAPY

INTRODUCTION

INDUCED REMISSION THERAPY COMBINES SEVERAL TREATMENT PROTOCOLS AS

INVENTED AND IMPLEMENTED BY DR. SAM CHACHOUA.

THIS THERAPY IS BASED ON OBSERVATIONS ON

1-SPONTANEOUS REMISSION

2-ORGAN RESISTANCE

3-ORGANISM RESISTANCE

WHEN SUCH DATA IS INCORPORATED WITH

1-CATEGORISATION PATENT

2-PRECURSOR/INTERMEDIATE/ENDPRODUCT THERAPY

3-MULTIPHASIC THERAPY

4-BIOLOGICAL ENHANCEMENT PATENT

5-EXTERNAL MACHINE/OTHER INTERVENTION

6-APPLICATION AND INDUCTION OF NEW WHITE AND RED BLOOD CELL

MECHANISMS.

INTERMEDIATE SUPPLEMENTS

SPONTANEOUS REMISSION OBSERVATIONS UNIQUE TO PATENT.

OBSERVATIONS OF SPONTANEOUS REMISSIONS FROM CANCER AND OTHER

DISEASES HAVE INDICATED THAT THESE HAVE OFTEN FOLLOWED AND/OR

BEEN CONCURRENT WITH INFECTIONS.

IT IS UNIQUE TO PATENT THAT THESE OBSERVATIONS HAVE BEEN COMPARED

AND CONTRASTED WITH CASES OF CANCER DETERIORATION AND/OR SUDDEN

AGGRAVATION/DETERIORATION IN CANCER CONDITION. IT WAS FOUND THAT

THERE WERE REPORTS OF THIS PHENOMENON ALSO OCCURING CONCURRENTLY

OR SUBSEQUENT TO INFECTIONS.

INFECTIONS REPORTED IN CASES OF IMPROVEMENT HAVE FALLEN UNDER A

WIDE CLASSIFICATION OF

MICROORGANISMS; VIRAL, BACTERIAL, FUNGAL, , YEAST, PARASITE ETC.

INTERESTINGLY,CASES OF DETERIORATION ALSO OFTEN OCCURRED AFTER

EXPOSURE TO ORGANISMS THAT MAY FALL ANYWHERE WITHIN SUCH A BROAD

SPECTRUM.

IT APPEARS THEREFORE THAT ORGANISMS MAY EXERT DIRECT OR INDIRECT

EFFECTS THAT MAY;

1-BENEFIT THE HOST(BIOLOGICAL ENHANCEMENT).

2-BENEFIT THE DISEASE

3-INHIBIT THE DISEASE

BENEFIT/INHIBITION OF DISEASE MAY BE ON DIRECT ACTIVITY ON

DISEASE/DISEASE-RELATED FACTORS , AND/OR INDIRECTLY SUCH AS BY

INHIBITION OR AUGMENTATION OF ANTI-DISEASE RESPONSE OF HOST.

PATENT DIFFERS FROM PRIOR AND IN THE USE OF MICROBIAL ORGANISMS

IN DEVELOPMENT OF CANCER THERAPIES IN THAT THIS PATENT SEEKS TO

DEFINE A FORMAT AND RELATIONSHIPS BETWEEN ORGANISMS AND DISEASE

IN ORDER TO ACHIEVE A LOGICAL BASIS FOR IMPROVED

NATURAL ORGANISMS MAY BE SELECTED, OTHERS MAY BE

MODIFIED, CREATED, BRED, ENGINEERED TO FULFIL, POTENTIATE, MIMIC

AMPLIFY OR COPY BENEFICIAL CHARACTERISTICS AND

OPPOSE,NEUTRALISE, ELIMINATE HARMFUL FACTORS THAT ASSIST DISEASE..

TO DATE THE USE OF MICROORGANISMS IN THE TREATMENT OF CANCER HAS BEEN RESTRICTED TO HAPHAZARD ATTEMPTS TO IMMUNOSTIMULATE AND/OR CAUSE DAMAGE TO THE DISEASE DIRECTLY OR BY GENERATION OF CHEMOTHERAPEUTIC AGENTS . TECH I QUES TO BE DEMONSTRATED WHICH

OUTLINE THE CLASSIFICATION, DEVELOPMENT AND PURIFICATION OF

PRECURSOR /INTERMEDIATE/ ENDPRODUCT

THERAPY.

AS WITH THE CLASSIFICATION PATENT, A MORE EXTENSIVE DISCUSSION IS

INCLUDED, THE AIM OF THE FOLLOWING IS TO INDICATE PRACTICAL

APPLICATION.

LIVING BIOLOGICAL SYSTEMS ARE DISCUSSED IN THE 2MEA-CU DIPSAL¬

BHT-PATENT . AS MENTIONED THIS PATENT REFERS TO IMMUNE-MODULATING

FUNCTION AS WELL AS CELL-PROTECTIVE EFFECTS OF THE COMBINED

FURMULA.

LIVING BIOLOGICAL SYSTEMS REFERS TO A COMBINATION OF

BACTERIA,VIRUSES.YEASTS AND FUNGII WHICH AS AWHOLE AND/OR IN PART

CAPABLE OP CONFERRING HEALTH BENEFITS TO HIGHER ORGANISMS.

BENEFITS MAY BE DIRECT OR INDIRECT. BY SUPPLEMENTATION, BIOLOGICAL

ENHANCEMENT AND/OR ANTIDISEASE THE FOLLOWING MECHANISMS ARE

PROVIDED AS EXAMPLES AND ARE NOT RESTRICTIVE OF PATENT.

.EXAMPLES OF LIVING BIOLOGICAL SYSTEM EFFICACY SOLELY AND AS PART

OF OTHER THERAPY ARE INCLUDED AS WELL AS EXAMPLES OF THEIR USE IN

PRECURSOR/INTERMEDIATE /'ENDPRODUCT THERAPY AND APPLICATIONS AS

THERAPY, PREVENTION, AND BIOLOGICALLY ENHANCED FOODS, CELLS OF

TARGET OR OTHER SPECIE(S) MAY ALSO BE INCLUDED IN THE LIVING

BIOLOGICAL SYSTEM.

SUPPLEMENTATION

BACTERIA SUCH AS LACTOBACILLI CAN PROVIDE MANY USEFUL NUTRIENTS AS WELL AS SUPPLEMENTS. THE CONCEPT OF LIVING BIOLOGICAL SYSTEMS DIFFERS FROM ORDINARY SUPPLEMENTATION IN THAT LIVING BIOLOGICAL SYSTEMS ARE LIVING IN WHOLE ORGASNISM SENSE OR IN REPLICATING UNIT SENSE

EXAMPLES OF LIVING BIOLOGICAL SYSTEMS(LBS)ACTING AS REPLICATING SUPPLEMENTATION INCLUDE LACTOBACILLI THAT GENERATE FOLIC ACID, VITAMIN B12-SUCH AS LACTOBACILLUS LACTIS, MANY ORGANISMS CAPABLE OF GENERATING THESE AND OTHER ESSENTIAL AND NON-ESSENTIAL BUT BENEFICIAL SUPPLEMENTS AND NUTRIENTS, WHEN PRESENTED TO THE BODY IN THE FORM OF LIVING BIOLOGICAL SYSTEMS, DESIGNED TO

GROW/REPLICATE IN HARMONY WITH THE BODY'S INTESTINAL OR OTHER

SO FAR BEEN- DEVELOPED FOR FOOD, SUPPLEMENT, TOPICAL AND COSMETIC APPLICATIONS AS WELL AS INHALATION BOTH AS SIMPLE AND MULTIPHASED .

A BASIC LBS CONSISTS OF FOOD-DERIVED ORGANISMS SUCH AS

ELIMINATION FROM THE SYSTEM; IF A LIVING BIOLOGICAL SYSTEM CAPABLE OF MANUFACTURING THE NUTRIENT IS GIVEN, THEN THE NUTRIENT WILL BE GENERATED DE-NOVO FOR THE DURATION THAT THE LBS OR AT LEAST THAT COMPONENT OF THE LBS REMAINS VIABLE. NUTRITION IS THEREFORE ALSO PROVIDED MORE CONTINUEOSLY THAN INERT BOLUS SUPPLEMENTATION.

SUPPLEMENTATION WITH A LIVING BIOLOGICAL SYSTEM CAPABLE OF PRODUCING REQUIRED ANTIBIOTIC WILL CONSTANTLY DELIVER SMALL DOSES INTO THE SYSTEM AFTER INITIAL APPLICATION/ADMINISTRATION, A

SPECIFICALLY DESIGNED AND/OR

MULTIPHASIC SYSTEM WILL CONFER HIGHER PROTECTIVE EFFICACY.

LBS MAY THEREFORE PROVIDE USEFUL SUPPLEMENTARY

FUNCTIONS, ANTIBIOTIC

ABILITY, ENZYMES(ASPERGILLI,YEASTS, LACTOBACILLI CAN CONTRIBUTE

DIGESTIVE AS WELL AS MANY OTHER ENZYMES) PROTECTION TO HOST

ORGANISM MAY BE DIRECTLY OR INDIRECTLY GIVEN

LACTOBACILLI-ACIDOPHILUS

THERMOPHILUS

CREMORIS

LACTIS

BIFIDUS

BULGARICUS( INCLUDING LACTOBACILLUS BULGARICUS 51)

PLANTARUM

FAECIUM

KEFIR CULTURE

RHIZOPII

ASPERGILLUS ORYZAE

BACILLUS SUBTILIS

FORMULA CONTAINS APPROX 300 MILLION ORGANISMS PER GRAM OF EACH

STRAIN AND SPECIE.

THESE ARE BASIC FOOD EXTRACTS AND CAPABLE OF BROAD SPECTRUM

NUTRITIONAL, ANTIBIOTIC, IMMUNOSTIMULATING, DIGESTIVE AND OTHER

FUNCTIONS.

IT IS POSSIBLE TO ADJUST FORMULATION FOR SPECIFIC FUNCTION,TO

PASS IT THROUGH MULTIPHASIC SYSTEM AND TO ADD SPECIFIC OTHER

ORGANISMS SUCH AS SACCAROMYCES CEREVISEAE

TORULA YEASTS

ASPERGILLUS ORYZAE

PENICILLIUM NOTATUM

CAUTION IS NEEDED WITH SPECIFIC FORMULATIONS WITH ACTIVE

PENICILLIUM/YEAST/ASPERGILLI ETC BECAUSE OF PROBLEMS OF

ALLERGY, FERMENTATION, GAS ETC.

LBS AND TS (TARGET SYSTEM) AS WELL AS

NTS (NON-TARGET SYSTEMS)ARE ESSENTIAL IN

PRECURSOR/INTERMEDIATE/ENDPRODUCT THERAPY. IN INCREASING

SPECIFICITY, EFFICACY AND DECREASING SIDE-EFFECTS .

DEFINING THESE SYSTEMS IS ALSO ESSENTIAL IN BIOLOGICAL ENHANCEMENT PATENT.

MULTIPHASIC THERAPY-CONTINUED

ALTHOUGH DEMONSTRATED CASES SPEAK OF MULTIPHASIC THERAPIES BEING DEVELOPED IN LINEAR SEQUENCE; IT IS ALSO POSSIBLE TO DEVELOP MULTIPHASIC THERAPY NON-SEQUENTIALLY AND BY CLONAL OR OTHER CELL/TARGET POPULATION EXPANSION, IN WHICH CASE TARGET MAY BE EXPOSED TO VARIOUS MUTATING AGENTS AND CONDITIONS, WHICH MAY INCLUDE THERAPEUTIC ORGANISM EXTRACT IN DOSES AND CONDITIONS WHICH ENABLE DEVELOPMENT OF RESISTANCE. THERAPEUTIC

ORGANISM/EXTRACTS MAY EVEN BE PROVIDED IN MULTIPLE PHASES SUCH THAT THE THERAPY TO BE DEVELOPED BY CO-CULTURING OF MULTIPLE- RESISTANCE TARGET WITH THERAPEUTIC ORGANISM WILL BE HIGHLY EFFECTIVE AND SUPERIOR TO SINGLE AND/OR LIMITED COMBINATIONS OF MULTI-PHASED THERAPY. PRELIMINARY CULTURE EXPERIMENTS HAVE

INDICATED THIS.

BY THE THIRD OR FOURTH , OCCASSIONALLY EVEN SECOND PHASE SHIFT IN THERAPEUTIC ORGANISM, TARGET MAY REGRESS TO ORIGINAL

SENSITIVITY, THIS MAY NOT BE COVERED BY LATTER PHASE THERAPY .

THERE ATRE THEORETICAL DANGERS IN THIS APPROACH;

1-CREATING RESISTANCE IN TARGET ORGANISMS COULD NOT ONLY POSE SERIOUS RISK IF IT EVER ESCAPED THE TEST TUBE SCENARIO BUT ALSO IT OPENS THE BASIC PHASE ONE POOL SO THAT EACH VARIATION NOW HAS THE POTENTIAL OF NECESSITATING NEW .DIFFERENT PHASE THERAPY. 2-IT APPEARS TO BE MORE LOGICAL TO ALLOW PHASE THERAPY TO MIMIC OR DUPLICATE BODY HOST CHANGES SO THAT SUBSEQUENT PHASES BEAR RELATIONSHIP TO WHAT WILL ARISE IN THE BODY IN THE FORM OF RESISTANCE . CO-CULTURING THE ORGANISMS IN FRESH BLOOD AND/OR OTHER RELEVANT PATIENT SAMPLE. BY PRODUCING CHANGES AS WILL OCCUR IN THE BODY AND/OR REFERRING TO A LIBRARY WITH PREDICTED CHANGE IN TARGET AND REQUIRED COMPENSATION BY THERAPY AS INDICATED BY PRELIMINARY TESTING THAT PLACES TARGET ON ANTICIPATED CHANGE CURVES.

3-USING BLOOD, TISSUE, OTHER PATIENT SAMPLES , DUPLICATION OF

IDENTICAL CONDITIONS PREVIOUSLY EXPERIENCED BY PATIENT.

ANTIBIOTICS, CHEMOTHERAPY , RADIOTHERAPY ETC . IN COMBINATION PERHAPS WITH A CULTURE MEDIUM WHICH CONTAINS PATIENT BLOOD AND/OR OTHER PATIENT-SPECIFIC FACTORS.

AN EXAMPLE OF AN OPEN-CULTURE TECHNIQUE THAT MAY BE OF BENEFIT INCLUDES THE CO-CULTURING OF TARGET ORGANISM WITH THERAPEUTIC ANTIPIBIOTIC ALONG WITH ANTIBIOTIC-RESISTANT ORGANISMS ISOLATED FROM PATIENT (STOOL,SKIN.MOUTH, SPUTUM ETC.)SUCH THAT DONATION OF RES I STANCE (FOR EXAMPLE BY PHAGE OR PLASMID )MAY BE ANTICIPATED AND THERAPY DEVELOPED ACCORDINGLY. DEFINING LIVING BIOLOGICAL SYSTEMS

LBS MAY BE DEFINED FOR VARIOUS SITUATIONS AND CONDITIONS.

USE OF LBS MAY BE ACTIVE(EG IN DEVELOPMENT OF THERAPY)OR PASSIVE

EG. IN EXPRESSION OF INTERMEDIATE AND ENDPRODUCT. LBS MAY BE A

CONGLOMERATE OF THERAPEUTIC ORGANISMS OF SIMILAR OR DIFFERENT

SPECIES OR MAY BE TARGET ORGANISM CONGLOMERATE.

AN EXAMPLE OF THERAPEUTIC ORGANISMS OF THE SAME SPECIES BEING

COMBINED IN A LIVING BIOLOGICAL SYSTEM WOULD BE A MIXTURE OF

PENICILLIA BEING COMBINED AS THERAPEUTIC LBS; EVEN THE SAME

PENICILLIUM MAY BE DEFINED AS A LBS IF COMBINED WITH OTHER

PHASES . LBS CAN BE DEFINED BY ORGANISMS CO-EXISTING IN CERTAIN

SAMPLES EG STOOL, SOIL BACTERIA ETC., IN DEFINED ENTITIES EG. KEFIR

CULTURE.SUCH LBS POOLS MAY BE TAPPED IN WIDE SEARCH FOR THERAPY

OR OTHER FACTOR.

LBS THERAPEUTIC MAY REPRESENT NATURALLY OCURRING ENTITIES AND/OR

THOSE ARTIFICIALLY OR OTHERWISE COMBINED OR MODIFIED. AN EXAMPLE

WOULD BE THE COMBINATION OF ANTIBIOTIC SYSTEM WITH PHAGE SYSTEM

AND/OR IMMUNE SYSTEM AS A MULTIFACTORIAL LBS THERAPEUTIC ENTITY.

LBS AS A THERAPEUTIC ENTITY MAY ALSO BE DEFINED AS A MIXTURE OF

ANTAGONISTIC AND NEMESIS FACTORS AS DEFINED IN CLASSIFICATION

PATENT.

TARGETED LIVING BIOLOGICAL SYSTEMS MAY INCLUDE DISEASE CAUSATIVE

ORGANISM ALONG WITH DISEASE SYNERGISTIC ORGANISM ALONG WITH

DISEASE -MODIFIED TISSUE-AN EXAMPLE IN AIDS WOULD BE A LBS

COMBINING HIV, PNEUMOCYSTIS CARINNI AND INFECTED T CELLS.

COMBINED THERAPEUTIC LBS MAY BE DRAMATICALLY MORE EFFECTIVE THAN

ANY SINGLE COMPONENT.

TARGET MAY BE CO-INCUBATED WITH LBS EMPIRICALLY, EG STAPHYLOCOCCUS

AUREUS MAY BE INCUBATED WITH PENICILLIUM,STAPHYLOCOCCUS PHAGE AND

ANTI-STAPHYLOCOICCUS AUREUS ANTISERUM .

THE IDEA OF SUCH EMPIRICAL METHOD IS THAT ANY ORGANISM MUTATION

RESISTANT TO ONE MODALITY MAY SUCCUMB TO ANOTHER ORGANISM IN THE

LBS, THIS TECHNIQUE MAY BE USEFUL IN REACHING FAST THERAPIES BUT

IS NOT ONLY INEFFICIENT-EG IT MAY BE IMPOSSIBLE TO RAISE PHAGE

SPECIFICALLY FOR ORGANISM IF ANTIBIOTIC OR ANTISERUM RAPIDLY

DESTROYS IT. IT IS ALSO POSSIBLE THAT THE VARIOUS INGREDIENTS OF

THE LBS MAY INTERFERE WITH EACH OTHER AND THEIR

ACTIVITY, PARTICULARLY IF THE LBS IS AN ARTIFICIAL ONE. IT IS

POSSIBLE, FOR EXAMPLE THAT THE ANTISERUM CAUSES BACTERIAL CLUMPING

AND THAT ANTIBIOTICS CANNOT THEN ADEQUATELY PERMEATE THE MASS. IT

IS ALSO POSSIBLE THAT CONDITIONS FOR OPTIMAL SURVIVAL AND

FUNCTION OF THE VARIOUS LBS COMPONENTS MAY DIFFER PARTICULARLY

WHERE THE LBS IS COMPRISED OF DIFFERENT SPECIES ARTIFICIALLY

COMBINED.

MUTATIONS RESISTANT TO L;BS, ALTHOUGH LESS LIKELY TO OCCUR THAN

AGAINST ANY SINGLE MODALITY OF LBS SEPARATELY MAY BE HARDER TO

DEAL WITH. EXPANDING THE RESISTANCE POOL TO MULTIPLE MODALITIES

MAY NOT BE AS PRUDENT AS EXPOSING THE TARGET TO SINGULAR

MODALITIES IN ISOLATION OPTIMISING THEM AND THEN USING THEM AS

MULTIMODAL/MULTIPHASIC THERAPY.

USING A LIVING SYSTEM/PATIENT TO DEVELOP MULTIPHASIC/MULTIMODAL

THERAPY IS ROBABLY THE OPTIMUM METHOD OF SPECIFYING THERAPY AND BUILDING RELEVANT LIBRARY.

THIS DATA ALLOWS FOR ACCUMULATION OF IN-VIVO MULTIPHASIC LIBRARY DATA WHICH MAY BE EFFECTIVELY APPLIED TO SUBSEQUENT PATIENTS. IT IS ALSO NOT NECESSARY TOWAIT FOR PHASE ONE FAILURE IN-VIVO TO SEARCH FOR PHASE TWO AS WITHIN HOURS TO DAYS OF PRELIMINARY APPLICATION OF THERAPY, RESISTANT TARGET FORMS MAY BE ISOLATED FROM PATIENT BEFORE BECOMING CLINICALLY SIGNIFICANT. IT MAY

LIVING BIOLOGICAL SYSTEMS CAN ALSO BE SELECTED TO AMPLIFY/EXPRESS SPECIFIC THERAPEUTIC MODALITY.LET AUS CONSIDER,FOR EXAMPLE THE SUPPLERMENT GLUTATHIONE; IT IS USEFUL IN THE GENERATION OF

GLUTATHIONE PEROXIDASE AS WELL AS CARRYING OUT SYSTEMIC ANTI-OXIDANT FUNCTIONS . CELLS SUCH AS HEPATIC CELLS AND OTHERS WHICH MAY BE TARGETED FOR OPTIMAL PRODUCTION OF ACTIVE INTERMEDIATES AND ENDPRODUCTS. IF HEPATIC CELLS AND/OR BLOOD CELLS FROM PATIENT OR OTHER CELLS FROM PATIENT OR FROM OTHER COMPATIBLE SOURCE INCLUDING ANIMAL CELLS AND/OR ORGANISMS/SYSTEMS CAPABLE OF

DESIGNING LBS AS PROCESSING INTERMEDIATES.

1-AMPLIFICATION OF INTRINSIC SYSTEM

WHERE INTRINSIC ANTIOXIDANT SYSTEM SUCH AS SOD IS STIMULATED.

2-AMPLIFICATION OF THERAPY

3-INHIBITION OF TOXICITY

BY PRODUCTION OF DESIRED ENDPOINTS AND CO-FACTORS , THESE MAY BE

SEPARATED PRIOR TO ADMINISTRATION.

THERAPIES/AGENTS MAY BE PROCESSED THROUGH LBS SIMPLY TO BE

PASSAGED THROUGH LIVING SYSTEMS THAT MAY NEUTRALISE SIDE-EFFECTS.

OR TOXIC FRAGMENTS INHERENT OR RELEASED DURING SOME PATHWAY OF

METABOLISM OF AGENT.

A SIMPLE EXAMPLE OF LIVING BIOLOGICAL SYSTEMS BEING USED TO PREPROCESS FACTORS WHICH MAY COMPROMISE A RECIPIENT INCLUDES THE USE OF LACTOBACILLI,AND RELEVANT ASPERGILLI AND OTHER SAFE ORGANISMS CONTAINING LACTASE ENZYMES TO PROCESS MILK PRODUCTS FOR LACTOSE INTOLERANT INDIVIDUALS.NEW INVENTION DIFFERS FROM PRIOR ART IS THAT PtilOR ART NECESSITATES ADMINISTRATION OF PURIFIED LACTASE ENZYME ALONG WITH.LACTOSE CONTAINING FOODS IN ORDER TO ADEQUATELY DIGEST THE FOOD. THIS PATENT AIMS TO INTRODUCE LACTOSE-DIGESTING ORGANISMS INTO BOWEL FLORA AS A LONGLASTING SOLUTION, IT IS ALSO POSSIBLE TO MODIFY AND ENHANCE INTRINSIC BOWEL ORGANISMS SO THAT THEY DEVELOP LACTASE ABILITY BY SIMPLE CO-INCUBATION WITH ORGANISMS WITH THAT ABILITY,WITH COMPLICATED GENETIC MANIPULATION TECHNIQUES OR BY SIMPLE ADDITION OF APPROPRIATE LBS INTO BOWEL FLORA.

LET US NOW CONSIDER A SPECIFIC EXAMPLE OF LBS USE WITH

SUPPLEMENTS AS RELATED TO 2-MEA, COPPER2

3 ,5DIISOPROPYL SALICYLATE PATENT.

LIVING BIOLOGICAL SYSTEM TESTED WAS COMPOSED OF;

LACTOBACILLI-STRAINS OF THE FOLLOWING;

ACIDOPHILUS

BIFIDUS

THERMOPHILUS

BULGARICUS

LACTIS

CREMORIS

FAECIUM

PLANTARUM

KEFIR

RHIZOPII

SACCHROMYCES CERVESEAE

EACH ORGANISM CONCENTRATION-50 MILLION VIABLE UNITS PER GRAM

MANY PAPERS HAVE BEEN WRITTEN REPORTING IMMIUNOSTIMULATING

PROPERTIES AS WELL AS ANTIBIOTIC, ANTIFUNGAL , ANTICANCER, AS WELL AS

A PLETHORA OF OTHER ATTRIBUTES.

ALL SUCH BENEFITS ARE OF USE,HOWEVER IN APPLICATION AS

INTERMEDIATE AND ENDPRODUCT GENERATION, THIS SAMPLE FORMULA AS

WELL AS OTHERS CONTAINING ORGANISMS WITH ABILITIES RANGING FROM

ANTIOXIDANT TO ANTIBIOTIC AND ANTIVIRAL WAS ADDED TO THE

FORMULATION OF THE 2-MEA AND CU DIPSAL.

IT WAS FOUND THAT PATIENTS TREATED NOTED A MORE RAPID INCREASE

AND VITALITY THAN WITH THE CHEMICAL FORMULATION ALONE.

AN EXPLANATION FOR THIS MAY RELATE TO THE LBS ABILITY TO GENERATE

SUPEROXIDE DISMUTASE AS WELL AS HAVING ITS OWN BENEFICIAL

INHERENT PROPERTIES . THE CHEMICAL PART OF THE FORMULATION WAS

THEREFORE ABLE TO INTERACT WITH MICROBIAL MECHANISMS TO BOOST AND

ENHANCE LBS ANTIOXIDANT ENZYME GENERATION. THE LBS WOULD IN TURN

PROVIDE INCREASED ENDPRODUCT LEVELS OF THE ANTIOXIDANT ENZYMES TO

THE BODY AS WELL AS COMPLEMENTS OF CO-FACTORS AND INTERMEDIATES

REQUIRED IN THE PATHWAYS OF GENERATION OF ENDPOINT.

PRELIMINARY TRIALS HAVE INDICATED THAT PHASE 2 LBS, IE. THAT WHICH

HAS BEEN PREVIOUSLY CULTURED WITH 2-MEA AND CUDIPSAL PROVIDED

APPROACH.

THAT IS TO SAY THAT VARIOUS MODES MAY BE USED TO AUGMENT EACH

OTHER'S FUNCTION.

PHAGES RAISED AGAINST OR WITH ACTIVITY AGAINST PENICILLIN

RESISTANT ORGANISMS WILL AUGMENT THE FUNCTION OF SAID ANTIBIOTIC.

FUNCTION IS EVEN AUGMENTED AGAINST PENICILLIN SENSITIVE ORGANISMS

AN EXAMPLE OF THIS IS THE PLATING ON BLOOD AGAR OF STREPTOCOCCAL

CULTURE WITH PENICILLIN SENSITIVITY.

STREPTOCOCCUS WAS ISOLATED FROM SKIN SAMPLE AND POSESSED

PENICILLIN SENSITIVITY (TEST WAS REPEATED ON SEVERAL OCCASSIONS

USING PENICILLIN AS WELL AS OTHER TYPES OF ANTIBIOTICS AND

STREPTOCOCCAL, STAPHYLOCOCCAL AND OTHER HOST ORGANISMS AS WELL AS

THEIR PHAGES AS SUPPLIED BY ATCC AND/OR RAISED INDEPENDANTLY, WITH

SIMILAR RESULTS)AFTER PLATING AND CULTURING FOR 3 DAYS AT ROOM

TEMPERATURE, THE PLATE WAS COVERED WITH MANY PURELY STREPTOCOCCAL

COLONIES . ON THE THIRD DAY,A DISC SATURATED WITH PROCAINE

PENICILLIN WAS PLACED IN THE CENTRE OF THE AGAR PLATE.WITHIN 24

HOURS A ZONE OF CLEARANCE WAS EVIDENT AROUND THE DISK AS A HALO

MEASURING 2MM IN DEPTH.THE FOLLOWING DAY THE ZONE MEASURED

3MM, THERE WAS NO FURTHER ENLAGEMENT OF ZONE WITH FURTHER

INCUBATION.

SREPTOCOCCAL PHAGE WAS ADDED TO THE PENICILLIN-SATURATED

DISC.PHAGE WAS EITHER ONE OBTAINED FROM ATCC WHICH HAD

DEMONSTRATED EFFICACY IN LYSIS OF THIS PARTICULAR STREPTOCOCCUS

OR ONE RAISED FROM THE BACTERIA BY TECHNIQUES PREVIOUSLY NOTED.

SOLUTION OF PHAGE ESTIMATED AT 10 TO THE NINTH POWER OF PLAQUE

FORMING UNITS 0.5CC OF PHAGE TSB SUSPENSION WAS ADDED TO DISC

SATURATED WITH PROCAINE PENICILLIN.

ZONE OF CLEARANCE FORMED AS IN PREVIOUS TEST; ZONE OF CLEARANCE

WAS MARGINALLY LARGER 0.5 MM, MORE IMPORTANTLY, WITHIN 24 HOURS

PLAQUE FORMATION WAS EVIDENT THROUGHOUT MANY OF THE COLONIES-AGAR

PLATE CONTAINED NO VIABLE COLONIES WITHIN 48 HOURS.

IN OTHER TEST SYSTEMS WHERE TOTAL COLONY CLEARANCE DID NOT

OCCUR,MULTIPHASED(USUALLY NO MORE THAN 3)WERE REQUIRED TO ACHIEVE

TOTAL BACTERIAL LYSIS.

THIS IN-VITRO DATA DOES NOT EASILY TRANSLATE IN IN-VIVO DATA AS

PHAGE OF SINGLE PHASE IS USUALLY UNABLE TO ERADICATE INFECTION

FROM A LIVING BODY; NOT ONLY IS A LIVING OPEN SYSTEM CONDUSIVE TO

THE BACTERIAL TARGET'S DEVELOPMENT OF RESISTANCE BUT THERE IS

ALSO THE PROBLEM OF THERAPY REACHING TARGET, MUCH OF THE PHAGE

LOAD MAY BE INTERCEPTED BY THE HOST'S IMMUNE RESPONSE AND

ELIMINATED PRIOR TO REACHING THE BACTERIA. PRIOR MECHANISMS AND

EXAMPLES DESCRIBED SHOW THE ABILITY OF MULTIPHASED PHAGES AND

IMMUNE RESPONSES TO AUGMENT EACH OTHERS ABILITY AS WELL AS OTHER

PATHWAYS OF THERAPY SUCH AS ANTIBIOTIC THERAPY..

MULTIPHASIC THERAPY IN MULTIPLE MODES CAN ENHANCE EACH OTHERS

FUNCTION AS WELL AS OFFER PREVENTION AGAINST THE DEVELOPMENT OF

RESISTANCE

PHAGES CAN BE RAISED SPECIFICALLY AGAINST ANTIBIOTIC -RESISTANT

STRAINS OF TARGET ORGANISM.

USE OF INTERTWINED MODALITIES P ATENT COVERS THE USE OF MULTIPHASIC THERAPY AS WELL AS THE USE O F PHAGES AND/OR ANTISERA AS ADJUNCTS TO ANTIBIOTIC

T HERAPY, ANTI CANCER AND ANTI-AIDS THERAPY.

I T IS ALSO TO BE STRESSED THAT ALTHOUGH CURRENT APPLICATIONS MAY

vPPEAR CRUDE,PATENT COVERS THE APPLICATION OF MORE REFINED

TARGETING OF THE VARIOUS MODALITIES SUCH AS THE RAISING OF SPECIFIC IMMUNE RESPONSES AGAINST PLASMIDS WHICH MAY CODE FOR ANTIBIOTIC RESISTANCE EXAMPLES OF ANTIBIOTIC ENHANCEMENT.

STAPHYLOCOCCAL TONSILITIS USUALLY REQUIRES 7-10 DAYS OF

ANTIBIOTIC THERAPY FOR ADEQUATE RESOLUTION.

3 PATIENTS AGE 15-19 SUFFERING FROM RECURRING BOUTS OF

TONSILLITIS HAD PREVIOUSLY BEEN TREATED WITH AMOXIL 250 MG TDS

FOR 10 DAYS ON THREE OCCASSIONS.EACH PRESENTATION YIELDED

STAPHYLOCOCCUS AUREUS CULTURE.WITH SENSITIVITY TO AMOXIL BUT NOT

TO PENICILLIN PHAGE WAS RAISED AGAINST THE CULTURE BY CULTURING

THE ISOLATED STAPHYLOCOCCUS IN 500CC OF TRYPTICATED SOY BROTH

,0.05CC OF 1% HYDROGEN PEROXIDE SOLUTION WERE ADDED ON THE THIRD

DAY OF CULTURE WHEN BACTERIAL GROWTH WAS RICH.BACTERIAL LYSIS

OCCURRED 2DAYS LATER. 0.1CC OF BROTH WAS THEN DRAWN FOR TESTING.

AND CAUSED LYSIS OF ESTABLISHED COLONIES OF THE BACTERIA ON AGAR

PLATE INDICATED PHAGE PRESENCE

BROTH WAS AGITATED AND FILTERED THROUGH 0.2 MICRONS.

HORSE ANTISERUM WAS RAISED BY INTRADERMAL INJECTION OF 0.5CC OF

TSB CONTAINING ONE MILLION ORGANISMS PER ML.

INTRADERMAL INNOCULATION WAS REPEATED EVERY THREE DAYS FOR 2

WEEKS.

3 CC OF BACTERIAL CULTURE WERE THEN TREATED WITH 100.000 U OF

PROCAINE PENICILLIN(CULTURE OT THIS SAMPLE INDICATED BACTERIAL

SURVIVAL)CULTURE WAS CONTINUED FOR A 12 HOUR PERIOD; ORGANISMS

WERE THEN LYSED BY 15 MINUTES OF SONICATION.

THE THEORY HERE IS THAT CHANGES IN BACTERIAL STRUCTURE AND

CONTENT WILL ALTER AS PENICILLIN-RESISTANCE SYSTEMS VARE

INDUCED, HORSE IMMUNE RESPONSE WILL THEN BE ABLE TO TARGET THESE

AS WELL AS BACTERIAL STRUCTURE IN UNCHALLANGED STATE.

IT SHOULD BE NOTED HERE THAT COMPARISON OF SERUM ELECTROPHORESIS

FROM ANIMALS VACCINATED WITH BACTERIA/BACTERIAL FRAGMENTS IN

UNCHALLANGED STATE AND THOSE CHALLANGED WITH THE ANTIBIOTICS

ENABLES DEFINITION OF IMMUNE RESPONSE RAISED AGAINST INDUCEABLE

RESISTANCE FACTORS.

100 CC OF HORSE BLOOD IS DRAINED TWO WEEKS FOLLOWING THE FINAL HORSE IMMUNISATION AND CENTRIFUGED TO YEILD SERUM, SERUM IS STORED AT 3 DEGREES CELSIUS FOR 9 MONTHS. THIS IS AN OLD TECHNIQUE THAT REMOVES MUCH OF ALLERGIC COMPONENT OF SERUM. IT IS WITHIN THIS PATENT PARAMETERS TO INCLUDE ANY MORE SOPHISTICATED PURIFICATION TECHNOLOGY INCLUDING 'WASHING' OF SERUM AGAINST HUMAN/AND/OR PATIENT'S OWN RED BLOOD OR OTHER CELLS/CELL FRAGMENTS AS WELL AS OTHER TECHNIQUES INCLUDING SELECTIVE FILTRATION, ELECTROPHORESIS AND OTHER TECHNOLOGIES INCLUDING ISOLATION AND GENETIC AMPLIFICATION TECHNOLOGY INCLUDING MONOCLONAL ANTIBODY PRODUCTION AND OTHER MECHANISMS INVOLVING HYBRID AND OTHER CELL LINES.

THE PATENT COVERS THE USE OF ANTISERA/WHITE BLOOD CELL

ACTIVITY AGAINS TARGET ORGANISM, TO RECOGNISE ISOLATE AND AMPLIFY USING INTERFERON, INTERLEUKIN AND/OR OTHER MODALITIES PATIENT CELLS WITH ACTIVITY AGAINST TARGET.

OVERCOME.

THERAPY

1 MILLION UNITS OF PROCAINE PENICILLIN

0.6CC OF PHAGE LYSATE (10 TO THE NINETH POWER PLAQUE FORMING

UNITS)

0.3CC HORSE SERUM. (ANECDOTAL CASES HAVE SUGGESTED THAT HUMAN AND

OR ANIMAL IMMUNOGLOBULINS INCLUDING THE COMMONLY AVAILABLE FORMS

SUCH AS POOLED IMMUNOGLOBULINS EVEN IF NOT SPECIFICALLY RAISED

AGAINST TARGET MAY BE OF BENEFIT BUT TEND TO NOT BE AS EFFECTIVE;

CURRENT RISK OF HEPATITIS AND AIDS CONTAMINATION OF HUMAN STOCK

MAY MAKE ANIMAL SERA MORE APPEALING.

TECHNIQUE

1 MILLION UNITS OF PROCAINE PENICILLIN WERE INJECTED

INTRAMUSCULARLY.

0.6CC OF PHAGE LYSATE WAS INJECTED INTRADERMALLY AT THE SAME

TIME.

0.3CC OF ANTISERUM WAS INJECTED INTRADERMALLY 6 HOURS LATER. THE

REASON FOR THE DELAY IS THE THEORETICAL POSSIBILITY THAT

ANTISERUM MAY BIND AND NEUTRALISE PHAGE LYSATE PRIOR TO ITS

CIRCULATION AND REACHING TARGETS.

THE PHAGE INJECTION IN ALL THREE PATIENTS GAVE RED MARKS 1-4 INCHES IN DIAMETER AND WAS ITCHY FOR SEVERAL MINUTES . ONE REPORTED A MILD HEADACHE AND TEMPERATURE OF 100 DEGREES CELSIUS THAT LASTED FOR 6 HOURS.

TONSILLITIS RESOLVED IN ALL PATIENTS WITHIN 48 HOURS OF TREATMENT

FOLLOWUP FOR 1 YEAR REVEALED NO RECURRENCE OF TONSILLITIS IN ANY OF THE THREE. THIS WAS QUITE UNUSUAL IN VIEW OF PREVIOUIS HISTORY OF AT LEAST TWO YEARLY BOUTS AMONGST THEM.

INDUCED REMISSION THERAPY.

USE OF MULTIPHASED MULTIMODAL THERAPY IN COMBINATION WITH CHEMOTHERAPY.

OVERCOMING CHEMOTHERAPY RESISTANCE.

AS MENTIONED IN CLASSIFICATION PATENT. THERE EXIST ORGANISMS CAPABLE OF INTERACTING WITH CANCER CELLS IN EITHER CAUSATIVE OR SYNERGISTIC FASHION. INHIBITION OR ELIMINATION OF THESE ORGANISMS CAN BENEFIT THE PATIENT.

IT HAS ALSO PREVIOUSLY BEEN MENTIONED THAT THE FAILING OP MODERN ADJUVANT IMMUNOTHERAPY IS THAT THE PATIENT'S IMMUNE RESPONSE IS FAULTY AS IN THEORY FURTHER STIMULATION MAY AUGMENT A SYSTEM WITH DISEASE BIAS ; FURTHERMORE , WHEN

CANCER WILL BE USED HERE AS AN EXAMPLE TO DEMONSTRATE APPLICATION

OF TECHNOLOGY; IT IS NOT TO RESTRICT THIS PATENT WHICH APPLIES TO

MANY, IF NOT ALL DISEASE AND OTHER CONDITIONS.

1-RAISING OF REPONSE AGAINST CANCER-SPECIFIC FACTORS.

THIS INVOLVES PREPARATION OF SUCH ENTITIES AND/OR REFERRING TO

LIBRARY SAMPLES.CANCER TISSUE, IN CERTAIN CASES OF NATURE OR AFTER

SPECIFIC CULTURE/PREPARATION TECHNIQUES,OCCURS IN HIGHLY

UNDIFFERENTIATED (OFTEN ASSOSCIATED WITH CLINICAL AGGRESSIVENESS)

FORM. INTERESTINGLY,THE GREATER THE DIFFERENTIATION,THE LESS

AGGRESSIVE THE DISEASE,SUGGESTING THAT REDIFFERENTIATIN EVEN

PARTIAL OF TARGET CANCER CELLS MAY PROMOTE GREATER

SURVIVAL.(SEE REDIFFERENTIATION SECTION OF BIOLOGICAL ENHANCEMENT-ALSO TIE IN OF LBS WITH INTERFERANCE PHENOMENON IN CANCER,ULCERS ETC.)

(ACTUALLY SYSTEM ALSO WORKS WELL WITH GENERAL POOLED ANTIHUMAN

ANTISERA(CONTRAST WITH MULTIPHASIC

HORSE IS VACCINATED WITH NORMAL HUMAN BLOOD CELLS WHICH HAVE BEEN

EXPOSED TO 10 ,000DB FOR 1 MINUTE. BLOOD FROM POOL IS INJECTED INTO

THE ANIMAL INTRADERMALLY AT 0.5 CC EVERY 3 DAYS FOR 3

WEEKS.ANIMAL SERUM AT THAT TIME CONTAINED SIGNIFICANT AMOUNTS OF

ANTI-HUMAN ANTISERUM.

LEUKEMIA CELLS WERE SUSPENDED IN SALINE(CML 150,000 X 10 TO THE

NINETH POWER PER CC FROM PATIENT MENTIONED PREVIOUSLY)AND TREATED

WITH ANTI-HUMAN ANTISERUM.

ICC OF LEUKEMIA SALINE SUSPENSION WAS ADDED TO 0.5CC OF ANTISERUM

AND INCUBATED FOR 6 HOURS.WHOLE CELLS WERE THEN SPUN DOWN AND

WASHED 3 TIMES WITH SALINE THEN RESUSPENDED IN 2CC OF

SALINE. AGAIN ALTHOUGH PATENT DETAILS USE OF ANTIHUMAN

ANTISERUM,ANY ANTI-HUMAN IMMUNOLOGICAL RESPONSE INCLUDING CELL

MEDIATED, ENZYMATIC, ORGANISM , CHEMICAL, PHYSICAL OR BIOLOGICAQL

AND/OR COMBINATIONS MAY BE USED THE PATENTED CONCEPT OF THIS

PATENT IS TO RAISE AN ANTI-NORMAL RESPONSE TO EFFECTIVELY TREAT

DISEASE AND REMOVE FROM IT ANY NORMAL FACTORS , HENCE FACILITATING

THE AIMING OF THERAPY WITH HIGH PRECISION AT THE RESIDUAL

FASCTORS WHICH WE WILL TERM CANCER-SPECIFIC OR DISEASE-SPECIFIC

FRACTION(DSF)

SIMILARLY TECHNIQUES PHYSICAL, CHEMICAL/BIOLOGICAL( INCLUDING THAT

OUTLINED ABOVE )CAN BE USED TO RAISE AN ANTI-DSE RESPONSE , UPON

TREATING HEALTNY CELLS WITH THE ANTI-DSE WE ARE LEFT WITH HEALTHY-CELL SPECIFIC EXTRACT(HCSE). IT IS A VALID ASSUMPTION THAT

HCSE MAY BE AUGMENTED WITHOUT ENHANCING DISEASE PROCESS(SEE

BIOLOGICAL ENHANCEMENT SECTION)

ANOTHER CRUDE BUT USEFUL PROCEDURE IS THE IMPLANTING OF TUMOUR

BIOPSIES INTO ANIMAL VACCINED AGAINST NORMAL HUMAN FACTORS AND

RECOVERING IMPLANT 3-6 DAYS LATER WHEN ANIMAL SYSTEMS WOULD HAVE

ATTACKED,RE MOVED OR DENATURED MUCH OF THE NORMAL HUMAN

COMPONENTS OF THE BIOPSY.EVEN NORMAL ANIMAL IMPLANTATION WITHOUT

ANY PRIOR ANTIHUMAN IMMUNISATION WOULD STILL REMOVE MUCH OF THE

NORMAL HUMAN COMPONENT OF DISEASED HUMAN CELLS BUT PERHAPS NOT AS

EFFICIENTLY.

THERAPEUTIC ORGANISM CAN THEN BE CULTURED WITH VARIBLE DEGREES OF

BIAS WITH THE SPECIFIC DISEASE FRACTIONS AS WELL AS WHOLE CVELLS

WHICH HAVE BEEN 'DEHUMANISED'.

SEVERAL STRAINS OF PENICILLIUM WERE INCUBATED WITH LEUKEMIA CELLS

THAT HAD SURVIVED THE 'DEHUMANISING' PROCEDURE FOR THREE WEEKS.

OTHER TECHNIQUES

AS PREVIOUSLY MENTIONED, IT IS POSSIBLE TO DEFINE LIVING

BIOLOGICAL SYSTEMS TO CERTAIN PROCEDURES;BY EXPOSING TARGET TO

LIVING BIOLOGICAL SYSTEMS TO TARGETS IT IS POSSIBLE TO ISOLATE

ORGANISMS WITH SPECIFIC AFFINITY

LIVING BIOLOGICAL SYSTEM MAY BE BROAD(SUCH AS SOIL ORGANISMS)

NARROW (WITH VARIOUS DEGREES OF DEFINITION EG BY

SPECIE7SUBSPECIE .

DEFINED FOR FUNCTION/OTHER; EXAMPLE -CHEMOTHERAPY GENERATING

ORGANISMS.

EXPANDED; NATURALLY BY ADDITION OF LIVING/NON-LIVING COMPONENTS.

EXPANDED ARTIFICIALLY BY EXPOSURE OF LBS TO MUTATING AGENTS.

A NARROW. DEFINED LBS WAS CHOSEN WHERE THE COMPOSITION WAS

PENICILLIUM SPECIES ISOLATED FROM VARIOUS FOOD SOURCES;

GRAPE JUICE, MOULDY BREAD,PENICILLIUM NOTATUM STOCK ATCC

CULTURES; ALL WERE CO-INCUBATED WITH CANCER CELLS AND CELL

FRAGMENTS THAT WERE 'HUMANISED ' FOR A PERIOD OF THREE WEEKS

TERMEDADAPTATION PHASE.

THE SECOND PHASE OF THE PROCESS IS THE SELECTIVE

I SOLATION PHASE DURING THIS PHASE THE LBS OF POOLED

PENICILLIUM ORGANISMS, HAVING BEEN CO-INCUBATED IN 500CC OF

TRYPTICATED SOY BROTH WITH DEHUMANISED LEUKEMIA CELLS (10CC OF SALINE SUSPENSION AT 150,000 CELLSX 10 TO THE NINETH POWER)FOR THREE WEEKS IN THE ADAPTATION PHASE; ARE NOW 'CHALLANGED WITH THREE LYMPH NODE BIOPSIES,EACH MEASURING ICMM DIAMETER

APPROXIMATELY WITH ATTATCHED PIN MARKERS OF DIFFERENT COLOURS. RED-NORMAL -HISTOLOGICALLY DISEASE-FREE LYMPH NODE FROM LEUKEMIA PATIENT

PENICILLIUM LBS AFTER THE ADAPTATION PHASE OF 3 WEEKS.

SAMPLES ARE IMMERSED IN BROTH FOR THREE DAYS,6 DAYS AND THREE WEEKS. AT EACH TIME ONE OF THE BIOPSY SAMPLES WAS WITHDRAWN HALF WAS INSERTED INTO 200CC OF TRYPTIC SOY BROTH, THE OTHER HALF WAS RINSED WITH 30 CC OF SALINE AND THEN PLACED INTO 200CC OF TSB HALF IS RINSED TO DIMINISH THE CHANCE OF CULTURING SUPERFICIAL , NON-SPECIFIC ORGANISMS FLOATING IN THE TSB AND SIMPLY WERE REMOVED ALONG WITH THE BIOPSIES WITHOUT HAVING ANY REAL AFFINITY FOR THEM .

(THIS MODEL IS AN EXAMPLE MODEL AIMED TO INDICATE HOW TO CREATE AND EXTRACT EFFICIENT, UNI AND/OR MULTIPHASIC THERAPY , ENHANCING CURRENT CHEMOTHERAPY PROTOCOLS, THE TIME PERIODS ARE DEPENDANT ON ORGANISM ACTIVITY, IF DEALING WITH FAST VIRUSES OR BACTERIA,THE IUMMERSION OF BIOPSIES MAY BE MEASURED IN MINUTES OR HOURS.FOR EXAMPLE, SLOWER ORGANISMS MAY REQUIRE MORE TIME.TUMOUR BIOPSIES ARE ABLE TO REMAIN STRUCTURALLY COHESIVE UP TO SEVERAL WEEKS, ORGANISM WITH THE HIGHEST AFFINITY MAY BE SLOWER THAN OTHERS IN THE LBS AND TAKE TIME TO ESTABLISH ITSELF AND DISPLACE OTHER ORGANISMS FROM THE BIOPSY.THE BEST LIVING MATCH WILL BE OBTAINED IF CANCER CELLS ARE STILL VIABLE AT THE TIME OF ORGANISM INVASION AND/OR IF THE BIOPSY SPECIMEN IS REPRESENTATIVE OF THE DISEASE AS IT EXISTS IN-VIVO. PATENT ALSO COVERS IN-VIVO MATCHING TECHNIQUES USING ANIMAL MODELS THAT CAN SUSTAIN LIVING CANCER CELLS AND LIVING LBS CULTURES OVER A DEFINED PERIOD AND ALTHOUGH SUCH A SYSTEM WAS TESTED OUT IN SHEEP, ONE WOULD REQUIRE EITHER ABSENCE OF IMMUNOLOGICAL RESPONSE OR ANIMAL MODEL WITH ITS OWN 'HUMAN EQUIVALENT' CANCER IN ORDER TO MAINTAIN CANCER EXPOSURE OVER A TIME PERIOD OF SEVERAL WEEKS. THERE ARE DIFFICULTIES IN FACTORING FOR ANIMAL-SPECIFIC CONDITIONS AND ALTHOUGH THE RESULTS CAN BE DRAMATIC(ANIMAL IMPLANTED WITH SOLID TUMOUR ON ONE

BUTTOCK, INJECTED WITH LBS IN OTHER BUTTOCK WILL WITHIN DAYS TO WEEKS DEVELOP PUS COLLECTION AT BOTH SITES, CULTURE OF THE LBS SITE WILL REVEAL MIXED ORGANISMS DOMINATED THE MOST HARDY/IMMUNE RESISTANT,THE CULTURE OF ABSCESS WHERE TUMOUR WAS INJECTED WILL OFTEN YEILD A PURE CULTURE OF ORGANISM, EITHER FROM THE LBS( IF SHORT TIME PERIOD, INDICATING THAT WITH HIGHEST AFFINITY, BUT OCCASSIONALLY OTHER ORGANISMS WOULD BE CULTURED AS WELL;THESE WERE ASSUMED TO BE FROM OTHER LBS IN THE ANIMAL MODEL BUT MAY HAVE BEEN OTHER DISEASE-RELATED ORGANISMS FROM WITHIN THE

BIOPSY. ) , ANIMAL MODELS WERE NOT EXTENSIVELY USED FOR THIS TESTING AS A CLOSED SYSTEM SEEMED EASIER, MORE PRACTICAL AND MORE HUMANE) .

THE BIOPSY FRAGMENT WERE THEN CULTURED INDIVIDUALLY IN SEPARATE

STERTILE MEDIA, MANY TYPES OF MEDIA COULD BE USED ,TSB IS CHOSEN

TO ILLUSTRATE PATENT.

WITHIN 2 WEEKS PURE CULTURES OF PENICILLIUM COULD BE ISOLATED FROM FROM THE SIX DAY AND 3 WEEK SPECIMENS, MACROSCOPIC AND

MICROSCOPIC EXAMINATION REVEALED INFIETRATION OF BIOPSIES BY

PENICILLIUM MOULD.

EARLIER SAMPLES WERE VARIABLY POSITIVE BUT AT THREE WEEKS. GROWTH

ORGANISMS THAT ATTATCH TO CANCER CELL/CANCER MASS SELECTIVELY MAY

BE USED TO DEVELOP TAGGING AND TARGETING

THERAPIES. TO BE COVERED LATER.

ORGANISMS CAN BE ISOLATED AND REINCUBATED REPEATEDLY UNTIL OBVIOUS AFFINITY FOR DISEASED TISSUE IS EXPRESSED.THIS MAY BE AIDED BY THE ANTISERA RAISED AGAINST ORGANISMS WITH AFFINITY FOR HEALTHY TISSUE AND/OR OTHER MECHANISMS AND FACTORS RAISING

CULTURE BIAS AGAINST THEM(ONCE THESE STRAINS AND F TYPES ARE DEFINED AS EXPRESSING PREFERANCE TO HEALTHY OR DISEASED TISSUE;THE HEALTH-PREFERRED ORGANISM TYPES MAY BE

INHIBITED,REMOVED OR NEUTRALISED AND THOSE WITH DISEASE

PREFERANCE PROMOTED.

FOLLOWING THREE SUCH PASSAGES,THE PENICILLIUM ISOLATED FROM THE LEUKEMIC LYMPH NODE WAS PLACED INTO 500CC TSB AND CULTURED FOR THREE WEEKS THE MEDIUM WAS THEN PASSED THROUGH A 0.2 MICRON FILTER. 0.1CC OF THIS PRODUCT WAS ADDED TO PATIENT'S BLOOD, SAME PATIENT WHO HAD DONATED THE DISEASED NODE BIOPSIES.WHITE CELLS WERE CENTRIFUGED DOWN AND RESUSPENDED IN SALINE LEUKEMIA COUNT AT THIS TIME WAS 220,000 X 10 TO THE NINETH POWER PER CC. ICC OF SALINE SUSPENSION WAS USED

WITHIN 2 HOURS OF SITTING AT ROOM TEMPERATURE, LEUKEMIA COUNT WAS 118,000 0.1 CC OF CRUDE SPECIFIC PENICILLIN EXTRACT(FILTRATE AS DEFINED ABOVE) WAS ALSO ADDED TO POOLED NORMAL WHITE BLOOD CELLS

RESUSPENDED IN SALINE AT 210,000 CELLS PER CC.

2 HOURS LATER COUNT WAS 200,000.

ORAL/INTRAMUSCULAR/INTRADERMAL/SUBCUTANEOUS DOSING ROUTES.

PATIENT WAS INJECTED WITH 3CC OF SCPE(SPECIFIC CRUDE PENICILLIN EXTRACT)INTRAMUSCULARLY. WBC COUNT BASELINE 220,000,24 HOURS LATER COUNT 180,000 REPEATED DOSE OF SCPE DROPPED COUNT TO

150,000 24 HOURS LATER.REPEATED DOSEAGE DROPPED LEVEL TO 120,000 THE WHITE BLOOD CELL COUNT REMAINED AT THAT LEVEL WITH VARIATIONS OF NO MORE THAN 20,000 FOR 6 WEEKS WITH DAILY DOSEAGE OF 3CC SCPE INTRAMUSCULAR THERE WAS NO FURTHER DROP DESPITE CONTINUED DOSEAGE. IN VITRO TESTING DEMONSTRATED LOSS OF EFFICACY OF SCPE. IN LEUKEMIA CELL KILL.

THIS SITUATION WOULD BE ANALAGOUB TO THE DEVELOPMENT OF

CHEMOTHERAPY RESISTANCE.

TO GENERATE NEW,EFFECTIVE THERAPY FROM THE SAME INITIAL

SOURCE,ANY NUMBER OF COINCUBATION METHODS WITH VARIOUS DEGREES OF

BIAS FOR THE PURPOSE OF THIS DEMONSTRATION,THE FOLLOWING WAS

DONE;

WHITE BLOOD CELLS FROM PATIENT WERE SPUN DOWN,RESUSPENDED IN

SALINE THEN SPUN DOWN AGAIN( IN THEORY, THIS PROCESS ALLOWS REMOVAL

OF OTHER BLOOD CELLS AND OTHER NORMAL BLOOD COMPONENT SO THAT

THESE ARE NOT ALSO TARGETED BY THE PENICILLIUM OR OTHER

THERAPEUTIC ORGANISM).WHITE BLOOD CELLS ARE SPUN DOWN INTO A

PASTE AND THE ORGANISM IS INNOCULATED INTO THIS

PASTE.ESSENTIALLY,THEREFORE,THE LEUKEMIC CELLS FORM ALL OF THE

SOURCES OF NUTRITION FOR THE FUNGUS.THE PENICILLIUM MOULD GREW

RAPIDLY AND WITHIN 3 WEEKS THE 10 CM BY ONE CM CANCER PASTE WAS

TOTALLY REPLACED BY MOULD MACROSCOPICALLY.THIS MOULD WAS THE

INNOCULATED INTO 500CC OF TSB AND FOLLOWING 3 WEEKS OF CULTURE,

SCPE WAS AGAIN PREPARED AND TESTED AGAINST LEUKEMIA CELLS FROM

THE PATIENT.THIS SECOND GENERATION OF SCPE PROVED HIGHLY

EFFECTIVE.SALINE LEUKEMIA SUSPENSIONS OF 200,000 COUNT PER CC

WERE REDUCED TO 80,000 WITHIN THREE HOURS OF INCUBATION OF ICC OF

SUSPENSION WITH 0.1CC OF SCPE SECOND GENERATION.

THIS PROCESS CAN AGAIN BE REPEATED WHEN RESISTANCE DEVELOPS TO

SECOND GENERATION SCPE.THE COMBINATION OF MULTIPLE

PHASES/GENERATIONS OF SCPE PROVES MORE EFFECTIVE AND LONGLASTING

THAN SINGLE PHASESTECHNIQUES PREVIOUSLY MENTIONED TO INCREASE

SPECIFICITY SUCH AS TESTING AGAINST NORMAL TISSUE,RAISING

ANTISERA TO FEATURES WITH ANTI-NORMAL EFFECTS AS WELL AS USING

BROAD OR EXPANDED LBS TO HAVE A LARGE SAMPLE GROUP FROM WHICH TO

CHOOSE.

PATET ALSO INCLUDES DESIGNING OF LBS FOR SELECTIVE TARGETING OF

CONDITIONS AS WELL AS CELL TYPES IT IS POSSIBLE TO CULTURE LBS

WITH ANAEROBIC OR MICROAEROPHILIC CHARACTERISTICS FOR EXAMPLE

WHICH THEY. MAY ENCOUNTER IN THE ANAEROBIC CENTRE OF TUMOUR MASSES

THE OBJECTIVE OF THIS AREA OF THE PATENT , HOWEVER , IS TO TEACH A PRINCIPLE THAT PRODUCTS OF ORGANISM A MAY BE MADE SPECIFIC FOR TARGET B AND SHOULD THAT TARGET DEVELOP RESISTANCE THEN CO-INCUBATION MAY ENABLE THE MODIFICATION OR EXPANSION OF THE ORGANISM'S ABILITY SO THAT IT IS AGAIN EFFECTIVELY ANTAGONISTIC TO TARGET.

SIMILAR EXPERIMENTS WERE CONDUCTED WITH ACTINOMYCETE AND STREPTOMYCETE SPECIES WHICH WERE ISOLATED BY LEAVING CANCER BIOPSIES OPEN TO AIRBORNE CONTAMINATION . AGAIN ,AS RESISTANCE DEVELOPED, RE-COINCUBATION PRODUCED NEW EFFECTIVE PATHWAYS.

THIS PATENT APPLIED TO MODERN CANCER THERAPY ESSENTIALLY PRESENTS THE ABILITY TO CONSTANTLY DEVELOP NEW SAFE THERAPIES AND AS PREVIOUSLY SEEN,MULTIPHASIC THERAPY PROVES MORE EFFECTIVE THAN SINGLE GENERATION. COMPOUND MULTIPHASIC(WHERE 2 OR MORE

AT ITS SIMPLEST APPLICATION, WHERE THERAPEUTIC ORGANISMS ARE CULTURED IN MEDIUM PURELY OF TARGET AS IT EXISTS IN PATIENT OR IN EXPANDED FORM(EXPOSED TO PRIOR THERAPY OR MUTATING AGENTS TO EXPAND CELL CLONE NUMBER TO ANTICIPATE MUTATION) THERAPEUTIC PRODUCTS WHICH ARE HIGHLY EFFECTIVE MAY BE OBTAINED. WHEN THE ORGANISM EXTRACT AND DISEASE ARE CO-INCUBATED WHERE THE DISEASE MAY DEVELOP RESISTANCE; INCUBATION OF THERAPEUTIC ORGANISM ON CULTURE MEDIUM COMPOSED WHOLLY OF RESISTANT CELLS WILL ALLOW FOR THE DEVELOPMENT OF NEW AGENTS FROM THE THERAPEUTIC ORGANISM TO DEAL WITH RESISTANT CELLS.

ORGANISM CAN BE SIMILARLY PROCESSED TO YEILD NEW THERAPIES) CULTURE MEDIA WHOLLY OR MOSTLY COMPRISED OF TARGET TEND TO CONFER STRONG ACTIVITY AND SPECIFICITY TO THE THERAPEUTIC ORGANISM, OTHER TECHNIQUES SUCH AS DE-HUMANISING THE CANCER CELLS OR WHATEVER TARGET AS MAY ALLOW FOR DISEASE-SPECIFIC MEDIA WHICH WOULD, IN TURN FURTHER INCREASE SPECIFICITY AND EFFICACY. IN PRACTISE, WITH CANCER, THIS OFTEN LEADS TO MICROBIOLOGICAL COMPLICATIONS AS DEHUMANISING THE CELLS OFTEN STIMULATES THE EXPRESSION OF SYNERGISTIC OR CAUSATIVE ORGANISMS.

IT ALSO HAS BEEN PROVEN THAT MANY ORGANISMS SUCH AS PENICILLIUM MOULD CAN EXERT POWERFUL ANTICANCER PROPERTIES . THIS PATENT COVERS THE USE OF CRUDE AND PURIFIED SPECIFIC EXTRACTS OF PENICILLIN IN THE TREATMENT OF CANCER AND AIDS

TESTS FOR BOTH CANCER AND AIDS WERE CONDUCTED WITH PENICILLIUM, STREPTOMYCETES, KAMBUCHA, ACTINOMYCETES, ASPERGILLI AS WELL AS OTHER UNIDENTIFIED MOULDS, IN EACH CASE, EVEN WHERE THERE WAS NO PREVIOUS ANTIDISEAE ACTIVITY OR SPECIFICITY, THESE WERE ENABLED BY THE PRECEDING TECHNOLOGY.

USE OF VIRAL/BACTERIAL AND OTHER

BIOLOGICAL AGENTS TO ATTACK DISEASED

CELLS-(THIS IS DIFFERENT TO TAGGING AND TARGETING THERAPY ALTHOUGH OVERLAPPING MECHANISMS MAY EXIST)

VIRUSES AND BACTERIA MAY BE PROCESSED IN MUCH THE SAME WAY AS THE PENICILLIUM WAS PROCESSED , HOWEVER, THERE ARE DISTINCTIVE FACTORS ALSO IN BIOLOGICAL MECHANISMS AS WELL AS SPEED OF CO-CULTURE.

VIRAL USE

CHOOSING AND DEVELOPING SPECIFICITY

EPIDEMIOLOGICAL, LOGICAL AND OTHER SEARCH TECHNIQUES WERE

PREVIOUSLY COVERED.

DIRECT INFECTION-VIRAL

VIRUSES TO BE USED AS EXAMPLES IN DEMONSTRATION OF USE OF VIRUSES

AS THERAPEUTIC AGENTS ARE LISTED BELOW BUT NOT INTENDED TO

RESTRICT PATENT, THESE AND ALL OTHERS ARE COVERED UNDER THE

GUIDELINES OF THIS PATENT.

FELINE PANLEUKOPENIA VIRUS

CANINE DISTEMPER VIRUS

NEWCASTLE VIRUS

PIDGEON POX

MEASLES VIRUS

MUMPS VIRUS

THESE WERE USED BECAUSE OF READY AVAILABILITY AND BECAUSE OF

RELATIVE HUMAN SAFETY.

FELINE PANLEUKOPENIA VIRUS AND CANINE DISTEMPER VIRUS WERE CHOSEN

FOR THE LEUKEMIA MODEL .

BLOOD WAS COLLECTED FROM PATIENT WITH CHRONIC LYMPHOCYTIC

LEUKEMIA COUNT 88,000.

FELINE PANLEUKOPENIA VIRUS WAS CHOSEN AS IT LOGICALLY APPEARED A

GOOD AGENT FOR INFECTING ROGUE WHITE BLOOD CELLS.

PREVIOUS STUDIES CIRCA THE MID 50'S DEMONSTRATED THE ABILITY OF

VACCINATION WITH FELINE PANLEUKOPENIA VIRUS TO CAUSE TEMPORARY

REMISSIONS OF LEUKEMIA, LASTING SEVERAL WEEKS AFTER SINGLE DOSE. THERE ARE SEVERAL MODIFICATIONS PRESENTED BY THIS PATENT.FPLV WAS PREVIOUSLY ADMINISTERED IN SINGLE DOSE AND OCCASSIONALLY CORTICOSTEROIDS TO ALLOW MAXIMUM TIME FOR INFECTION TO ATTACK TARGET BEFORE IMMUNE REJECTION TAKES PLACE .SUCH TECHNIQUES SELDOM IMPACTED FAVOURABLY ON THE DISEASE,LEUKEMIA INVARIABLY RECURRED WITH RAPID DEATH WITHIN WEEK8 TO MONTHS.

IT SEEMED THAT AS A UNIMODAL THERAPY VIRAL INFECTION OF LEUKEMIA CELLS WAS INEFFECTIVE LONGTERM, YET , OBVIOUSLY THE THERAPY WAS EFFECTIVE IN THE SHORTERM, POSSIBLE HYPOTHESES FROR THIS

OBSERVATION FOLLOW;

1-DISEASE MUTATES TO RESIST VIRUS

THE ANSWER APPPEARS TO LIE IN A MIXTURE OF 1 AND THREE

LARGELY; ALTHOUGH IMMUNE ELIMINATION OF VIRUS MAY BE A FACTOR IT DOES NOT APPEAR TO BE MAJOR. THIS IS STATED FOLLOWING OBSERVATIONS THAT CORTICOSTEROID AND OTHER INHIBITION OF IMMUNE RESPONSE DOES NOT SEEM TO FAVOURABLY EFFECT OUTCOME; FURTHERMORE , IF THE IMMUNE RESPONSE DOES ATTACK THE VIRUS IT SHOULD ALSO ATTACK THE VIRALLY

-INFECTED CANCER CELLS.

IT APPEARS THAT THE MAJOR FACTOR AT PLAY IS THE ADAPTION AND/OR MUTATION OF CANCER CELLS TO SURVIVE AND FUNCTION WHILE CO-EXISTING WITH VIRAL INFECTION( ANOTHER FEATURE WHICH APPEARS TO INDICATE THAT VIRUS MAINTAINS ACTIVITY AND THAT IMMUNE RESPONSE DOES NOT PROTECT CANCER CELLS FROM THE VIRUS IN THE LONGTERM IS THAT THE CYTOPLASMIC VACUOLATION WHICH MARKS VIRAL ACTIVITY CASN BE SEEN IN THE MAJORITY OF CANCER CELLS EVEN AFTER RECURRENCE OF DISEASE.THESE CELLS ARE CAPABLE OF INFECTING OTHERS THAT HAVE NEVER BEEN EXPOSED TO THE VIRUS. ) ATTEMPTS TO DEVELOP VIRUSES WITH GREATER ANTICANCER VIRULENCE HAVE INVOLVED REPEATED PASSAGES OF VIRUS THRUGH CANCER CELL GENERATIONS; AS SEEN FROM THE ABOVE, IT APPEARS THAT VIRUS AND CANCER DEVELOP A SYNERGISTIC RELATIONSHIP AFTER THE INITIAL THERAPEUTIC RESPONSE HENCE ATTEMPTS TO DEVELOP GREATER VIRULENCE THROUGH REPEATED PASSAGING WAS,NOT

SURPRISINGLY,OFTEN MET WITH FAILURE.

A CASE DESCRIBING THESE FEATURES WILL NOW BE DESCRIBED.

FEMALE 50,WITH 6 YEAR HISTORY OF CHRONIC LYMPHOCYTIC LEUKEMIA PRESENTS WITH RISING WHITE BLOOD CELL COUNT -30,000 AT

PRESENTATION AND 87% LYMPHOCYTES . PATIENT WAS UNRESPONSIVE TO CHEMOTHERAPY.IT WAS DECIDED TO ATTEMPT RAPID LEUKEMIA SATURATION WITH VIRUS AND RAISE MINIMAL IMMUNE RESPONSE WITHOUT 'TSING

IMMUNOSUPPRESSIVE TECHNIQUES (AS NOTED STEROIDS HAD PROVEN OF NO USE IN PRIOR EXPERIMENTS. )WHITE BLOOD CELLS OF PATIENT WERE SPUN DOWN AND SEPARATED,THEY WERE THEN RESUSPENDED AT 100,000 X 10 TO THE NINETH "POWER PER CC IN 5CC OF SALINE.FELINE PANLEUKOPENIA VIRUS 1 CC AS PRESENTED FOR VETERINARY USE WAS INCUBATED WITH THE LEUKEMIA CELLS FOR 24 HOURS THE CELLS WERE THEN WASHED WITH 10 CC OF SALINE THREE TIMES (CELLS WERE SPUN DOWN THEN RESUSPENDED IN 10CC OF SALINE THREE TIMES) . THE POINT OF THIS PROCEDURE IS TO INTRODUCE AS MUCH OF THE VIRUS INTRACELLULARLY AS POSSIBLE, MINIMISING FREE VIRUS INJECTION AND INCREASING DELIVERY DOSE. PATIENT'S INFECTED CELLS DEMONSTRATED CYTOPLASMIC

INCLUSIONS. THEY WERE PLACED INTO 500CC OF SALINE AND INJECTED INTRAVENOUSLY INTO THE PATIENT (APPROXIMATELY 500,000 X 10 TO THE NINETH POWER INFECTED CELLS) INTRAVENOUS DRIP INJECTED OVER A SIX HOUR PERIOD. PATIENT WAS OBSERVED FOR SIGNS OF A REACTION, NONE WAS NOTED.

PROCEDURE WAS REPEATED DAILY FOR SIX DAYS . SLIGHT TEMPERATURE (100 DEGREES CELSIUS)WAS NOTED BUT ONLY LASTED FOR A FEW HOURS ON DAY THREE. NO OTHER SIDE EFFECTS WERE NOTED. BY THE SECOND DAY WBC COUNT HAD DROPPED TO 25 , 000; AND PERHAPS MORE SIGNIFICANTLY , LYMPHOCYTE PERCENTAGE DROPPED TO 65% OVER 24 HOURS,BLOOD SMEAR SHOWED 30% OF WHITE BLOOD CELLS WITH CYTOPLASMIC INCLUSIONS . BY THE SECOND TEST(48 HOURS AFTER FIRST INJECTION) WBC COUNT HAD DROPPED TO 15,000 AND 80% OF WBC DEMONSTRATED CYTOPLASMIC

INCLUSIONS.LYMPHOCYTE PERCENTAGE DROPPED TO 50%. IT IS NOTED HERE THAT, ALTHOUGH THE PRACTISE OF INJECTING INFECTED CANCER CELLS INTO THE PATIENT IS AN ADVANCED FORM OF GENE THERAPY, SUPERIOR SEPARATION TECHNIQUES , WHERE LEUKEMIC CELLS CAN BE SEPARATED FROM NORMAL WHITE BLOOD CELLS AND OTHER NORMAL CELLS VIRUS MAY BE

RESTRICTED TO INFECTION OF LEUKEMIA CELLS SEE ALSO

SPECIFICATION TECHNOLOGY TO BE DISCUSSED LATER.

IMPROVEMENT CONTINUED, THE NIGHT SWEATS WHICH HAD PLAGUED THE PATIENT FOR THREE YEARS STOPPED AFTER THIRD TREATMENT . WBC AND PERCENTAGE LYMPHOCYTES WILL NOW BE DISPLAYED FOR SUBSEQUENT DAYS DAY3-11.000 - 50%

DAY4- 9.800- 54%

DAY5- 7,200- 48%

DAY 6- 5,600- 34%

AT THE END OF 1 WEEK, ALL WBC S STILL DISPLAYED CYTOPLASMIC

BODIES;NEUTROPHILS AND OTHER NORMAL CELLS REGAINED NORMAL

MORPHOLOGY. A PERCENTAGE OF LYMPHOCYTES ( 15% ) CONTINUED TO DISPLAY INCLUSION BODIES ALTHOUGH NO BIZARRE NUCLEAR CHANGES OR HEAVY CHROMATIN STAINING SUGGESTIVE OF MALIGNANCY WERE PRESENT.

PATIENT REMAINED IN REMISSION FOR 6 WEEKS , FOLLOWING WHICH THE COUNTS OF WBC AS WELL AS % OF LYMPHOCYTES BEGAN TO RISE. BY WEEK 8 COUTS WERE 20,000-84%. ALMOST M.L LEUKEMIC CELLS DEMONSTRATED CYTOPLASMIC INCLUSION BODIES SUGGESTIVE OF CONTINUED VIRAL ACTIVITY IN THE LEUKEMIC CELLS. CO- INCUBATING THESE CELLS WITH NORMAL AND/OR LEUKEMIC WBC FROM ANOTHER SOURCE RESULTED IN

INTERLEUKIN LEVELS WAS NOTED AT START OF THERAPY . THESE REMAINED ELEVATED; THE IMMUNE SYSTEM WAS , HOWEVER, APPARENTLY AS BLIND TO THE VIRUS AS IT WAS TO THE CANCER CELLS.

STAGE 2 VIRAL THERAPY

THE SECOND STAGE OF VIRAL THERAPY ATTEMPTED INVOLVED THE INTRODUCTION OF ANOTHER VIRUS WITH AFFINITY FOR LEUKEMIA IN ITS MODE OF APPLICATION. CANINE DISTEMPER VIRUS WAS NOTED IN IN-VITRO STUDIES TO CAUSE NUCLEAR VACUOLATION AND CELL DESTRUCTION IN LEUKEMIA CELLS(OTHER STUDIES ALSO DEMONSTRATED THAT CULTURING MANY FORMS OF VIRUSES IN LEUKEMIA CELLS THEN INJECTING INFECTED LEUKEMIA CELLS INTO THE BODY WOULD LEAD TO THE

PREFERRENTIAL, ACCELERATED INFECTION OF OTHER LEUKEMIA CELLS . EVEN IN CASE DISCUSSED ABOVE IT CAN BE SEEN THAT MASSIVE IMPROVEMENT OCCURRED BEFORE MAXIMUM VIRAEMIA ON DAY 12, PRIOR USE OF VIRAL; VACCINES WOULD NECESSITATE DAYS TO WEEKS PRIOR TO MARKED IMPROVEMENT BEING EVIDENT ; IT IS AS IF LEUKEMIC CELLS/CELL

FRAGMENTS FORM OPTIMAL VECTORS FOR THE DELIVERY OF VIRAL AGENT TO OTHER LEUKEMIC CELLS . THE INTRACELLULAR VIRAL REPLICATION AND HENCE AMPLIFICATION OF ADMINISTERED DOSEAGE IS ALSO A FEATURE OF THIS PATENT.

CANINE DISTEMPER VIRUS WAS INCUBATED WITH THE RECURRED LEUKEMIA CELLS FOR 24 HOURS AS PER PREVIOUS TECHNIQUE DESCRIBED FOR FELNE PANLEUKOPENIA VIRUS . NUCLEAR VACUOLATION WAS APPARENT WITHIN 24 HOURS . PROTOCOL DESCRIBED ABOVE WAS REPEATED.

IT APPEARED THAT THE SAME PROCESS TOOK PLACE WHEREBY THE LEUKEMIA CELLS BECAME RAPIDLY INFECTED AND WBC DROPPED INTO NORMAL RANGE WITHIN 10 DAYS.LEUKEMIA CELLS ONLY APPEARED TO BE INFECTED IN THIS SECOND STAGE OF VIRAL; INFECTION AND DISPLAYED BOTH THE CYTOPLASMIC INCLUSIONS OF THE FPLV AND NUCLEAR VACUOLATION OF THE CDTV.PRESUMABLY, THE VIRAL INTERFERANCE PHENOMENON PROTECTED NORMAL CELLS BUT WAS NOT AS PROTECTIVE FOR LEUKEMIA CELLS.COUNTS REMAINED WITHIN NORMAL RANGE FOR A PERIOD OF 4 WEEKS THE DISEASE RECURRED; DEMONSTRATING BOTH NUCLEAR VACUOLATION AND CYTOPLASMIC INCLUSIONS.CELLS RETAINED INFECTIVE CAPACITY FOR CDTV AND FPLV. OTHER IN-VITRO; ANIMAL AND HUMAN STUDIES WERRE CONDUCTED WHERE A THIRD STAGE THERAPY WITH FOWL POX VIRUS WAS ADDED AS WELL AS THE USE OF 2 OR MORE VIRUSES TOGETHER IN INFECTING AND DESTROYING LEUKEMIA CELLS. IT APPEARED THAT THE COMBINATION OF CDTV AND FPLV DESTROYED MORE LEUKLEMIA CELLS IN-VITRO THAN EITHER ONE ALONE; YET IN THE LIVING SYSTEM, ALTHOUGH BOTH INFECTED THE LEUKEMIC CELL AND CAUSED REMISSION,THAT WAS AS SHORT LASTING AS USING ONLY ONE AGENT. IN THESE LIMITED TRIALS,THE SEQUENTIAL USE OF VIRAL AGENTS COULD REPEATEDLY CAUSE

TAG WITH INHERENT VIRUSES TOO CANCERE IMPLANTS INFECTED ADRIAMYCIN/STREPTOMYCETE.

CARRY HUMAN ANTIGENS ON V

TARGETING OF CAUSATIVE AND SYNERGISTIC

ORGANISMS.

ASCITESD/EFFUSIONS HAVE ORGS

IDENTIFY, ANTIBIOTIC, TAG , PHAGE, INTERFERANCE, CARRIER OF ORGS/TARGET

CELLS

GENETIC/OTHER IMBALANCE EVIDENT BY ATTACK

; IF THE SEARCH FOR AGENTS AND ORGANISMS THAT ' STICK' TO CANCER CELLS AND/OR CELL MASSES IS MADE WITH THE PURPOSE OF TAGGING SUCH TARGETS

TO SURFACE LIGHT AMPLIFYING X-RAYS.

BROAD , DEFINED, SPECIFIC, EXPANDED NATURAL, /ARTIFICIAL

(FPLV,CDV, FOWL POX VIRUS) DID NOT EXTEND REMISSION TIME ACHIEVED BY FPLV ALONE(UNLESS THEY WERE APPLIED IN SEQUENCE RATHER THAN SIMULTANEOUSLY).

IT APPEARS THAT ANTIVIRAL IMMUNOLOGICAL RESPONSE IS HAMPERED WHEN THE VIRUS IS INTRACELLULAR IN LEUKEMIA CELLS.TWO OBERVATIONS ARE IMPORTANT, THE LEUKEMIA CELLS DISPLAY VIRAL ACTIVITY YET THERE ARE NO SYSTEMIC MANIFESTATIONS OF THE VIRUS UPON LEUKEMIA RECURRENCE; FURTHERMORE, RE-ACTIVATION OF VIRUS APPEARS RESTRICTED AND LIMITED,THE LONGER IT IS ASSOSCIATED WITH THE LEUKEMIA; IT IS AS IF THE VIRUS INCORPORATES AND SYNERGISES WITH THE LEUKEMIC CELL MECHANISM,VIRAL RECOVERY AND INFECTION OF OTHER CELLS

DECREASES.

VIRAL INFECTION,HOWEVER,HAS BEEN NOTED TO CAUSE SPONTANEOUS REMISSION IN THE PAST (EG NEWCASTLE VIRUS INFECTION LINK WITH REMISSION FROM STOMACH CANCER REPORTED IN LANCET)

VIRAL SOURCE SHOULD ALSO BE CONSIDERED.MOST VACCINES ARE CULTURED ON EMBRYONIC CELLS OR ON CONTINUOUS CELL LINES(CANCER CELLS) A CHANCE OF VIRAL ADAPTATION ALREADY THEREFORE MAY HAVE TAKEN PLACE.MANY VIRUSES ARE ABLE TO CANNIBALISE FRACTIONS OF CELLS IN WHICH THEY ARE CULTURED AND EXPRESS THEM. SPONTANEOUS REMISSION FOLLOWING VIRAL INFECTION AND/OR TRIALS USING VIRUSES TO INFECT CANCER CELLS HAVE DEMONSTRATED MAXIMAL EFFECTS AFTER INITIAL INCUBATION PERIOD OF SEVERAL DAYS . TO THREE WEEKS;THIS TIME PERIOD ALLOWS FOR MAXIMUM VIRAL CELL LYSIS AS WELL AS ANTIVIRAL IMMUNOLOGICAL RESPONSE.

THE RECURRENCE OF CANCER FOLLOWING VIRAL-INDUCED REMISSION IS OFTEN MOPRE AGGRESSIVE THAN PREVIOUS CANCER ACTIVITY;THIS MAY BE DUE TO HOST FACTOR DEPLETION BY VIRAL INFECTION,E.G.BY DIRECT VIRAL ACTIVITY.BY ALLOWING SUPERADDED INFECTION OR OPPURTUNISTIC INFECTION TO ENTER THE SYSTEM,OR BY THRESHOLD INHIBITION OF IMMUNE RESPONSE; IF VIRUS REACHES ADEQUATE LEVELS , AND EXPRESSES ITSELF ON THE CANCER CELL SURFACE IT MAY BY THRESHOLD EFFECT LEAD TO FURTHER IMMUNE RESISTANCE OF CANCER CELLS.

NEUTRALISED,MAINTENANCE OF CELL INTEGRITY IN THE FACE OF FURTHER CHALLANGE MAY BE COMPROMISED; INITIAL STUDIES APPEAR TO INDICATE THAT SENSITIVITY TO OTHER CHEMICAL OR PHYSICAL THERAPIES RISES DEPENDING ON THE NUMBER OF VIRAL STAGES USED.

SOME WAY; THE PRESENCE OF THE VIRUS MAY EVEN CHOOSE FOR OR CAUSE

THE REVERSION OF CELLS TO MORE PRIMITIVE, UNDIFFERENTIATED

LEVELS(THIS RAISES THE INTERESTING HYPOTHESIS THAT AS CANCER CELL

DIVIUSION RATES MAY SYNCHRONISE WITH INVADING VIRUS THAT SLOW

VIRUSES OR VIRUSES INSERTED THEN INHIBITED IN SOME WAY MAY SLOW

CANCER REPLICATION.

THERE APPEARS TO BE A LIMIT IN CANCER CELL'S COPING ABILITY WITH

SUPERADDED INFECTIONS TO THE POINT WHERE A SPECIFIC OR MULTIPLE

INFECTIONS CAN TAX THE CANCER CELLS ABILITY TO COPE WITH FURTHER

INSULTS, EVEN WHERE SUCH INSULTS WERE PREVIOUSLY INEFFECTIVE.

THERE APPEAR TO BE THREE TIMES AT WHICH FURTHER INTERVENTION MAY

OPTIMISE RESULTS;

1-INITIAL VIRAL SATURATION

2-POINT OF OPTIMAL EXPRESSION

3-TIME OF ADAPTATION/RECURRENCE

INITIAL VIRAL SATURATION

OPTIMAL,RAPID TUMOUR LOAD DECREASE CAN BE ACCOMPLISHED BY THE

GUIDELINES OF THIS PATENT WHEREBY TARGET CELLS ARE INCUBATED WITH

VIRUS PRIOR TO REINSERTION INTO THE SYSTEM.SLOW INTRAVENOUS

INSERTION OF VIRUS AND VIRALLY TAGGED CELLS SEEK TO SATURATE

DISEASED CELLS .USE OF CORTISONE TO FASCILITATE DISEASED CE4LL

SATURATION(IE EXTEND UNOPPOSED PERIOD OF VIRAEMIA) ,THIS IS NOT

RECOMMENDED AS NORMAL CELLS THEN ALSO BECOME AT INCREASED RISK OF

VIRAL INFECTION.

IF MULTIPLE VIRUSES ARE TO BE USED SIMULTANEOUSLY,THEIR

COMPATIBILITRY IN CULTURE AND MECHANISMS SHOULD FIRST BE

DEMONSTRASTED SO THAT INTERFERANCE DOES NOT OCCUR BETWEEN

THEM.OPTIMISING THE VIRAL VECTOR CAN BE ACCOMPLISHED BY SEVERAL

PROCESSES

1-INCREASING AFFINITY OF VIRUS FOR CANCER CELLS.

SELECTIVE CULTURE AND 'WASHING' PROCEDURES MAY BE DONE TO ISOLATE

MOST SPECIFIC STRAINS.AS WITH THE PENICILLIUM EXAMPLE PREVIOUSLY

DESCRIBED LBS OF THE VARIOUS CLASSIFICATIONS MAY BE INCLUDED IN

SALINE,WASHING RELATES TO THE REPEATED ADDITION OF NORMAL CELLS

TO THE SOLUTION AND, ALLOWING 30 MINUTES FOR ADSORPTION AND THEN

SPINNING DOWN AND REMOVING CELLS SEVERAL TIMES UNTIL THE FINAL

BATCH OF SPUN DOWN CELLS SHOW MINIMAL TO NO VIRAL INFECTION AFTER

24 HOUR CULTURE.THE REMAINING PORTION OF THE LBS IS LIKELY TO

THEREFORE HAVE LITTLE AFFINITY FOR THE HEALTHY CELLS TESTED.

IN SELECTING FRACTIONS OF LBS WITH PARTICULAR AFFINITY FOR CANCER

CELLS,THEY CAN BE ADDED ALONG WITH COMPLIMENTARY NORMAL CELLS TO

THE SOLUTION AND ADSORPTION ALLOWED TO OCCUR OVER,SAY 30

MINUTES, SUBSEQUENT SEPARATION AND INCUBATION OF CANCER CELLS ONLY

WILL IN THEORY YEILD VIRUS WITH PREFERRED AFFINITY FOR CANCER

CELLS.THESE CELLS ARE CULTURED TO LYSIS,VIRUS RESUSPENDED AND

EXPOSURE TO NORMAL AND HEALTHY CELLS AGAIN

UNDERTAKEN. ADSORPTION , CULTURE, SEPARATION PROCEDURE IS REPEATED

UNTIL ONLY CANCER CELLS APPEAR INFECTED,VIRUS THEN MAY BE SAID TO

HAVE PARTICULAR AFFINITY FOR TUMOUR CELLS.

MANY VIRUSES WILL DEVERLOP TUMOUR CELL AFFINITY;CANCER CELLS HAVE

OFTEN BEEN REPORTED TO HAVE VIRAL STRUCTURES AND IT IS BELIEVED

THAT CANCER CELLS HAVE RESTRICTED RESISTANCE TO VIRAL INFECTION

AS COMPARED TO NORMAL CELLS . AS THESE CELLS ARE ABLE TO SURVIVE WITH MULTIPLE INFECTIONS IT CAN BE SEEN WHY SUCH CELLS APPEAR TO SUIRVIVE IN A CHAOS DEADLY TO NORMAL CELLS , HENCE DO NOT NEED OTHER DEFENSE MECHANISMS AS ADVANCED AS THOSE OF NORMAL CELLS..

IN-VITRO TESTING, HOWEVER SHOWS TOTAL CELL LYSIS OF PERIPHERAL CIRCULATING LEUKEMIA CELLS, IT IS LIKELY THAT RESISTANCE BEGINS IN THE BONE MARROW OR WHEREVER STEM CELLS MAY BE. INCUBATION OF BONE MARROW LEUKEMIA CELLS WITH VIRUS , SEARCHING FOR OPTIMAL LYTIC FRACTION.

DURING THIS TIME IT HAS BEEN SHOWN THAT ANIMAL OR HUMAN ANTISERA TO THE

IN-VITRO TESTING, HOWEVER SHOWS TOTAL CELL LYSIS OF PERIPHERAL CIRCULATING LEUKEMIA CELLS, IT IS LIKELY THAT RESISTANCE BEGINS IN THE BONE MARROW OR WHEREVER STEM CELLS MAY BE. INCUBATION OF BONE MARROW LEUKEMIA CELLS WITH VIRUS,SEARCHING FOR OPTIMAL LYTIC FRACTION

OPTIMISING VIRAL SATURATION INVOLVES IDENTIFICATION OF TARGET IN WHATEVER MANIFESTATION (STEM CELL,CIRCULATING PERIPHERAL CELL ETC.), INCUBATING ALL CELL FORMS POSSIBLE WITH VIRUS,USE OF VIRUS CULTURED FOR SPECIFICITY IN FREE FORM AS WELL TO SATURATE ALL TARGET CELLS.

VIRUS AS CARRIER

IT IS KNOWN THAT MOST HUMAN CANCERS WILL BE DESTROYED WHEN IMPLANTED INTO ANIMALS,THIS IS DUE TO THE ANIMAL'S RECOGNITION OF FOREIGN SPECIE ANTIGENS AND MOUNTING AN IMMUNOLOGICAL RESPONSE AGAINST THEM.

IT IS THEREFORE A FEATURE OF THIS PATENT THAT VIRUSES TO BE USED IN THE THERAPY OF CANCER SHOULD BE INITIALLY CULTURED ON IMMUNOGENIC MEDIA ,SUCH AS ADULT, PERHAPS EVEN NON-HUMAN SOURCES. IN THEORY,ALLOWING THE VIRUS TO CANNIBALISE ANTIGENIC STRUCTURES AND/OR GENETICS THAT EXPRESS ANTIGENIC STRUCTURES,ENABLES THEIR EXPRESSION TO MARK CANCER CELLS MORE STRONGLY, IE TO GIVE NON-SELF ANTIGENS AS WELL AS VIRAL ANTIGENS FOR THE IMMUNE SYSTEM TO

RESPOND AGAINST.

IT APPEARS THAT THE ABILITY OF CANCER TO MUTATE SO READILY IS AT

LEAST IN PART DUE TO ITS EXISTANCE IN AN OPEN SYSTEM WHERE IT CAN

READILY ABSORB AND INCORPORATE OTHER ORGANISMS;THESE ORGANISMS

MAY. IN TURN,ABSORB AND INCORPORATE CANCER-REL;ATED INFORMATION

WHICH MAY ALLOW THEM TO BE USED AS A VECTOR IN ITS PREPETUATION

AND/OR SPREAD. NUMEROUS STUDIES HAVE SHOWN THAT ORGANISMS ISOLATED

FROM CANCERS, WHEN INJECTED INTO ANIMALS. CAUSE GENERATION OF

CANCER IN ANIMAL (ALEXANDER, LIVINGSTON, SCOTT)

IN RESPONSE TO MANY INFECTIONS AT LEAST ONE AND USUALLY ALL THREE

OF THE FOLLOWING PHASES WILL BE DESCRIBED;

1-CANCER SHRINKAGE/LOSS OF DENSITY

2-CANCER SPREAD/ACCELLERATION OF GROWTH (ORGANISM OF INFECTION

STILL IDENTIFIABLE/CULTUREABLE)

3-AGGRAVATION OF DISEASE CONDITION/FAILURE OF HOST SYSTEM/DEATH.

FOR EVERY INFECTIOUS/OTHER ORGANISM TIME AND POTENTIALS MAY BE

ESTIMATED FOR ANTIDISEASE ACTIVITY/DISEASE SYNERGY.

INTERNAL OR EXTERNAL INTERVENTION ALONG ANY OF THESE PHASES MAY

DRASTICALLY EFFECT OUTCOME.

AS PREVIOUSLY DEFIED, THERE IS AN INITIAL PERIOD OF VIRAL SATURATION WHERE THE THERAPEUTIC OBJECTIVE IS TO ACCOMPLISH AS COMPLETE A SATURATION OF DISEASE AS POSSIBLE; HOPEFULLY WITH .AN ORGANISM WHICH HAS BEEN MADE HIGHLY SPECIFIC AND AGGRESSIVE.

THE POINT OF OPTIMAL EXPRESSION OCCURS WHERE ORGANISMS SATURATING THE DISEASED CELL HAVE CONVERTED IT INTO A VIRAL REPLICATION FACTORY AND ARE EXPRESSING ON THE CELL SURFACE AS WELL AS WITHIN CELL STRUCTURE . THIS PHASE OFFERS AN EXCELLENT WINDOW FOR

IMMUNOLOGICAL OR OTHER THERAPY.

HOWEVER, USUALLY BE A MORE AGGRESSIVE DISEASE UPON ITS RECURRENCE. DEPENDING ON WHETHER OR NOT THE ORGANISM HAS SURVIVED IN ACTIVE FORM,THE CANCER CELL MAY STILL PROVE TO BE SENSITIVE TO OTHER THERAPY (IF ORGANISM/S ARE STILL ACTIVE, THEY MAY BE TAXING THE CANCER CELL'S ABILITY TO COMPENSATE FOR FURTHER INSULTS SUCH AS CHEMOTHERAPY OR RADIOTHERAPY.

USING VIRUSES AS ADJUNCTS TO CONVENTIONAL THERAPY.

ADMINISTRATION CAN BE DIRECT (DOSE OF RECONSTITUTED PELLET AS USED FOR ANIMAL VACCINATION INJECTED DIRECTLY INTO TUMOUR. IN THE VICINITY OF THE TUMOUR AND/OR AT A DISTANT

SITE . INTRAMUSCULAR/INTRADERMAL AND SUBCUTANEOUS ROUTES WERE ALL TRIED.

PATIENT,38 PRESENTED WITH GRAPEFRUIT SIZED BREAST CANCER WITH ATTATCHMENT TO PECTORAL MUSCLES SDIMPLE SURGERY WAS NOT POSSIBLE AND CANCER HAD GROWN DESPITE CHEMOTHERAPY AND LOCALISED RADIATION.FOR THREE DAYS, DAILY INTRATUMOURAL APPLICATION OF THE PIGEON-POX VIRUS WAS DONE AT 3 SEPARATE SITES SURROUNDING THE TUMOUR PATIENT DEVELOPE AN AREA OF ERYTHEMA ABOUT 2CC DIAMETER AT SITE OF EACH INJECTION (MADE AT 3 CM DEPTH INTO TUMOUR WHICH WAS ATTATCHED TO SKIN)THE END OF THE THIRD DAY OF APPLICATION COULD BE NOTED AS OPTIMAL EXOGENOES SATURATION AS DEFINED IN THIS EXPERIMENT.12 ON DAY 12 PATIENT DEMONSTRATED A GENERAL REDDENING OF DISEASED BREAST AND A TEMPERATURE OF 104,THESE FEATURES MARK THE PERIOD OF OPTIMAL EXPRESSION;AT THIS TIME TUMOUR WAS

RADIOGRAPHICALLY PROVEN TO HAVE SHUNK BY 333 AND WAS NO LONGER

ATTATCHED TO MUSCLE OR TO SKIN. IT WAS EASILY REMOVED SURGICALLY. VIRUSES CAN THEREFORE BE USED AS DIRECT KILLING/NEUTRALISING AGENTS WHICH ,APPEAR USEFUL IN CAUSING AT LEAST A TEMPORARY REDUCTION IN TUMOUR BULK. IT ALSO APPEARS THAT EVEN UPON

RECURRENCE,CANCER CELLS WOULD OFTEN BE MORE SENSITIVE TO

THERAPIES THAT THEY WERE INITIALLY RESISTANT TO.

USE OF VIRUS AS THERAPY MAY BE DIRECT AND IN THREE PHASES

1-MAXIMUM SATURATION WHERE ACTION IS LARGELY BY DIRECT VIRAL

LYSIS THIS OCCURS WITHIN A FEW DAYS OF INFECTION

2-MAXIMUM EXPRESSION -THIS OCCURS WITHIN 1-3 WEEKS OF INFECTION

WITH THE VIRUSES MENTIONED AND VARIES WITH INCUBATION

PERIOD.MAXIMUM EXPRESSION OCCURS WHEN VIRUS EXPRESSES BEYOND

SATURATION AND OFTEN INVOLVES SIGNIFICANT VIRAEMIA.

THIS STAGE INVOLVES BOTH DIRECT VIRAL ACTIVITY AS WELL AS MAJOR

IMMUNOLOGICAL INVOLVEMENT;BY THIS TIME NOT ONLY ARE CELLULAR

IMMUNE MECHANISMS ALERTED BUT ANTIVIRAL ANTISERUM SHOULD ALSO BE

AT HIGH TITRE.ALL IMMUNOSTIMULATING AND/OR IMMUNE AUGMENTING

MECHANISMS CAN COME HEAVILY INTO PLAY HERE . PATENT THEREFORE

COVERS PRIOR VACCINATIONS, INTERFERON, INTERLEUKIN AND OTHER

LYMPHOKINES, IMMUNOSTIMULANTS AS WELL AS PASSIVE IMMUNISATION OF

HUMAN OR NON-HUMAN ORIGIN.

THIS RAISES THE TWO FIELDS OF TAGGING AND TASRGETIONG WHICH WILL

BE DISCUSSED LATER.

IT SHOULD BE NOTED THAT THE VIRUSES MENTIONED WILL CAUSE MARKED

RISE IN INTERFERON/INTERLEUKIN LEVELS.

3-REGRESSION/DEVELOPMENT OF SYNERGY /COEXISTANCE BETWEEN CANCER AND VIRUS.

THESE CELLS ARE OFTEN MORE VULNEREABLE TO

CHEMOTHERAPY/RADIOTHERAPY THAN THEIR PREDECESSORS AND ARE

FEATURES OF PATENT AS RELATE TO ABOVE CLASSIFICATION.

1-MAXIMUM SATURATION.

IN THEORY, THE MORE RAPID AND COMPLETE THE SATURATION. THE LESS THE

CHANCE OF DEVELOPING OF RESISTANCE AND THE GREATER THE

POSSIBILITY OF LONGTERM REMIBSION.

PATENT FEATURES IN DEVELOPMENT OF THERAPY;

1-DEVELOPMENT OF VIRAL VECTOR/VECTORS

A UNIQUE FEATURE OF THE PATENT IS THE DEVELOPMENT OF A VIRAL

THERAPY PROTOCOL INVOLVING MORE THAN ONE VIRUS; IN-VITRO DATA CAN

INDICATE WHICH VIRUS IS BEST SUITED IN WHICH ORDER;GENERALLY IT

IS THE VIRUS CAPABLE OF CAUSING THE GREATEST TUMOUR CELL

DESTRUCTION AS WELL AS CAPABLE OF SYNERGISING WITH SUBSEQUENT

VIRAL INFECTIONS. IT WOULD NOT BE WISE, FOR EXAMPLE, TO FIRST INFECT

WITH AN ORGANISM WHICH WILL IMMUNISE OR INTERFERE WITH SUBSEQUENT

THERAPEUTIC ORGANISMS.

IT IS A FEATURE OF THE PATENT TO SELECT FOR AND BREAD VIRUSES TO

BE HIGHLY ACTIVE AS WELL AS HIGHLY SPECIFIC FOR CANCER CELLS.THIS

CAN BE ACCOMPLISHED BY CO- CULTURE AND SELECTIVE WASHING . SOME SUCH MECHANISMS WILL NOW BE OUTLINED;

1-INCREASING VIRAL POOL-THIS MAY REFER TO SINGLE VIRUS AND/OR

VIRAL MIXTURE.

VIRUS IS PASSAGED THROUGH VARIOUS CELL TYPES IN ORDER TO CREATE A

LIBRARY.

THE FELINE PANLEUKOPENIA VIRUS,FOR EXAMPLE COULD BE INCUBATED IN

VARIOUS CANCER CELL LINES AS WELL AS NORMAL CELL LINES AS WELL AS

VARIOUS FRESH TISSUE AND CELL BIOPSIES.THIS WOULD THEN INDICATE

NOT ONLY WHICH TISSUES FORM TARGETS FOR THE VIRUS BUT ALSO THE

AGGRESSIVENESS AND RATE OF GROWTH IN EACH.TESTING CANCER CELL

LINES AND BIOPSIES IS IMPORTANT AS REGARDLESS OF WHAT IS KNOWN OF VIRAL BEHAVIOUR AND FAVOURED TARGET CELL TYPE;IT IS LIKELY THAT CANCER CELLS OF VASTLY DIFFERENT TYPES MAY ALSO BE VULNEREABLE.

TESTING THE AFFINITY OF THESE FOR THE CANCER TO BE TARGETED MAY BE ACHIEVED IN VITRO OR IN-VIVO.IN-VIVO TESTING MAY BE

PHYSICAL/CHEMICAL/BIOLOGICAL MANIPULATION,ALONE OR AS PART OF LBS CONTAINING OTHER VIRUSES(THESE ALSO PERHAPS EXPANDED)CAN BE INJECTED OR OTHERWISE ADMINISTERED TO ANIMALS BEARING AN IMPLANT OF THE TARGET TISSUE TO BE ASESSED.ANIMAL CHOSEN WOULD BE TESTED TO DEMONSTRATE NO PRIOR EXPOSURE/INHERENT RESISTANCE TO VIRUSES BEING TESTED(AS WITH PENICILLIUM LBS);SAMPLES OF THE TUMOUR IMPLANT ARE REMOVED AT VARIOUS INTERVALS OVER A TWO WEEK PERIOD

(IT IS POSSIBLE TO USE NUDE MICE AND/OR SKID RATS FOR TESTING WITHOUT THE INCUMBERENCE OF THE IMMUNE SYSTEM,THIS

WILL,HOWEVER,OFTEN RESULT IN ANIMAL DEATH.)

A PROTOCOL WOULD BE AT 6 HOURS, 12 HOURS THEN DAILY FOLLOWING ORAL,RECTAL. SUBLINGUAL , INTRADERMAL, SUBCUTASNEOUS, INTRAMUSCULAR ADMINISTRATION. FOLLOWING INTRAVENOUS APPLICATION,SAMPLES MAY BE TAKEN EARLIER,PERHAPS AT 30 MINUTES THEN AT DAILY INTERVALS.

THE TEST CAN BE REPEATED FOR EACH STAGE OF VIRAL INFECTION;AS IN FOLLOWING FPLV INFECTION,OTHER VIRUSES CAN THEN BE TESTED IN THE SAME AS ABOVE MANNER AGAINST THE INFECTED CANCER CELLS TO INDICATE OPTIMAL SECOND STAGE VIRUS TO BE USED.TEST CELLS COULD BE FROM IN-VITRO OR IN-VIVO CULTURES,FROM PATIENT SAMPLES POST TREATMENT.

VIRAL AFFINITY FOR TARGET TISSUE MAY BE GIVEN AND/OR

AMPLIFIED/AUGMENTED BY REPEATED PASSAGE THROUGH A TARGET . PASSAGE OF VIRUS THROUGH TARGET CELLS IS A COMMONLY USED METHOD IN VIRAL RESEARCH; EXPANDING THE VIRAL LBS AND THE USE OF MULTIPLE VIRUSES IN THERAPY ARE UNIQUE IN THIS PATENT . A FURTHER PROBLEM WITH ATTEMPTS TO REPEATEDLY PASSAGE VIRUS THROUGH CANCER CELLS INVOLVES THE PREVIOUSLY DESCRIBED PHENOMENON OF VIRAL/CANCER ADAPTATION WHERE FOLLOWING A SHORT REMISSION,LEUKEMIA CELLS RECURRED WITH VACUOLATION SUGGESTING VIRAL ACTIVITY PRESENT;VIRUS COULD BE RECOVERED FROM LKEUKEMIA CELLS RECURRING AFTER INITIAL REMISSION.THIS SUGGESTS THAT REPEATED PASSAGING IN-VITRO MAY ALSO RESULT IN LOSS OF VIRULENCE AND EFFECTIVENESS.

IT IS ALSO TRUE THAT TWO UNIQUE PHENOMENON HAVE BEEN OBSERVED BY THE INVENTOR;VIRUS(S) CO-EXISTING IN CANCER CELLS MAY BE

REACTIVATED INTO VIRULENT STATE AND CELLS MAY BE REINFECTED BY THE SAME VIRUS.FPLV,UPON REPEAT CHALLANGE OF LEUKEMIA CELLS CARRYING FPLV MAY REINFECT THE CANCER,ALTERNATIVELY,REACTIVATION MAY OCCUR.REACTIVATION OF VIRAL VIRULANCE MAY ALSO BE

ACCOMPLISHED BY HEAT-KILLED VACCINE PREPARATIONS OF THE SAME VIRUS.FOLLOWING THE PHASE OF TUMOUR RECURRENCE THEREFORE,AT LEAST PARTIAL INHIBITION OF DISEASE MAY BE ACCOMPLISHED BY REACTIVATION OF VIRAL AGENT INFECTING THE CELL.

ANOTHER UNIQUE FEATURE OF THIS PATENT THEREFORE IS THE REACTIVATION OF VIRAL AGENT . A CASE OF CHRONIC MYELOID LEUKEMIA IN A 38 YEAR OLD MAN WAS PUT INTO REMISSION BY IDENTICAL PROTOCOL TO THAT USED IN THE CASE OF CHRONIC LYMPHOCYTIC LEUKEMIA PREVIOUSLY DESCRIBED,PATIENT HAD BEEN SUFFERING FROM THE DISEASE FOR THREE YEARS AND WAS NO LONGER RESPONDING TO CHEMOTHERAPY.WBC COUNT 53,000 AT BASELINE,-FOLLOWING FPLV INNOCULATION, PATIENT WAS IN REMISSION THREE WEEKS LATER,LEUKEMIA RECURRED WITHIN TWO

MONTHS.CYTOPLASMIC INCLUSION BODIES CHARACTERISTIC OF FPLV COULD BE SEEN IN ALL LEUKEMIA CELLS UPON RECURRENCE OF DISEASE;COINCUBATION OF RECURRED LEUKEMIA CELL LYSATES WITH OTHER LEUKEMIA CELLS/WHITE BLOOD CELLS SHOWED LITTLE TO NO VIRAL ACTIVITY.ADMINISTRATION DAILY BY INTRADERMAL INJECTION OF HEAT- KILLED FPLV, CAUSED REACTIVATION OF VIRUS AND MARKED DROP IN LEUKEMIC CELL COUNT. (COUNT PRIOR TO THERAPY BY HEAT-KILLED

PREPARATION; 38 , 000 , COUNT DROPPED WITHIN 24 HOURS TO 35 , 000 , THEN 28,000 WITHIN 48 HOURS; AT THE END OF 1 WEEK OF INJECTING 1CC OF HEAT-KILLED FPLV,COUNT DROPPED TO 18, 000. IT REMAINED STABLE FOR SEVERAL DAYS BUT THEN BEGAN TO RISE AGAIN FOLLOWING TWO WEEKS OF THERAPY WITH HEAT KILLED FPLV- (PREPARATION WAS VETERINARY AND INJECTED AS ICC AMPOULE).

RECHALLANGE AT THIS POINT WITH FPLV LIVE VIRUS ASGAIN CAUSED DROP IN COUNT. IN VITRO ASSAY DEMONSTRATED THAT FPLV LYTIC ACTIVITY COULD STILL BE DETECTED DESPITE SYNERGY ARISING WITH PRIOR VACCINATION, AGAIN THERAPEUTIC EFFECT WAS SHORT- LIVED. AT A CUNT OF 60,000WBC 4 MONTHS AFTER COMMENCING THERAPY;HYDROXYUREA WAS ADMINISTERED(PRIOR DOSEAGE OF 6 TABLETS DAILY FOR THREE DAYS A WEEK WAS INEFFECTIVE AT PRESENTATION BUT NOW DISPLAYED SOME ACTIVITY); COUNT WAS STABLE AT 45,0006 WEEKS LATER; HYDROXYUREA WAS DISCONTINUED FOR A WEEK(TO ALLOW FOR SOME AUGMENTATION OF IMMUNOLOGICAL RESPONSE.PATIENT WAS THEN TREATED WITH CANINE DISTEMPER VIRUS AS PER PRIOR PROTOCOL; REMISSION FOLLOWED WITHIN TWO WEEKS AND LASTED FOR EIGHT WEEKS. AT THE TIME OF

RECURRANCE, LEUKEMIA CELLS DISPLAYED BOTH THE CYTOPLASMIC

INCLUSION BODIES CHARACTERISTIC OF FPLV AS WELL AS INTRANUCLEAR VACUOLATION CHARACTERISTIC OF CDTV, CELL LYSATES SHOWED LITTLE TO NO ACTIVITY OF VIRAL PARTICLES WHEN TESTED AGAINST UNINFECTED LEUKEMIA CELLS.THE RECURRENCE OF LEUKEMIA WAS MARKED BY GREATER LEUKEMIA GROWTH RATE. WBC COUNT ROSE FROM 50,000 TO 145,000 WITHIN TWO WEEKS. INTERESTINGLY, HEAT KILLED FPLV VACCINE ADMINISTERED AS PREVIOUSLY WAS CAPABLE OF RESTORING BOTH FPLV AND CDTV VIRULENCE AND FOLLOWING A WEEK OF VACCINATION, COUNT DROPPED TO 80,000.

PATIENT REFUSED CHEMOTHERAPY OFFERS AT THIS STAGE AND WISHED TO CONTINUE VIRAL THERAPY. THIRD STAGE VIRAL THERAPY INVOLVED THE USE OF THE FOWL POX VACCINE.VACCINE WAS APPLIED AS PER PREVIOUS PROTOCOLS; THERE WAS NO FURTHER DROP IN WHITE CELL COUNTS.

COUNT REMAINED 80-90,000 FOR 4 WEEKS

PERIOD. FOLLOWUP FOR A FURTHER 4 MONTHS SHOWED GOOD DISEASE

CONTROL AT THIS DOSE.

THIS CASE CARRIED OUT AT AN EXPERIMENTAL RESEARCH INSTITUTE WITH FULL PATIENT AUTHORISATION, DEMONSTRATED A THREE STAGE THRESHOLD PRIOR TO DRAMATIC RETURN TO LEUKEMIA SENSITIVITY TO THERAPY. IT ALSO DEMONSTRATED THE ABILITY TO REACTIVATE TWO UNRELATED VIRUSES WITH HEAT-KILLED FRACTIONS OF ONE;THIS SUGGESTS A COMMON

IT SHOULD BE NOTED THAT THESE OBSERVATIONS ARE ON LIMITED VIRAL TYPES;OTHERS MAY BE CAPABLE OF MORE EFFECTIVE ANTI-CANCER

ABILITIES.

IT SHOULD ALSO BE NOTED THAT IMMUNE RESPONSES WHICH PROTECT NORMAL CELLS FROM VIRAL INPECTION(PARTICULARLY,MULTIPLE VIRAL INFECTIONS) DO NOT SEEM TO FUNCTION IN CANCER CELLS.THIS IS USEFUL KNOWLEDGE AS IT MAY BE POSSIBLE TO CHOOSE SPECIFICITY BY USING A VIRUS TO WHICH THE BODY IS ALREADY IMMUNE; SUCH AS MEASLES OR MUMPS . ANTISERA AS WELL AS OTHER SYSTEMS WOULD PREVENT NORMAL CELLS FROM BEING REINFECTED.WHEREAS CANCER CELLS WOULD BE EASIER TO INFECT.

80 YEAR OLD PATIENT SUFFERING FROM CHRONIC LYMPHOCYTIC LEUKEMIA WAS VACCINATED WITH THE MUMPS VACCINE AFTER IT HAD BEEN INCUBATED WITH HIS CELLS IN THE MANNER PREVIOUSLY DESCRIBED. WBC COUNT AT START OF THERAPY WAS 86,000; PATIENT ACHIEVED REMISSION WITHIN 2 WEEKS, STILL DISEASE-FREE AT 2 YEAR FOLLOWUP.

INJECTION OF MEASLES VACCINES AND MUMPS VACCINES INTO PATIENTS SUFFERING FROM VARIOUS CANCERS RANGING FROM BTRAIN, BREAST AND BOWEL TO LEUKEMIA, LYMPHOMA AND OTHERS RESAULKTED IN MINIMAL TO NO EFFICACY. IT IS UNLIKELY THAT MAXIMUM SATURATION WAS EVER ACHIEVED AS IMMUNE RESPONSE MEMORY WOULD ELIMINATE VIRUS PRIOR TO REACHING ITS TARGET. EVEN DIRECT INTRATUMOUR INJECTION MET WITH LITTLE EFFICACY. THIS COULD ALSO HAVE BEEN DUE TO THE ATTENUATED FORM OF VIRUS AVAILABLE IN COMMERCIAL VACCINES(PRIOR STUDIES IN THE EARLY SEVENTIES SHOWED MARKED SOLID TUMOUR, SHRINKAGE FOLLOWING

INNOCULATION OF VIRULENT FORM OF MUMPS INTO THE TUMOURS.

IN THE CASES TESTED BY INVENTOR, THERE NEVER APPEARED TO BE A STAGE OF MAXIMUM EXPRESSION FOLLOWING DIRECT INNOCULATION OF VACCINE . THE LEUKEMIA CASE, HOWEVER, WAS TREATED WITH PATIENTS LEUKEMIA CELLS WHICH HAD ABSORBED THE VIRUS VAS PER THE TEACHINGS OF THIS PATENT.VIRAL LOAD WAS THEREFORE AMPLIFIED; THIS PROCESS ALSO APPEARS TO BE MORE EFFICIENT IN SPREADING THERAPY AMONGST DISEASED CELLS THAN SIMPLE APPLICATION OF VIRUS.

2-MAXIMAL EXPRESSION.

ADMIN-TAGGED CELLS ETC

PROTECT OTHER , NORMAL CELLS BYVACCINE/OTHER V, ANTISERA

TAILOR FOR PATIENT BLOOD AND IMMUNITY

REACTIVATION USING DEAD V

AS CARRIER

AS INHIB/DIRECT ATTACK

AS TAG

TARGET1

STAGE OF MAXIMUM EXPRESSION FOLLOWING DIRECT INNOCULATION OF VACCINE.THE LEUKEMIA CASE,HOWEVER,WAS TREATED WITH PATIENTS LEUKEMIA CELLS WHICH HAD ABSORBED THE VIRUS VAS PER THE TEACHINGS OF THIS PATENT . VIRAL LOAD WAS THEREFORE AMPLIFIED ; THIS PROCESS ALSO APPEARS TO BE MORE EFFICIENT IN SPREADING THERAPY AMONGST DISEASED CELLS THAN SIMPLE APPLICATION OF VIRUS.

PATENT TEACHINGS FOR MAXIMAL SATURATION

1-SELECT VIRUS/GROUP OF VIRUSES WITH HIGH AFFINITY FOR TARGET CELL.

2-CULTURE TO DEVELOP AFFINITY BUT NOT ADAPTATION.

IN MULTIPHASIC THERAPY INVENTOR SPEAKS OF REPEATED CHALLANGE OF THERAPEUTIC ORGANISM WITH RESISTANT TARGET . WE HAVE SPOKEN HERE OF THERAPY WITH VARIOUS STAGES CORRESPONDING TO THE USE OF VARIOUS VIRAL AGENTS .THE PROBLEM WITH USING MULTIPHASIC THERAPY HERE IS THAT THE TARGET HAS NOT REALLY DEVELOPED RESISTANCE BUT, RATHER , SYNERGY WITH THERAPEUTIC AGENT . THERE IS THE FURTHER RISK THAT CO-INCUBATION WILL MORE LIKELY RESULT IN ATTENUATION AND ADAPTATION OF VIRUS.

IN CASES WHERE THE CANCER RECURRS WITHOUT PRESENCE OF VIRUS . PHASE THERAPY IS EASY AS ONE WOULD THEN SEARCH FOR VIRAL MUTATION OR OTHER VARIATION OF THE SAME VIRUS WHICH COULD RE-INFECT THE TARGET CELL,ALTERNATIVELY ONE CAN TRY TO TRIGGER REACTIVATION OF ATTENUATED VIRUS OR SEARCH FOR VIRAL VARIANT WHICH CAN REINFECT OR INFECT RESISTANT CELL CLONES . DIFFICULTY HERE ARISES AS. UNLIKE WITH MANY HIGHER ORGANISMS SUCH AS BACTERIA AND FUNGII,VIRAL CO-INCUBATION WITH CANCER CELLS TENDS TO RESULT IN ATTENUATION AND ADAPTATION OF VIRUS AND TARGET CELLS

ANIMAL)TISSUE. THEREFORE WE HAVE TWO SEPARATE SITUATIONS IN DEVELOPMENT OF MULTIPHASED THERAPY;ONE INVOLVES EXPOSING CANCER CELLS TO A VIRUS WHERE THE VIRUS DOE6 NOT ACHIEVE TOTAL CELL DESTRUCTION, IE WHERE RESISTANT CELLS ARE PRESENT AND/OR WHERE DI

KILL VIRUS THEN REINFECT 2-MAXIMAL EXPRESSION.

THE PREVIOUSLY DISCUSSED CASE OF CLL,FOR EXAMPLE HAS BEEN

TOTAL CANCER CELL DESTRUCTION OCCURS IN VITRO USING ONLY THESE VIRAL AGENTS,IT APPEARS THAT A MECHANISM OTHER THAN CELLULAR REGENERATION IS RESPONSIBLE FOR CANCER CELL RECURRENCE.

PATENT

Inventor: Samir Chachoua, M.D.

Filed:

U.S. Claim:

International Claim:

Field of Search: (Use patent nos.)

References Cited:

Abstract

This invention concerns a totally new conceptual therapy for preventing, diagnosing, treating, ameliorating, placing into remission and curing disease and disease-mimicking conditions which assault humans and animals physically, mentally, and emotionally either through infection, genetics, biology, alteration of RDA/DNA, radiation and/or nucleic or chromosomal damage. It utilizes a heretofore unknown and unused arm of the immune system with a new technology and it provides for the use of disease-provoking organisms (fungi, parasites, microbes, viruses, anti-biotics and particles recently discovered which are smaller than viruses) which, with other particles, cells, living or dead forms, extracts, sera, anti-sera, phages, concoctions, infusions, mixtures, broths, etc. cause remissions. The total concept of the new therapy embraces three aspects of healing: organisms and immunology; electromagnetic energy, mechanical and other electrical devices for healing and surgenics, and a new science involving advanced genetics, Nemesis organisms, and immunology called Surgenics. This can be expressed by the ensuing diagram under whose grid or umbrella are embodied all the components of this science of new healing.

A. Organisms and Immunology

B. Electromagnetic Energy, Mechanical, and other Electrical

Devices For Healing

C. Surgenics: A New Science Involving Advanced Genetics,

Nemesis Organisms, and Immunology

No. of claims

No of diagrams No. of slides, photos, etc.

I.

Name of Invention

Induced Remission Therapy or Nemesis Extracts Therapy

2.

Background of Invention

Modern Medicine dates from Pasteur's germ theory of the last century which holds that germs alone are the causative factor of disease. As a result, allopathic medicine was formulated from chemicals and drugs to counteract what has been perceived as the cause of all human and animal diseases. Many chemically-based therapies for tumorous conditions or other diseases ( degenerative, auto-immune, infectious, or genetic) involve the use of anti-mitotic and anti-biotic drugs such as adriamycin, vincristine, cisplatin, daunomycin and methotrexat which all have strong undesirable side-effects on the normal cells of the patient. These side effect include hair loss, nausea, vomiting, fatigue, weakness, sterility, damage to the kidneys and heart and can impact severely the body's immune system. Immuno-deficient diseases are thought to be caused by microbes so well camouflaged that the immune system has difficulty distinguishing these microbes from normal tissue components which the disease attacks. Physicians have attempted to overcome this deficiency by using immuno-suppressive agents to keep the body from being flooded with infected T-cells, as in AIDS.

There is a need, therefore, for anti-disease and anti-cancer agents which have greater specificity in their targeting capability without damaging normal cells such as treatments which are capable of inducing a broad range of different elements in the body's total immune system (e.g. neutrophils, eosinophils, basophils, etc.) into action which may not be as susceptible to the targeted infection. Also needed are methods effective in eliminating less massive, non-tumorous pathogenic cellular materials, such as independent microorganisms contained in bodily fluids, tissues, and muscles.

One significant advantage of the present invention over such non-living therapeutic systems is the ability to counter quickly the transformations made by therapeutic agents. A related dillema occurs when a therapy will center on surgery, as in bone marrow transplants, and work for a time before the cancer-causing agents remaining in the body transform the bone marrow into cancerous tissue. Chief rival to Pasteur's germ theory was a scientist equally famaous at another university named Antoine Bechamps who held that the germ theory was erroneous and that cells had within them the causative factors of disease, that they were not extrinsic necessarily.

The present inventor, on the basis of the invention of this technology, feels that every disease has various causative factors, many of which can be linked to a micro-organism. Some earlier researchers, however, have linked only one causative organism . Among these have been, in recent years, Dr. John E. Gregory (Pathogenesis of Cancer, 1955), the late Dr. Virgina Livingston (The Conquest of Cancer. 1984) and Dr. Alan Cantwell's The Cancer Microbe. 1990).

Other physicians for the last several hundred years, however, have made similar observations and based their successwful treatment of diseases upon these observations. They have noticed an antagonistic action between certain infections and cancer.

Over two hundred years ago, a French physician, Dr. Didot, observed that prostitutes infected with syphilis suffered fewer cancers than the general population. Reasoning that syphilis must exert an anti-cancer effect, he treated several cancer patients successfully by inoculating them with syphilis. The Academy of Medicine at Lyons (1773) spoke of cancer as an infection and sixty years later (1836) Dr. Johannes Mueller (Germany) described the pathology of the infection. Professor Antoine Bechamps (1816-1908) felt disease was born of us and was in us. Campbell De Morgan reported in The Lancet (15 July 1871) the contagiousness of cancer. Dr. Crisp, speaking 17 March 1874 at the Pathological Society of London said it was "positively a parasitic disease." Dr. Ernst Scheurien in 1887 discovered the organism he thought to be the cause of cancer when he isolated a bacillus from a breast cancer. Dr. Guelliot of Reims in Etiology and Parthogenesis of Cancer observed by the end of the century that the transmission of cancer was contagious.

More scientific evidence was forthcoming: Erwin F. Smith in the Journal of Cancer Research (April 1916) reported the discovery of Bacterium tumerfaciens. The German scientists, Blumenthal, Auler et al. writing in Zeitschrift Fluer Krebs Forschung (26 August 1924) reported the results of inoculation that had been made with the same cancerous materials into plants, mice and rats. All developed tumors.

Dr. James Young (reported in The British Medical Journal. 25 June 1921) how he had isolated the life cycle of a human carcinoma. A year later he reported isolating the same organism in three cases of leukemia. Young's work was corroborated by Arthur B. and Sydney M. Smith of Cambridge. These doctors made vaccines from the organism and tried them on forty cases of cancer with great success.

In Surgery, Gynecology and Obstetrics (March 1925), Dr. Coley expressed the belief that the parasitic theory was the only one that offered hope of controlling the disease. He cultured bacteria from a skin infection acquired by a patient just prior to his undergoing a miraculous remission. Dr. Coley used these bacteria as the basis for one of the most successful anti-tumor vaccine therapy programs ever instituted. He used extracts of streptococcus pyogenes and serratia maracescens to mimic the effect of erysipelas. Thus, several solid tumors disappeared in terminal patients. Many others followed with variations of Coley's toxins, as well as the utilization of many other bacteria and their extracts, including gonόccocci and treponema.

Other researchers such as Deaken and Glover in America, and Issels in Germany, along with many others have reported varying rates of success with cancer vaccines, yet no systematic investigation of these claims have ever been made by any medical research facility or governmental health agency with the sole exception of the massive vaccination of millions of infants in China during the last decade with BCG. The result has been that the incidence of leukemia was astronomically reduced. This report, although made with the joint efforts of physicians from a distinguished medical institution in Chicago, has never been given any publicity in the United States. And greater numbers of children in America than ever before are coming down with leukemia, (q.v. H. Christine Reilly, Microbiology and Cancer Therapy: a. Review, 1953).

It is the inventor's contention that there exists for each disease associated organism a naturally occurring cytotoxic or "Nemeis" organism which is capable of substantially inhibiting morbid effects of the particular disease without preciptating significant pejorative side effects. The inventor has observed three naturally occurring phenomena which affect disease cures and are primary sources for Nemesis organisms. These are:

1. Spontaneous remission;

2. Organ and Species resistance; and

3. Cellular redifferentiation.

Connell (Canadian M. A. J. 33:363-370, 1935) reported the first article describing an attempt to instill specific anti-cancer activity into a bacterial extract by first incubating the bacteria with cancer tissue. This publication provided encouraging data related to clostridium hystolyticum. In 1947 the same organism was used in an attempt to mark cancer cells with bacterial antigens which were then treated successfully with an antitoxin (q.v. Parker et al., Proc Soc Exper Biol and Med. 66:461-467, 1947). More recently, Volker Schirrmacher disclosed in his United States patent (# 5,273,745 and F.R.G. patent # 3806565), a similar technique in which inactivated autologous tumor cells are marked by incubating the same with similarly inactivated Newcastle Disease Virus (NDV) in a serum-free medium. Because of the natural ability of the NDV to activate tumor-specific T- cells, the number of such T-cells which are ultimately activated against the tumor is sufficiently greater than the number of such cells the tumor itself is able to activate. A particular problem which Schirrmacher's research attempts to address is the well-known capability of a cancer-type malignancy to hide itself from the defenses of an immune system. Such concealment is accomplished via the stimulation by the cancer of only a small and highly specific immune response which results in the precipitation of various blocking anti-bodies that coat the diseased cells with structures from the patient's own body. Unfortunately, Schirrmacher's research shows how to increase T-cells but such cells comoprise less than one per cent of the body's total known immune system. Thus, this aforementioned patent fails to include a greater portion of a body's defense system against the target disease, and it does not add the benefits of a live micro-organism which demonstrates an antagonistic behavior toward the tumor, as does this invention.

It is well-known that certain organs and systems of the body, such as the spleen, small intestine and muscular system, are rarely infected by metastatic diseases which readily encroach upon more susceptible bodily organs and systems, such as the lungs, liver and skeletal system, (q.v. Lewisohn et al. Am. J. Pathol. 17:251-260, 1941; and Chachoua et al., Clinical Oncology gociety of Australia Precis. 1981). This indicates either an inherent resistance within the uninvolved tissue or the presence of a powerful local immune system operating within the unaffected tissue. It may also be indicative of a heretofore unknown presence of a particular micro-organism which may or may not be a natural part of the host organ, but which is antagonistic toward such metatastic diseases. By utilizing the method of the present invention, such metatastic resistance of these bodily organs, tissues and micro-organisms may be used in the production of disease- specific therapeutic agents for use in other, more susceptible areas of the body.

it is further known that certain non-microscopic, non-human life forms are resistant to the ravages of cancer and other various diseases. Although such knowledge and research appear to be promising, great diffulty has been found generally in using such anti-disease sera extracted from animals. The limitation of this promising technique has lain usually in the non-specificity of anti-sera developed from such non-human life forms, especially with the tendency of such sera to include high levels of an anti-human factor which has often proven to be quite toxic.

In regard to cellular redifferentiation, many reports exist of cases in which malignant tumors have suddenly redifferentiated into normal cells. Such reports have noted the association of the redifferentiating tumors with some other abnormal occurrence within the body. For example, such redifferentiation has been reported in leukemia after the occurrence of a staphyloccal infection. Redifferentiation of cancer cells has also been found in tumor masses which were placed in proximity to a developing notochord, or grafted onto a salamander's regenerating stump. The ability of such diverse situations to cause redifferentiaon in various tumor types strongly suggests that cancer cells are not irreversible, but rather, under certain situations, can be returned to a normal state (q.v. Laclau, Compt . Rend. Soc. de Biol. 92:840-842, 1925; Nevorojkin, Vestnik Roentαenol Radiol. 15:344-345, 1935; Maisin, Compt. Rend. Soc. de Biol. 127:1477-1478, 1938; Protti, Tumori 22:222-229, 1948; Protti, Tumori 24:14-24, 1950; Lewisohn, Science 94:70-71, 1941; Lewisohn, Cancer Research 1:799-8066, 1941; and Suiguira, AAAS Approaches to Tumor Chemotherapy. 208-213, 1947).

Basically, all current research has, for the most part, an inappropriate immunological response because vaccines, sera, chemo and all other therapies stimulate an inappropriate immune response due to threshold phenomona, abundance of causative agents which mask themselves within the cells, and activation of partial or miniscule immune responses as well as cell resistance to the therapy and the destruction of normal cells and diseased ones. This new invention addresses itself to all these factors which are overcome by the technology described.

3.

Description of Invention

There is a basic library of disease organisms which can be raised against any bacterium, fungus, virus, parasite, phage, or yeast and which has an affinity for normal tissue. When one vaccinates against the organism causing the disease, the host's immunity against the disease-producing organism is raised. Thus the patent targets three things within the superstructure of the six aspects of the disease and disease- fighting mechanisms: the disease cell, the cause of the diseased cell; everything that is antagonistic to the diseased cell; raising the organisms to be specific against the diseased cells; and organisms specific against all causative and all synergistic organisms. Thus, this invention covers AIDS, cancer, pathogenic angiogenesis and vascularizion, systematic lupus erythromatosis, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, Alzheimer's disease, muscular distrophy, asthma, chronic fatigue syndrome, ALS, ITP. This patent covers all currently known diseases and all diseases which may develop in the future due to external facters such as environmental pollution; radiation, chemical and or biological poisoning, etc. Whether the disease is caused by an infectious agent or an opportunistic infectious agent, autoimmune or genetic, it is covered by this invention. In fact, new diseases such as Eboli and some that have not even surfaced yet are curable with the new technology covered by this invention. There is no disease that cannot be eradicated now or in the future with this invention.

This new technology can be expressed by the ensuing data and descriptions.

This system defines the cause of disease, the use of different therapeutic agents (organisms, extracts, parts thereof), regulates reroutes until efficient immunological mechanisms and general immune reactions can be developed. This can be accomplished with red blood cells, for example, an original discovery inherent in this invention which can act as a vector or new immune system that can generate totally new enveloping immune responses which are effective in combatting all existing and future auto-immune, infectious degenerative, genetic diseases and cancers. The red blood cell is a cell without a nucleus so it becomes a vector expressing the biological cell and makes an ideal vessel for physical, biological and chemical agents that can modify the cell function. For example, it can become an alternate immune system and can be used in binding immunabilty using bacterial, phage, biological and chemical extracts. (See illustrations pictures and text accompanying illustrations, cite p. number) This is the first use ever of this newly identified immune system to fight cancer and all diseases. It is this inventor's sole discovery.

The differences between previous attempts to use viruses, bacteria, phages, antibiotics, fungi, yeasts, and sera and this new technology lay in the expression of various categories (as seen below) and their logical progression through a library of disease organisms. This has never before been done and, as such, creates an entirely new branch of medical science called, as previously stated, "Induced Remission Therapy," or "Nemesis Extracts Therapy."

This invention provides for the following:

A. A. method for creating disease-specific therapeutic agents from organisms, extracts or parts thereof (which are viral, microbial, parasitic, fungal, bacterial, phagial or antibiotic) and whose origin are animal, chemical, botanical, biological, organic or inorganic substances, elemental, molecular, metalurgical, electro-magnetic machines with varying frequencies and coils, (Sam, in this category we can include all the machines so as not to have a separate set of patents) and which will destroy the cause of disease or render it harmless;

1. organisms and Immunology

2. Electromagnetic Energy, Mechanical, and other Electrical

3. Devices For Healing

G.Surgenics: A New Science Involving Advanced Genetics,

Nemesis Organisms, and Immunology

D. Disease

This category includes all conditions which cause insult to the body so that it exhibits abnormal manifestations of ailments, diseases, etc. either physical, emotional or mental. Clinical studies using microbial extracts in the treatment of cancer have usually demonstrated the expected elevations in levels of Interferon, Interleukin,, and T-cells. A perhaps unanticipated finding of this study is that red blood cells may play an active role in the immunological defense system of man.

Certain microbial extracts are capable of causing a morphological change in the appearance of the red blood cells. These alterations may be functional and may assist in movement and in perforation of the cancer cell membrane.

A phenomenon of considerable interest, which may accompany these morpholoical changes, is that of cell membrane fusion. It is important to note at this juncture that the morphological changes occurring in these red blood cells are temporary, and often resolved from within a few hours to a few days. The cellular fusion, however, may be a more permanent condition.

E. Organisms Causing Disease

The library of organisms, listed below, are found in all diseases which are chronic, auto-immune, all inflammatory diseases, cardio-vascular diseases, infectious, genetic diseases and all cancers and cell-proliferative diseases.

1. virus

When disruption of cancer cells (physical, chemical or biolgoical) is such that the cancer cells are fragmented, they can then be passed through a micro-filter which will only pass viruses as a cell wall-deficient form. Placing this sterile "filtrate" into a culture medium will allow some cell walldeficient viruses to reconstitute their walls and as cell walldeficient viruses can usually only exist intracellularly; then these viruses are likely to be causa tive viruses which reconstitute with .2 micron filter.

2. bacterium

a. When disruption of cancer cells (physical, chemical or biological) is such that cancer cells are fragmented, they can then be passed through a micro filter which will only pass bacteria as a cell wall- deficient form. Placing this sterile "filtrate" into a culture medium will allow some cell wall- deficient bacteria to reconstitute their walls and as cell wall-deficient bacteia can usually only exist intracellularly. Then these bacteria are likely to be causative bacteria which recostitutes with a .2 micron filter.

3. fungus When disruption of cancer cells (physical, chemical or biolgoical) is such that the cancer cells are fragmented, they can then be passed through a micro-filter which will pass fungi as a cell wall-deficient form. Placing this sterile "filtrate" into a culture medium will allow some cell wall-deficient fungi to reconstitute their walls and as cell wall-deficient fungi can usually only exist intracellularly; then these fungi are likely to be caustive fungi which reconstitute with .2 micron filter.

4. parasite

5. yeast When disruption of cancer cells (physical, chemical or biolgoical) is such that the cancer cells are fragmented, they can then be passed through a micro-filter which will pass yeast as a cell wall-deficient form. Placing this sterile "filtrate" into a culture medium will allow some cell wall-deficient yeasts to reconstitute their walls and as cell wall- deficient yeasts can usually only exist intracellularly; then these yeasts are likely to be causative yeasts which reconstitute with .2 micron filter.

6. phage

When disruption of cancer cells (physical, chemical or biolgoical) is such that the cancer cells are fragmented, they can then be passed through a micro filter. When irradiated, bathed in ultra-violet light or treated with phenol, a phage can be raised which will pass as a cell wall-deficient form. Placing this sterile "filtrate" into a culture medium will allow some cell wall- deficient phages to reconstitute their walls and as cell wall- deficient phages can usually only exist intracellularly; then these phages are likely to be causative phages which reconstitute with .2 micron filter. 7. antibiotics

Synergistic (organisms which live within a host organism in a beneficial relationship to a targeted disease.)

D. Disease

1. Diagnosis:

Samples of a patient's blood or diseased tissue may be tested in vitro against a library of prior-found organisms. Any precipitation may indicate the presence of free-floating antigens associated with the disease, and further indicate thereby the potential association between such disease and the tested organism. Also in vitro testing of antibodies from the patient's immune system may indicate how any of the patient's normal antibodies may be useful as a disease-associated organism against the targeted disease. Very low titers from the in vitro tests of the patient's immune system components may indicate no prior exposure of the immune system components to the disease, or a suppressed immune system with regard to a particular agent, which agent should then be considered a possible synergistic or causative organism. Such indication would be confirmed with significant antigen titers in serum. Conversely, high titers of antibody or dermal reactivity may indicate previous exposure which may again be indicative of a possble synergistic or causative organism. Again, confirmation of this would be given by the occurrence of significant antigen titers in serum. In tests where there is a low antigen titer, a high reactivity to a particular organism or organism fraction may indicate the presence of a very useful tagging or immuno-stimulating organism. Titers of antibodies or antigens of any of the causative synergistic or otherwise antagonistic organisms may also indicate the presence or susceptibilty of the patient to another disease which is associated with such organism. Thus the spectrum search of the patient's body may be further useful as a method for monitoring the potential threat to the patient by a previously undiagnosed disease. Such a spectrum search may be used, therefore, to diagnose the presence of various diseases in a patient's body which diseases can be subsequently vaccinated against by use of various organisms in the existing library of known Nemesis organisms.

E. Organisms Causing Disease

Should a first organism antagonistic toward a secnd organism be found in slight amounts in a patient's body having a target disease, and the second organism is susceptible to various components of the body's immune system, an affnity frequencies transmitted from the antenna as well as those generated from the unit itself. The shielding unit can be a complete metallic shield or can be of meshed metallic (Diagram 9); it can be hand-held (Diagram 10) or can even contain grounding arrangements so that energy may be grounded to the earth (Diagram 11).

This patent covers all shieldings designed to protect operator and those in immediate proximity as these have not been patented before nor have they been in broad scale use.

This patent covers any complete or partial shielding of personal hand-held or office equipment and communication, all types of equipment which radiate fields which may interface and interact with living or other systems whereby such interaction may or may not be desirable.

3.

References

Publications on similar devices should be listed here, also the medical reports regarding causation of brain cancer by cellular phones and the high incidence of leukemias among ham operators. (The American Cancer Society could probably furnish both references or the Med-line at the Medical School Library would have them.)

What is claimed is:

1. All the devices described herein will prevent dangerous emissions from reaching people who both operate the equipment which emit such rays or bystanders; also sensitive equipment will similarly be protected;

2. Dangerous frequencies can be modulated in such a way as to render them harmless;

3. Changing the design mechanisms of antennnae or shielding devices should afford ample protection;

4. Hand-held shields (such as gloves) and metallic shields as described herein will provide suffiencient barriers between harmful emissions and possible victims;

5. The devices described herein can be used to make dangerous equipment emissions from computers or portable radios safe to use in airplanes.

1008 TAPE # *1

PROTOCOL

The ideal object of this invention is to provide an antenna system which will not transmit any harmful frequencies to living ╌ or rather target the systems by use of isolation of harmless frequencies by techniques described in previous patents. Immediate application, however, can be found in simple shielding constructs or in simple antenna design arrangement. Many fields of transmission it's not necessary nor intended that the beam heads in a direct straight line manner. In fact, a long distance communication necessitates that emitted energy leaves the antenna in the fields and because of its structure which ??? radiation which reaches desired party often travels in a curve. It is therefore ╌or rebounds from the atmosphere outer structure. It is therefore not essential for the part of the antenna close to the operator or to people in the immediate vicinity to be unshielded or transmitting. Particularly in the case of personal communication devices. This can easily be seen. The hand-held cellular phone for example, will have a short antenna arrangement which radiates the field in greatest intensity closest to the antenna and as hand held cellulars are in close proximity to the body of the operator, this exposes the operator to considerable risk of harmful frequencies as evidenced by recent studies which claim that cellular phone operators have an increased risk of brain cancers. It has long also been known that ham radio operators have a higher risk of Leukemia, hence it is important to shield these operators. The purpose of this invention is to A. Shield the ability to utilize frequencies which are harmless to the human body, by features covered in previous patents, by use of frequencies which are harmless, and B. to share the simple shielding devices and simple antenna arrangements can be made which are harmless or which will shield the operator and those in proximity. A simple example of this would be a sealed metal case for such devices which would enclose the operating body. It's perhaps more important, however, to enclose the antenna, at least partially such that the area which transmits out is restricted to the uppermost part of the antenna which is at a considerable distance to the operator. A further metallic or other shield of various arrangement but preferably of metallic consistency can be formed at the base of the antenna in the shape of an inverted umbrella, such that the parabolic shaped metal shield will inflict any of the frequencies emitted from the upper part of the antenna such that they do not largely impact on the operator or those in close proximity. A simple cylindrical metallic shield or any partial cylinder or any partial shields which separates the operator or those in proximity from transmitted frequency of the antenna are covered by this patent. A few designs may now be shown, both complete and incomplete methods of shielding I included in this patent, a simple application being cylindrical or parabolic shielding of personal communication devices change of antenna arrangement of personal communication devices, change of antenna arrangement of personal communication devices such that they resemble upside down umbrellas, and/or any other antenna arrangements whereby the frequencies are transmitted away from the operator. Such antenna arrangements need to be covered, the concept is to be patented here is that all such transmission devices transmission occurs away from living personnel or items with which we need no direct interaction for safety or other reasons. This will also cover partial antenna shielding or shielding of transmission and communication equipment and any directional arrangements of such equipment such that they do not interfere with any other equipment in proximity. Another application there would be shielding ???? of communication equipment such that it can be used in airplanes or other areas with sophisticated and sensitive equipment. Such ??? transmitted frequencies of communication equipment are aimed away from sensitive machines. Even though the shielding and antenna arrangements may not provide 100% efficacy, even minor shielding will significantly decrease the amount of radiation to which a personal unit operator is exposed with even minor shielding and angulation or change of design on broadcast antennas for radio and television will cause the transmitted frequencies to not impact directly on personnel in close proximity. Hence this patent covers devices which shield immediate living objects A,B, use frequencies which are not harmful to immediate living objects or to sensitive equipment by techniques indicated in previous patent, and C present new antenna designs aimed at keeping frequencies which arise from personal device antennas and from good transmission antennas as used in radio/television Army, Navy, etc., from impacting on people or equipment in close proximity which may be affected by such transmittable frequencies. Shielding devices are best made of metal with personal communication equipment a small hand-held metalic glove can be used to shield against both electromagnetic frequencies transmitted from the antenna as well as those generated from the unit itself. Shielding unit can be complete metalic shield or can be meshed metalic can be hand held or can even contain grounding arrangements so that energy may be grounded to the earth. This patent covers all shieldings designed to protect operator and those in immediate proximity as these have not been patented before nor have they been in broad scale use. This patent covers any complete or partial shielding of personal hand-held or office equipment and communication, all types of equipment which radiate fields which may interface and interact with living or other systems whereby such interaction may or may not be desirable. Anti-blocking, anti-body, anti-serum, MUMBLING SOMETHING back to previous shielding may be added to the antenna may be incorporated in antenna design.

i

Claims

I claim:

1. A method for creating therapeutic agents for use in treating a patient having a targeted disease or condition, said method comprising the steps of: a) performing a spectrum search for potential disease-associated agents

selected from the group consisting of biological agents, chemical agents and physical agents: b) testing each found potential disease-associated agent to gauge the type and level of its activity toward the targeted disease or condition, for classifying each found potential disease-associated agent as a disease-associated agent selected from the group consisting of causative agents, synergistic agents, neutral agents, infective agents, antagonistic agents, and nemesis agents: and c) preparing a first therapeutic agent using at least one disease-associated agent.

2. The method for creating therapeutic agents according to claim 1. wherein at least one disease-associated agent is a disease-associated organism.

3. The method for creating therapeutic agents according to claim 2. wherein the disease-associated organism is detrimental toward the targeted disease, said disease-associated organism being selected from the group consisting of infective organisms, antagonistic organisms, and nemesis organisms.

4. The method for creating therapeutic agents according to claim 2. wherein the disease-associated organism is found in vivo.

5. The method for creating therapeutic agents according to claim 4. wherein the disease-associated organism is found within the patient.

6. The method for creating therapeutic agents according to claim 4, wherein the disease-associated organism is found within a host organism substantially similar to the patient.

7. The method for creating therapeutic agents according to claim 6, wherein the host organism substantially similar to the patient has the targeted disease, but which targeted disease in the similar host organism is in remission.

8. The method for creating therapeutic agents according to claim 4, wherein the at least a disease-associated organism is found within an organism of a different specie than the patient.

9. The method for creating therapeutic agents according to claim 8, wherein the disease-associated organism is an antibody raised in a first host organism against the targeted disease.

10. The method for creating therapeutic agents according to claim 9, further comprising the following steps: d) raising in a second host organism at least an antibody to normal cells of the patient, and e) applying in vitro to a targeted disease or condition antibody raised in the first host organism, the at least an antibody to patient normal cells raised in the second host, for precipitating any anti-patient-specie factor out of the antibody raised in the first host.

1 1. The method for creating therapeutic agents according to claim 2, further comprising the step of infecting with a phage at least a disease-associated organism having a microbial affinity toward the targeted disease, said step of infecting occurring as part of the step of preparing a first therapeutic agent, so that the targeted disease may be subjected to infection by the phage.

12. The method for creating therapeutic agents according to claim 1, wherein the potential disease-associated agents include at least an agent precipitated by the patient as part of an immunological response.

13. The method for creating therapeutic agents according to claim 12, wherein the at least an agent precipitated by the patient is a red blood cell.

14. The method for creating therapeutic agents according to claim 12, wherein at least one agent precipitated by the patient is used as a carrier of material which is antagonistic toward the targeted disease.

15. The method for creating therapeutic agents according to claim 2, wherein the disease-associated organism, extract or modification thereof, is able to genetically modify at least a red blood cell of the patient such that the red blood cell becomes a therapeutic agent against the targeted disease.

16. The method for creating therapeutic agents according to claim 15, wherein the red blood cell is used as a carrier of material which is antagonistic toward the targeted disease.

17. The method for creating therapeutic agents according to claim 15, wherein the red blood cell becomes an antagonistic agent toward the targeted disease.

18. The method for creating therapeutic agents according to claim 1, wherein the first therapeutic agent is able to stimulate at least a cell of the patient to perform a function which has not been heretofore associated with said patient cell.

19. The method for creating therapeutic agents according to claim 2, wherein the disease-associated organism is found in vitro.

20. The method for creating therapeutic agents according to claim 2, wherein the disease-associated organism is beneficial toward the targeted disease.

21. The method for creating therapeutic agents according to claim 19, wherein at least one disease-associated organism is found in vivo.

22. The method for creating therapeutic agents according to claim 20, wherein at least one disease-associated organism is found within the patient.

23. The method for creating therapeutic agents according to claim 1, wherein at least one disease-associated agent has a strong microbial affinity toward the targeted disease so that it may be used for tagging the targeted disease such that the targeted disease is made more visible to the immune system.

24. The method for creating therapeutic agents according to claim 23, wherein the step of preparing a first therapeutic agent further comprises the step of affixing at least a radio-isotope to the disease-associated agent.

25. The method for creating therapeutic agents according to claim 23, further comprising the steps of: d) performing a spectrum search for organisms which are antagonistic toward the at least a disease-associated agent: and e) preparing a second therapeutic agent from each found such antagonistic organism, for use in assisting the patient's body in attacking components of the at least a disease-associated agent.

26. A method of treating a patient using the first and second therapeutic agents prepared according to claim 25. wherein the second therapeutic agent is applied to the patient by injection directly into diseased tissue.

27. The method for creating therapeutic agents according to claim 23, further comprising the steps of: d) co-culturing cells of the disease with components of the at least a disease-associated agent, for allowing disease cells to combine into a complex with components of the at least a disease-associated agent; e) performing a spectrum search for organisms which are antagonistic toward said complex; and e) preparing a second therapeutic agent from each found such antagonistic organism, for use in assisting the patient's body in attacking said complex once the complex is allowed to form in the patient.

28. The method for creating therapeutic agents according to claim 2. wherein the step of testing further includes the additional step of culturing at least a potential disease-associated organism in restricted media with diseased tissue, such that the at least a potential disease-associated organism may depend on the diseased tissue for nutrition.

29. The method for creating therapeutic agents according to claim 28. wherein the at least a potential disease-associated organism is a component of the patient's immune system.

30. The method for creating therapeutic agents according to claim 2, wherein the step of testing further includes the additional step of culturing at least a potential disease-associated organism in restricted media with cells of the targeted disease, such that the at least a potential disease-associated organism may depend on the disease cells for nutrition.

31. The method for creating therapeutic agents according to claim 30, wherein the at least a potential disease-associated organism is a component of the patient's immune system.

32. The method for creating therapeutic agents according to claim 2. wherein the step of testing further includes the additional steps of: l) culturing at least a potential disease-associated organism in restricted media with cells of at least a disease-associated organism having a tagging capability, such that the at least a potential disease-associated organism may depend on the disease-associated organism for nutrition; and e) preparing a second therapeutic agent from each found such potential

disease-associated organism, for use in assisting the patient's body in attacking components of the at least a disease-associated organism, which components may be administered to the patient via the first therapeutic agent.

33. The method for creating therapeutic agents according to claim 2, wherein the step of testing further includes the additional step of culturing at least a disease-associated organism in restricted media with cells of the targeted disease, after said disease cells have been challenged by a first therapeutic agent prepared using the at least a disease-associated organism, such that the at least a disease-associated organism may depend on the disease cells for nutrition.

34. The method for creating therapeutic agents according to claim 2, wherein the step of testing further includes the additional step of washing against each

disease-associated agent cells of the targeted disease for gauging the affinity of each disease-associated agent against the affinity of other disease-associated agents.

35. The method for creating therapeutic agents according to claim 1 , wherein the targeted disease is cancer related.

36. The method for creating therapeutic agents according to claim 1, wherein the targeted disease is related to degeneration of body tissue due to natural causes.

37. The method for creating therapeutic agents according to claim 1 , wherein the targeted disease is AIDS related.

38. The method for creating therapeutic agents according to claim 1. wherein at least a disease-associated agent demonstrates a regenerative effect on cellular material.

39. A method of treating a patient using the first therapeutic agent prepared according to claim 1, wherein the first therapeutic agent is used as a preventative agent for preventing the patient from contracting the targeted disease.

40. A method of treating a patient using the first therapeutic agent prepared according to claim 1 , wherein the first therapeutic agent is used to diagnose the targeted disease.

41. A method of treating a patient using the first therapeutic agent prepared according to claim 1. wherein the first therapeutic agent is used in the prognosis of the targeted disease.

42. A method of treating a patient using the first therapeutic agent prepared according to claim 1, wherein the first therapeutic agent is used to monitor the targeted disease within the patient's body.

43. A method of treating a patient using the first therapeutic agent prepared according to claim 1, wherein the first therapeutic agent is used to energize at least one of the patient's biological systems.

44. A method of treating a patient using at least a therapeutic agent prepared according to claim 1 , wherein the at least a therapeutic agent is introduced to the patient via administration means selected from the group consisting of topical administration, injection directly to diseased tissue, oral administration, rectal administration, intraurethral administration, intravesical administration, inhalation, intradermal administration, intradural administration, intrathecal administration, catheter administration, intravenous administration, intramuscular administration, sub-cutaneous administration, intravenous administration, and intradermal

administration.

45. A method of treating a patient using at least one therapeutic agent prepared according to claim 1, wherein the therapeutic agent is administered orally.

46. A method of treating a patient using at least one therapeutic agent prepared according to claim 1, wherein the therapeutic agent is a food.

47. A method of treating a patient using at least a therapeutic agent prepared according to claim 1. wherein the at least a therapeutic agent is a dietary supplement.

48. A method of treating a patient using at least a therapeutic agent prepared according to claim 1 , wherein the at least a therapeutic agent is administered extradermally.

49. A method of treating a patient using at least a therapeutic agent prepared according to claim 41, wherein the at least a therapeutic agent is a cosmetic.

50. A method of treating a patient using at least a therapeutic agent prepared according to claim 1, wherein a patient who has been administered the at least a therapeutic agent is subjected to bombardment by a wide band of electro-magnetic-induced frequencies, for stimulating cells of the patient's body and cells of the targeted disease to resonate at natural resonance levels such that diseased cells may be differentiated from normal cells.

51. A method for isolating a health-related extract from a diseased organism, comprising the following steps: a) isolating a disease-associated agent in an health-related extract from an organism which is detrimental to a targeted disease, said agent having the capability of destroying the disease components of the organism; and b) presenting said disease-associated agent to the organism such that the disease components of the organism are destroyed and the health-related extract remains intact.

52. A method for producing a multiphasic phage/plasmid preparation for use as an antibiotic in treating a patient with a microbial infection, comprising the steps of: a) stressing a first generation microbial culture comprising microorganisms isolated from a patient under conditions sufficient to initiate the destruction of the microorganisms and to produce and release a first phage/plasmid from the culture;

b) creating a second generation microbial culture comprising surviving

microorganisms from the first generation microbial culture and stressing the second generation microbial culture under conditions sufficient to initiate destruction of the microorganisms and to produce and release a second phage from the culture;

c) creating a third generation microbial culture comprising surviving

microorganisms from the second generation microbial culture and stressing the second generation microbial culture under conditions sufficient to initiate destruction of the microorganisms and to produce and release a third phage from the culture;

d) combining the first, second and third phages/plasmids into a single dosage for administration in vivo.

53. The method according to claim 52. further including the steps of creating a fourth generation microbial culture comprising surviving microorganisms from the third generation microbial culture and stressing the fourth generation microbial culture under conditions sufficient to initiate destruction of the microorganisms and to produce and release a fourth phage/plasmid from the culture, and thereafter repeatedly taking the survivors from a preceding generation microbial culture and stressing the survivors under conditions sufficient to initiate destruction of the microorganisms and to produce and release a phage/plasmid from the survivors until a phage/plasmid library is sufficiently complete so that a target microorganism is forced to undergo the efficacy of the multiphasic phage preparation.

54. A therapeutic agent in accordance with the method of claim 52.

55. A multiphasic phage/plasmid preparation for use as an antibiotic in treating a patient with a microbial injection, the preparation comprising multiple

phages/plasmids raised against resistant microorganisms isolated from a patient having at least one microbial infection, wherein each phage/plasmid exhibits specificity for the microorganisms against which it is raised.

56. A method for producing a multiphasic phage/plasmid preparation from a phage/plasmid library for use as an antibiotic in treating a patient with a microbial infection, comprising the steps of:

a) isolating microorganisms from a patient having an infection;

b) phage/plasmid typing successive generations of the microorganisms to produce a phage/plasmid lytic profile and selecting the most lytic of the phage/plasmid types; and

c) thereafter combining the lytic phage/plasmid types having the greatest capability of lysing into a single dosage for administration in vivo.

57. A therapeutic agent produced in accordance with the method of claim 56.

58. A multiphasic phage/plasmid preparation for use as an antibiotic in treating a patient with a microbial infection, the preparation comprising lytic phages/plasmids lacking the capacity for synergy for a specific species of microorganism and a carrier therefor.

59. A therapeutic method for destroying microorganisms in a patient comprising, the steps of:

a) isolating a microorganism from a patient with a targeted disease;

b) vaccinating the patient actively or passively against the microorganism to allow the patient to build up an immunological response against the microorganism; and

c) administering a multiphasic. multivalent lytic phage/plasmid preparation specific for the microorganism to the patient to lyse the organisms of the targeted disease.

60. A therapeutic method for tagging and destroying targeted cells in a patient, comprising the steps of:

a) isolating microbial extracts that are capable of adhering to the exterior of pre-selected targeted cells as a cell marker;

b) mixing the microbial extracts with the targeted cells in culture for a sufficient period of time to adhere the microbial extracts to the targeted cells, thereby facilitating the destruction of the targeted cells by a patient's immune system.

61. The therapeutic method according to claim 60. further including the step of adding phages/plasmids to the mixture which carry the genes for the cell marker.

62. A polyphasic, multivalent chemotherapeutic assay, comprising the steps of: a) subjecting preselected cancer cells to a variety of preselected

chemotherapeutic agents;

b) selecting at least one chemotherapeutic agent which causes substantial cancer cell death;

c) incubating the chemotherapeutic agent of step (b) in an in vitro or in vivo system comprising cancer cells of the type against which the chemotherapeutic agent causes substantial cell death;

d) assaying samples of the incubated mixture of step (c) against a variety of preselected chemotherapeutic agents and selecting at least one chemotherapeutic agent which causes substantial cancer cell death; and e) thereafter repeating steps (c) and (d) until such time a sufficient

combination of chemotherapeutic agent has been determined which is capable of preventing resistant cancer cell before they occur.

63. Chemotherapeutic agents and combinations thereof produced in accordance with the assay of claim 62.

64. A method for producing an effective polyphasic chemotherapeutic agent, comprising the steps of:

a) incubating cancerous tissue removed from a patient with the biological source of a chemotherapeutic agent which the patient has developed resistance against for a sufficient time to allow the biological source to develop a new killing mechanism to kill the cancerous tissue; and thereafter

b) administering the new killing mechanism to the patient.

65. A polyphasic chemotherapeutic agent produced in accordance with the method of claim 64.

66. A method to produce a chemotherapeutic agent with increased specificity, comprising the steps of:

a) placing a cancer cell suspension into an in vitro system:

b) washing the suspension at least once to separate organisms which do not adhere to the cancer cells from the organisms which remain adhered to the cancer cells after washing;

c) resuspending the organisms which remain adhered to the cancer cells; d) adding normal tissue to the resuspended organisms;

e) washing the mixture of step (d) at least once;

f) discarding the washed out portion from the remaining portion containing the organisms with affinity for the cancer cells; and

g) allowing the organisms with affinity for the cancer cells to produce

chemotherapeutic agents.

67. A method for producing a chemotherapy with high specificity and no side effects, comprising the steps of:

a) producing a solution comprising chemotherapeutic agents produced in accordance with the method of claim 66;

b) washing normal cells with the solution to allow the normal cells to absorb the chemotherapeutic agents which are toxic to the normal cells; c) removing the normal cells that have absorbed the chemotherapeutic

agents;

d) repeatedly washing normal cells with the solution and removing the

normal cells that have absorbed the chemotherapeutic agents until such time when the normal cells exhibit minimal or no damage from the chemotherapeutic agents, whereby a chemotherapy having no specificity for normal cells and having high specificity for cancer cells is produced.

68. A method for producing an autogenous chemotherapy, comprising the steps of: a) removing a cancer biopsy from a patient;

b) incubating the cancer cell biopsy with an organism that produces at least one chemotherapeutic agent that is capable of killing the patient's cancer cells;

c) removing the chemotherapeutic agent that is specific for the patient's cancer cells; and

d) repeatedly washing the patient's normal cells with the chemotherapeutic agent and removing the normal cells that have absorbed the agent and died until such time when the remaining normal cells exhibit minimal or no damage from the agent.

69. A vaccine produced in accordance with the method of claim 68.

70. A method for evaluating whether a patient is in spontaneous remission for a targeted disease, comprising the steps of:

a) isolating at least one microorganism that is associated with a patient going into spontaneous remission;

b) phage/plasmid typing the microorganism to produce the microorganism's phage/plasmid lytic profile;

c) matching the patient's microorganism phage/plasmid profile against a database containing phage/plasmid profiles for known organisms that existed or infected other persons at the time their disease was in remission to identify the remission-related organism in the patient; and d) culturing the remission-related organism in vitro with the patient's cancer cells to determine if the organism exhibits anti-cancer activity.

71. The method according to claim 70, further including the steps of creating an antibiotic profile for the patient's organism by culturing the microorganism with pre-selected antibiotics to determine if there is any effect, and then matching the patient's antibiotic profile against a database containing antibiotic profiles for known microorganisms that existed or infected other persons at the time their disease was in remission to identify the remission-related organism in the patient.

72. The method according to claim 70, further including the steps of creating an antisera profile for the patient's organism by culturing the organism with pre-selected antisera from animals to determine if there is any effect, and then matching the patient's antisera profile against a database containing antisera profiles for known organisms that existed or infected other persons at the time their disease was in remission to identify the remission-related organism in the patient.

73. A multilayer therapeutic method for treating a patient with a targeted disease, comprising the steps of:

a) placing pre-selected microorganisms in a culture with targeted cells from a patient and manipulating the culture in a manner so that the organisms develop a strong affinity for the targeted cells;

b) adding a cancer biopsy from the patient to the culture for a sufficient period of time to allow for selective penetration of the targeted cells into the layers of the cancer biopsy and formation of a cancer penetration gradient; and

c) removing the cancer biopsy from the culture to determine which layers of the cancer biopsy are penetrated and destroyed by the organisms.

74. Vaccines prepared from toxins and cellular components of organisms that selectively penetrate and destroy each layer of a biopsy from a patient with a targeted disease, each vaccine being effective against at least one layer of the biopsy.

75. A method for enhancing a biological function at the cellular or systemic level, comprising the step of:

administering of a living composition or extracts thereof or genetic material from said living composition to an organism to augment pre-existing function, to introduce desirable capabilities and/or to inhibit or neutralize undesirable capabilities or influences.

76. The method according to claim 75, wherein the living composition is

administered topically.

77. The method according to claim 75, wherein the living composition comprises specifically cultured microorganisms including saccharomyces cerevisiae. bacillus subtillis, bacillus macerns, lactobacilli, and other microorganisms which exhibit hydrating, rejuvenating, enzymatic and other characteristics desirable for cosmetics.

78. The use of a dynamic model for diagnosis, prognosis and therapy, comprising the steps of:

a) determining physical, chemical and biological changes that occur as part of the natural or therapeutic progress of a targeted condition or other factors; and

b) performing a spectrum search for potential disease-associated agents for the targeted condition to enable a user to develop continuous agents in response to modifications in the targeted condition as they occur, said agents selected from the group consisting of biological agents, chemical agents and physical agents.

79. The use of an anticipatory model for diagnosis, prognosis and therapy.

comprising the steps of:

b) performing a spectrum search for potential disease-associated agents in order to anticipate the changes in the targeted condition and respond therapeutically to the changes before they arise, said agents selected from the group consisting of biological agents, chemical agents and physical agents.

80. Use of precursors, intermediates and/or end products of therapeutic agents to optimize the effect against the targeted condition, wherein said precursors, intermediates and/or end products are produced by the method of claim 1.

81. Use of precursors, intermediates and/or end products of therapeutic agents to optimize the effect against the targeted condition, wherein said precursors, intermediates and/or end products are produced by the method of claim 78.

82. Use of precursors, intermediates and/or end products of therapeutic agents to optimize the effect against the targeted condition, wherein said precursors,

intermediates and/or end products are produced by the method of claim 79.

83. Use of precursors, intermediates and/or end products of therapeutic agents to optimize the effect against the targeted condition, wherein said precursors, intermediates and/or end products are produced by the method of claim 73.

84. Use of precursors, intermediates and/or end products of therapeutic agents that are passaged through a targeted condition.

85. Use of the method of claim 78 to produce agents targeted at specific organs, cells or conditions.

86. Use of the method of claim 79 to produce agents targeted at specific organs, cells or conditions.

87. Use of the method of claim 73 to produce agents targeted at specific organs, cells or conditions.

88. Non-autogenous and autogenous vaccines produced by the method of claim 1.

89. Non-autogenous and autogenous vaccines produced by the method of claim 78.

90. Non-autogenous and autogenous vaccines produced by the method of claim 79.

91. Use of phages, antisera and/or other agents, including transfer factor in accordance with claim 1 to target a specific condition.

92. Use of phages, antisera and/or other agents, including transfer factor in accordance with claim 78 to target a specific condition.

93. Use of phages, antisera and/or other agents, including transfer factor in accordance with claim 79 to target a specific condition.

94. Use of multiphasic technology to produce improved and/or novel agents in diagnosis, prognosis and therapy related to a targeted condition.

95. Use of a multivalent technology to produce improved and/or novel agents in diagnosis, prognosis and therapy related to a targeted condition.

96. Use of a multivalent and multiphasic technology to produce improved and/or novel agents in diagnosis, prognosis and therapy related to a targeted condition.

97. Red blood cells as a tool for carrying and/or expressing genetic material.

98. Red blood cells as a tool in genetic engineering.

99. Red blood cells as an active immunological and/or therapeutic agent.

100. Use of interference phenomena as therapy, wherein an interfering agent is selected from the group consisting of non-pathogenic, attenuated, live and inert compositions, and wherein the agent poses less of a threat to the host of a particular condition than the condition itself, and the interplay of the agent, pre-existing condition or host result in a more favorable state for a host.

101. Use of reactivation phenomena in a manner so that inert or relatively dormant agents are reactivated at the site of a targeted condition to produce desirable conditions for a host.

102. Use of graft rejection phenomena to facilitate the elimination of an unwanted bodily condition.

103. Diagnostic, screening and therapeutic equipment designed in accordance to the method of claim 1.

104. Hybrid equipment comprising mechanical and living components designed to carry out beneficial and therapeutic functions, wherein an interplay exists between the mechanical equipment and/or its living component and/or the host and/or a targeted condition.

105. The equipment according to claim 104, wherein the living component controls the mechanical functions of the equipment.

106. Shielding and transmission devices functioning in accordance with the method of claim 1.

107. Biological and non-biological devices developed in accordance with the classification, targeting, anticipation and dynamic flow models.

108. A multiphasic, multivalent therapy which incorporates phages. antibiotics, antisera and/or other agents, each targeting the disease/condition associated with a microorganism and/or the disease/condition itself, resulting in improved efficacy against the targeted condition or disease.

109. Use of biological and other extracts from organisms and organs with specific resistance to a targeted condition, wherein the resistance may be naturally inherent or induced according to the classification, tagging, anticipation and dynamic flow models.

1 10. The biological and other extracts according to claim 109, wherein the biological extracts originate from the small intestine including Peyer's Patches.

111. A method for producing antisera and other immunological extracts with efficacy against a targeted condition and minimal effects against a host whether the antisera or other immunological extracts originate from the host species or not.

112. A method for producing immunological extracts of high efficacy and minimal side affects according to classification, anticipation, targeting and dynamic models.

1 13. Use of ascitic and other tissue fluid including cancer-related fluid in the production of diagnostic, prognostic and therapeutic products.

114. Use of penicillin and other fungi in the production of specific anti-disease factors according to classification, anticipation, dynamic and targeting models.

1 15. Preferential and specific culture techniques yielding a range of useful and therapeutic agents.

116. Use of antibiotics and other agents to augment and activate phage/plasmid effects for diagnostic, therapeutic and prognostic applications.