Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • A—HUMAN NECESSITIES
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  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
• • A—HUMAN NECESSITIES
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  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
  • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
  • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
  • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
  • A61K31/404—Indoles, e.g. pindolol
  • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
  • A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
  • A61K31/50—Pyridazines; Hydrogenated pyridazines
  • A61K31/503—Pyridazines; Hydrogenated pyridazines spiro-condensed
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
  • A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/60—Salicylic acid; Derivatives thereof
  • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
  • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
  • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
  • A61K31/728—Hyaluronic acid
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
  • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P35/00—Antineoplastic agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P35/00—Antineoplastic agents
  • A61P35/04—Antineoplastic agents specific for metastasis

Definitions

• This invention relates to the treatment of cancer and the prevention of metastases in patients having cancer.
• This invention also relates to pharmaceutical compositions and dosage amounts suitable for such treatment and prevention.
• this invention relates to the treatment of breast cancer and the prevention of metastases in a patient with breast cancer.
• Conventional treatment of breast cancer involves a mastectomy, the surgical removal of breast tissue.
• the procedure can vary from a simple lumpectomy to the radical procedure during which the surgeon removes the internal mammary chain of lymph nodes, the underlying pectoral muscles and the adjacent axillary lymph nodes.
• WO91/04058 provides a new treatment for among other diseases, cancer providing for administration of dosage amounts of pharmaceutical compositions comprising effective amounts of each of NSAIDs, Vitamin C, anti-cancer agents, among other medicines and therapeutic agents with a form of hyaluronic acid, for example sodium hyaluronate having a molecular weight less than 750,000 daltons, in an amount equal to or exceeding 10 mg/70 kg person.
• hyaluronic acid for example sodium hyaluronate having a molecular weight less than 750,000 daltons, in an amount equal to or exceeding 10 mg/70 kg person.
• the doses can be administered intravenously, intra-arterially, intraperitoneally, intra-pleurally and directly into the tumour by injection through a needle placed under sonograph or CT guidance .
• Case VII found at page 42-43 discloses the treatment of massive cancer of the breast with supraclavicular and auxiliary lymph nodes palpable.
• the treatment involved combinations "of hyaluronic acid and/or salts thereof added to conventional chemotherapy used systemically by injection into the tumour and by intra-pleural cavity instillation" (page 45, lines 3-5).
• NSAIDs non-steroidal anti-inflammatory drug
• ascorbic acid Vitamin C
• anti-cancer drugs among other drugs.
• Publication WO/CA93/00061 relates to the topical treatment of skin diseases and conditions and involves the topical administration of specified dosage amounts of pharmaceutical compositions taught.
• Basal cell carcinoma for example is treated and resolved by such topical administration.
• the dosage amounts when discharged from the skin, unload into the lymphatic system (page 31 , line 35).
• the drugs treat the disease or condition in the skin with the form of hyaluronic acid (for example sodium hyaluronate having a molecular weight less than 750,000 daltons) transporting the drugs into the skin.
• hyaluronic acid for example sodium hyaluronate having a molecular weight less than 750,000 daltons
• synthesis of prostaglandin is inhibited, deblocking the macrophages and N.K. cells (page 26, line 27 to page 27, line 35) thereby permitting the macrophages and N.K. cells to destroy the disease or condition.
• Applicants have discovered a new treatment for cancer (for example breast cancer - malignant tumours of the breast) which not only causes the malignant tumours (such as those of the breast) to shrink, recede and disappear, but also unexpectedly reduces the risk of metastases.
• cancer for example breast cancer - malignant tumours of the breast
• malignant tumours such as those of the breast
• Applicants have provided a new method for the treatment cancer in a human particularly malignant tumours, for example those in a breast or breasts, said method comprising the steps of:
• a non-toxic dosage amount of a pharmaceutical composition comprising an effective non-toxic amount of an anti-cancer drug and/or drug suitable for use to treat cancer (for example about 1 to about 2 mg Novantrone [tm] (Mitoxantrone) or other chemotherapeutic agent, (interferon or an NSAID) and an effective amount of a form of hyaluronic acid, for example hyaluronic acid and/or pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight of less than 750,000 daltons (for example 150,000 - 225,000 daltons) (for example about 10 to about 20 mg sodium hyaluronate) in sterile water.
• the size of the tumour will limit the amount that can be directly injected into the tumour.
• a combination preferably a dosage amount of a pharmaceutical composition, comprising
• a form of hyaluronic acid for example hyaluronic acid and pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg or more (because of a lack of toxicity and to reduce the side effects of any medicine (for example NSAID) administered therewith if the amount of the form of hyaluronic acid exceeds about 200mg/70kg pers on )
• hyaluronic acid for example hyaluronic acid and pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg or more (because of a lack of toxicity and to reduce the side effects of any medicine (for example NSAID) administered therewith if the amount of the form of hyaluronic acid exceeds about 200mg/70
• a drug selected from the group comprising (a) a non-steroidal anti-inflammatory drug (NSAID) for example in an effective non-toxic amount of from about 30 mg to about 100 mg (for example 30 to 60 mg of tromethamine salt of ketoralac (sold under the trade mark Toradol) and 50 to 100 mg of diclofenac or diclofenac sodium (for example sold under the trade mark Voltarol);
• NSAID non-steroidal anti-inflammatory drug
• an anti-oxidant for example Vitamin C (in one embodiment 25 gm of Vitamin C).
• the frequency of treatment for malignant tumours generally can be one (1 ) to four (4) times monthly or more (as may be required).
• a dosage amount of a pharmaceutical composition comprising ( i ) an effective amount of a form of hyaluronic acid (for example hyaluronic acid and salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg of the drug administered with the form of hyaluronic acid with the amounts of the form of hyaluronic acid exceeding 200mg/70kg person or more (because of a lack of toxicity)
• a form of hyaluronic acid for example hyaluronic acid and salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg of the drug administered with the form of hy
• NSAID non-steroidal anti-inflammatory drug
• an anti-oxidant for example Vitamin C in one embodiment 25 gm of Vitamin C
• an anti-oxidant for example Vitamin C is about one (1 ) to three (3) times per month.
• Hyperthermia (heat) treatments may be applied to the breast having the malignant tumour.
• Other regimens of therapeutic treatment may also be given.
• an ulcerative medicine such as Ranitidine may also be administered intravenously with sodium hyaluronate.
• Applicants have provided a new method for the treatment of cancer, said method comprising the steps of
• a dosage amount comprising an effective non-toxic amount of a drug suitable for treating cancer, alone or preferably with an effective amount of a form of hyaluronic acid, for example, hyaluronic acid or pharmaceutically acceptable salts thereof, preferably sodium hyaluronate having a molecular weight of less than 750,000 daltons (for example 150,000 - 225,000 daltons) (for example about 10 to about 20 mg sodium hyaluronate) and
• hyaluronic acid for example hyal uronic acid and/or pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg or more (because of a lack of toxicity)
• NSAID non-steroidal anti-inflammatory drug
• a non-steroidal anti-inflammatory drug for example in an amount of from about 30 mg to about 100 mg (for example 30 to 60 mg of tromethamine salt of ketoralac (sold under the trade mark Toradol) and 50 to 100 mg of diclofenac or diclofenac sodium (for example sold under the trade mark Voltarol);
• an anti-oxidant for example Vitamin C (in one embodiment 25 gm of Vitamin C).
• the steps are repeated over a period of time at chosen intervals suitable for the patient.
• Applicants have provided a new treatment for the reduction of the risk of a patient suffering from a cancer of having the cancer metastasize (reduce the risk of such patient suffering from a metastasis or suffering from a metastatic effect), said treatment comprising (preferably with other treatment for cancer for example those described above) administering s y s te mi cal ly ( preferab l y intravenously) a dosage amount of a pharmaceutical composition comprising
• hyaluronic acid for example hyaluronic acid and/or pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg or more (because of a lack of toxicity)
• NSAID non-steroidal anti-inflammatory drug
• a chemotherapeutic agent an anti-cancer agent or a drug suitable to treat cancer and combinations thereof, preferably w i th
• an anti-oxidant for example Vitamin C (in one embodiment 25 gm of Vitamin C),
• said administration continuing at regular intervals (for example 1 - 4 times monthly) over the period the treatment is being administered to the patient for the treatment of the cancer.
• the sodium hyaluronate transports carries and causes the transport of the drug
• the drug is also carried to and liberated in the lymph nodes.
• the blood stream will also take up for example the sodium hyaluronate and thus the drug
• the sodium hyaluronate and drug will be delivered to the liver (with the sodium hyaluronate transporting the drug into the tissue and cells of the liver).
• two major sites of nascent metastasis have for example sodium hyaluronate and drug (for example NSAID, anti-cancer drug) delivered to them with the sodium hyaluronate facilitating the transport of drug into the tissue (of the lymph nodes and liver) wherein to prevent cancer development and/or metastasis.
• the sodium hyaluronate (and other forms of hyaluronic acid, including hyaluronic acid) can be administered systemically with a drug and such administration delivers the drug with the form of hyaluronic acid to the lymph nodes and liver.
• Such administration helps to reduce the risk of metastasis and appears as a result of Applicant's tests to inhibit and even prevent metastasis of the cancer being treated in a human.
• Such administration may also be used to treat cancers in the lymph system and liver if cancer is found to be present there .
• the cancer being treated is malignant tumours of the breast
• the treatment involves systemic administration
• the direct injection a number of times a month over the period of cancer treatment
• the tumours reduced in size and cleared. Unexpectedly the reduction was without metastases.
• each such dosage amount comprising
• hyaluronic acid for example hyaluronic acid and pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg or more (because of a lack of toxicity and to reduce side effects of the medicine administered with the form of hyaluronic acid where the form of hyaluronic acid exceeds about 200mg/70kg person
• hyaluronic acid for example hyaluronic acid and pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg or more (because of a lack of toxicity and to reduce side effects of the medicine administered with the form of hyaluronic acid where the form of hyaluronic acid exceeds about 200mg/70kg person
• NSAID non-steroidal anti-inflammatory drug
• an effective non-toxic amount of from about 30 mg to about 100 mg for example 30 to 60 mg of tromethamine salt of ketoralac (sold under the trade mark Toradol) and 50 to 100 mg of diclofenac or diclofenac sodium
• a chemotherapeutic agent an anti-cancer agent or a drug suitable to treat cancer and c o m b i n a t i o n s t h e r e o f , preferably with
• an anti-oxidant for example Vitamin C (in one embodiment 25 gm of Vitamin C).
• Applicants have provided new dosage amounts of a pharmaceutical composition for injection (in a suitable form for injection) suitable for use with for example the above dosage amount, said dosage amount being in the container or vial suitable for use for injection (for example in a syringe) and comprising an effective amount of an anti-cancer drug and/or a drug suitable for use to treat cancer (for example breast cancer, in which event the dosage amount is injected into each tumour of the breast) (for example about 1 to about 2 mg of Mitoxantrone) and an effective amount of a form of hyaluronic acid, for example hyaluronic acid and/or pharmaceutically acceptable salts thereof, preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) (for example about 10 to about 20 mg sodium hyaluronate) in sterile water.
• a pharmaceutical composition for injection in a suitable form for injection
• said dosage amount being in the container or vial suitable for use for injection
• hyaluronic acid for example hyaluronic acid and/or pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg or more (because of a lack of toxicity)
• NSAID for example in an amount of from about 30 mg to about 100 mg (for example 30 to 60 mg of tromethamine salt of ketoralac (sold under the trade mark Toradol) and 50 to 100 mg of diclofenac or diclofenac sodium (for example sold under the trade mark Voltarol); and an effective non-toxic amount of a chemotherapeutic agent (anti-cancer agent or an agent suitable to treat cancer)
• a chemotherapeutic agent anti-cancer agent or an agent suitable to treat cancer
• Vitamin C in one embodiment 25 gm of Vitamin C
• a dosage amount of a pharmaceutical composition for injection in a suitable form for injection, said dosage amount being in the container or vial for injection and comprising an effective amount of an anti-cancer drug and/or a drug suitable for use to treat cancer (for example breast cancer, in which event the dosage amount is to be injected into each tumour of the breast) (for example about 1 to about 2 mg of Mitoxantrone and an effective amount of a form of hyaluronic acid, for example hyaluronic acid and/or pharmaceutically acceptable salts thereof, preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) (for example about 10 to about 20 mg sodium hyaluronate) in sterile water; an d
• hyaluronic acid for example hyaluronic acid and/or pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg or more (because of a lack of toxicity)
• NSAID for example in an amount of from about 30 mg to about 100 mg (for example 30 to 60 mg of tromethamine salt of ketoralac (sold under the trade mark Toradol) and 50 to 100 mg of diclofenac or diclofenac sodium (for example sold under the trade mark Voltarol) an d
• chemotherapeutic agent an agent suitable to treat cancer
• an anti-oxidant for example Vitamin C (in one embodiment 25 gm of Vitamin C), for example
• non-toxic dosage amounts of a pharmaceutical composition for injection in a suitable form for injection
• said dosage amount being in the container or vial for injection and comprising an effective amount of an anticancer drug and/or a drug suitable for use to treat cancer (for example breast cancer, in which event the dosage amount is injected into each tumour of the breast)
• an effective amount of an anticancer drug and/or a drug suitable for use to treat cancer for example breast cancer, in which event the dosage amount is injected into each tumour of the breast
• hyaluronic acid for example hyaluronic acid and/or pharmaceutically acceptable salts thereof, preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) (for example about 10 to about 20 mg sodium hyaluronate) in sterile water a n d
• hyaluronic acid for example hyaluronic acid and/or pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg or more (because of a lack of toxicity)
• NSAID non-steroidal anti-inflammatory drug
• a non-steroidal anti-inflammatory drug for example in an amount of from about 30 mg to about 100 mg (for example 30 to 60 mg of tromethamine salt of ketoralac (sold under the trade mark Toradol) and 50 to 100 mg of diclofenac or diclofenac sodium (for example sold under the trade mark Voltarol) an d
• a therapeutically effective non-toxic dosage amount of a chemotherapeutic agent (anti-cancer agent or an agent to treat cancer)
• Vitamin C in one embodiment 25 gm of Vitamin C
• an effective non-toxic dosage amount of an anti-cancer drug and/or a drug suitable for use to treat cancer for example breast cancer, in which event the dosage amount is injected into each tumour of the breast
• cancer for example breast cancer, in which event the dosage amount is injected into each tumour of the breast
• a form of hyaluronic acid for example hyaluronic acid and/or pharmaceutically acceptable salts thereof, preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) (for example about 10 to about 20 mg sodium hyaluronate) in sterile water an d
• hyaluronic acid for example hyaluronic acid and/or pharmaceutically acceptable salts thereof preferably sodium hyaluronate having a molecular weight less than 750,000 daltons (for example 150,000 - 225,000 daltons) for example about 100 - 200 mg or more (because of a lack of toxicity)
• NSAID for example in an amount of from about 30 mg to about 100 mg (for example 30 to 60 mg of tromethamine salt of ketoralac (sold under the trade mark Toradol) and 50 to 100 mg of diclofenac or diclofenac sodium (for example sold under the trade mark Voltarol); and
• chemotherapeutic agent for example an anti-cancer agent or an agent to treat cancer
• an anti-oxidant for example Vitamin C in one embodiment 25 gm of Vitamin C.
• Suitable forms of sodium hyaluronate may include a fraction supplied by Hyal Pharmaceutical Corporation supplied in a 15 ml vial of sodium hyaluronate 20mg/ml (300mg/vial - Lot 2F3).
• the sodium hyaluronate fraction is a 2% solution with a mean average molecular weight of about 225,000 daltons.
• the fraction also contains water q.s. which is triple distilled and sterile in accordance with the U.S. P. for injection formulations.
• the vials of hyaluronic acid and/or salts thereof may be carried in a Type 1 borosilicate glass vial closed by a butyl stopper which does not react with the contents of the vial.
• the fraction of hyaluronic acid and/or salts thereof may comprise hyaluronic acid and/or salts thereof having the following characteristics:
• a purified, substantially pyrogen-free fraction of hyaluronic acid obtained from a natural source having at least one characteristic selected from the group (and preferably all characteristics) consisting of the following:
• the hyaluronic acid is mixed with water and the fraction of hyaluronic acid has a mean average molecular weight within the range of 150,000-225,000. More preferably, the fraction of hyaluronic acid may comprise at least one characteristic selected from the group (and preferably all characteristics) consisting of the following characteristics:
• Hyaluronan HA-M5070 Another form of sodium hyaluronate is sold under the name Hyaluronan HA-M5070 by Skymart Enterprises, Inc. having the following specifications :
• hyaluronic acid and/or its salts, and analogues, homologues, derivatives, complexes, esters, fragments and sub units of hyaluronic acid may be chosen from other suppliers, for example those described in prior art documents provided the form of hyaluronic acid chosen is suitable for transport of the medicine.
• a kinematic viscosity of a 1 % solution of sodium hyaluronate in physiological buffer greater than about 1000 centistokes, preferably greater than 10,000 centistokes;
• a schedule of the dosage amounts received by each patient is attached and refers to the letter used to identify the patient.
• the chronology of the administration of the dosage amounts in each Schedule is in reverse order with the dosage given earliest being at the end of the Schedule and the most recent dosage being at the beginning of the Schedule.
• the local reaction was not excessive although it consisted on initial enlargement of the area of the tumour site. What was impressive was the return of the breast to normal in some instances, and with only minimal scar tissue apparent on mammography in others.

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• 1994
  • 1994-04-29 CA CA002122519A patent/CA2122519C/en not_active Expired - Lifetime
• 1995
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  • 1995-04-28 RU RU96122884/14A patent/RU2162327C2/ru active
  • 1995-04-28 CZ CZ963089A patent/CZ308996A3/cs unknown
  • 1995-04-28 HU HU9602965A patent/HUT75868A/hu unknown
  • 1995-04-28 KR KR1019960706101A patent/KR970702728A/ko not_active Ceased
  • 1995-04-28 JP JP7528564A patent/JPH09512797A/ja not_active Ceased
  • 1995-04-28 EP EP95917846A patent/EP0760667A1/en not_active Withdrawn
  • 1995-04-28 CN CN95193689A patent/CN1151118A/zh active Pending
  • 1995-04-28 WO PCT/CA1995/000259 patent/WO1995030423A2/en not_active Ceased
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