WO2010045512A3 - Processes and compositions for liposomal and efficient delivery of gene silencing therapeutics - Google Patents

Processes and compositions for liposomal and efficient delivery of gene silencing therapeutics Download PDF

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Publication number
WO2010045512A3
WO2010045512A3 PCT/US2009/060930 US2009060930W WO2010045512A3 WO 2010045512 A3 WO2010045512 A3 WO 2010045512A3 US 2009060930 W US2009060930 W US 2009060930W WO 2010045512 A3 WO2010045512 A3 WO 2010045512A3
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WO
WIPO (PCT)
Prior art keywords
liposomal
active agent
compositions
mass
liposome
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2009/060930
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French (fr)
Other versions
WO2010045512A2 (en
Inventor
Barry A. Polisky
Roger C. Adami
Michael V. Templin
Pierrot Harvie
Rachel E. Johns
Jaya S. Giyanani
Michael E. Houston
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Marina Biotech Inc
Original Assignee
MDRNA Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to CN200980148321.3A priority Critical patent/CN102231979B/en
Priority to CA2739046A priority patent/CA2739046A1/en
Priority to EP09744527.4A priority patent/EP2349210B1/en
Priority to JP2011532268A priority patent/JP2012505913A/en
Priority to AU2009305639A priority patent/AU2009305639B2/en
Priority to BRPI0920171A priority patent/BRPI0920171A2/en
Application filed by MDRNA Inc filed Critical MDRNA Inc
Publication of WO2010045512A2 publication Critical patent/WO2010045512A2/en
Publication of WO2010045512A3 publication Critical patent/WO2010045512A3/en
Priority to ZA2011/02319A priority patent/ZA201102319B/en
Priority to IL212329A priority patent/IL212329A0/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • A61K9/1277—Preparation processes; Proliposomes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
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    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
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    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
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    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
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    • C12N15/111—General methods applicable to biologically active non-coding nucleic acids
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    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • C—CHEMISTRY; METALLURGY
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    • C12N15/09—Recombinant DNA-technology
    • C12N15/87—Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation
    • C12N15/88—Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation using microencapsulation, e.g. using amphiphile liposome vesicle
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/10—Type of nucleic acid
    • C12N2310/14—Type of nucleic acid interfering nucleic acids [NA]
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    • C12N2320/00—Applications; Uses
    • C12N2320/30—Special therapeutic applications
    • C12N2320/32—Special delivery means, e.g. tissue-specific

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  • Bioinformatics & Cheminformatics (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
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Abstract

Processes and compositions for liposomal delivery of therapeuticals prepared by contacting an aqueous solution of an active agent with a solution of liposome-forming components containing one or more DILA2 amino acid compounds or lipids in organic solvent to form an impinging stream. A protocol including flow rates, pH, and an incubation period are used to control formation of liposomal components for therapeutic applications. The impinging stream may be collected and incubated to prepare a liposomal formulation which encapsulates the active agent. The composition can be quenched with buffer and filtered by tangential flow and diafiltration and other means for finishing as a pharmaceutical composition. An efficiency for delivering a drug cargo is provided. Compositions can include a liposome containing one or more carrier particles, each carrier particle having an active agent and a peptide, wherein the ratio of the mass of the peptide plus the mass of the liposome to the mass of the active agent is less than about 15.
PCT/US2009/060930 2008-10-16 2009-10-16 Processes and compositions for liposomal and efficient delivery of gene silencing therapeutics Ceased WO2010045512A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
CA2739046A CA2739046A1 (en) 2008-10-16 2009-10-16 Process and compositions for liposomal and effective delivery of nucleic acids
EP09744527.4A EP2349210B1 (en) 2008-10-16 2009-10-16 Processes and compositions for liposomal and efficient delivery of gene silencing therapeutics
JP2011532268A JP2012505913A (en) 2008-10-16 2009-10-16 Processes and compositions for efficient delivery by liposomes in therapy to suppress gene expression
AU2009305639A AU2009305639B2 (en) 2008-10-16 2009-10-16 Processes and compositions for liposomal and efficient delivery of gene silencing therapeutics
BRPI0920171A BRPI0920171A2 (en) 2008-10-16 2009-10-16 processes and compositions for liposomal and efficient release of gene silencing therapies.
CN200980148321.3A CN102231979B (en) 2008-10-16 2009-10-16 Liposome efficient delivery methods and compositions for gene silencing therapeutics
ZA2011/02319A ZA201102319B (en) 2008-10-16 2011-03-29 Processes and compositions for liposomal and efficient delivery of gene silencing therapeutics
IL212329A IL212329A0 (en) 2008-10-16 2011-04-14 Processes and compositions for liposomal and efficient delivery of gene silencing therapeutics

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US10606208P 2008-10-16 2008-10-16
US61/106,062 2008-10-16
US16737909P 2009-04-07 2009-04-07
US61/167,379 2009-04-07

Publications (2)

Publication Number Publication Date
WO2010045512A2 WO2010045512A2 (en) 2010-04-22
WO2010045512A3 true WO2010045512A3 (en) 2011-01-27

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PCT/US2009/060930 Ceased WO2010045512A2 (en) 2008-10-16 2009-10-16 Processes and compositions for liposomal and efficient delivery of gene silencing therapeutics

Country Status (12)

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US (3) US20100112042A1 (en)
EP (2) EP2349210B1 (en)
JP (2) JP2012505913A (en)
KR (1) KR20110071017A (en)
CN (2) CN104382853A (en)
AU (3) AU2009305639B2 (en)
BR (1) BRPI0920171A2 (en)
CA (1) CA2739046A1 (en)
IL (1) IL212329A0 (en)
SG (1) SG196818A1 (en)
WO (1) WO2010045512A2 (en)
ZA (1) ZA201102319B (en)

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