WO2008019346A3 - Microsphere-based composition for preventing and/or reversing new-onset autoimmune diabetes - Google Patents

Microsphere-based composition for preventing and/or reversing new-onset autoimmune diabetes Download PDF

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Publication number
WO2008019346A3
WO2008019346A3 PCT/US2007/075292 US2007075292W WO2008019346A3 WO 2008019346 A3 WO2008019346 A3 WO 2008019346A3 US 2007075292 W US2007075292 W US 2007075292W WO 2008019346 A3 WO2008019346 A3 WO 2008019346A3
Authority
WO
WIPO (PCT)
Prior art keywords
microsphere
autoimmune diabetes
preventing
based composition
onset autoimmune
Prior art date
Application number
PCT/US2007/075292
Other languages
French (fr)
Other versions
WO2008019346A2 (en
Inventor
Larry R Brown
Nick Giannoukakis
Kimberly A Gillis
Original Assignee
Baxter Int
Baxter Healthcare Sa
Children S Hospital Of Pittsbu
Larry R Brown
Nick Giannoukakis
Kimberly A Gillis
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
Application filed by Baxter Int, Baxter Healthcare Sa, Children S Hospital Of Pittsbu, Larry R Brown, Nick Giannoukakis, Kimberly A Gillis filed Critical Baxter Int
Priority to AU2007281737A priority Critical patent/AU2007281737B2/en
Priority to JP2009523082A priority patent/JP5118139B2/en
Priority to CA2657517A priority patent/CA2657517C/en
Priority to MX2009001226A priority patent/MX2009001226A/en
Priority to EP07813820.3A priority patent/EP2056883B1/en
Publication of WO2008019346A2 publication Critical patent/WO2008019346A2/en
Publication of WO2008019346A3 publication Critical patent/WO2008019346A3/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088Compounds having three or more nucleosides or nucleotides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/111General methods applicable to biologically active non-coding nucleic acids
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113Non-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
    • C12N15/1138Non-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 against receptors or cell surface proteins
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2310/00Structure or type of the nucleic acid
    • C12N2310/10Type of nucleic acid
    • C12N2310/11Antisense
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2310/00Structure or type of the nucleic acid
    • C12N2310/30Chemical structure
    • C12N2310/31Chemical structure of the backbone
    • C12N2310/315Phosphorothioates
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2320/00Applications; Uses
    • C12N2320/30Special therapeutic applications
    • C12N2320/32Special delivery means, e.g. tissue-specific

Abstract

AS-oIigonucleotides are delivered in microsphere form in order to induce dendritic cell tolerance, particularly in the non-obese-diabetic (NOD) mouse model. The microspheres incorporate antisense (AS) oligonucleotides. A process includes using an antisense approach to reverse an autoimmune diabetes condition in NOD mice in vivo. The oligonucleotides are targeted to bind to primary transcripts CD40, CD80, CD86 and their combinations.
PCT/US2007/075292 2006-08-04 2007-08-06 Microsphere-based composition for preventing and/or reversing new-onset autoimmune diabetes WO2008019346A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AU2007281737A AU2007281737B2 (en) 2006-08-04 2007-08-06 Microsphere-based composition for preventing and/or reversing new-onset autoimmune diabetes
JP2009523082A JP5118139B2 (en) 2006-08-04 2007-08-06 Microsphere-based composition for preventing and / or reversing newly-onset autoimmune diabetes
CA2657517A CA2657517C (en) 2006-08-04 2007-08-06 Microsphere-based composition for preventing and/or reversing new-onset autoimmune diabetes
MX2009001226A MX2009001226A (en) 2006-08-04 2007-08-06 Microsphere-based composition for preventing and/or reversing new-onset autoimmune diabetes.
EP07813820.3A EP2056883B1 (en) 2006-08-04 2007-08-06 Microsphere-based composition for preventing and/or reversing new-onset autoimmune diabetes

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US83574206P 2006-08-04 2006-08-04
US60/835,742 2006-08-04
US86491406P 2006-11-08 2006-11-08
US60/864,914 2006-11-08

Publications (2)

Publication Number Publication Date
WO2008019346A2 WO2008019346A2 (en) 2008-02-14
WO2008019346A3 true WO2008019346A3 (en) 2008-11-13

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/075292 WO2008019346A2 (en) 2006-08-04 2007-08-06 Microsphere-based composition for preventing and/or reversing new-onset autoimmune diabetes

Country Status (8)

Country Link
US (2) US7964574B2 (en)
EP (2) EP2056883B1 (en)
JP (2) JP5118139B2 (en)
CN (2) CN101500616A (en)
AU (1) AU2007281737B2 (en)
CA (2) CA2657517C (en)
MX (1) MX2009001226A (en)
WO (1) WO2008019346A2 (en)

Families Citing this family (7)

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CA2723192A1 (en) * 2008-05-07 2009-11-12 Surmodics, Inc. Delivery of nucleic acid complexes from particles
US8901092B2 (en) 2010-12-29 2014-12-02 Surmodics, Inc. Functionalized polysaccharides for active agent delivery
TWI718086B (en) 2013-01-07 2021-02-11 英屬維爾京群島商遠東超級實驗室有限公司 Methods and compositions for treatment of bone, skin, subcutaneous, mucosal and/or submucosal cancer by percutaneous and/or transmucosal administration of interferon
WO2015048395A1 (en) * 2013-09-26 2015-04-02 University Of Pittsburgh-Of The Commonwealth System Of Higher Education Tolerogenic dendritic cells to treat inflammatory bowel disease
EP3071688B1 (en) * 2013-11-18 2020-07-08 University of Pittsburgh - Of the Commonwealth System of Higher Education Microsphere-based delivery and ex vivo manipulation of dendritic cells for autoimmune therapies

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