DK2281042T3 - Mikrokuglebaseret sammensætning til forebyggelse og/eller ophævelse af begyndende autoimmun diabetes - Google Patents

Mikrokuglebaseret sammensætning til forebyggelse og/eller ophævelse af begyndende autoimmun diabetes Download PDF

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Publication number
DK2281042T3
DK2281042T3 DK09732817.3T DK09732817T DK2281042T3 DK 2281042 T3 DK2281042 T3 DK 2281042T3 DK 09732817 T DK09732817 T DK 09732817T DK 2281042 T3 DK2281042 T3 DK 2281042T3
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Prior art keywords
seq
human
oligonucleotides
microspheres
diabetes
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DK09732817.3T
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English (en)
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Larry R Brown
Nick Giannoukakis
Massimo Trucco
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Baxter Int
Baxter Healthcare Sa
Univ Pittsburgh
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • 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
    • C12N15/87—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
    • 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
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • 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
    • C12N15/1138—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 against receptors or cell surface proteins
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/10—Type of nucleic acid
    • C12N2310/11—Antisense
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2320/00—Applications; Uses
    • C12N2320/30—Special therapeutic applications
    • C12N2320/32—Special delivery means, e.g. tissue-specific

Claims (13)

1. Farmaceutisk sammensætning omfattende: (i) et antisense-oligonukleotid, som er SEQ ID NO: 4, eller et antisense- 5 oligonukleotid, som har mindst 90% polynukleotidsekvenshomologi med SEQ ID NO: 4, som er rettet mod det humane primære CD40-transkript og binder sig til dette, (ii) et antisense-oligonukleotid, som er SEQ ID NO: 6, eller et antisense-oligonukleotid, som har mindst 90% polynukleotidsekvenshomologi med SEQ 10 ID NO: 6, som er rettet mod det humane primære CD86-transkript og binder sig til dette, og (iii) et antisense-oligonukleotid, som er SEQ ID NO: 7, eller et antisense-oligonukleotid, som har mindst 90% polynukleotidsekvenshomologi med SEQ ID NO: 7, og som er rettet mod det humane primære CD80-transkript og binder 15 sig til dette, idet oligonukleotiderne er formuleret i mikrokugler.
2. Farmaceutisk sammensætning ifølge krav 1, hvori hvert enkelt af antisense-oligonukleotiderne har mindst 95% polynukleotidsekvenshomologi med en vilkårlig af SEQ ID NO: 4, SEQ ID NO: 6 eller SEQ ID NO: 7. 20
3. Farmaceutisk sammensætning ifølge krav 1 eller krav 2, hvori mindst 70 vægt% af mikrokuglerne er oligonukleotider, eventuelt hvori forholdet mellem de enkelte antisense-oligonukleotider i sammensætningen CD40-antisense/CD80-antisense/-CD86-antisense er 1:1:1. 25
4. Farmaceutisk sammensætning ifølge krav 1 eller krav 2, hvori sammensætningen omfatter antisense-oligonukleotider, der hvert især omfatter polynukleotidsekvenserne SEQ ID NO: 4, SEQ ID NO: 6 og SEQ ID NO: 7.
5. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 4 til anvendelse ved behandling af en sygdom eller en lidelse i et menneske.
6. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 4 til anvendelse ved behandling af diabetes type 1 i et menneske, idet sammensætningen 35 indgives før eller efter klinisk indtræden af diabetes type 1.
7. Farmaceutisk sammensætning ifølge krav 5 eller 6 til anvendelse ved normalisering af blodglucoseniveauer i det pågældende menneske i sammenligning med menneskets blodglucoseniveauer inden indgivelsen.
8. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 5 til 7 til anvendelse ved regenerering af det pågældende menneskes betacellebestand.
9. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 5 til 7 til anvendelse ved bevaring af resterende betacellemasse i et menneske, idet menneskets 10 betacellemasse ved anvendelse af sammensætningen opretholdes på mindst ca. 15% af den før indtræden af diabetes tilstedeværende masse, eller til anvendelse ved behandling eller ophævelse af diabetes type 1 i et menneske eller til anvendelse ved beskyttelse af betaceller i et menneskes pankreas eller til anvendelse ved nedsættelse af T-celleformidlet pankreasinflammation eller pankreascelledød i et menneske. 15
10. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 5 til 9, hvor sammensætningen indgives i kombination med insulin, eventuelt hvor insulin indgives før, samtidig med eller efter indgivelse af sammensætningen.
11. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, hvor sammensætningen indgives som en injicerbar form.
12. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, hvor sammensætningen er formuleret til gentagen indgivelse. 25
13. Anvendelse af den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 1 til 4 ved fremstilling af et medikament til behandling af diabetes type 1 i et menneske, idet sammensætningen indgives før eller efter klinisk indtræden af diabetes type 1. 30
DK09732817.3T 2008-04-18 2009-04-20 Mikrokuglebaseret sammensætning til forebyggelse og/eller ophævelse af begyndende autoimmun diabetes DK2281042T3 (da)

Applications Claiming Priority (3)

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US4603408P 2008-04-18 2008-04-18
US4824608P 2008-04-28 2008-04-28
PCT/US2009/041167 WO2009129544A1 (en) 2008-04-18 2009-04-20 Microsphere-based composition for preventing and/or reversing new-onset autoimmune diabetes

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DK09732817.3T DK2281042T3 (da) 2008-04-18 2009-04-20 Mikrokuglebaseret sammensætning til forebyggelse og/eller ophævelse af begyndende autoimmun diabetes
DK15174152.7T DK2982753T3 (da) 2008-04-18 2009-04-20 Mikrosfære-baseret sammensætning til at forebygge og/eller reversere nystartet autoimmun diabetes

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US (1) US8022046B2 (da)
EP (2) EP2982753B1 (da)
JP (4) JP5685182B2 (da)
CN (1) CN102007213B (da)
AU (1) AU2009237577B2 (da)
CA (1) CA2720675C (da)
DK (2) DK2281042T3 (da)
ES (2) ES2554168T3 (da)
HK (1) HK1221261A1 (da)
MX (1) MX2010011508A (da)
PL (2) PL2281042T3 (da)
WO (1) WO2009129544A1 (da)

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EP2982753B1 (en) * 2008-04-18 2018-06-06 Baxter International Inc. Microsphere-based composition for preventing and/or reversing new-onset autoimmune diabetes
US9072766B2 (en) 2010-11-18 2015-07-07 Beth Israel Deaconess Medical Center, Inc. Methods of treating obesity by inhibiting nicotinamide N-methyl transferase (NNMT)
JP6348484B2 (ja) * 2012-04-18 2018-06-27 ノグラ ファーマ リミテッド 糖尿病を処置する方法および／または移植後の膵島の生存を促進する方法
AU2014348184B2 (en) * 2013-11-18 2020-08-27 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Microsphere-based delivery and ex vivo manipulation of dendritic cells for autoimmune therapies
PL424035A1 (pl) 2015-06-30 2019-01-02 Northwest Biotherapeutics, Inc. Optymalnie aktywowane komórki dendrytyczne, które indukują ulepszoną lub zwiększoną przeciwnowotworową odpowiedź odpornościową

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EP2281042A1 (en) 2011-02-09
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US20090291145A1 (en) 2009-11-26
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