JP2018531936A - バイオマーカー発現に基づいてｓｍａｄ７アンチセンスオリゴヌクレオチドを使用する方法 - Google Patents

バイオマーカー発現に基づいてｓｍａｄ７アンチセンスオリゴヌクレオチドを使用する方法 Download PDF

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JP2018531936A
JP2018531936A JP2018516772A JP2018516772A JP2018531936A JP 2018531936 A JP2018531936 A JP 2018531936A JP 2018516772 A JP2018516772 A JP 2018516772A JP 2018516772 A JP2018516772 A JP 2018516772A JP 2018531936 A JP2018531936 A JP 2018531936A
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dose
smad7 aon
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JP2018531936A5 (enExample
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サルバトーレ ベリンビア，
サルバトーレ ベリンビア，
ジョヴァニ モンテレオーネ，
ジョヴァニ モンテレオーネ，
ホラン， ジェラルド スコット バーデン
ホラン， ジェラルド スコット バーデン
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ノグラ ファーマ リミテッド
ノグラ ファーマ リミテッド
セルジーン アルパイン インベストメント カンパニー Ｉｉ， エルエルシー
セルジーン アルパイン インベストメント カンパニー Ｉｉ， エルエルシー
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    • 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
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/7125—Nucleic acids or oligonucleotides having modified internucleoside linkage, i.e. other than 3'-5' phosphodiesters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • 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
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • C—CHEMISTRY; METALLURGY
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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
    • C12N15/1136—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 growth factors, growth regulators, cytokines, lymphokines or hormones
    • 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
    • C12N2310/11—Antisense
    • C—CHEMISTRY; METALLURGY
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    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/30—Chemical structure
    • C12N2310/31—Chemical structure of the backbone
    • C12N2310/315—Phosphorothioates
    • 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
    • C12N2310/30—Chemical structure
    • C12N2310/33—Chemical structure of the base
    • C12N2310/334—Modified C
    • C12N2310/3341—5-Methylcytosine
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701—Details
    • G01N2333/4733—Acute pancreatitis-associated protein
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G01N2333/5409—IL-5
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G01N2333/5437—IL-13
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/06—Gastro-intestinal diseases
    • G01N2800/065—Bowel diseases, e.g. Crohn, ulcerative colitis, IBS
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
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  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
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  • Biotechnology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
JP2018516772A 2015-09-30 2016-09-30 バイオマーカー発現に基づいてｓｍａｄ７アンチセンスオリゴヌクレオチドを使用する方法 Pending JP2018531936A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562235556P 2015-09-30 2015-09-30
US62/235,556 2015-09-30
PCT/EP2016/073518 WO2017055611A2 (en) 2015-09-30 2016-09-30 Methods of using smad7 antisense oligonucleotides based on biomarker expression

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JP2018531936A true JP2018531936A (ja) 2018-11-01
JP2018531936A5 JP2018531936A5 (enExample) 2019-11-07

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EP (1) EP3355896A2 (enExample)
JP (1) JP2018531936A (enExample)
CA (1) CA3000569A1 (enExample)
WO (1) WO2017055611A2 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20210098487A (ko) * 2018-11-30 2021-08-10 아레나 파마슈티칼스, 인크. S1p1 수용체와 관련된 병태의 치료 방법

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITRM20030149A1 (it) 2003-04-02 2004-10-03 Giuliani Spa Oligonucleotidi (odn) antisenso per smad7 e loro usi in campo medico
RS56049B1 (sr) 2008-11-13 2017-09-29 Nogra Pharma Ltd Antisens kompozicije i postupci za pripremu i upotrebu istih
KR102099990B1 (ko) 2011-09-15 2020-04-13 노그라 파마 리미티드 항-smad7 요법의 반응성을 모니터링하는 방법
RU2667960C2 (ru) 2012-04-18 2018-09-25 Ногра Фарма Лимитед Способы лечения диабета и/или улучшения выживания панкреатических островков после трансплантации
US10006029B2 (en) 2013-03-15 2018-06-26 Nogra Pharma Limited Methods of treating colorectal cancer
CN106573065A (zh) 2014-05-09 2017-04-19 诺格尔制药有限公司 用于治疗炎症性肠病的方法
EP3207136A1 (en) 2014-10-17 2017-08-23 Nogra Pharma Limited Methods and compositions for treating a subject with a smad7 antisense oligonucleotide
US11162097B2 (en) 2016-02-23 2021-11-02 Nogra Pharma Limited Methods of treating intestinal fibrosis using SMAD7 inhibition
WO2019023439A1 (en) * 2017-07-28 2019-01-31 Celgene Corporation PROCESS FOR THE PREPARATION OF OLIGONUCLEOTIDE COMPOUNDS
US20220267428A1 (en) * 2018-10-10 2022-08-25 The Board Of Trustees Of The Leland Stanford Junior University BLOCKADE OF RGMb FOR TREATING INFLAMMATORY BOWEL DISEASE AND COLITIS

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008525441A (ja) * 2004-12-22 2008-07-17 ドラッグテック コーポレイション 心血管用組成物
JP2012507723A (ja) * 2008-11-03 2012-03-29 シェーリング コーポレイション 炎症性腸疾患生物マーカーおよび関連治療方法
JP2012508705A (ja) * 2008-11-13 2012-04-12 ジュリアーニ インターナショナル リミテッド アンチセンス組成物およびその作製および使用
JP2014516944A (ja) * 2011-04-29 2014-07-17 ブリストル−マイヤーズ スクイブ カンパニー Ｉｐ１０抗体の用量漸増計画
JP2014531584A (ja) * 2011-09-15 2014-11-27 ノグラ ファーマ リミテッド 抗ｓｍａｄ７治療に対する応答性をモニターするための方法

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI20075968A0 (fi) * 2007-12-28 2007-12-28 Licentia Oy Menetelmä immunomodulaattorihoitojen tehokkuuden tarkkailemiseksi

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008525441A (ja) * 2004-12-22 2008-07-17 ドラッグテック コーポレイション 心血管用組成物
JP2012507723A (ja) * 2008-11-03 2012-03-29 シェーリング コーポレイション 炎症性腸疾患生物マーカーおよび関連治療方法
JP2012508705A (ja) * 2008-11-13 2012-04-12 ジュリアーニ インターナショナル リミテッド アンチセンス組成物およびその作製および使用
JP2014516944A (ja) * 2011-04-29 2014-07-17 ブリストル−マイヤーズ スクイブ カンパニー Ｉｐ１０抗体の用量漸増計画
JP2014531584A (ja) * 2011-09-15 2014-11-27 ノグラ ファーマ リミテッド 抗ｓｍａｄ７治療に対する応答性をモニターするための方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
GREUTER, THOMAS ET AL., DIGESTION, vol. 92, no. 2, JPN7020002347, 1 August 2015 (2015-08-01), pages 83 - 89, ISSN: 0004461586 *
MONTELEONE, GIOVANNI ET AL., THE NEW ENGLAND JOURNAL OF MEDICINE, vol. 372, no. 12, JPN6020028993, 19 March 2015 (2015-03-19), pages 1104 - 1113, ISSN: 0004461585 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20210098487A (ko) * 2018-11-30 2021-08-10 아레나 파마슈티칼스, 인크. S1p1 수용체와 관련된 병태의 치료 방법
KR102824401B1 (ko) * 2018-11-30 2025-06-25 아레나 파마슈티칼스, 인크. S1p1 수용체와 관련된 병태의 치료 방법

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EP3355896A2 (en) 2018-08-08
CA3000569A1 (en) 2017-04-06
WO2017055611A3 (en) 2017-08-31
WO2017055611A2 (en) 2017-04-06

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