JP2017537973A - バイオマーカーレベルを使用してｓｍａｄ７アンチセンスオリゴヌクレオチドを投与するおよびモニタリングするための方法 - Google Patents

バイオマーカーレベルを使用してｓｍａｄ７アンチセンスオリゴヌクレオチドを投与するおよびモニタリングするための方法 Download PDF

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JP2017537973A
JP2017537973A JP2017540317A JP2017540317A JP2017537973A JP 2017537973 A JP2017537973 A JP 2017537973A JP 2017540317 A JP2017540317 A JP 2017540317A JP 2017540317 A JP2017540317 A JP 2017540317A JP 2017537973 A JP2017537973 A JP 2017537973A
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JP2017537973A5 (enExample
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ジョヴァニ モンテレオーネ，
ジョヴァニ モンテレオーネ，
サルバトーレ ベリンビア，
サルバトーレ ベリンビア，
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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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    • G—PHYSICS
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    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
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JP2017540317A 2014-10-17 2015-10-16 バイオマーカーレベルを使用してｓｍａｄ７アンチセンスオリゴヌクレオチドを投与するおよびモニタリングするための方法 Pending JP2017537973A (ja)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201462065596P 2014-10-17 2014-10-17
US201462065586P 2014-10-17 2014-10-17
US62/065,586 2014-10-17
US62/065,596 2014-10-17
US201462085949P 2014-12-01 2014-12-01
US62/085,949 2014-12-01
PCT/EP2015/074070 WO2016059243A2 (en) 2014-10-17 2015-10-16 Methods for dosing and monitoring smad7 antisense oligonucleotide treatment using biomarker levels

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JP2017537973A true JP2017537973A (ja) 2017-12-21
JP2017537973A5 JP2017537973A5 (enExample) 2018-11-29

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JP2017540317A Pending JP2017537973A (ja) 2014-10-17 2015-10-16 バイオマーカーレベルを使用してｓｍａｄ７アンチセンスオリゴヌクレオチドを投与するおよびモニタリングするための方法

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US (2) US20170233736A1 (enExample)
EP (2) EP3693736A3 (enExample)
JP (1) JP2017537973A (enExample)
CA (1) CA2964673A1 (enExample)
WO (1) WO2016059243A2 (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018502107A (ja) * 2014-12-26 2018-01-25 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 Ｓｍａｄ７アンチセンスオリゴヌクレオチドの使用方法
US11123963B2 (en) 2016-08-15 2021-09-21 Intercontinental Great Brands Llc Multi-layer film and reclosable film package
US11267633B2 (en) 2016-08-15 2022-03-08 Intercontinental Great Brands Llc Multi-layer film and reclosable film package

Families Citing this family (8)

* 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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
WO2013037970A1 (en) * 2011-09-15 2013-03-21 Nogra Pharma Limited Methods for monitoring responsiveness to anti-smad7 therapy

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6159697A (en) 2000-01-19 2000-12-12 Isis Pharmaceuticals, Inc. Antisense modulation of Smad7 expression
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
US20150125398A1 (en) * 2012-05-11 2015-05-07 University Of Iowa Research Foundation Multimodal imaging methods using mesoporous silica nanoparticles
EP3207136A1 (en) * 2014-10-17 2017-08-23 Nogra Pharma Limited Methods and compositions for treating a subject with a smad7 antisense oligonucleotide

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
WO2013037970A1 (en) * 2011-09-15 2013-03-21 Nogra Pharma Limited Methods for monitoring responsiveness to anti-smad7 therapy

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
BRAND S: "CROHN'S DISEASE: TH1, TH17 OR BOTH? THE CHANGE OF A PARADIGM: NEW IMMUNOLOGICAL AND GENETIC 以下備考", GUT, vol. VOL:58, NR:8,, JPN5017008738, August 2009 (2009-08-01), GB, pages 1152 - 1167, ISSN: 0004182181 *
HE CHUN: "HIGHER LEVELS OF CCL20 EXPRESSION ON PERIPHERAL BLOOD MONONUCLEAR CELLS OF CHINESE 以下備考", IMMUNOLOGICAL INVESTIGATIONS, vol. VOL:39, NR:1,, JPN5017008737, 2010, pages 16 - 26, ISSN: 0004182179 *
MONTELEONE G: "BLOCKING SMAD7 RESTORES TGF-BETA1 SIGNALING IN CHRONIC INFLAMMATORY BOWEL DISEASE", JOURNAL OF CLINICAL INVESTIGATION, vol. VOL:108, NR:4,, JPN5017008739, August 2001 (2001-08-01), US, pages 601 - 609, ISSN: 0004182180 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018502107A (ja) * 2014-12-26 2018-01-25 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 Ｓｍａｄ７アンチセンスオリゴヌクレオチドの使用方法
US11123963B2 (en) 2016-08-15 2021-09-21 Intercontinental Great Brands Llc Multi-layer film and reclosable film package
US11267633B2 (en) 2016-08-15 2022-03-08 Intercontinental Great Brands Llc Multi-layer film and reclosable film package
US11752742B2 (en) 2016-08-15 2023-09-12 Intercontinental Great Brands Llc Multi-layer film and reclosable film package

Also Published As

Publication number Publication date
EP3693736A3 (en) 2020-10-14
US20200032264A1 (en) 2020-01-30
WO2016059243A2 (en) 2016-04-21
CA2964673A1 (en) 2016-04-21
WO2016059243A3 (en) 2016-06-23
EP3213070A2 (en) 2017-09-06
EP3693736A2 (en) 2020-08-12
US20170233736A1 (en) 2017-08-17

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