JP2013541010A5 - - Google Patents
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- Publication number
- JP2013541010A5 JP2013541010A5 JP2013533913A JP2013533913A JP2013541010A5 JP 2013541010 A5 JP2013541010 A5 JP 2013541010A5 JP 2013533913 A JP2013533913 A JP 2013533913A JP 2013533913 A JP2013533913 A JP 2013533913A JP 2013541010 A5 JP2013541010 A5 JP 2013541010A5
- Authority
- JP
- Japan
- Prior art keywords
- concentration
- pbmcs
- pharmaceutical composition
- glatiramer acetate
- iii
- 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.)
- Withdrawn
Links
- 210000003819 peripheral blood mononuclear cell Anatomy 0.000 claims description 23
- 102000013691 Interleukin-17 Human genes 0.000 claims description 11
- 239000006228 supernatant Substances 0.000 claims description 10
- 210000004369 blood Anatomy 0.000 claims description 6
- 239000008280 blood Substances 0.000 claims description 6
- PGHMRUGBZOYCAA-ADZNBVRBSA-N ionomycin Chemical compound O1[C@H](C[C@H](O)[C@H](C)[C@H](O)[C@H](C)/C=C/C[C@@H](C)C[C@@H](C)C(/O)=C/C(=O)[C@@H](C)C[C@@H](C)C[C@@H](CCC(O)=O)C)CC[C@@]1(C)[C@@H]1O[C@](C)([C@@H](C)O)CC1 PGHMRUGBZOYCAA-ADZNBVRBSA-N 0.000 claims description 3
- PGHMRUGBZOYCAA-UHFFFAOYSA-N ionomycin Natural products O1C(CC(O)C(C)C(O)C(C)C=CCC(C)CC(C)C(O)=CC(=O)C(C)CC(C)CC(CCC(O)=O)C)CCC1(C)C1OC(C)(C(C)O)CC1 PGHMRUGBZOYCAA-UHFFFAOYSA-N 0.000 claims description 3
- 210000002966 serum Anatomy 0.000 claims description 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 17
- 108010072051 Glatiramer Acetate Proteins 0.000 claims 14
- FHEAIOHRHQGZPC-KIWGSFCNSA-N acetic acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid Chemical compound CC(O)=O.C[C@H](N)C(O)=O.NCCCC[C@H](N)C(O)=O.OC(=O)[C@@H](N)CCC(O)=O.OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 FHEAIOHRHQGZPC-KIWGSFCNSA-N 0.000 claims 14
- 229960003776 glatiramer acetate Drugs 0.000 claims 14
- 238000000034 method Methods 0.000 claims 13
- MZOFCQQQCNRIBI-VMXHOPILSA-N (3s)-4-[[(2s)-1-[[(2s)-1-[[(1s)-1-carboxy-2-hydroxyethyl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-3-[[2-[[(2s)-2,6-diaminohexanoyl]amino]acetyl]amino]-4-oxobutanoic acid Chemical compound OC[C@@H](C(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCN=C(N)N)NC(=O)[C@H](CC(O)=O)NC(=O)CNC(=O)[C@@H](N)CCCCN MZOFCQQQCNRIBI-VMXHOPILSA-N 0.000 claims 8
- 102100037850 Interferon gamma Human genes 0.000 claims 8
- 108010074328 Interferon-gamma Proteins 0.000 claims 8
- 108010002350 Interleukin-2 Proteins 0.000 claims 8
- 108060008682 Tumor Necrosis Factor Proteins 0.000 claims 8
- 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 claims 8
- 201000006417 multiple sclerosis Diseases 0.000 claims 5
- 239000000090 biomarker Substances 0.000 claims 4
- 238000010254 subcutaneous injection Methods 0.000 claims 4
- 239000007929 subcutaneous injection Substances 0.000 claims 4
- 239000007864 aqueous solution Substances 0.000 claims 2
- 238000012258 culturing Methods 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 239000003937 drug carrier Substances 0.000 claims 2
- 239000001963 growth medium Substances 0.000 claims 2
- 238000010257 thawing Methods 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 238000009097 single-agent therapy Methods 0.000 claims 1
- 230000004936 stimulating effect Effects 0.000 claims 1
- 102000004127 Cytokines Human genes 0.000 description 3
- 108090000695 Cytokines Proteins 0.000 description 3
- 238000003556 assay Methods 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US39196810P | 2010-10-11 | 2010-10-11 | |
| US61/391,968 | 2010-10-11 | ||
| PCT/US2011/055588 WO2012051106A1 (en) | 2010-10-11 | 2011-10-10 | Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016093309A Division JP2016188214A (ja) | 2010-10-11 | 2016-05-06 | グラチラマーアセテートに対する臨床的な反応の予測可能なバイオマーカーとしてのサイトカインバイオマーカー |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2013541010A JP2013541010A (ja) | 2013-11-07 |
| JP2013541010A5 true JP2013541010A5 (https=) | 2016-07-28 |
Family
ID=45938670
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013533913A Withdrawn JP2013541010A (ja) | 2010-10-11 | 2011-10-10 | グラチラマーアセテートに対する臨床的な反応の予測可能なバイオマーカーとしてのサイトカインバイオマーカー |
| JP2016093309A Withdrawn JP2016188214A (ja) | 2010-10-11 | 2016-05-06 | グラチラマーアセテートに対する臨床的な反応の予測可能なバイオマーカーとしてのサイトカインバイオマーカー |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016093309A Withdrawn JP2016188214A (ja) | 2010-10-11 | 2016-05-06 | グラチラマーアセテートに対する臨床的な反応の予測可能なバイオマーカーとしてのサイトカインバイオマーカー |
Country Status (15)
| Country | Link |
|---|---|
| US (3) | US8709433B2 (https=) |
| EP (1) | EP2627669B1 (https=) |
| JP (2) | JP2013541010A (https=) |
| KR (1) | KR20140019296A (https=) |
| AU (1) | AU2011313842B2 (https=) |
| BR (1) | BR112013008573A2 (https=) |
| CA (1) | CA2814500A1 (https=) |
| EA (1) | EA025780B1 (https=) |
| ES (1) | ES2602977T3 (https=) |
| IL (1) | IL225118A (https=) |
| MX (1) | MX347871B (https=) |
| NZ (2) | NZ609938A (https=) |
| PL (1) | PL2627669T3 (https=) |
| PT (1) | PT2627669T (https=) |
| WO (1) | WO2012051106A1 (https=) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ598661A (en) | 2009-08-20 | 2013-02-22 | Yeda Res & Dev | Low frequency glatiramer acetate therapy |
| USRE49251E1 (en) | 2010-01-04 | 2022-10-18 | Mapi Pharma Ltd. | Depot systems comprising glatiramer or pharmacologically acceptable salt thereof |
| CA2814500A1 (en) | 2010-10-11 | 2012-04-19 | Teva Pharmaceutical Industries Ltd | Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate |
| HK1200274A1 (en) | 2011-10-10 | 2015-08-07 | Teva Pharmaceutical Industries Ltd. | Single nucleotide polymorphisms useful to predict clinical response for glatiramer acetate |
| HK1213830A1 (zh) * | 2012-10-10 | 2016-07-15 | Teva Pharmaceutical Industries Ltd. | 用於预测醋酸格拉替雷临床反应的生物标志物 |
| CN105377308B (zh) | 2013-03-14 | 2019-07-26 | 迈兰公司 | 醋酸格拉替雷响应生物标志物mRNA效力测定 |
| UY35790A (es) | 2013-10-21 | 2015-05-29 | Teva Pharma | Marcadores genéticos que predicen la respuesta al acetato de glatiramer |
| US9995734B2 (en) | 2013-10-24 | 2018-06-12 | Mylan Inc. | Human T cell line assay for evaluating the immunologic identity of glatiramer acetate preparations |
| US20160213633A1 (en) * | 2015-01-28 | 2016-07-28 | Teva Pharmaceutical Industries, Ltd. | Method of inducing anti-glatiramer acetate antibody response |
| US9155775B1 (en) | 2015-01-28 | 2015-10-13 | Teva Pharmaceutical Industries, Ltd. | Process for manufacturing glatiramer acetate product |
| US12097292B2 (en) | 2016-08-28 | 2024-09-24 | Mapi Pharma Ltd. | Process for preparing microparticles containing glatiramer acetate |
| CN109982712A (zh) | 2016-08-31 | 2019-07-05 | Mapi医药公司 | 包含醋酸格拉替雷的储库系统 |
| CN110382052A (zh) | 2017-03-26 | 2019-10-25 | Mapi医药公司 | 用于治疗进展型形式的多发性硬化症的格拉替雷储库系统 |
| EP3844501A1 (en) * | 2018-08-30 | 2021-07-07 | Essen Instruments, Inc. d/b/a Essen BioScience, Inc. | Methods for determining concentration of low and high concentration proteins in a single sample |
| WO2025181335A1 (en) * | 2024-02-29 | 2025-09-04 | Grifols Worldwide Operations Limited | Methods of treating a cognitive impairment |
Family Cites Families (61)
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|---|---|---|---|---|
| IL36670A (en) | 1971-04-21 | 1974-09-10 | Sela M | Therapeutic basic copolymers of amino acids |
| IL113812A (en) | 1994-05-24 | 2000-06-29 | Yeda Res & Dev | Copolymer-1 pharmaceutical compositions containing it and its use |
| US6214791B1 (en) | 1997-01-10 | 2001-04-10 | Yeda Research And Development Co. Ltd. | Treatment of multiple sclerosis through ingestion or inhalation of copolymer-1 |
| IL119989A0 (en) | 1997-01-10 | 1997-04-15 | Yeda Res & Dev | Pharmaceutical compositions for oral treatment of multiple sclerosis |
| ES2527760T3 (es) | 1998-07-23 | 2015-01-29 | Yeda Research And Development Co., Ltd. | Tratamiento de enfermedad de Crohn con copolímero 1 y polipéptidos |
| WO2000005249A2 (en) | 1998-07-23 | 2000-02-03 | The President And Fellows Of Harvard College | Synthetic peptides and methods of use for autoimmune disease therapies |
| IL141021A0 (en) | 1998-07-23 | 2002-02-10 | Yeda Res & Dev | Treatment of autoimmune conditions with copolymer 1 and related copolymers |
| DK2239269T3 (da) | 1998-09-25 | 2013-04-29 | Yeda Res & Dev | Anvendelse af peptider afledt af copolymer-1 som molekylvægtsmarkører |
| US6514938B1 (en) | 1998-09-25 | 2003-02-04 | Yeda Research And Development Co. Ltd. At The Weizmann Institute Of Science | Copolymer 1 related polypeptides for use as molecular weight markers and for therapeutic use |
| US6800287B2 (en) | 1998-09-25 | 2004-10-05 | Yeda Research And Development Co., Ltd. | Copolymer 1 related polypeptides for use as molecular weight markers and for therapeutic use |
| WO2000020010A1 (en) | 1998-10-02 | 2000-04-13 | Yeda Research And Development Co., Ltd. | Alternate day administration of copolymer 1 for treating autoimmune diseases |
| AU775073C (en) | 1998-11-12 | 2007-05-03 | Yeda Research And Development Co. Ltd. | Pharmaceutical compositions comprising synthetic peptide copolymers and methods for preventing and treating GVHD and HVGD |
| JP4328050B2 (ja) | 2000-01-20 | 2009-09-09 | イエダ リサーチ アンド デベロップメント カンパニー リミテッド | 神経保護療法のためのコポリマー1、関連ペプチド及びポリペプチドならびにそれらによって処理されたt細胞の使用 |
| IL150895A0 (en) | 2000-02-18 | 2003-02-12 | Teva Pharma | Oral, nasal and pulmonary formulations of copolymer-1 |
| US7022663B2 (en) | 2000-02-18 | 2006-04-04 | Yeda Research And Development Co., Ltd. | Oral, nasal and pulmonary dosage formulations of copolymer 1 |
| HUP0302333A3 (en) | 2000-06-05 | 2005-07-28 | Teva Pharma | The use of glatiramer acetate (copolymer 1) for the preparation of pharmaceutical compositions available in the treatment of central nervous system disorders |
| US20020077278A1 (en) | 2000-06-05 | 2002-06-20 | Yong V. Wee | Use of glatiramer acetate (copolymer 1) in the treatment of central nervous system disorders |
| EP1294390B1 (en) | 2000-06-07 | 2006-01-04 | YEDA RESEARCH AND DEVELOPMENT CO., Ltd. | The use of copolymer 1 and related peptides and polypeptides and t cells treated therewith for neuroprotection from glutamate toxicity |
| WO2002076503A1 (en) | 2000-06-20 | 2002-10-03 | Mayo Foundation For Medical Education And Research | Treatment of central nervous system diseases by antibodies against glatiramer acetate |
| US7429374B2 (en) | 2001-12-04 | 2008-09-30 | Teva Pharmaceutical Industries, Ltd. | Process for the measurement of the potency of glatiramer acetate |
| US7351686B2 (en) | 2001-12-06 | 2008-04-01 | Yeda Research And Development Co. Ltd. | Method for neuronal protection in amyotrophic lateral sclerosis by a vaccine comprising Copolymer-1 or Copolymer-1 related peptides |
| WO2004043995A2 (en) | 2002-11-13 | 2004-05-27 | Apotex Pharmachem Inc. | Process for the preparation of glatiramer acetate by polymerisation of n-carboxy anhydrides of l-alanine, l-tyrosine, benzyl l-glutamate and benzyloxycarbonyl l-lysine |
| ES2386435T3 (es) | 2003-01-07 | 2012-08-21 | Yeda Research And Development Co., Ltd. | Vacuna en forma de gotas oculares que contiene copolímero 1 para inmunización terapéutica |
| RU2339397C2 (ru) | 2003-01-21 | 2008-11-27 | Йеда Рисерч Энд Дивелопмент Ко.Лтд. | Сор1 для лечения воспалительных заболеваний кишечника |
| US20070037740A1 (en) | 2003-03-04 | 2007-02-15 | Irit Pinchasi | Combination therapy with glatiramer acetate and alphacalcidol for the treatment of multiple sclerosis |
| WO2004103297A2 (en) | 2003-05-14 | 2004-12-02 | Teva Pharmaceutical Industries, Ltd. | Combination therapy with glatiramer acetate and mitoxantrone for the treatment of multiple sclerosis |
| US7812116B2 (en) * | 2003-07-03 | 2010-10-12 | Rush University Medical Center | Immunogenic peptides |
| WO2005030955A1 (ja) | 2003-09-29 | 2005-04-07 | Chugai Seiyaku Kabushiki Kaisha | Nk細胞に発現するタンパク質 |
| JP2007509981A (ja) | 2003-10-31 | 2007-04-19 | テバ ファーマシューティカル インダストリーズ リミティド | 薬物デリバリー用ナノ粒子 |
| JP5456235B2 (ja) | 2003-11-12 | 2014-03-26 | イエダ リサーチ アンド デベロップメント カンパニー リミテッド | 神経変性疾患を治療するためのワクチン及び方法 |
| EP1778286A4 (en) | 2004-03-03 | 2009-04-08 | Teva Pharma | COMBINATION THERAPY WITH ACETATE OF GLATIRAMER AND RILUZOLE |
| EP1796710A4 (en) | 2004-09-02 | 2010-05-26 | Teva Pharma | THERAPY COMBINED WITH GLATIRAMER ACETATE AND N-ACETYLCYSTEINE TO TREAT MULTIPLE SCLEROSIS |
| ZA200702591B (en) | 2004-09-09 | 2009-03-25 | Teva Pharma | Process for preparation of mixtures of polypeptides using purified hydrobromic acid |
| HRP20160455T1 (hr) | 2004-09-09 | 2016-07-15 | Yeda Research And Development Co., Ltd. | Smjese polipeptida, sastavi koji ih sadrže i postupci za njihovu pripremu, te njihove primjene |
| AR052321A1 (es) | 2004-10-29 | 2007-03-14 | Sandoz Ag | Procesos para la preparacion de un polipeptido |
| JP2008528589A (ja) | 2005-02-02 | 2008-07-31 | テバ ファーマシューティカル インダストリーズ リミティド | 水素化分解を用いてポリペプチド混合物を作成する方法 |
| US20100167983A1 (en) | 2007-10-22 | 2010-07-01 | Teva Pharmaceutical Industries, Ltd. | Combination therapy with glatiramer acetate and rasagiline for the treatment of multiple sclerosis |
| WO2006089164A1 (en) | 2005-02-17 | 2006-08-24 | Teva Pharmaceutical Industries, Ltd. | Combination therapy with glatiramer acetate and rasagiline for the treatment of multiple sclerosis |
| CA2606194A1 (en) | 2005-04-25 | 2006-11-02 | Yeda Research And Development Company | Markers associated with the therapeutic efficacy of glatiramer acetate |
| US20070059798A1 (en) | 2005-09-09 | 2007-03-15 | Alexander Gad | Polypeptides useful for molecular weight determinations |
| DK1929297T3 (da) * | 2005-09-29 | 2013-03-04 | Caprion Proteomics Usa Llc | Biomarkører for dissemineret sklerose og fremgangsmåder til anvendelse heraf |
| WO2007081975A2 (en) * | 2006-01-11 | 2007-07-19 | Teva Pharmaceutical Industries, Ltd. | Method of treating multiple sclerosis |
| US20080118553A1 (en) | 2006-06-12 | 2008-05-22 | Anton Frenkel | Tannate salt form of polypeptide mixtures, their preparation and use |
| JP2009542864A (ja) | 2006-07-05 | 2009-12-03 | モメンタ ファーマシューティカルズ インコーポレイテッド | コポリマー1の調製のための改良法 |
| EP2171044A1 (en) * | 2007-06-25 | 2010-04-07 | Vertex Pharmceuticals Incorporated | Th-17 cells |
| CA2702437C (en) | 2007-11-28 | 2013-06-25 | Teva Pharmaceutical Industries Ltd. | Method of delaying the onset of clinically definite multiple sclerosis |
| EP2113560A1 (en) * | 2008-04-28 | 2009-11-04 | TXCell | Compositions for treating an arthritic condition |
| EP2335066B1 (en) * | 2008-09-19 | 2016-12-28 | University of Utah Research Foundation | Methods for prediction of multiple sclerosis disease and therapy response |
| CA2697570C (en) | 2009-07-15 | 2011-11-01 | Teva Pharmaceutical Industries, Ltd. | Reduced volume formulation of glatiramer acetate and methods of administration |
| US8920373B2 (en) | 2009-07-15 | 2014-12-30 | Teva Pharmaceutical Industries, Ltd. | Reduced volume formulation of glatiramer acetate and methods of administration |
| NZ598661A (en) | 2009-08-20 | 2013-02-22 | Yeda Res & Dev | Low frequency glatiramer acetate therapy |
| US8759302B2 (en) * | 2010-03-16 | 2014-06-24 | Teva Pharmaceutical Industries, Ltd. | Methods of treating a subject afflicted with an autoimmune disease using predictive biomarkers of clinical response to glatiramer acetate therapy in multiple sclerosis |
| CA2814500A1 (en) | 2010-10-11 | 2012-04-19 | Teva Pharmaceutical Industries Ltd | Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate |
| HK1200274A1 (en) | 2011-10-10 | 2015-08-07 | Teva Pharmaceutical Industries Ltd. | Single nucleotide polymorphisms useful to predict clinical response for glatiramer acetate |
| HK1213830A1 (zh) | 2012-10-10 | 2016-07-15 | Teva Pharmaceutical Industries Ltd. | 用於预测醋酸格拉替雷临床反应的生物标志物 |
| AU2013361057A1 (en) | 2012-12-21 | 2015-07-30 | Teva Pharmaceutical Industries Ltd. | Oral transmucosal delivery of glatiramer acetate |
| KR20150111918A (ko) | 2012-12-21 | 2015-10-06 | 테바 파마슈티컬 인더스트리즈 리미티드 | 글라티라머 아세테이트의 경점막 전달 |
| MX2015008754A (es) | 2013-01-04 | 2016-04-11 | Teva Pharma | Caracterizacion de un medicamento relacionado con acetato de glatiramer. |
| US20140271630A1 (en) | 2013-03-12 | 2014-09-18 | Teva Pharmaceutical Industries, Ltd. | Rituximab induction therapy followed by glatiramer acetate therapy |
| UY35790A (es) | 2013-10-21 | 2015-05-29 | Teva Pharma | Marcadores genéticos que predicen la respuesta al acetato de glatiramer |
| US9155775B1 (en) | 2015-01-28 | 2015-10-13 | Teva Pharmaceutical Industries, Ltd. | Process for manufacturing glatiramer acetate product |
-
2011
- 2011-10-10 CA CA2814500A patent/CA2814500A1/en not_active Abandoned
- 2011-10-10 AU AU2011313842A patent/AU2011313842B2/en not_active Ceased
- 2011-10-10 EP EP11833199.0A patent/EP2627669B1/en active Active
- 2011-10-10 ES ES11833199.0T patent/ES2602977T3/es active Active
- 2011-10-10 NZ NZ609938A patent/NZ609938A/en not_active IP Right Cessation
- 2011-10-10 EA EA201390543A patent/EA025780B1/ru not_active IP Right Cessation
- 2011-10-10 MX MX2013003929A patent/MX347871B/es active IP Right Grant
- 2011-10-10 PT PT118331990T patent/PT2627669T/pt unknown
- 2011-10-10 NZ NZ703122A patent/NZ703122A/en not_active IP Right Cessation
- 2011-10-10 KR KR1020137012245A patent/KR20140019296A/ko not_active Ceased
- 2011-10-10 US US13/269,913 patent/US8709433B2/en not_active Expired - Fee Related
- 2011-10-10 BR BR112013008573A patent/BR112013008573A2/pt not_active IP Right Cessation
- 2011-10-10 PL PL11833199T patent/PL2627669T3/pl unknown
- 2011-10-10 JP JP2013533913A patent/JP2013541010A/ja not_active Withdrawn
- 2011-10-10 WO PCT/US2011/055588 patent/WO2012051106A1/en not_active Ceased
-
2013
- 2013-03-07 IL IL225118A patent/IL225118A/en not_active IP Right Cessation
-
2014
- 2014-04-11 US US14/250,955 patent/US9063153B2/en not_active Expired - Fee Related
-
2015
- 2015-05-07 US US14/706,843 patent/US9625473B2/en not_active Expired - Fee Related
-
2016
- 2016-05-06 JP JP2016093309A patent/JP2016188214A/ja not_active Withdrawn
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