JP5414959B2 - sFcγRIIbまたはsFcγRIIIを含有する医薬品組成物 - Google Patents
sFcγRIIbまたはsFcγRIIIを含有する医薬品組成物 Download PDFInfo
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- JP5414959B2 JP5414959B2 JP2003545329A JP2003545329A JP5414959B2 JP 5414959 B2 JP5414959 B2 JP 5414959B2 JP 2003545329 A JP2003545329 A JP 2003545329A JP 2003545329 A JP2003545329 A JP 2003545329A JP 5414959 B2 JP5414959 B2 JP 5414959B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/1774—Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
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- 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
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- 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
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
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Description
図1:DBA/1 マウス中で誘発されたEAEの疾病経過
DBA/1 マウス中での実験によるアレルギー性脳脊髄炎(EAE)は、多発性硬化症(MS)の動物モデルである。このマウス株中でのMS様の症状(例えば、麻痺徴候、脳内での傷害)は、ミエリン−オリゴデンドロサイト−グリコ蛋白質(MOG)での免疫後に観察される。このように免役されたDBA/1 マウス10匹毎に、48時間の周期でPBS(対照1)、E.coliからのTrp−シンターゼ100μg(対照2)または可溶性Fc受容体100μg(sFcγR IIb)で処理した。EAEの症状を個別的に評価し、グループ平均としてプロットした。”疾病インデックス”(Abdul-Majid, K.B., Jirholt, J., Stadelman, C., Stefferl, A., Kjellen, P., Wallstrom, E., Holmdahl, R., Lassmann, H., Olsson, T., Harris, R.A. (2000), Screening of several H-2 congenic mouse strains identified H-2(q) mice as highly susceptible to MOG-induced EAE with minimal adjuvant requirement, J. Neuroimmunol, 111: 23-33)を次のように評価した:0、EAEの徴候なし;1、尻尾の麻痺;2、後脚の弛緩;3、後脚の麻痺;4、前脚および後脚の完全な麻痺;5、死亡。
NZBW/F1マウスは、全身性紅斑性狼そう(SLE)の疾病についての公認の動物モデルである(Theofilopoulos, A. N., Dixon, F. J. (1985), Murine models of systemic lupus erythematosus, Adv. Immunol. 37; 269-390)。NZBW/F1マウス10匹宛、1週間毎にPBS(対照群)または可溶性Fc100μg(sFcγR IIb)で皮下治療した。Fc受容体によって治療したマウスの中、40週間後になお全てのマウスが生存し、この時間後に対照グループの70%が死亡した。
成長した糸球体腎炎の結果としての罹病したNZBW/F1マウスの蛋白尿症は、疾病SLEの進行に対する重要な判断基準である。図1aの説明文に記載された処置されたマウスの中、蛋白尿症のマウス(>0.3g/l尿)を定め、纏めてプロットした。
AIAは、リウマチ様関節炎についての公認の動物モデルである。炎症反応は、関節内への抗原の侵入によって触発される。治療は、1週間毎に可溶性FcγR IIb 100μgで腹腔内で行なった(IP)。(Waksman, B.H., Immune regulation in adjuvant disease and other arthritis models: relevance to pathogenesis of chronic arthritis,2002, Scand. J. Immunol. 56(1); 12-34; Holmdahl, R., Lorentzen, J. C., Lu, S., Olofsson, P., Wester, L., Holmberg, J. & Pettersson, U., 2001, Arthritis induced in rats wih nonimmunogenic adjuvants as models for etheumatoid arthritis, Immunol, Rev, 184: 184-202参照)。
IK肺胞炎は、高い1K負荷に付随して現れる炎症性疾患についての公認の動物モデルである。誘発のために、マウスに抗原を腹腔内(IP)で注射し、この抗原に向けて抗体を気管内に(IT)投与した。その結果として、炎症反応を生じる免疫複合体が肺内に形成される。好中球(PMN)の浸入および出血を評価する。抗原と抗体とからなる前成形された免疫複合体ITを投与する場合には、前記動物モデル中での反応は、なお強化させることができる。FcγR IIb IP 100μgの同時の投与は、炎症反応を殆んど完全に抑制する。(Tanoue, M., Yoshizawa, Y., Sato, T., Yano, H., Kimura, Y. & Miyamoto, K., 1993, The role of complement-derived chemotactic factors in lung injury induced by preformed immune complexes. Int. Arch. Allergy Immunol. 101(1): 47-51; Yoshizawa, Y., Tanoue, M., Yano, H., Sato, T., Ohtsuka, M., Hasegawa, S. & Kimula, Y.1991, Sequential change in lung injury induced by preformed immune complexes. Clin. Immunol. Immunopathol. 61(3): 376-396参照)。
Claims (7)
- 過剰の免疫反応および自己抗体の病的に増殖された形成によって惹起された疾病または状態を治療するための水溶液の形の医薬品組成物において、該医薬品組成物が真核または原核の発現系からなる、組換えにより得られた可溶性のFcγR IIbを40〜4000mgの量および50mg/mlまでの濃度で含有し、および前記医薬品組成物が注射溶液の形で存在することを特徴とする、過剰の免疫反応および自己抗体の病的に増殖された形成によって惹起された疾病または状態を治療するための水溶液の形の医薬品組成物。
- 該医薬品組成物が真核または原核の発現系からなる、組換えにより得られた可溶性のFcγR IIbを100〜1000mgの量および50mg/mlまでの濃度で含有する、請求項1記載の医薬品組成物。
- 該医薬品組成物が他の製薬学的に認容性の助剤および/または担持剤を含有する、請求項1または2記載の医薬品組成物。
- 多発性硬化症、全身性紅斑性狼そう、リウマチ様関節炎または高められた数のNK細胞に付随して現れる流産を治療するための、請求項1から3までのいずれか1項に記載の医薬品組成物。
- 前記医薬品組成物がSEQ ID NO.1に記載のFcγR IIbまたは野生型の蛋白質の適当な配列を有するN末端および/またはC末端で延長された形を含有する、請求項1から4までのいずれか1項に記載の医薬品組成物。
- 野生型の蛋白質の配列を有するN末端および/またはC末端で延長された形がSEQ ID NO.3である、請求項5記載の医薬品組成物。
- 前記医薬品組成物が野生型の蛋白質の配列を有するN末端および/またはC末端で延長された形を含有し、その際、抗原性が惹起されない限り、延長された配列中に突然変異または欠失は導入されてもよい、請求項5記載の医薬品組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10157290.5 | 2001-11-22 | ||
DE10157290A DE10157290A1 (de) | 2001-11-22 | 2001-11-22 | Pharmazeutische Zusammensetzung enthaltend sFcRgamma IIb oder sFcRgamma III |
PCT/EP2002/013080 WO2003043648A2 (de) | 2001-11-22 | 2002-11-21 | Sfcyr iib oder sfcyr iii für die behandlung von autoimmunkrankheiten |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2005515981A JP2005515981A (ja) | 2005-06-02 |
JP2005515981A5 JP2005515981A5 (ja) | 2006-01-19 |
JP5414959B2 true JP5414959B2 (ja) | 2014-02-12 |
Family
ID=7706571
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2003545329A Expired - Lifetime JP5414959B2 (ja) | 2001-11-22 | 2002-11-21 | sFcγRIIbまたはsFcγRIIIを含有する医薬品組成物 |
Country Status (10)
Country | Link |
---|---|
US (2) | US20050002924A1 (ja) |
EP (1) | EP1446139B1 (ja) |
JP (1) | JP5414959B2 (ja) |
AT (1) | ATE409045T1 (ja) |
AU (1) | AU2002366200A1 (ja) |
CA (1) | CA2506068C (ja) |
CO (1) | CO5590936A2 (ja) |
DE (2) | DE10157290A1 (ja) |
ES (1) | ES2309238T3 (ja) |
WO (1) | WO2003043648A2 (ja) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1709073B1 (en) * | 2003-11-26 | 2011-08-10 | Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. | SUBSTANCE BINDING HUMAN IgG Fc RECEPTOR IIb (FcgammaRIIb) |
US10028998B2 (en) | 2012-10-30 | 2018-07-24 | Suppremol Gmbh | Method for treating an inflammatory disease and/or an autoimmune disease with a soluble FcγRIIb |
US10669324B2 (en) | 2012-10-30 | 2020-06-02 | Suppremol Gmbh | Vector encoding an Fc gamma receptor IIB protein and composition of the encoded protein |
EP2914623B1 (en) | 2012-10-30 | 2016-12-28 | SuppreMol GmbH | A pharmaceutical composition for use in treating or preventing either one or both of an inflammatory disease and an autoimmune disease |
AU2012244302B2 (en) * | 2012-10-31 | 2014-08-21 | Suppremol Gmbh | A method for treating or preventing either one or both of an inflammatory disease and an autoimmune disease |
EP2796144A1 (en) | 2013-04-26 | 2014-10-29 | SuppreMol GmbH | Highly concentrated Formulations of soluble Fc receptors |
EP2833139A1 (en) * | 2013-08-01 | 2015-02-04 | SuppreMol GmbH | In vitro method for determining the stability of compositions comprising soluble Fc gamma receptor(s) |
EP2837637A1 (en) | 2013-08-16 | 2015-02-18 | SuppreMol GmbH | Novel anti-FcyRIIB IgG-type antibody |
JP6893223B2 (ja) * | 2013-10-16 | 2021-06-23 | ズプレモル ゲーエムベーハー | 医薬品組成物およびキット |
CA2927263C (en) * | 2013-10-16 | 2022-12-13 | Suppremol Gmbh | Soluble fc gamma receptor for treatment of autoimmune bullous diseases |
JP2018050616A (ja) | 2016-09-23 | 2018-04-05 | 東ソー株式会社 | 改良型組換えFcγRII |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1053255A4 (en) * | 1998-02-06 | 2003-01-02 | Ilexus Pty Ltd | THREE-DIMENSIONAL STRUCTURES AND MODELS OF Fc RECEPTORS, AND USES THEREOF |
EP1006183A1 (en) * | 1998-12-03 | 2000-06-07 | Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. | Recombinant soluble Fc receptors |
EP1201681A1 (en) * | 2000-10-30 | 2002-05-02 | Millennium Pharmaceuticals, Inc. | "Fail" molecules and uses thereof |
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2001
- 2001-11-22 DE DE10157290A patent/DE10157290A1/de not_active Withdrawn
-
2002
- 2002-11-21 WO PCT/EP2002/013080 patent/WO2003043648A2/de active IP Right Grant
- 2002-11-21 AU AU2002366200A patent/AU2002366200A1/en not_active Abandoned
- 2002-11-21 JP JP2003545329A patent/JP5414959B2/ja not_active Expired - Lifetime
- 2002-11-21 DE DE50212814T patent/DE50212814D1/de not_active Expired - Lifetime
- 2002-11-21 CA CA2506068A patent/CA2506068C/en not_active Expired - Lifetime
- 2002-11-21 ES ES02803402T patent/ES2309238T3/es not_active Expired - Lifetime
- 2002-11-21 AT AT02803402T patent/ATE409045T1/de active
- 2002-11-21 EP EP02803402A patent/EP1446139B1/de not_active Expired - Lifetime
-
2004
- 2004-05-24 US US10/851,655 patent/US20050002924A1/en not_active Abandoned
- 2004-06-18 CO CO04057552A patent/CO5590936A2/es not_active Application Discontinuation
-
2008
- 2008-01-09 US US11/971,438 patent/US20080214459A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
US20050002924A1 (en) | 2005-01-06 |
CA2506068A1 (en) | 2003-05-30 |
JP2005515981A (ja) | 2005-06-02 |
ATE409045T1 (de) | 2008-10-15 |
DE10157290A1 (de) | 2003-06-05 |
WO2003043648A2 (de) | 2003-05-30 |
CO5590936A2 (es) | 2005-12-30 |
ES2309238T3 (es) | 2008-12-16 |
AU2002366200A8 (en) | 2003-06-10 |
US20080214459A1 (en) | 2008-09-04 |
EP1446139B1 (de) | 2008-09-24 |
WO2003043648A3 (de) | 2004-01-08 |
DE50212814D1 (de) | 2008-11-06 |
EP1446139A2 (de) | 2004-08-18 |
CA2506068C (en) | 2011-09-20 |
AU2002366200A1 (en) | 2003-06-10 |
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