JP5291878B2 - 治療的免疫のためのコポリマー1を含む点眼ワクチン - Google Patents
治療的免疫のためのコポリマー1を含む点眼ワクチン Download PDFInfo
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Description
材料及び方法
(i)動物。純系成体雄性Lewisラット及びSprague−Dawley(SPD)ラット(8週齢;平均体重300g)はAnimal Breeding Center at The Weizmann Institute of Science(Rehovot、Israel)によって供給された。ラットを光及び温度制御室で維持し、各実験前に齢及び体重について一致させた。すべての動物を、IACUC(International Animal Care and Use Committee)によって作成された規則に従って取り扱った。
以前の研究は、アジュバント中で乳化されたCop1がIOP誘導性のRGCの死に対して保護することを示した。ここで、本発明者らは、その効果が慢性モデルにおいて長期的に持続するか否かを試験した。
Cop−1は複数のエピトープを有する高分子量化合物であるので、本発明者らは、それがアジュバントを伴わない場合でさえ免疫原性であり得る可能性を考慮した。
Cop−1の効果が確かに免疫媒介性であり、かつ局所的薬物として作用しないことを確認するために、本発明者らは、IOPが上昇した、T細胞枯渇している動物にCop−1を投与した。
Cop−1治療はT細胞媒介され、本発明者らはアジュバントを伴わない単回注射が保護を示すために十分であることを上記で示したので、ここで本発明者らは、アジュバントを伴わない点眼剤としてCop−1を使用する可能性を探索した。点眼剤の約10%が血液中に入っていくと仮定して、本発明者らは、5mgのCop−1(皮下的に与えられた場合に活性であることが見出されている最適量500μgの10倍)に等価な点眼剤を適用した。Cop−1点眼剤を、慢性モデルにおいてIOP上昇の直後(図4A)又は7日後(図4B)のいずれかに与えた。点眼剤を用いるCop−1保護は、皮下的に与えた場合に、同様に効果的であった。これは、圧力上昇の3週間後に評価した(p<10−5;103 RGC対150 RGC)。
慢性IOPの結果は、緑内障の急性モデルにおいてCop−1がRGCのIOP誘導性損失から保護し得るか否かを試験するよう本発明者らを促した。
Aharoni R.、Teitelbaum D.、Armon R.、Sela M.。コポリマー1は移植拒絶の徴候を阻害する(Copolymer 1 inhibits manifestation of graft rejection)。Transplantation 27、598(2001)
Bakalash,S.、Kipnis,J.、Yoles,E.及びSchwartz,M.。眼圧の増加に対する網膜神経節細胞の抵抗性は免疫依存性である(Resistance of retinal ganglion cells to an increase in intraocular pressure is immune−dependent)。Invest.Ophthalmol.Vis.Sci.43、2648−2653(2002)
Fridkis−Hareli M、Neveu JM、Robionson RA、Lane WS、Gauthier L、Wucherpfennig KW、Sela M、Strominger JL。多発性硬化症及び関節リウマチに関連するHLA−DR分子に対するコポリマー1の結合モチーフ(Binding motifs of copolymer 1 to multiple sclerosis− and rheumatoid arthritis−associated HLA−DR molecules)。J Immunol.162(8):4697−4704(1999)
Fridkis−Hareli M、Santambrogio L.、Stern JN、Fugger L、Brosnan C、Strominger JL。自己抗原特異的T細胞応答を阻害しかつ実験的自己免疫脳脊髄炎を抑制する、新規な合成アミノ酸コポリマー(Novel synthetic amino acid copolymers that inhibit autoantigen−specific T cell responses and suppress experimental autoimmune encephalomyelitis)。J Clin Invest 109(12):1635−1643(2002)
Hauben,E.、Nevo,U.、Yoles,E.、Moalem,G.、Agramov,E.、Mor,F.、Akselrod,S.、Neeman,M.、Cohen,I.R.、及びSchwartz,M.。脊髄損傷のための潜在的神経保護治療としての自己免疫T細胞(Autoimmune T cells as potential neuroprotective therapy for spinal cord injury)。Lancet 355:286−287(2000)
Jia,L.、Cepurna,W.O.、Johnson,E.C.及びMorrison,J.C.。ラットにおける眼房水流出閉塞後の眼圧上昇のパターン(Patterns of intraocular pressure elevation after aqueous humor outflow obstruction in rats)。Invest.Ophthalmol.Vis.Sci.41、1380−1385(2000a)
Jia,L.、Cepurna,W.O.、Johnson,E.C.及びMorrison,J.C.。実験的眼房水流出閉塞を有するラットにおけるIOPに対する一般的麻酔剤の効果(Effect of general anesthetics on IOP in rats with experimental aqueous outflow obstruction)。Invest.Ophthalmol.Vis.Sci.41、3415−3419(2000b)
Kipnis,J.及びSchwartz,M.。自己免疫疾患の治療剤及びCNS損傷後の保護的自己免疫のためのワクチンとしての酢酸グラチラマー(Cop−1)の2重作用(Dual Action of Glatiramer Acetate(Cop−1)as a Treatment for Autoimmune Diseases and a Vaccine for Protective Autoimmunity after CNS Injury)。Trends Mol.Med.8、319−323(2002)
Kipnis,J、Yoles E、Porat Z、Cohen A、Mor F、Sela M、Cohen IR、Schwartz M.。コポリマー1に対するT細胞免疫は損傷した視神経に神経保護を付与する:視神経障害のための治療の可能性(T cell immunity to copolymer 1 confers neuroprotection on the damaged optic nerve:possible therapy for optic neuropathies)。Proc.Natl.Acad.Sci.USA 97、7446−7451、(2001)
Kipnis,J、Yoles E、Schori H、Hauben E、Shaked I、Schwartz M.。CNS損傷後のニューロン生存は遺伝子にコードされた自己免疫応答によって決定される(Neuronal survival after CNS insult is determined by a genetically encoded autoimmune response)。J.Neurosci.21、4564−4571、(2001)
Levkovitch−Verbin H、Quigley HA、Martin KR、Valenta D、Baumrind LA、Pease ME。ラットにおける緑内障のモデルとしての小柱網への縁を横切ったレーザー光凝固(Translimbal laser photocoagulation to the trabecular meshwork as a model of glaucoma in rats)。Invest.Ophthalmol.Vis.Sci.43、402−410、(2002)
Mizrahi,T.、Hauben,E.及びSchwartz,M.。組織特異的自己病原体は保護的自己抗原である:ブドウ膜炎の場合(The tissue−specific self−pathogen is the protective self−antigen:The case of uveitis)。J.Immunol.169、5971−5977(2002)
Moalem,G.、Leibowitz−Amit R、Yoles E、Mor F、Cohen IR、Schwartz M。自己免疫T細胞は中枢神経系軸索切断後の二次的変性からニューロンを保護する(Autoimmune T Cells Protect neurons from secondary degeneration after central nervous system axotomy)。Nat.Med.5、49−55(1999)
Mukibi−Muka G、Jones RC、Kibenge FS。異なる経路を通してレオウイルスを摂取したニワトリの血清学的応答及びウイルスの脱落(Serological response and virus shedding of chickens inoculated with reovirus via different routes)。Res Vet Sci 37(2):227−9(1984)
Russell PH、Mackie A。点眼DNAはニワトリの涙液及び胆液中でIgAを誘導し得る(Eye−drop DNA can induce IgA in the tears and bile of chickens)。Vet Immunol Immunopathol 80(3−4):327−32(2001)
Schlegel PG、Aharoni Rら。クラスII MHC分子に不規則に結合する合成ランダムコポリマーは主要又は主要でない組織適合抗原に対するT細胞増殖性応答をインビトロで阻害し、かつインビボにおけるマウス移植片対宿主病を予防する能力を付与する(A synthetic random copolymer with promiscuous binding to class II MHC molecules inhibits T−Cell proliferative response to major and minor histocompatibility antigens in vitro and confers the capacity to prevent murine graft−versus−host disease in vivo)。Proc.Natl.Acad.Sci.USA、93、5061(1996)
Schori,H.、J.Kipnis、E.Yoles、E.WoldeMussie、G.Ruiz、L.A.Wheeler、及びM.Schwartz。グルタミン酸細胞毒性及び高眼圧症からの死に対する網膜神経節細胞の保護のためのワクチン接種:緑内障についての関連(Vaccination for protection of retinal ganglion cells against death from glutamate cytotoxicity and ocular hypertension:implications for glaucoma)。Proc.Natl.Acad.Sci.USA 98、3398−3403.(2001)
Schori,H.、Lantner,F.、Shachar,I.及びSchwartz,M.。重篤な免疫欠損はグルタミン感受性マウス及びグルタミン抵抗性マウスにおいてニューロン生存に対して反対の効果を有する:B細胞の副作用(Severe immunodeficiency has opposite effects on neuronal survival in glutamate−susceptible and −resistant mice:Adverse effect of B cells)。J.Immunol.169、2861−2865(2002)
Schwartz,M.、Belkin,M.、Yoles,E.及びSolomon,A.。緑内障性神経障害のための潜在的治療様式:神経保護及び神経再生(Potential treatment modalities for glaucomatous neuropathy:neuroprotection and neuroregeneration)。J.Glaucoma 5、427−432(1996)
Schwartz,M.及びKipnis,J.。保護的自己免疫を維持することの失敗の副産物としての多発性硬化症:パラダイムシフト(Multiple sclerosis as a by−product of the failure to sustain protective autoimmunity:A paradigm shift)。The Neuroscientist 8、405−413(2002)
Schwartz,M.及びYoles,E.。神経保護:緑内障のための新たな治療様式?(Neuroprotection:a new treatment modality for glaucoma?)Curr.Opin.Ophthalmol.11、107−111(2000a)。
Schwartz,M.及びYoles,E.。損傷した視神経における自己破壊的プロセス及び自己保護プロセス:緑内障についての関連(Self−destructive and self−protective processes in the damaged optic nerve:implications for glaucoma)。Invest.Ophthalmol.Vis.Sci.41、349−351(2000b)
Sharma JM.。家禽のワクチン及び免疫についての序論(Introduction to poultry vaccines and immunity)。Adv.Vet.Med.41、481−94(1999)
Yoles E、Hauben E、Palgi O、Agranov E、Gothilf A、Cohen A、Kuchroo V、Cohen IR、Weiner H、Schwartz M。保護的自己免疫はCNS外傷に対する生理学的応答である(Protective autoimmunity is a physiological response to CNS trauma)。J.Neurosci.21、3740−3748(2001)
Claims (1)
- アジュバントを伴わないコポリマー1を含む、全身性の神経保護を付与しそれによって緑内障患者に治療的免疫を付与するための点眼ワクチン。
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US43831003P | 2003-01-07 | 2003-01-07 | |
US60/438,310 | 2003-01-07 | ||
PCT/IL2004/000006 WO2004060265A2 (en) | 2003-01-07 | 2004-01-06 | Eye-drop vaccine containing copolymer 1 for therapeutic immunization |
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JP2006515870A JP2006515870A (ja) | 2006-06-08 |
JP2006515870A5 JP2006515870A5 (ja) | 2007-03-01 |
JP5291878B2 true JP5291878B2 (ja) | 2013-09-18 |
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JP2006500369A Expired - Fee Related JP5291878B2 (ja) | 2003-01-07 | 2004-01-06 | 治療的免疫のためのコポリマー1を含む点眼ワクチン |
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EP (1) | EP1583506B1 (ja) |
JP (1) | JP5291878B2 (ja) |
CN (2) | CN1758922A (ja) |
AT (1) | ATE548045T1 (ja) |
AU (1) | AU2004203772B2 (ja) |
CA (1) | CA2512735C (ja) |
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HK (1) | HK1084034A1 (ja) |
IL (1) | IL169552A (ja) |
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EP2046366B1 (en) * | 2006-06-28 | 2016-08-31 | Yeda Research And Development Company Limited | Copolymer-1 for treatment of age-related macular degeneration |
US8193147B2 (en) | 2007-09-24 | 2012-06-05 | Hadasit Medical Research Services & Development Ltd. | Use of copolymer 1 for treatment of muscular dystrophy |
WO2010019839A1 (en) * | 2008-08-15 | 2010-02-18 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Methods for using interferon gamma to absorb fluid from the subretinal space |
WO2011060104A2 (en) | 2009-11-10 | 2011-05-19 | Allegro Pharmaceuticals, Inc. | Compositions and methods for inhibiting cellular adhesion or directing diagnostic or therapeutic agents to rgd binding sites |
US11673914B2 (en) | 2009-11-10 | 2023-06-13 | Allegro Pharmaceuticals, LLC | Peptide therapies for reduction of macular thickening |
USRE49251E1 (en) | 2010-01-04 | 2022-10-18 | Mapi Pharma Ltd. | Depot systems comprising glatiramer or pharmacologically acceptable salt thereof |
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 |
ES2602977T3 (es) | 2010-10-11 | 2017-02-23 | Teva Pharmaceutical Industries Ltd. | Biomarcadores de citocinas como biomarcadores predictivos de la respuesta clínica para acetato de glatirámero |
ES2601892T3 (es) | 2011-04-21 | 2017-02-16 | Mapi Pharma Limited | Pentapolímero aleatorio para el tratamiento de enfermedades autoinmunes |
EA201490749A1 (ru) | 2011-10-10 | 2014-09-30 | Тева Фармасьютикал Индастриз Лтд. | Однонуклеотидные полиморфизмы, полезные для прогнозирования клинической реакции на глатирамера ацетат |
US9611314B2 (en) | 2013-09-13 | 2017-04-04 | The Penn State Research Foundation | Functional peptide analogs of PEDF |
CN106491614A (zh) * | 2016-12-06 | 2017-03-15 | 郑州郑先医药科技有限公司 | 一种用于治疗脊髓损伤的西药组合及用途 |
CA3050904A1 (en) * | 2017-01-19 | 2018-07-26 | Hampar L. Karageozian | Therapeutic and neuroprotective peptides |
WO2018178973A1 (en) | 2017-03-26 | 2018-10-04 | Mapi Pharma Ltd. | Glatiramer depot systems for treating progressive forms of multiple sclerosis |
AU2019232730A1 (en) | 2018-03-05 | 2020-10-01 | The Schepens Eye Research Institute, Inc. | A therapy for glaucoma and optic neuropathy by targeting colony stimulating factors |
US20230181458A1 (en) * | 2020-04-30 | 2023-06-15 | Jeffrey E. Koziol | Micro dosing of viral vaccines |
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JP2955314B2 (ja) | 1988-10-27 | 1999-10-04 | リージェンツ・オブ・ザ・ユニバーシティー・オブ・ミネソタ | Il―2含有リポソーム免疫アジュバント |
IL104382A0 (en) | 1992-01-17 | 1993-05-13 | Solvay Animal Health Inc | Vaccine containing acemannan as an adjuvant |
US5571515A (en) * | 1994-04-18 | 1996-11-05 | The Wistar Institute Of Anatomy & Biology | Compositions and methods for use of IL-12 as an adjuvant |
US5800808A (en) | 1994-05-24 | 1998-09-01 | Veda Research And Development Co., Ltd. | Copolymer-1 improvements in compositions of copolymers |
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 |
US6153182A (en) * | 1997-12-19 | 2000-11-28 | Uab Research Foundation | Lymphotactin as an adjuvant |
EP1054880A1 (en) * | 1998-02-13 | 2000-11-29 | Autoimmune, Inc. | TREATMENT OF MULTIPLE SCLEROSIS USING COP-1 AND Th2-ENHANCING CYTOKINES |
US6616925B1 (en) * | 1998-04-02 | 2003-09-09 | I.D.M. Immuno-Designed Molecules | Combined preparation for the treatment of neoplasic diseases or of infectious diseases |
WO2000045847A1 (en) * | 1999-02-05 | 2000-08-10 | Alk-Abelló A/S | Novel mucosal delivery system |
ES2605109T3 (es) * | 1999-08-24 | 2017-03-13 | Abic Biological Laboratories Ltd. | Composición de vacuna y procedimiento de uso de la misma |
MXPA02007106A (es) * | 2000-01-20 | 2002-12-13 | Mcinnis Patricia A | El uso del copolimero 1 y peptidos y polipeptidos relacionados y celulas t tratadas con estos para terapia neuroprotectora. |
NZ520282A (en) | 2000-06-07 | 2004-09-24 | Yeda Res & Dev | The use of copolymer 1 and related peptides and polypeptides and T cells treated therewith for neuroprotective therapy |
SI1429800T1 (sl) * | 2001-12-06 | 2009-08-31 | Yeda Res & Dev | Cepivo in njegova uporaba za zdravljenje amiotrofiäśne lateralne skleroze |
KR20060090715A (ko) * | 2003-09-29 | 2006-08-14 | 추가이 세이야쿠 가부시키가이샤 | Nk 세포에 발현하는 단백질 |
JP4501562B2 (ja) | 2004-07-09 | 2010-07-14 | 旭硝子株式会社 | 積層膜付き基材およびその製造方法 |
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WO2004060265A2 (en) | 2004-07-22 |
US20070248569A1 (en) | 2007-10-25 |
CN102580069A (zh) | 2012-07-18 |
EP1583506A4 (en) | 2009-01-07 |
CN1758922A (zh) | 2006-04-12 |
CN102580069B (zh) | 2015-09-30 |
ATE548045T1 (de) | 2012-03-15 |
EP1583506A2 (en) | 2005-10-12 |
CA2512735A1 (en) | 2004-07-22 |
US8895501B2 (en) | 2014-11-25 |
MXPA05007329A (es) | 2005-09-30 |
AU2004203772A1 (en) | 2004-07-22 |
JP2006515870A (ja) | 2006-06-08 |
US20090214470A1 (en) | 2009-08-27 |
AU2004203772B2 (en) | 2009-07-16 |
WO2004060265A3 (en) | 2005-09-22 |
ES2386435T3 (es) | 2012-08-21 |
EP1583506B1 (en) | 2012-03-07 |
HK1084034A1 (en) | 2006-07-21 |
CA2512735C (en) | 2016-03-08 |
IL169552A (en) | 2012-05-31 |
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