JP2011529064A - 閉経期、ホルモン変動および関節炎と関連する症状を治療するための組成物および方法 - Google Patents
閉経期、ホルモン変動および関節炎と関連する症状を治療するための組成物および方法 Download PDFInfo
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Abstract
Description
本願は、2008年7月22日に出願された米国仮特許出願第61/082,761号の優先権の利益を主張し、この米国仮特許出願の全体の内容は、本明細書中に参考として援用される。
本発明の実施は、特に明記しない限り、当業者に周知の分子生物学(組換え技術を含む)、微生物学、細胞生物学、生化学、核酸化学、および免疫学の従来の技術を利用する。そのような技術は、Molecular Cloning:A Laboratory Manual,第2版(Sambrook等,1989)、およびMolecular Cloning:A Laboratory Manual,第3版(SambrookおよびRussel,2001),(本明細書においては共に「Sambrook」と言及);Current Protocols in Molecular Biology(F.M.Ausubel等編,1987,2001年中の補遺を含む);PCR:The Polymerase Chain Reaction,(Mullis等編,1994);HarlowおよびLane(1988)Antibodies,A Laboratory Manual,Cold Spring Harbor Publications,New York;HarlowおよびLane(1999)Using Antibodies:A Laboratory Manual Cold Spring Harbor Laboratory Press,Cold Spring Harbor,NY(本明細書においては共に「HarlowおよびLane」と言及),Beaucage等編,Current Protocols in Nucleic Acid Chemistry John Wiley & Sons,Inc.,New York,2000);Casarett and Doull’s Toxicology The Basic Science of Poisons,C.Klaassen編,第6版(2001),およびVaccines,S.PlotkinおよびW.Orenstein編,第3版(1999)等の文献に十分に説明されている。別の断りがない限り、本明細書において用いられる専門用語および科学用語は、本発明が属する技術分野の当業者により一般に理解されるのと同じ意味を有する。
本明細書を解釈する上では、以下の定義があてはまり、単数形で使用される用語には適宜複数形を含み、逆も同様である。下記の定義のいずれかが、参照により本明細書に組み込まれるいずれかの文書と矛盾する場合には、下記の定義が優先するものとする。
本発明は、必要な個体に有効量の顆粒球コロニー刺激因子(G‐CSF)を投与することにより、その個体において、閉経期、ホルモン変動、および/または関節炎と関連する症状を治療および/または改善する方法を提供する。
コロニー刺激因子は、特定の細胞表面受容体と結合して、増殖、分化関与、およびいくつかの終末細胞機能活性化を刺激することにより造血細胞に作用する糖タンパク質類である。G‐CSFは系統特異的コロニー刺激因子であり、単核細胞、繊維芽細胞、および血管内皮細胞により産生される。それは、骨髄中の好中球の産生を調節し、好中球前駆体の増殖および分化に影響する。さらに、G‐CSFは、抗体媒介性細胞障害活性によりin vitroで腫瘍細胞を殺す好中球の能力を著しく増加させうる(Souza等,Science 232:61‐65(1986))。
本発明の方法を実施する上で、G‐CSFは、閉経期、ホルモン変動および関節炎と関連する痛みおよび/または不快感の改善等の治療的利益を達成するのに有効な量(例えば治療上有効量)で典型的に投与される。臨床医等の当業者は、個体の体重および既往等の周知のパラメータに基づいて、治療上有効量である量を決定するのを助けうる。
本発明は、閉経期、ホルモン変動または関節炎(例えば骨関節炎)と関連する症状のあるヒト個体用に調製される治療上有効量のG‐CSFを含むキットを提供する。使用指示書が、任意に提供される。キットは、G‐CSFを最も有効な送達(皮下、静脈、非経口、経腸、局所、吸入、経皮等)のために調製される治療量で含みうる。G‐CSFは、一回の使用または複数回の使用を可能にする様式でパッケージされうる。
G‐CSFは閉経期の症状を軽減する
閉経期の症状のある女性の個体に、好中性顆粒球の産生を促進するために、単回用量300mcg(5mcg/kg)のフィルグラスチムを与えた。女性の個体には、フィルグラスチム投与の一週間以内にのぼせ、疲労、睡眠障害、寝汗、関節痛、健忘および気分変動等の閉経期の症状の劇減がもたらされ、それは4〜6週間持続した。
G‐CSFは骨関節炎と関連する症状を軽減する
閉経期の症状および関節炎痛の症状のある女性の個体に、好中性顆粒球の産生を促進するために、単回用量300mcg(5mcg/kg)のフィルグラスチムを与えた。女性の個体には、8〜12週間フィルグラスチムを受けてから一週間以内に、骨関節炎と関連する関節痛腫張および硬直の劇減がもたらされた。
Claims (55)
- 閉経期と関連する症状の治療が必要な個体において、閉経期と関連する症状を治療する方法であり、
前記個体に有効量の顆粒球コロニー刺激因子(G‐CSF)を投与するステップ
を含む、方法。 - 前記閉経期が自然発生的、薬物誘発性、または手術誘発性である、請求項1に記載の方法。
- 個体のホルモン変動と関連する症状を改善する方法であり、
前記個体に有効量の顆粒球コロニー刺激因子(G‐CSF)を投与するステップ
を含む、方法。 - 前記個体が、女性である、請求項3に記載の方法。
- 前記個体が、男性である、請求項3に記載の方法。
- 前記ホルモン変動が、薬物誘発性、手術誘発性、または自然のものである、請求項3に記載の方法。
- 前記治療が、のぼせの頻度を減少させる、請求項1または3に記載の方法。
- 前記G‐CSFが、体重1kgあたり約5mcgの用量で投与される、請求項1または3に記載の方法。
- 前記G‐CSFが、体重1kgあたり約5〜10mcgの用量で投与される、請求項1または3に記載の方法。
- 前記G‐CSFが、体重1kgあたり約2〜10mcgの用量で投与される、請求項1または3に記載の方法。
- 前記G‐CSFが、体重1kgあたり約2〜20mcgの用量で投与される、請求項1または3に記載の方法。
- 前記G‐CSFが、約1〜2ヵ月毎に一回投与される、請求項1または3に記載の方法。
- 前記G‐CSFが、約2〜3ヵ月毎に一回投与される、請求項1または3に記載の方法。
- 前記G‐CSFが、約3〜4ヵ月毎に一回投与される、請求項1または3に記載の方法。
- 前記G‐CSFが、皮下または静脈内投与される、請求項1または3に記載の方法。
- 前記G‐CSFが、非経口的に、経腸的に、局所的に、または吸入により、投与される、請求項1または3に記載の方法。
- 前記G‐CSFが、市販の組成物フィルグラスチム、ペグフィルグラスチム、またはレノグラスチムにおいて調製される、請求項1または3に記載の方法。
- 前記G‐CSFが、G‐CSFと薬学的に許容可能な担体とを含む医薬組成物に存在する、請求項1または3に記載の方法。
- 関節炎と関連する一つ以上の症状の治療が必要な個体において、関節炎と関連する一つ以上の症状を治療する方法であり、
前記個体に有効量の顆粒球コロニー刺激因子(G‐CSF)を投与するステップ
を含む、方法。 - 前記個体が、閉経期にある女性である、請求項19に記載の方法。
- 前記閉経期が、自然発生的、薬物誘発性、または手術誘発性である、請求項20に記載の方法。
- 前記個体が、ホルモン変動のある男性である、請求項19に記載の方法。
- 前記関節炎が、骨関節炎である、請求項19に記載の方法。
- 前記治療が、前記関節炎と関連する一つ以上の症状を改善し、前記症状が、関節痛、関節機能制限、関節硬直、腫張、赤みおよび温覚からなる群より選択される、請求項19に記載の方法。
- 前記治療が、前記関節炎と関連する一つ以上の症状を改善し、前記症状が、熱、腺腫張、体重減少および疲労からなる群より選択される、請求項19に記載の方法。
- 前記治療が、個体の関節痛を減少させる、請求項19に記載の方法。
- 前記G‐CSFが、体重1kgあたり約5mcgの用量で投与される、請求項19に記載の方法。
- 前記G‐CSFが、体重1kgあたり約5〜10mcgの用量で投与される、請求項19に記載の方法。
- 前記G‐CSFが、体重1kgあたり約2〜10mcgの用量で投与される、請求項19に記載の方法。
- 前記G‐CSFが、体重1kgあたり約2〜20mcgの用量で投与される、請求項19に記載の方法。
- 前記G‐CSFが、約1〜2ヵ月毎に一回投与される、請求項19に記載の方法。
- 前記G‐CSFが、約2〜3ヵ月毎に一回投与される、請求項19に記載の方法。
- 前記G‐CSFが、約3〜4ヵ月毎に一回投与される、請求項19に記載の方法。
- 前記G‐CSFが、皮下または静脈内投与される、請求項19に記載の方法。
- 前記G‐CSFが、非経口的に、経腸的に、局所的に、または吸入により、投与される、請求項19に記載の方法。
- 前記G‐CSFが、市販の組成物フィルグラスチム、ペグフィルグラスチム、またはレノグラスチムにおいて調製される、請求項19に記載の方法。
- 前記G‐CSFが、G‐CSFと薬学的に許容可能な担体とを含む医薬組成物に存在する、請求項19に記載の方法。
- 閉経期の症状と関連する不快感または痛みの軽減が必要な個体において、閉経期の症状と関連する不快感または痛みを軽減する方法であり、
前記個体に有効量の顆粒球コロニー刺激因子(G‐CSF)を投与するステップ
を含む、方法。 - 前記閉経期の症状が、薬物誘発性、手術誘発性、または自然のものである、請求項38に記載の方法。
- ホルモン変動により生じる症状と関連する不快感または痛みの軽減が必要な個体において、ホルモン変動により生じる症状と関連する不快感または痛みを軽減する方法であり、
前記個体に有効量の顆粒球コロニー刺激因子(G‐CSF)を投与するステップ
を含む、方法。 - 前記個体が、男性である、請求項40に記載の方法。
- 前記個体が、女性である、請求項40に記載の方法。
- 前記ホルモン変動が、薬物誘発性、手術誘発性、または自然のものである、請求項40に記載の方法。
- 関節炎と関連する不快感または痛みの軽減が必要な個体において、関節炎と関連する不快感または痛みを軽減する方法であり、
前記個体に有効量の顆粒球コロニー刺激因子(G‐CSF)を投与するステップ
を含む、方法。 - 前記G‐CSFが、体重1kgあたり約5mcgの用量で投与される、請求項38、40または44に記載の方法。
- 前記G‐CSFが、体重1kgあたり約5〜10mcgの用量で投与される、請求項38、40または44に記載の方法。
- 前記G‐CSFが、体重1kgあたり約2〜10mcgの用量で投与される、請求項38、40または44に記載の方法。
- 前記G‐CSFが、体重1kgあたり約2〜20mcgの用量で投与される、請求項38、40または44に記載の方法。
- 前記G‐CSFが、約1〜2ヵ月毎に一回投与される、請求項38、40または44に記載の方法。
- 前記G‐CSFが、約2〜3ヵ月毎に一回投与される、請求項38、40または44に記載の方法。
- 前記G‐CSFが、約3〜4ヵ月毎に一回投与される、請求項38、40または44に記載の方法。
- 前記G‐CSFが、皮下または静脈内投与される、請求項38、40または44に記載の方法。
- 前記G‐CSFが、非経口的に、経腸的に、局所的に、または吸入により、投与される、請求項38、40または44に記載の方法。
- 前記G‐CSFが、市販の組成物フィルグラスチム、ペグフィルグラスチムまたはレノグラスチムにおいて調製される、請求項38、40または44に記載の方法。
- 前記G‐CSFが、G‐CSFと薬学的に許容可能な担体とを含む医薬組成物に存在する、請求項38、40または44に記載の方法。
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JPN6013051288; 佐藤攻ら: 日本病理学会会誌 Vol.92, No.1, 2003, p.224 * |
JPN6013051290; T. Oda et al.: J. Orthop. Sci. Vol.10, 2005, p.70-76 * |
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IL210761A0 (en) | 2011-03-31 |
EP2323688B1 (en) | 2018-10-17 |
WO2010011767A3 (en) | 2011-07-07 |
US20120014910A1 (en) | 2012-01-19 |
WO2010011767A2 (en) | 2010-01-28 |
CN102223893A (zh) | 2011-10-19 |
US9216206B2 (en) | 2015-12-22 |
CA2731827A1 (en) | 2010-01-28 |
WO2010011767A8 (en) | 2011-03-03 |
CA2731827C (en) | 2017-11-07 |
AU2009274022B2 (en) | 2016-06-02 |
AU2009274022A1 (en) | 2010-01-28 |
EP2323688A2 (en) | 2011-05-25 |
JP5667565B2 (ja) | 2015-02-12 |
JP2014198731A (ja) | 2014-10-23 |
IL210761A (en) | 2017-10-31 |
CN102223893B (zh) | 2014-07-16 |
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