JP2019510047A - 神経の過剰興奮を治療するための方法および組成物 - Google Patents
神経の過剰興奮を治療するための方法および組成物 Download PDFInfo
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Abstract
Description
本出願は、その全体の内容が参照により本明細書に組み入れられる、2016年3月28日に出願された米国特許出願第62/314,128号に基づいて、米国特許法(35 U.S.C.)第119条(e)の下における優先権の恩典を主張する。
本発明は、米国国立衛生研究所により付与された助成金第NS051644-02A2号の下での米国政府の支援を受けてなされた。本発明においては米国政府が一定の権利を有する。
本発明は脊髄損傷の治療一般に関連し、より具体的には、外傷性または虚血性の脊髄損傷後の患者における慢性的な痙縮を調節するための併用治療計画に関連する。
(外傷性または虚血性の)脊髄損傷は臨床的に定義付けられた痙縮や硬直の発現をもたらし得る。脊髄損傷後に痙縮の出現を導く発症機序の1つは局所的な分節抑制の減弱であり、その結果として起こる:i)緊張性運動ニューロンの発火の増加、ii)筋肉伸張中の一次求心性インプットの増加、および/またはiii)末梢感覚刺激に対する増悪した反応(即ち異痛)であると考えられる。γ-アミノ酪酸(GABA)仲介性シナプス前抑制、シナプス後の反回抑制および相反性抑制の減弱、ならびに屈筋求心経路におけるその抑制効果の減弱が主要な機構の1つであることが示されている。
本発明は、虚血誘導の痙縮を有するラットにおけるGAD65(グルタミン酸デカルボキシラーゼ)遺伝子およびVGAT(小胞GABA輸送体)遺伝子の脊髄分節特異的なアップレギュレーションからなる併用治療が抗痙縮効果をもたらし、そのような併用治療によって筋痙直が低減するという知見に基づく。
1)アラニン(A)、グリシン(G);
2)アスパラギン酸(D)、グルタミン酸(E);
3)アスパラギン(N)、グルタミン(Q);
4)アルギニン(R)、リシン(K);
5)イソロイシン(I)、ロイシン(L)、メチオニン(M)、バリン(V);
6)フェニルアラニン(F)、チロシン(Y)、トリプトファン(W);
7)セリン(S)、スレオニン(T);および
8)システイン(C)、メチオニン(M)(例えばCreighton, Proteins(1984)を参照のこと)。
。
例えば以下の核酸配列(SEQ ID NO.2)を提供する、Genbankアクセッション番号:X69936、グルタミン酸デカルボキシラーゼ(GAD2/GAD65)についてのホモサピエンスmRNAも参照のこと:
。
。
例えば、以下の核酸配列(SEQ ID NO:4)を提供する、GenBankアクセッション番号:NM_080552、ホモサピエンスsolute carrier family 32 member 1(SLC32A1)mRNAも参照のこと:
。
。例えばMicrobix Biosystems of Toronto, Ontario(例えばMicrobix Product Information Sheet: Plasmids for Adenovirus Vector Construction, 1996を参照のこと。)を含む、商業的供給源からの様々なアデノウイルスプラスミドも利用可能である。
軟膜下送達法を用いてGAD65(グルタミン酸デカルボキシラーゼ65)およびVGAT(小胞GABA輸送体)をコードするAAV9ウイルスを標的分節に注射する(図1)。脊髄損傷誘導の筋痙直を有する動物個体(ラット)を使用した。腰部軟膜下AAV9-UBI-GFP送達後に得られた導入遺伝子発現の分布が図2において示される。灰白質中の介在ニューロンにおける広範囲にわたるGFPの発現が認められる。
Claims (25)
- GAD65(グルタミン酸デカルボキシラーゼ)遺伝子およびVGAT(小胞GABA輸送体)遺伝子をアップレギュレートする段階を含み、それにより対象における痙縮を治療する、対象における痙縮を治療する方法。
- GAD65遺伝子およびVGAT遺伝子のアップレギュレーションがGAD65遺伝子およびVGAT遺伝子の脊髄特異的なアップレギュレーションである、請求項1記載の方法。
- GAD65遺伝子およびVGAT遺伝子のアップレギュレーションが、GAD65およびVGATをコードするポリヌクレオチドを含むウイルスベクターを対象に投与する段階を含み、ここでGAD65およびVGATが発現され、それにより痙縮が低減される、請求項1記載の方法。
- GAD65およびVGATが過剰発現される、請求項3記載の方法。
- 前記ベクターが、レンチウイルスベクター、アデノウイルスベクター(AV)、またはアデノ随伴ベクター(AAV)である、請求項3記載の方法。
- 前記ベクターがレンチウイルスベクターである、請求項5記載の方法。
- 前記ベクターがAAVである、請求項5記載の方法。
- AAVがAAV9である、請求項7記載の方法。
- 前記ウイルスベクターが、対象の脊髄実質に、対象の髄腔内空間に、対象の脊髄軟膜下空間に、または対象の末梢痙直筋肉に直接投与される、請求項3記載の方法。
- 必要とする対象に、GAD65およびVGATをコードするポリヌクレオチドを含むウイルスベクターを治療的有効量で投与する段階を含み、それにより対象における痙縮を治療する、対象における痙縮を治療する方法。
- 前記ベクターが、レンチウイルスベクター、AV、またはAAVである、請求項10記載の方法。
- 前記ベクターがAAVである、請求項11記載の方法。
- AAVがAAV9である、請求項12記載の方法。
- 前記ベクターが、対象の脊髄実質に、対象の髄腔内空間に、対象の脊髄軟膜下空間に、または対象の末梢痙直筋肉に直接投与される、請求項10記載の方法。
- GAD65およびVGATをコードするポリヌクレオチドを含むウイルスベクターを投与する段階を含み、ここでGAD65およびVGATが発現され、それにより脊髄損傷が治療される、脊髄損傷を有する対象を治療するための治療計画。
- GAD65およびVGATが過剰発現される、請求項15記載の治療計画。
- 前記ベクターが、レンチウイルスベクター、AV、またはAAVである、請求項15記載の治療計画。
- 前記ベクターがレンチウイルスベクターである、請求項17記載の治療計画。
- 前記ベクターがAAVである、請求項17記載の治療計画。
- AAVがAAV9である、請求項19記載の治療計画。
- 前記ベクターが、対象の脊髄実質に、対象の髄腔内空間に、対象の脊髄軟膜下空間に、または対象の末梢痙直筋肉に直接投与される、請求項15記載の治療計画。
- GAD65およびVGATをコードするポリヌクレオチドに機能的に連結されたプロモーターを含む、ベクター。
- レンチウイルスベクター、アデノウイルスベクター、およびAAVベクターからなる群より選択されるウイルスベクターである、請求項22記載のベクター。
- AAV9-UBI-GAD65+VGATである、請求項23記載のベクター。
- 請求項22記載のベクターを含有する、単離された哺乳動物宿主細胞。
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US201662314128P | 2016-03-28 | 2016-03-28 | |
US62/314,128 | 2016-03-28 | ||
PCT/US2017/024285 WO2017172606A1 (en) | 2016-03-28 | 2017-03-27 | Method and composition for treating neuronal hyper-excitability |
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JP2019510047A true JP2019510047A (ja) | 2019-04-11 |
JP2019510047A5 JP2019510047A5 (ja) | 2020-05-07 |
JP6949867B2 JP6949867B2 (ja) | 2021-10-13 |
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EP (1) | EP3436427B1 (ja) |
JP (1) | JP6949867B2 (ja) |
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CN (1) | CN108884022B (ja) |
AU (1) | AU2017241534A1 (ja) |
CA (1) | CA3018960C (ja) |
WO (1) | WO2017172606A1 (ja) |
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US10688285B2 (en) | 2015-01-30 | 2020-06-23 | The Regents Of The University Of California | Spinal subpial gene delivery system |
KR102489437B1 (ko) | 2016-03-28 | 2023-01-16 | 더 리젠츠 오브 더 유니버시티 오브 캘리포니아 | 뉴런 과흥분성 치료를 위한 방법 및 조성물 |
KR102640462B1 (ko) * | 2017-09-08 | 2024-02-23 | 더 리젠츠 오브 더 유니버시티 오브 캘리포니아 | 신경병증성 통증의 치료를 위한 방법 및 조성물 |
GB201810301D0 (en) * | 2018-06-22 | 2018-08-08 | Evox Therapeutics Ltd | Combinatorial gene therapy |
CN113260317B (zh) | 2019-01-10 | 2024-05-07 | 加利福尼亚大学董事会 | 软膜下递送系统和使用方法 |
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US20150224331A1 (en) | 2012-09-24 | 2015-08-13 | The Regents Of The University Of California | Spinal cord pulsation-cancelation injection system |
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US20180008727A1 (en) | 2015-01-30 | 2018-01-11 | The Regents Of The University Of California | Spinal subpial gene delivery system |
US20170151416A1 (en) * | 2015-12-01 | 2017-06-01 | Invivo Therapeutics Corporation | Methods and Systems for Delivery of a Trail of a Therapeutic Substance into an Anatomical Space |
KR102489437B1 (ko) | 2016-03-28 | 2023-01-16 | 더 리젠츠 오브 더 유니버시티 오브 캘리포니아 | 뉴런 과흥분성 치료를 위한 방법 및 조성물 |
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CN108884022B (zh) | 2022-01-28 |
AU2017241534A1 (en) | 2018-10-04 |
CA3018960A1 (en) | 2017-10-05 |
EP3436427B1 (en) | 2021-12-08 |
CA3018960C (en) | 2023-09-26 |
CN108884022A (zh) | 2018-11-23 |
JP6949867B2 (ja) | 2021-10-13 |
KR102489437B1 (ko) | 2023-01-16 |
US11472859B2 (en) | 2022-10-18 |
WO2017172606A1 (en) | 2017-10-05 |
US20190071486A1 (en) | 2019-03-07 |
EP3436427A1 (en) | 2019-02-06 |
EP3436427A4 (en) | 2019-08-28 |
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