JP7329860B2 - S-エクオールを用いた乳癌の治療及び予防方法 - Google Patents
S-エクオールを用いた乳癌の治療及び予防方法 Download PDFInfo
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Description
本発明は、アメリカ国立衛生研究所及びテキサス州癌研究助成契約により認められた助成番号CA206529及びテキサス州癌予防研究所により認められた助成番号DP150055のもと米国政府支援により実現した。米国政府及びテキサス州政府は、本発明における一定の権利を有する。
本願は、2018年06月15日出願の米国仮出願第62/685,392号の優先権を主張し、その開示のすべてが参照により本明細書に援用される。
本発明は、S-エクオール又はS-エクオールを含む製剤組成物を薬学的有効量用いて乳癌を治療又は予防するための方法及び組成物に関する。好ましい実施形態において、本発明は、トリプルネガティブ乳癌の治療に関する。別の実施形態において、本方法は、S-エクオールを用いた治療と、免疫療法等の別の抗癌治療との組み合わせに関する。
乳癌は、不均一性が高く、複数のサブタイプからなる。トリプルネガティブ乳癌(TNBC)は、エストロゲン受容体α(ERα)、プロゲステロン受容体(PR)及びヒト上皮増殖因子受容体2型(HER2)の発現がない、乳癌のサブタイプである(Cleator他(2007)、Kang他(2008)、Chia及びTutt(2007)、Diaz他(2007)、Gonzalez-Angulo(2007)、Reis-Filho及びTutt(2008)、Irvin及びCarey(2008))。TNBCはすべての乳癌のおよそ15%を占めるが、TNBCの患者の死亡率は、他のサブタイプの乳癌に比べて不相応な程高い。TNBCは、さらに急速な増悪が起こりやすいが(Gerson他(2008)、Dent他(2007)、Haffty他(2006)、Kaplan及びMalmgren(2008))、「トリプルネガティブ」という特徴が、TNBC患者に、標準的なホルモン療法及びHER2標的療法の利益を得られなくしている(Baum他(2002)、Davies他(2013)、Goss他(2005)、Santen他(2009)、Shou他(2004)、Smith他(2005))。TNBCに対して治療の展望がいくらかあるにもかかわらず、化学療法は、TNBC患者にとって依然として唯一の標準的な治療である。現在の化学療法に抵抗性を示す患者は、実質的な臨床的有用性がなく、不必要な毒性を被ってしまう。したがって、TNBCにとってさらに安全で有効な治療を開発することが、急務である。
(Bitesized Immunologyより: https://www.immunology.org/public-information/bitesized-immunology/cells/cd8-t-cells)
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1.S-エクオールを含む製剤を、その必要がある対象に薬学的有効量投与することにより、乳癌を治療又は予防する方法。
2.前記対象は、トリプルネガティブ乳癌と診断されている、項目1に記載の方法。
3.前記製剤は、10~200mgのS-エクオールを含む、項目1に記載の方法。
4.前記製剤は、50~150mgのS-エクオールを含む、項目1に記載の方法。
5.前記製剤は、約50mgのS-エクオールを含む、項目1に記載の方法。
6.前記製剤は、約150mgのS-エクオールを含む、項目1に記載の方法。
7.前記製剤は、経口、静脈内、腹腔内又は皮下投与される、項目1に記載の方法。
8.前記対象はヒトである、項目1に記載の方法。
9.前記S-エクオールは、1つ以上の他の癌治療と組み合わせて投与される、項目1に記載の方法。
10.前記S-エクオールは、免疫療法剤と組み合わせて投与される、項目9に記載の方法。
11.前記免疫療法剤は、抗体である、項目10に記載の方法。
12.前記抗体は、プログラム細胞死タンパク質1(PD-1)を対象とする、項目11に記載の方法。
13.前記抗体は、プログラム細胞死リガンド1(PDL-1)を対象とする、項目12に記載の方法。
14.前記抗体は、ペムブロリズマブである、項目12に記載の方法。
15.前記抗体は、アテゾリズマブである、項目13に記載の方法。
16.前記抗体は、アベルマブである、項目13に記載の方法。
17.前記製剤は、本質的に、ゲニステイン、ダイゼイン及び/又はIBSO03569である、項目1に記載の方法。
18.ゲニステイン、ダイゼイン及び/又はIBSO03569は、S-エクオールとともに同時投与されることはない、項目1に記載の方法。
19.前記製剤は、本質的にR-エクオールを含まない、項目1に記載の方法。
20.前記S-エクオールは、化学的に製造される、項目1に記載の方法。
21.前記製剤は、日に1回投与される、項目1に記載の方法。
22.前記製剤は、日に2回投与される、項目1に記載の方法。
23.前記製剤は、日に3回投与される、項目1に記載の方法。
24.前記製剤は、日に4回投与される、項目1に記載の方法。
本発明のプロセスは、以下の実施例に関連してさらによく理解されるであろうが、実施例は、例証に過ぎず、本発明の範囲を限定することは意図していない。開示の実施形態への種々の変更及び改変は、当業者に明らかであろう。また、このような変更及び改変は、限定はしないが、本発明の趣旨及び添付の特許請求の範囲から逸脱せずに行うことができる本発明のプロセス、製剤及び/又は方法に関するものを含む。
Claims (10)
- 50~150mgのS-エクオールを含む、対象のトリプルネガティブ乳癌を治療するための製剤であって、
前記対象の体重(kg)を基準として0.5~10mg/kgのプログラム細胞死タンパク質1(PD-1)を対象とする抗体と組み合わせられた、製剤。 - 前記製剤は、50mgのS-エクオール又は150mgのS-エクオールを含む、請求項1に記載の製剤。
- 前記製剤は、経口、静脈内、腹腔内又は皮下投与される、請求項1に記載の製剤。
- 前記対象はヒトである、請求項1に記載の製剤。
- 前記抗体は、ペムブロリズマブである、請求項1に記載の製剤。
- 前記製剤は、本質的に、ゲニステイン、ダイゼイン及び/又はIBSO03569を含まない、請求項1に記載の製剤。
- ゲニステイン、ダイゼイン及び/又はIBSO03569は、S-エクオールとともに同時投与されることはない、請求項1に記載の製剤。
- 前記製剤は、本質的にR-エクオールを含まない、請求項1に記載の製剤。
- 前記製剤は、日に1回、日に2回、日に3回又は日に4回投与される、請求項1に記載の製剤。
- 前記プログラム細胞死タンパク質1(PD-1)を対象とする抗体は、50~500mg/日、好ましくは100~400mg/日、より好ましくは150~250mg/日で投与される、請求項1に記載の製剤。
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AU2017247006B2 (en) | 2016-04-06 | 2022-05-12 | Noxopharm Limited | Radiotherapy improvements |
AU2019285640A1 (en) * | 2018-06-15 | 2021-01-21 | Board Of Regents Of The University Of Texas System | Methods of treating and preventing breast cancer with S-equol |
BR112021026559A2 (pt) * | 2019-07-17 | 2022-02-15 | Noxopharm Ltd | Terapia imuno-oncológica usando compostos isoflavona |
EP4125870A1 (en) | 2020-03-30 | 2023-02-08 | Noxopharm Limited | Methods for the treatment of inflammation associated with infection |
JP2023551071A (ja) * | 2020-11-24 | 2023-12-06 | リー,ロン | S-エクオールを用いた分子マーカーの調節 |
JP7286861B1 (ja) * | 2022-11-16 | 2023-06-05 | 三和酒類株式会社 | Gabaを有効成分とする乳腺組織の健康維持剤 |
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