JP2020500922A - がんの相乗的治療方法 - Google Patents
がんの相乗的治療方法 Download PDFInfo
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- JP2020500922A JP2020500922A JP2019531255A JP2019531255A JP2020500922A JP 2020500922 A JP2020500922 A JP 2020500922A JP 2019531255 A JP2019531255 A JP 2019531255A JP 2019531255 A JP2019531255 A JP 2019531255A JP 2020500922 A JP2020500922 A JP 2020500922A
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Abstract
Description
本願は、2016年12月7日出願の米国特許出願第62/430,962号に対する優先権を主張する。同出願の全内容は本明細書中に援用される。
BALB−neuTモデルは遺伝子改変マウスモデルで、ヒト上皮細胞増殖因子受容体2の恒常活性化したラット相同体を発現させることによって乳房腫瘍を発症させられている。このモデルでは自発性腫瘍が数か月の間に発症し、約16週齢の雌のマウスの乳房組織で触知できる。この腫瘍は、ヒト患者に見られるHer2により発生した悪性度の高いがんによく似ている。
(方法)
(結果)
Claims (40)
- がんの治療方法であって、
一用量の化学療法薬と一用量の弱毒化ネズミチフス菌から本質的になる組成物の組み合わせを投与することを含み、
前記化学療法薬の用量は、前記化学療法薬の最大有効量よりも少なく、
前記組み合わせは、同用量の前記化学療法薬を弱毒化ネズミチフス菌から本質的になる前記組成物なしで投与した場合に比べて腫瘍量を相乗的に減少させ、
前記組み合わせの毒性は、最大有効量の前記化学療法薬の毒性よりも低い、
方法。 - 前記化学療法薬の用量は約1.25mg/kg以下である、請求項1に記載の方法。
- 前記化学療法薬の用量は前記化学療法薬および前記組み合わせの最大有効量の25%である、請求項1に記載の方法。
- 弱毒化ネズミチフス菌の前記用量は約2×106コロニー形成単位である、請求項1に記載の方法。
- 前記弱毒化ネズミチフス菌は静脈内投与される、請求項1に記載の方法。
- 第1の用量の前記化学療法薬と前記用量の弱毒化ネズミチフス菌が第1の日に投与される、請求項1に記載の方法。
- 第2の用量の前記化学療法薬が前記第1の日の1週間後の第2の日に投与される、請求項6に記載の方法。
- 第3の用量の前記化学療法薬が前記第2の日の1週間後の第3の日に投与される、請求項7に記載の方法。
- 複数の用量の前記化学療法薬と複数の用量の前記弱毒化ネズミチフス菌が前記第1の日の後の複数の日に投与される、請求項6に記載の方法。
- 前記化学療法薬は、ドキソルビシン、カルボプラチン、シスプラチン、シクロホスファミド、ダウノルビシン、オキサリプラチン、5−フルオロウラシル、ゲムシタビンからなる群から選択される、請求項1に記載の方法。
- がんの治療方法であって、
一用量の化学療法薬と一用量の切断型ヒトインターロイキン2をコードするコード配列を有するプラスミドを含む弱毒化ネズミチフス菌の組み合わせを投与することを含み、前記切断型ヒトインターロイキン2は配列番号2に示されるアミノ酸配列からなり、
前記化学療法薬の用量は、前記化学療法薬の最大有効量よりも少なく、
前記組み合わせは、同用量の前記化学療法薬を前記切断型ヒトインターロイキン2をコードするコード配列を有する前記プラスミドを含む前記弱毒化ネズミチフス菌なしで投与した場合に比べて腫瘍量を相乗的に減少させ、かつ
前記組み合わせの毒性は、最大有効量の前記化学療法薬の毒性よりも低い、
方法。 - 前記化学療法薬の用量は1.25mg/kg以下である、請求項11に記載の方法。
- 前記化学療法薬の用量は前記化学療法薬の最大有効量の25%である、請求項11に記載の方法。
- 前記切断型ヒトインターロイキン2をコードするコード配列を有する前記プラスミドを含む弱毒化ネズミチフス菌の前記用量は約1×109コロニー形成単位である、請求項9に記載の方法。
- 前記切断型ヒトインターロイキン2をコードするコード配列を有する前記プラスミドを含む前記弱毒化ネズミチフス菌は経口投与される、請求項9に記載の方法。
- 第1の用量の前記化学療法薬と前記用量の切断型ヒトインターロイキン2をコードするコード配列を有する前記プラスミドを含む前記弱毒化ネズミチフス菌が第1の日に投与される、請求項11に記載の方法。
- 第2の用量の前記化学療法薬が前記第1の日の1週間後の第2の日に投与される、請求項16に記載の方法。
- 第3の用量の前記化学療法薬が前記第2の日の1週間後の第3の日に投与される、請求項17に記載の方法。
- 複数の用量の前記化学療法薬と複数の用量の前記弱毒化ネズミチフス菌が前記第1の日の後の複数の日に投与される、請求項16に記載の方法。
- 前記化学療法薬は、ドキソルビシン、カルボプラチン、シスプラチン、シクロホスファミド、ダウノルビシン、オキサリプラチン、5−フルオロウラシル、ゲムシタビンからなる群から選択される、請求項9に記載の方法。
- がんの治療方法で使用するための一用量の化学療法薬と一用量の弱毒化ネズミチフス菌から本質的になる組成物の組み合わせを含む、がんの治療方法で使用するための抗腫瘍薬であって、前記方法は、
一用量の前記化学療法薬と一用量の弱毒化ネズミチフス菌から本質的になる前記組成物の前記組み合わせを投与することを含み、
前記化学療法薬の用量は、前記化学療法薬の最大有効量よりも少なく、
前記組み合わせは、同用量の前記化学療法薬を弱毒化ネズミチフス菌から本質的になる前記組成物なしで投与した場合に比べて腫瘍量を相乗的に減少させ、かつ
前記組み合わせの毒性は、最大有効量の前記化学療法薬の毒性よりも低い、
抗腫瘍薬。 - 前記化学療法薬の用量は約1.25mg/kg以下である、請求項21に記載の抗腫瘍薬。
- 前記化学療法薬の用量は前記化学療法薬の最大有効量の25%である、請求項21に記載の方法。
- 前記弱毒化ネズミチフス菌の前記用量は約2×106コロニー形成単位である、請求項21に記載の抗腫瘍薬。
- 前記弱毒化ネズミチフス菌は静脈内投与される、請求項21に記載の抗腫瘍薬。
- 第1の用量の前記化学療法薬と前記用量の前記弱毒化ネズミチフス菌が第1の日に投与される、請求項21に記載の抗腫瘍薬。
- 第2の用量の前記化学療法薬が前記第1の日の1週間後の第2の日に投与される、請求項26に記載の抗腫瘍薬。
- 第3の用量の前記化学療法薬が前記第2の日の1週間後の第3の日に投与される、請求項27に記載の抗腫瘍薬。
- 複数の用量の前記化学療法薬と複数の用量の前記弱毒化ネズミチフス菌が前記第1の日の後の複数の日に投与される、請求項26に記載の方法。
- 前記化学療法薬は、ドキソルビシン、カルボプラチン、シスプラチン、シクロホスファミド、ダウノルビシン、オキサリプラチン、5−フルオロウラシル、ゲムシタビンからなる群から選択される、請求項21に記載の抗腫瘍薬。
- がんの治療方法で使用するための抗腫瘍薬であって、一用量の化学療法薬と一用量の切断型ヒトインターロイキン2をコードするコード配列を有するプラスミドを含む弱毒化ネズミチフス菌の組み合わせを含み、前記切断型ヒトインターロイキン2は配列番号2に示されるアミノ酸配列からなり、前記方法は、
一用量の前記化学療法薬と一用量の前記切断型ヒトインターロイキン2をコードするコード配列を有する前記プラスミドを含む前記弱毒化ネズミチフス菌の前記組み合わせを投与することを含み、
前記化学療法薬の用量は、前記化学療法薬の最大有効量よりも少なく、
前記組み合わせは、同用量の前記化学療法薬を前記切断型ヒトインターロイキン2をコードするコード配列を有するプラスミドを含む前記弱毒化ネズミチフス菌なしで投与した場合に比べて腫瘍量を相乗的に減少させ、かつ
前記組み合わせの毒性は最大有効量の前記化学療法薬の毒性よりも低い、
抗腫瘍薬。 - 前記化学療法薬の用量は約1.25mg/kg以下である、請求項31に記載の抗腫瘍薬。
- 前記化学療法薬の用量は前記化学療法薬の最大有効量の25%である、請求項31に記載の方法。
- 前記切断型ヒトインターロイキン2をコードするコード配列を有する前記プラスミドを含む弱毒化ネズミチフス菌の前記用量は約1×109コロニー形成単位である、請求項31に記載の抗腫瘍薬。
- 前記切断型ヒトインターロイキン2をコードするコード配列を有する前記プラスミドを含む前記弱毒化ネズミチフス菌は経口投与される、請求項31に記載の抗腫瘍薬。
- 第1の用量の前記化学療法薬と前記用量の前記切断型ヒトインターロイキン2をコードするコード配列を有する前記プラスミドを含む前記弱毒化ネズミチフス菌が第1の日に投与される、請求項31に記載の抗腫瘍薬。
- 第2の用量の前記化学療法薬が前記第1の日の1週間後の第2の日に投与される、請求項36に記載の抗腫瘍薬。
- 第3の用量の前記化学療法薬が前記第2の日の1週間後の第3の日に投与される、請求項37に記載の抗腫瘍薬。
- 複数の用量の前記化学療法薬と複数の用量の前記弱毒化ネズミチフス菌が前記第1の日の後の複数の日に投与される、請求項36に記載の方法。
- 前記化学療法薬は、ドキソルビシン、カルボプラチン、シスプラチン、シクロホスファミド、ダウノルビシン、オキサリプラチン、5−フルオロウラシル、ゲムシタビンからなる群から選択される、請求項31に記載の抗腫瘍薬。
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