JP2021517889A - 抗生物質を使用した良性前立腺過形成の治療方法 - Google Patents
抗生物質を使用した良性前立腺過形成の治療方法 Download PDFInfo
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Abstract
Description
本出願は、米国特許出願第15/938,920号(出願日:2018年3月28日)に基づく優先権を主張するものであり、この米国特許出願の開示は、参照により全体として本明細書に組み込まれる。
FTは、
SEQ ID NO.1(配列番号1):IDQQVLSRIKLEIKRCL または Ile−Asp−Gln−Gln−Val−Leu−Ser−Arg−Ile−Lys−Leu− Glu−Ile−Lys−Arg−Cys−Leuで表される。
次いで、アルゴリズムによってパーセント同一性が計算される。相同体は、場合によって、対応するタンパク質またはペプチドと比較した際、典型的には1つ以上のアミノ酸置換、欠失、および/または挿入を有するであろう。
完全な非ペプチドであれ、または部分的な非ペプチドであれ、各実施形態によるペプチド模倣体は、そのペプチド模倣体の基となるペプチドの活性基の三次元配置を緊密に真似る、反応性化学部分の空間的配置を提供する。活性部位の幾何学的形状がこのように類似である結果、ペプチド模倣体は、ペプチドの生物学的活性に似た、生物学的系に対する影響を有する。
この修飾に従って、ペプチドのアミノ酸配列は、1つ以上のペプチド結合が、逆反転偽ペプチド結合と交換されていることを除いて、上述のペプチドの配列と同一であってもよい。好ましくは、最もN末端のペプチド結合が置換されており、これはこうした置換が、N末端に作用するエキソペプチダーゼによるタンパク質分解に対して、耐性を与えるであろうためである。アミノ酸の化学基を類似構造の他の化学基で置換することによって更に修飾することもできる。生物学的活性を全く損失させないか、またはほとんど損失させずに、酵素的切断に対する安定性を増進させることが知られる別の適切な偽ペプチド結合は、還元アイソスター偽ペプチド結合である(Couderら(1993年)、Int.J.Peptide Protein Res.、41:181−184、参照により全体として本明細書に組み込まれる)。
診療室環境における泌尿器科医による超音波誘導下の二重盲検条件下で、BPHを患う患者に、a)NX−1207含有のpH7.2のリン酸緩衝生理食塩水(「PBS」)またはb)PBS単独、の何れかの前立腺内注射を行った。治療薬またはプラセボの投与の前に、各患者は、7日間のフルオロキノロン系の抗生物質の投与、7日間のメトロニダゾールの投与および第3の広域抗生物質(イミペネム、ゲンタマイシン、セファロチン等)の筋肉内注射で構成される広域抗生物質の投与1コースを開始した。それぞれの患者を、1年以上、定期的な身体診断、臨床検査、および症状の評価について追跡した。症状の評価は、前立腺症状の改善または悪化を評価するために使用される定量的尺度である国際前立腺症状スコア(IPSS)によって測定した。IPSSは以下を定量化している。1)残尿感。2)頻尿。3)尿線途絶。4)尿意切迫感。5)尿勢低下。6)腹圧排尿。7)夜間頻尿。ベースラインIPSSからの差分を、NX−1207を投与した患者とPBSのみを投与した患者との比較した。驚くべきことに、抗生物質とプラセボとのみを投与された患者では、90日後にBPH症状スコアが改善され、従来の経口BPH薬で通常見られる改善よりも優れていることが分かった。これらの試験の結果を表4に示す。
診療室環境における泌尿器科医による超音波誘導下の二重盲検条件下で、BPHを患う患者に、a)NX−1207含有のpH7.2のリン酸緩衝生理食塩水(「PBS」)またはb)PBS単独、の何れかの前立腺内注射を行った。治療薬またはプラセボの投与の前に、各患者は、7日間のフルオロキノロン系の抗生物質の投与、7日間のメトロニダゾールの投与および第3の広域抗生物質(イミペネム、ゲンタマイシン、セファロチン等)の筋肉内注射で構成される広域抗生物質の投与1コースを開始した。それぞれの患者を、1年以上、定期的な身体診断、臨床検査、および症状の評価について追跡した。症状の評価は、前立腺症状の改善または悪化を評価するために使用される定量的尺度である国際前立腺症状スコア(IPSS)によって測定した。IPSSは以下を定量化している。1)残尿感。2)頻尿。3)尿線途絶。4)尿意切迫感。5)尿勢低下。6)腹圧排尿。7)夜間頻尿。ベースラインIPSSからの差分を、NX−1207を投与した患者とPBSのみを投与した患者との比較した。驚くべきことに、抗生物質とプラセボとのみを投与された患者では、12か月後にBPH症状スコアが改善され、従来の経口BPH薬で通常見られる改善よりも優れていることが分かった。これらの試験結果をまとめたものを表5に示す。
診療室環境における泌尿器科医による超音波誘導下の二重盲検条件下で、BPHを患う患者に、a)NX−1207含有のpH7.2のリン酸緩衝生理食塩水(「PBS」)またはb)PBS単独、の何れかの前立腺内注射を行った。治療薬またはプラセボの投与の前に、各患者は、7日間のフルオロキノロン系の抗生物質の投与、7日間のメトロニダゾールの投与および第3の広域抗生物質(イミペネム、ゲンタマイシン、セファロチン等)の筋肉内注射で構成される広域抗生物質の投与1コースを開始した。それぞれの患者を、1年以上、定期的な身体診断、臨床検査、および症状の評価について追跡した。尿ピーク流量(Qmax)は、最大尿流量をmL/秒単位で電子的記録値を出力する流量計を使用して測定された。NX−1207を投与した患者とPBSのみを投与した患者とのQmaxを比較した。驚くべきことに、抗生物質とプラセボとのみを投与された患者では、3か月後に最大尿流量が改善され、従来の経口BPH薬で通常見られる改善と同程度または優れた改善がもたらされることが分かった。これらの試験結果をまとめたものを表6に示す。
診療室環境における泌尿器科医による超音波誘導下の二重盲検条件下で、BPHを患う患者に、a)NX−1207含有のpH7.2のリン酸緩衝生理食塩水(「PBS」)またはb)PBS単独、の何れかの前立腺内注射を行った。治療薬またはプラセボの投与の前に、各患者は、7日間のフルオロキノロン系の抗生物質の投与、7日間のメトロニダゾールの投与および第3の広域抗生物質(イミペネム、ゲンタマイシン、セファロチン等)の筋肉内注射で構成される広域抗生物質の投与1コースを開始した。それぞれの患者を、1年以上、定期的な身体診断、臨床検査、および症状の評価について追跡した。尿ピーク流量(Qmax)は、最大尿流量の電子的記録値を出力する流量計を使用して測定された。NX−1207を投与した患者とPBSのみを投与した患者とのQmaxを比較した。驚くべきことに、抗生物質とプラセボとのみを投与された患者では、12か月後に最大尿流量が改善され、従来の経口BPH薬で通常見られる改善と同程度の改善がもたらされることが分かった。これらの試験結果をまとめたものを表7に示す。
診療室環境における泌尿器科医による超音波誘導下の二重盲検条件下で、BPHを患う患者に、a)NX−1207含有のpH7.2のリン酸緩衝生理食塩水(「PBS」)またはb)PBS単独、の何れかの前立腺内注射を行った。治療薬またはプラセボの投与の前に、各患者は、7日間のフルオロキノロン系の抗生物質の投与、7日間のメトロニダゾールの投与および第3の広域抗生物質(イミペネム、ゲンタマイシン、セファロチン等)の筋肉内注射で構成される広域抗生物質の投与1コースを開始した。それぞれの患者を、1年以上、定期的な身体診断、臨床検査、および症状の評価について追跡した。症状の評価は、前立腺症状の改善または悪化を評価するために使用される定量的尺度である国際前立腺症状スコア(IPSS)によって測定した。IPSSは以下を定量化している。1)残尿感。2)頻尿。3)尿線途絶。4)尿意切迫感。5)尿勢低下。6)腹圧排尿。7)夜間頻尿。ベースラインIPSSからの差分を、NX−1207を投与した患者とPBSのみを投与した患者との比較した。驚くべきことに、抗生物質とプラセボとのみを投与された患者では、90日後のBPH症状スコアが改善され、経口プラセボ薬のみを投与したBPHの臨床試験で通常見られる改善よりも優れていることが分かった。これらの試験結果をまとめたものを表8に示す。
診療室環境における泌尿器科医による超音波誘導下の二重盲検条件下で、BPHを患う患者に、a)NX−1207含有のpH7.2のリン酸緩衝生理食塩水(「PBS」)またはb)PBS単独、の何れかの前立腺内注射を行った。治療薬またはプラセボの投与の前に、各患者は、7日間のフルオロキノロン系の抗生物質の投与、7日間のメトロニダゾールの投与および第3の広域抗生物質(イミペネム、ゲンタマイシン、セファロチン等)の筋肉内注射で構成される広域抗生物質の投与1コースを開始した。それぞれの患者を、1年以上、定期的な身体診断、臨床検査、および症状の評価について追跡した。症状の評価は、前立腺症状の改善または悪化を評価するために使用される定量的尺度である国際前立腺症状スコア(IPSS)によって測定した。IPSSは以下を定量化している。1)残尿感。2)頻尿。3)尿線途絶。4)尿意切迫感。5)尿勢低下。6)腹圧排尿。7)夜間頻尿。ベースラインIPSSからの差分を、NX−1207を投与した患者とPBSのみを投与した患者との比較した。驚くべきことに、抗生物質とプラセボとのみを投与された患者では、12ヶ月後のBPH症状スコアが改善され、経口プラセボ薬のみを投与したBPHの臨床試験で通常見られる改善よりも優れていることが分かった。これらの試験結果をまとめたものを表9に示す。
診療室環境における泌尿器科医による超音波誘導下の二重盲検条件下で、BPHを患う患者に、a)NX−1207含有のpH7.2のリン酸緩衝生理食塩水(「PBS」)またはb)PBS単独、の何れかの前立腺内注射を行った。治療薬またはプラセボの投与の前に、各患者は、7日間のフルオロキノロン系の抗生物質の投与、7日間のメトロニダゾールの投与および第3の広域抗生物質(イミペネム、ゲンタマイシン、セファロチン等)の筋肉内注射で構成される広域抗生物質の投与1コースを開始した。それぞれの患者を、1年以上、定期的な身体診断、臨床検査、および症状の評価について追跡した。尿ピーク流量(Qmax)は、最大尿流量の電子的記録値を出力する流量計を使用して測定された。NX−1207を投与した患者とPBSのみを投与した患者とのQmaxを比較した。驚くべきことに、抗生物質とプラセボとのみを投与された患者では、3ヶ月後の尿最大流量が改善され、経口プラセボ薬のみを投与したBPHの臨床試験で通常見られる改善よりも優れていることが分かった。これらの試験結果をまとめたものを表10に示す。
診療室環境における泌尿器科医による超音波誘導下の二重盲検条件下で、BPHを患う患者に、a)NX−1207含有のpH7.2のリン酸緩衝生理食塩水(「PBS」)またはb)PBS単独、の何れかの前立腺内注射を行った。治療薬またはプラセボの投与の前に、各患者は、7日間のフルオロキノロン系の抗生物質の投与、7日間のメトロニダゾールの投与および第3の広域抗生物質(イミペネム、ゲンタマイシン、セファロチン等)の筋肉内注射で構成される広域抗生物質の投与1コースを開始した。それぞれの患者を、1年以上、定期的な身体診断、臨床検査、および症状の評価について追跡した。尿ピーク流量(Qmax)は、最大尿流量の電子的記録値を出力する流量計を使用して測定された。NX−1207を投与した患者とPBSのみを投与した患者とのQmaxを比較した。驚くべきことに、抗生物質とプラセボとのみを投与された患者では、12ヶ月後の尿最大流量が改善され、経口プラセボ薬のみを投与したBPHの臨床試験で通常見られる改善よりも優れていることが分かった。これらの試験結果をまとめたものを表11に示す。
診療室環境における泌尿器科医による超音波誘導下の二重盲検条件下で、BPHを患う患者に、a)NX−1207含有のpH7.2のリン酸緩衝生理食塩水(「PBS」)またはb)PBS単独、の何れかの前立腺内注射を行った。治療薬またはプラセボの投与の前に、各患者は、7日間のフルオロキノロン系の抗生物質の投与、7日間のメトロニダゾールの投与および第3の広域抗生物質(イミペネム、ゲンタマイシン、セファロチン等)の筋肉内注射で構成される広域抗生物質の投与1コースを開始した。それぞれの患者を、1年以上、定期的な身体診断、臨床検査、および症状の評価について追跡した。症状の評価は、前立腺症状の改善または悪化を評価するために使用される定量的尺度である国際前立腺症状スコア(IPSS)によって測定した。IPSSは以下を定量化している。1)残尿感。2)頻尿。3)尿線途絶。4)尿意切迫感。5)尿勢低下。6)腹圧排尿。7)夜間頻尿。ベースラインIPSSからの差分を、NX−1207を投与した患者とPBSのみを投与した患者との比較した。驚くべきことに、抗生物質とプラセボとのみを投与された患者では、長期間経過(平均42ヶ月)後にBPH症状スコアが改善され、従来の経口BPH薬で通常見られる改善と同程度またはそれよりも優れていることが分かった。これらの試験結果をまとめたものを表12に示す。
診療室環境における泌尿器科医による超音波誘導下の二重盲検条件下で、BPHを患う患者に、a)NX−1207含有のpH7.2のリン酸緩衝生理食塩水(「PBS」)またはb)PBS単独、の何れかの前立腺内注射を行った。治療薬またはプラセボの投与の前に、各患者は、7日間のフルオロキノロン系抗生物質の投与、7日間のメトロニダゾールの投与および第3の広域抗生物質(イミペネム、ゲンタマイシン、セファロチン等)の筋肉内注射で構成される広域抗生物質の投与1コースを開始した。それぞれの患者を、1年以上、定期的な身体診断、臨床検査、および症状の評価について追跡した。症状の評価は、前立腺症状の改善または悪化を評価するために使用される定量的尺度である国際前立腺症状スコア(IPSS)によって測定した。IPSSは以下を定量化している。1)残尿感。2)頻尿。3)尿線途絶。4)尿意切迫感。5)尿勢低下。6)腹圧排尿。7)夜間頻尿。ベースラインIPSSからの差分を、NX−1207を投与した患者とPBSのみを投与した患者との比較した。驚くべきことに、抗生物質とプラセボとのみを投与された患者では、長期間経過(平均42ヶ月)後のBPH症状スコアが改善され、経口プラセボ薬のみを投与した場合に通常見られる改善よりも優れていることが分かった。これらの試験結果をまとめたものを表13に示す。
Claims (18)
- BPHに罹患している哺乳動物の症状を改善する方法であって、
1つまたは複数の抗生物質を治療有効量含有する組成物を前記哺乳動物に投与する段階を備える方法。 - 前記方法は、少なくとも2つの異なる抗生物質を治療有効量投与することを含む、請求項1に記載の方法。
- 前記抗生物質は、エリスロマイシン、キタサマイシン、ストレプトマイシン、セファロチン、セファゾリン、テトラサイクリン、グラミシジン、グリセオフルビン、ゲンタマイシン、ノボビオシン、アンピシリン、イミペネム、メトロニダゾール、セフトリアキソン、セファレキシン、シプロフロキサシン、ゲミフロキサシン、ホスホマイシン、レボフロキサシン、モキシフロキサシン、ノルフロキサシン、ニトロフラントイン、オフロキサシン、トリメトプリム/スルファメトキサキソール、ならびに、これらの誘導体および塩からなる群から選択される、請求項2に記載の方法。
- 前記抗生物質は、アンピシリン、ゲンタマイシン、イミペネム、セファロチン、メトロニダゾール、シプロフロキサシン、ゲミフロキサシン、ホスホマイシン、レボフロキサシン、モキシフロキサシン、ノルフロキサシン、ニトロフラントインおよびオフロキサシンからなる群から選択される、請求項3に記載の方法。
- フルオロキノロン系抗生物質の1コースの投与、メトロニダゾールの1コースの投与、ならびに、イメペネム、ゲンタマイシンおよびセファロチンから選択される1つの抗生物質の筋肉内注射により、前記抗生物質の投与が行われる、請求項4に記載の方法。
- 前記フルオロキノロン系抗生物質は、シプロフロキサシン、ゲミフロキサシン、ホスホマイシン、レボフロキサシン、モキシフロキサシン、ノルフロキサシンおよびオフロキサシンからなる群から選択される、請求項4に記載の方法。
- 1年以内に平均国際前立腺症状スコア(IPSS)をベースラインから5〜7ポイント下げることにより、前記IPPSを改善する段階を更に備える、請求項1に記載の方法。
- BPHの経口治療薬による平均IPSSの平均改善と比較して、平均IPSSスコアが最初の1年で約30%〜150%改善する段階を更に備える、請求項1に記載の方法。
- プラセボを投与した対照群と比較して、平均IPSSスコアが最初の1年で約75%〜500%改善する段階を更に備える、請求項1に記載の方法。
- 42ヶ月以内に平均国際前立腺症状スコア(IPSS)をベースラインから4〜5ポイント下げることにより、前記IPPSを改善する段階を更に備える、請求項1に記載の方法。
- BPHの経口治療薬による平均IPSSの平均改善と比較して、平均IPSSスコアが42ヶ月以内に約0%〜200%改善する段階を更に備える、請求項1に記載の方法。
- プラセボを投与した対照群と比較して、平均IPSSスコアが42ヶ月以内に約75%〜350%改善する段階を更に備える、請求項1に記載の方法。
- 最初の1年で最大尿流量を約1.3〜3.0ml/秒増加させることにより、尿ピーク流量(Qmax)を改善する段階を更に備える、請求項1に記載の方法。
- プラセボを投与した対照群と比較して、最初の1年で尿ピーク流量(Qmax)を最初の1年で約100%〜325%改善する段階を更に備える、請求項1に記載の方法。
- フェキサポチドトリフルタートおよび薬学的に許容される担体を投与する段階、を更に備える請求項1に記載の方法。
- 前記フェキサポチドトリフルタートは、筋肉内、経口、静脈内、髄腔内、腫瘍内、鼻腔内、局所および経皮からなる群から選択されるルートで投与される、請求項15に記載の方法。
- タムスロシン、フィナステリド、テラゾシン、ドキサゾシン、プラゾシン、タダラフィル、アルフゾシン、シロドシン、デュタステリド、デュタステリドとタムスロシンとの組み合わせ、ならびにこれらの混合物および組み合わせからなる群から選択される医薬活性剤を投与する段階を更に備える、請求項1に記載の方法。
- タムスロシン、フィナステリド、テラゾシン、ドキサゾシン、プラゾシン、タダラフィル、アルフゾシン、シロドシン、デュタステリド、デュタステリドとタムスロシンとの組み合わせ、ならびにこれらの混合物および組み合わせからなる群から選択される医薬活性剤を投与する段階を更に備える、請求項15に記載の方法。
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THERAPEUTIC ADVANCES IN CHRONIC DISEASE, vol. 2, no. 6, JPN6023010127, 2011, pages 377 - 383, ISSN: 0005012139 * |
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RU2020129543A (ru) | 2022-04-28 |
JP2024023279A (ja) | 2024-02-21 |
US10835538B2 (en) | 2020-11-17 |
ZA202005590B (en) | 2022-01-26 |
EP3743089A1 (en) | 2020-12-02 |
US20190298731A1 (en) | 2019-10-03 |
AU2019243713A1 (en) | 2020-09-24 |
KR20200140272A (ko) | 2020-12-15 |
CA3093763A1 (en) | 2019-10-03 |
MX2020008703A (es) | 2020-10-28 |
WO2019191253A1 (en) | 2019-10-03 |
RU2020129543A3 (ja) | 2022-04-28 |
CN112188896A (zh) | 2021-01-05 |
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