JP2011515481A - 癌の処置のための方法および組成物 - Google Patents
癌の処置のための方法および組成物 Download PDFInfo
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- JP2011515481A JP2011515481A JP2011501983A JP2011501983A JP2011515481A JP 2011515481 A JP2011515481 A JP 2011515481A JP 2011501983 A JP2011501983 A JP 2011501983A JP 2011501983 A JP2011501983 A JP 2011501983A JP 2011515481 A JP2011515481 A JP 2011515481A
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- cancer
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- arsenic
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Abstract
Description
この出願は、2008年3月27日に出願された米国仮出願第61/039,987号および2009年3月23日に出願された米国第12/408,864号(これは、それらの全体が参考として本明細書に援用される)に対する優先権を主張する。
(発明の分野)
本発明は、一般に、癌の成長および/もしくは増殖の相乗的阻害を示す組み合わせ処置に関する。より具体的には、本発明は、キット、組成物、ならびにメタ亜ヒ酸ナトリウムもしくは三酸化ヒ素、およびテロメアを阻害する第2の細胞傷害性薬剤(例えば、シスプラチンもしくはタキサン)が、固形腫瘍および白血病を含む癌の処置に使用される組み合わせ療法を含む方法に関する。
外科手術および/もしくは放射線処置とともに、およびしばしばこれに関連して、化学療法(血液循環系を介して身体全体を移動する抗新生物薬剤の全身投与)は、広く種々の癌の処置において長年広く利用されてきた。
本発明のキット、組成物もしくは方法(例えば、組み合わせ療法)の使用は、相乗効果的な抗癌効果を生じて、最大の治療的恩恵を達成し、そしてより高い用量もしくはより長期の単一療法(monotherapy)(すなわち、各化合物単独での治療)の使用からしばしば生じる副作用のリスクが低下した、治療に対する寛容性を改善し得る。従って、本発明の組成物、キットおよび方法は、各化合物の有害作用が低下した(例えば、ヒ素化合物もしくは癌の薬剤(例えば、シスプラチン)の副作用が低下した)、各化合物のより低い用量(例えば、より低い用量の上記ヒ素化合物もしくはシスプラチン)の使用を可能にし得る。最適に及ばない用量(suboptimal dosage)は、増大した安全性限界を提供し得、予防および治療を達成するために必要な薬物のコストも下げ得る。上記ヒ素化合物と、シスプラチン、アドリアマイシン、ドセタキセルおよび/もしくはパクリタキセル、または他のタキサンとの組み合わせを利用する相乗効果的処置はまた、便利さが増大し得、高められたコンプライアンスを生じ得る。組み合わせ療法の利点は、分解および代謝に対するより高い安定性、より長期の作用時間、ならびに/または特に低用量でのより長い作用時間もしくは有効時間をさらに含み得る。
本発明の活性成分は、癌の処置のために、哺乳動物への投与のための薬学的調製物(例えば、組み合わせ療法において使用されるように、組成物中で一緒にもしくは別個に)に処方される。
本発明の薬学的調製物中の上記活性成分の含有量が、多くの要因(例えば、望ましい投与量および使用されている薬学的に受容可能なキャリア)に依存して、極めて広範に変動し得ることは、当業者によって認識されている。投与に関して、上記ヒ素化合物の投与量は、通常、約0.1mg/kg〜約100mg/kgの範囲、特定の実施形態において、約1.0〜約50mg/kgの範囲、他の実施形態において、約2.5〜約25mg/kgの範囲、および他の実施形態において、約3〜約15mg/kgの範囲である。
シスプラチンおよびメタ亜ヒ酸ナトリウムでのインビトロ研究。シスプラチンおよびメタ亜ヒ酸ナトリウムの両方が、テロメア損傷を引き起こし得る。従って、これら2種の抗癌剤の組み合わせを試験して、上記2種の薬剤が、2種の非小細胞肺癌細胞株においてインビトロでの相乗効果の証拠を示すか否かを決定した。H460(4kb,IC50,IC50=10μM)およびA549(6kb,IC50=13μM)を選択した。なぜなら、これらは、比較的短いテロメアを有し、National Cancer Institute(NCI)の60の細胞株パネルのうちの一部であるからである。シスプラチンおよびKML001のIC50濃度を、MTTアッセイおよびChou and Talalay(Advances in Enzyme Regulation(1984),22:27−55(その全体が参考として援用される))による広く受け入れられたメジアン効果方法論によって、相乗効果、相加的なものもしくは拮抗性の決定のために使用される固定されたIC50比に基づいて決定した(図1A〜1C)。
(項目1)
治療上有効な量のメタ亜ヒ酸ナトリウム、三酸化ヒ素もしくはこれらの組み合わせを含む第1の組成物、ならびにシスプラチン、アドリアマイシンおよびタキソールからなる群より選択される、治療上有効な量の細胞傷害性抗癌剤を含む第2の組成物を含む、癌の処置のためのキット。
(項目2)
上記第1の組成物は、メタ亜ヒ酸ナトリウムを含み、上記第2の組成物は、シスプラチンを含む、項目1に記載のキット。
(項目3)
上記第1の組成物は、経口投与のために処方されている、項目2に記載のキット。
(項目4)
上記第1の組成物は、三酸化ヒ素を含み、上記第2の組成物は、シスプラチンを含む、項目1に記載のキット。
(項目5)
上記癌は、肺癌である、項目1に記載のキット。
(項目6)
上記癌は、長いテロメアを有する染色体を含む癌細胞と関連する癌である、項目1に記載のキット。
(項目7)
患者における癌の処置のための非ヒ素抗癌剤の使用であって、ここで該患者は、メタ亜ヒ酸ナトリウム、三酸化ヒ素もしくはこれらの組み合わせのうちの少なくとも1つの該患者への投与を含む処置レジメンに供されている、使用。
(項目8)
上記患者は、肺癌を有する、項目7に記載の使用。
(項目9)
上記癌は、長いテロメアを有する染色体を含む癌細胞と関連する、項目7に記載の使用。
(項目10)
上記非ヒ素抗癌剤は、シスプラチン、アドリアマイシン、タキサンおよびこれらの組み合わせから選択される、項目7に記載の使用。
(項目11)
上記タキサンは、パクリタキセルもしくはドセタキセルである、項目10に記載の使用。
(項目12)
上記非ヒ素抗癌剤は、シスプラチンである、項目7に記載の使用。
Claims (12)
- 治療上有効な量の、メタ亜ヒ酸ナトリウム、もしくはメタ亜ヒ酸ナトリウムと三酸化ヒ素との組み合わせを含む第1の組成物、ならびにシスプラチン、アドリアマイシンおよびタキソールからなる群より選択される、治療上有効な量の細胞傷害性抗癌剤を含む第2の組成物を含む、癌の処置のためのキット。
- 前記第1の組成物は、メタ亜ヒ酸ナトリウムを含み、前記第2の組成物は、シスプラチンを含む、請求項1に記載のキット。
- 前記第1の組成物は、経口投与のために処方されている、請求項2に記載のキット。
- 前記第1の組成物は、メタ亜ヒ酸ナトリウムと三酸化ヒ素との組み合わせを含み、前記第2の組成物は、シスプラチンを含む、請求項1に記載のキット。
- 前記癌は、肺癌である、請求項1に記載のキット。
- 前記癌は、長いテロメアを有する染色体を含む癌細胞と関連する癌である、請求項1に記載のキット。
- 患者における癌の処置のための非ヒ素抗癌剤の使用であって、ここで該患者は、メタ亜ヒ酸ナトリウム、メタ亜ヒ酸ナトリウムと三酸化ヒ素との組み合わせもしくはこれらの組み合わせの該患者への投与を含む処置レジメンに供されている、使用。
- 前記患者は、肺癌を有する、請求項7に記載の使用。
- 前記癌は、長いテロメアを有する染色体を含む癌細胞と関連する、請求項7に記載の使用。
- 前記非ヒ素抗癌剤は、シスプラチン、アドリアマイシン、タキサンおよびこれらの組み合わせから選択される、請求項7に記載の使用。
- 前記タキサンは、パクリタキセルもしくはドセタキセルである、請求項10に記載の使用。
- 前記非ヒ素抗癌剤は、シスプラチンである、請求項7に記載の使用。
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JP2021518434A (ja) * | 2018-03-22 | 2021-08-02 | コミファーム インターナショナル オーストラリア ピーティーワイ リミテッド | メタ亜ヒ酸塩を含む医薬組成物および製造方法 |
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US9447049B2 (en) | 2010-03-01 | 2016-09-20 | University Of Tennessee Research Foundation | Compounds for treatment of cancer |
RU2568834C2 (ru) * | 2009-09-10 | 2015-11-20 | Коминокс, Инк. | Противораковая терапия, направленная против раковых стволовых клеток и форм рака, устойчивых к лечению лекарственными препаратами |
US8795738B2 (en) * | 2009-11-12 | 2014-08-05 | Board Of Regents Of The University Of Texas System | Use of arsenic for cancer therapy protection |
US11084811B2 (en) | 2010-03-01 | 2021-08-10 | Oncternal Therapeutics, Inc. | Compounds for treatment of cancer |
JP6034288B2 (ja) * | 2010-07-18 | 2016-11-30 | ニーキ ファーマ インコーポレイテッド | ルテニウム錯体を用いる併用療法 |
ES2718637T3 (es) * | 2010-08-24 | 2019-07-03 | Gtx Inc | Compuestos para el tratamiento del cáncer |
US20120251628A1 (en) * | 2011-03-30 | 2012-10-04 | Young Joo Min | Compositions and methods for treatment of cancer |
CN103826645A (zh) * | 2011-05-12 | 2014-05-28 | 得克萨斯系统大学评议会 | 砷在癌症治疗保护中的用途 |
US8834938B2 (en) | 2011-05-18 | 2014-09-16 | Board Of Regents Of The University Of Texas System | Use of arsenic for cancer therapy protection |
US20160184356A1 (en) * | 2013-03-15 | 2016-06-30 | Ke Jian Jim Liu | Arsenic-based treatment of cancers and inflammatory disorders |
KR101309844B1 (ko) | 2013-03-15 | 2013-09-23 | 박상채 | 항암 활성 증진용 한약재 및 이의 제조방법 |
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JP2016525118A (ja) * | 2013-07-19 | 2016-08-22 | オニキス セラピューティクス, インク.Onyx Therapeutics, Inc. | がんの治療のためのpimキナーゼ阻害剤と組み合わせたペプチドエポキシケトンプロテアソーム阻害剤 |
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JP2021518434A (ja) * | 2018-03-22 | 2021-08-02 | コミファーム インターナショナル オーストラリア ピーティーワイ リミテッド | メタ亜ヒ酸塩を含む医薬組成物および製造方法 |
JP7419333B2 (ja) | 2018-03-22 | 2024-01-22 | コミファーム インターナショナル オーストラリア ピーティーワイ リミテッド | メタ亜ヒ酸塩を含む医薬組成物および製造方法 |
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DK2268292T3 (en) | 2018-03-12 |
JP5543956B2 (ja) | 2014-07-09 |
JP2014101387A (ja) | 2014-06-05 |
RU2508116C2 (ru) | 2014-02-27 |
CN102046187A (zh) | 2011-05-04 |
EP2268292A4 (en) | 2011-05-11 |
AU2009228378A1 (en) | 2009-10-01 |
EP2268292A2 (en) | 2011-01-05 |
PT2268292T (pt) | 2018-02-19 |
EP2268292B1 (en) | 2017-12-27 |
US20090246291A1 (en) | 2009-10-01 |
WO2009120697A3 (en) | 2010-02-18 |
MX2010010621A (es) | 2011-04-05 |
HUE036609T2 (hu) | 2018-07-30 |
ES2656762T3 (es) | 2018-02-28 |
ZA201006988B (en) | 2012-05-30 |
CA2719766A1 (en) | 2009-10-01 |
RU2010143893A (ru) | 2012-05-10 |
KR101634138B1 (ko) | 2016-06-28 |
CY1120536T1 (el) | 2019-07-10 |
PL2268292T3 (pl) | 2018-06-29 |
BRPI0909164A2 (pt) | 2016-06-21 |
AU2009228378B2 (en) | 2014-07-17 |
CA2719766C (en) | 2017-10-31 |
US20180055812A1 (en) | 2018-03-01 |
SI2268292T1 (en) | 2018-03-30 |
CN104997808A (zh) | 2015-10-28 |
WO2009120697A2 (en) | 2009-10-01 |
WO2009120697A4 (en) | 2010-04-15 |
LT2268292T (lt) | 2018-03-26 |
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