JP5791221B2 - 血管疾患の治療のための抗増殖薬と抗炎症薬の組み合わせ - Google Patents
血管疾患の治療のための抗増殖薬と抗炎症薬の組み合わせ Download PDFInfo
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Description
1つの実施形態に従って、ドラッグデリバリーシステムおよびそのドラッグデリバリーシステムの使用方法を本明細書に記載する。用語「治療」は、血管疾患の予防、軽減、遅延または除去を含む。一部の実施形態において、治療は、疾患および/または機械的介入に起因する損傷の修復も含む。本ドラッグデリバリーシステムは、血管疾患または関連疾患を治療するための2つ以上の薬剤を有する。前記薬剤は、少なくとも1つの抗増殖薬と、少なくとも1つの抗炎症薬と、場合によっては第三の生体活性薬剤との組み合わせであり得る。
バルーンまたはステント留置などによる血管の機械的変形に関連した一般的な疾患は、再狭窄である。血管の再狭窄を導く多数の細胞メカニズムが報告されている。これらのメカニズムのうちの2つは、(1)損傷部位への平滑筋細胞の移動およびその損傷部位での平滑筋細胞の増殖、ならびに(2)損傷および異物の存在に対する急性および慢性炎症反応。
用語「移植可能医療器具」は、自己拡張式ステント、バルーン拡張式ステント、ステント・グラフトおよびグラフトを含むことを意図する。移植可能医療器具は、構造体、基質、または足場を含む。この器具の構造は、実際にはいずれのデザインのものであってもよい。例えばステントは、相互に連結している構造要素またはストラットのパターンまたは網目構造を含むことができる。図1は、ステント10の三次元投影図の一例を図示する。このステントは、多数の相互に連結している要素またはストラット15を含むパターンを有することができる。本明細書に開示する実施形態は、図1に図解されているステントまたはステントパターンに限定されない。例えば、ストラットの断面は、(図1に図示されているような)長方形、円形、楕円形などであり得る。
抗増殖効果を有するあらゆる薬剤を本発明で使用することができる。抗増殖薬は、細胞毒素などの天然タンパク質系物質であってもよく、合成分子であってもよい。好ましくは、活性薬剤には、抗増殖性物質、例えば、アクチノマイシンDまたはその誘導体および類似体(Sigma−Aldrich 1001 West Saint Paul Avenue,Milwaukee,WI53233製;またはMerckから入手可能なCOSMEGEN)(アクチノマイシンDの別名としては、ダクチノマイシン、アクチノマイシンIV、アクチノマイシンI1、アクチノマイシンX1、およびアクチノマイシンC1が挙げられる)、すべてのタキソイド類、例えばタキソール、ドセタキソール、およびパクリタキセル、パクリタキセル誘導体、すべてのオリムス薬、例えばマクロライド系抗生物質、ラパマイシン、エベロリムス、ラパマイシンの構造的誘導体および機能的類似体、エベロリムスの構造的誘導体および機能的類似体、FKBP−12媒介mTOR阻害剤、バイオリムス、パーフェニドン、これらのプロドラッグ、これらのコドラッグ(co−drug)、およびこれらの組み合わせが挙げられる。代表的なラパマイシン誘導体としては、40−O−(3−ヒドロキシ)プロピル−ラパマイシン、40−O−[2−(2−ヒドロキシ)エトキシ]エチル−ラパマイシン、または40−O−テトラゾール−ラパマイシン、40−エピ−(N1−テトラゾリル)−ラパマイシン(イリノイ州、Abott ParkのAbbot Laboratories製のABT−578)、これらのプロドラッグ、これらのコドラッグ、これらの組み合わせが挙げられる。
抗炎症効果を有するあらゆる薬剤を本発明で使用することができる。この抗炎症薬は、ステロイド性抗炎症薬であってもよく、非ステロイド性抗炎症薬であってもよく、またはこれらの組み合わせであってもよい。一部の実施形態において、抗炎症薬としては、アルクロフェナク、ジプロピオン酸アルクロメタゾン、アルゲストンアセトニド、アルファアミラーゼ、アムシナファル、アムシナフィド、アンフェナクナトリウム、塩酸アミプリロース、アナキンラ、アニロラク、アニトラザフェン、アパゾン、バルサラジド二ナトリウム、ベンダザク、ベノキサプロフェン、塩酸ベンジダミン、ブロメラインス、ブロフェラモール、ブデソニド、カルプロフェン、シクロプロフェン、シンタゾン、クリプロフェン、プロピオン酸クロベタゾール、酪酸クロベタゾン、クロピラク、プロピオン酸クロチカゾン、酢酸コルメタゾン、コルトドキソン、デフラザコルト、デソニド、デソキシメタゾン、ジプロピオン酸デキサメタゾン、ジクロフェナクカリウム、ジクロフェナクナトリウム、二酢酸ジフロラゾン、ジフルミドンナトリウム、ジフルニサル、ジフルプレドナート、ジフタロン、ジメチルスルホキシド、ドロシノニド、エンドリゾン、エンリモマブ、エノリカムナトリウム、エピリゾール、エトドラク、エトフェナメート、フェルビナク、フェナモール、フェンブフェン、フェンクロフェナク、フェンクロラク、フェンドサル、フェンピパロン、フェンチアザク、フラザロン、フルアザコルト、フルフェナム酸、フルミゾール、酢酸フルニゾリド、フルニキシン、フルニキシンメグルミン、フルオコルチンブチル、酢酸フルオロメトロン、フルキアゾン、フルルビプロフェン、フルレトフェン、プロピオン酸フルチカゾン、フラプロフェン、フロブフェン、ハルシノニド、プロピオン酸ハロベタゾール、酢酸ハロプレドン、イブフェナク、イブプロフェン、イブプロフェンアルミニウム、イブプロフェンピコノール、イロニダプ、インドメタシン、インドメタシンナトリウム、インドプロフェン、インドキソール、イントラゾール、酢酸イソフルプレドン、イソキセパク、イソキシカム、ケトプロフェン、塩酸ロフェミゾール、ロモキシカム、エタボン酸ロテプレドノール、メクロフェナム酸ナトリウム、メクロフェナム酸、二酪酸メクロリゾン、メフェナム酸、メサラミン、メセクラゾン、スレプタン酸メチルプレドニゾロン、モミフルメート、ナブメトン、ナプロキセン、ナプロキセンナトリウム、ナプロキソール、ニマゾン、オルサラジンナトリウム、オルゴテイン、オルパノキシン、オキサプロジン、オキシフェンブタゾン、塩酸パラニリン、ペントサン多硫酸ナトリウム、グリセリン酸フェンブタゾンナトリウム、パーフェニドン、ピロキシカム、桂皮酸ピロキシカム、ピロキシカムオラミン、ピルプロフェン、プレドナゼート、プリフェロン、プロドール酸、プロカゾン、プロキサゾール、クエン酸プロキサゾール、リメキソロン、ロマザリット、サルコレックス、サルナセジン、サルサレート、塩化サンギナリウム、セクラゾン、セルメタシン、スドキシカム、スリンダク、スプロフェン、タルメタシン、タルニフルメート、ラロサレート、テブフェロン、テニダップ、テニダップナトリウム、テノキシカム、テシカム、テシミド、テトリダミン、チオピナク、ピバル酸チキソコルトール、トルメチン、トルメチンナトリウム、トリクロニド、トリフルミデート、ジドメタシン、ゾメピラクナトリウム、アスピリン(アセチルサリチル酸)、サリチル酸、コルチコステロイド、グルココルチコイド、タクロリムス、ピメコルリムス、これらのプロドラッグ、これらのコドラッグ、およびこれらの組み合わせが挙げられるが、それらに限定されない。
好ましい治療効果を生じさせるために必要な抗増殖薬および抗炎症薬の投薬量または濃度は、その生体活性薬剤が毒性効果を生じさせるレベルより低く、且つ、未治療の結果が得られるレベルより高くなければならない。これらの薬剤の投薬量または濃度は、患者の特定の環境、外傷の性質、望まれる療法の性質、投与された成分が血管部位に存在する時間、ならびに他の活性薬剤を利用する場合には、その物質または物質の組み合わせの性質およびタイプなどの因子に依存し得る。治療有効投薬量は、経験的に、例えば、適する動物モデル系から血管を浸出させ、免疫組織化学的、蛍光または電子顕微鏡法を用いて、薬剤およびその効果を検出することにより、または適するインビトロ試験を行うことにより、決定することができる。
一部の実施形態において、他の薬剤を抗増殖薬および抗炎症薬と併用することができる。これらの生物活性薬剤は、治療薬、予防薬または診断薬である任意の薬剤であり得る。これらの薬剤も抗増殖特性および/もしくは抗炎症特性を有することがあり、または抗新生物薬、抗血小板物質、抗凝血薬、抗フィブリン薬、抗血栓症薬、細胞***抑制薬、抗生物質、抗アレルギー薬、抗酸化物質ならびに細胞増殖抑制剤のように他の特性を有することもある。適する治療および予防薬の例としては、合成無機および有機化合物、タンパク質およびペプチド、多糖類および他の糖類、脂質、ならびに治療、予防または診断活性を有するDNAおよびRNA核酸配列が挙げられる。核酸配列としては、遺伝子、相補DNAに結合して転写を阻害するアンチセンス分子、およびリボザイムが挙げられる。他の生体活性薬剤の他の幾つかの例としては、抗体、受容体リガンド、酵素、接着ペプチド、血液凝固因子、阻害剤または血餅溶解剤、例えばストレプトキナーゼおよび組織プラスミノーゲン活性化因子、免疫用抗原、ホルモンおよび成長因子、オリゴヌクレオチド、例えばアンチセンスオリゴヌクレオチド、ならびに遺伝子療法用のリボザイムおよびレトロウイルスベクターが挙げられる。抗新生物薬および/または細胞***抑制薬の例としては、メトトレキセート、アザチオプリン、ビンクリスチン、ビンブラスチン、フルオロウラシル、塩酸ドキソルビシン(例えば、ニュージャージー州、PeapackのPharmacia & UpjohnからのAdriamycin(登録商標))、およびマイトマイシン(例えば、コネチカット州、StamfordのBristol−Myers Squibb Co.からのMutamycin(登録商標))が挙げられる。このような抗血小板物質、抗凝血薬、抗フィブリン薬、抗トロンビン物質の例としては、ヘパリンナトリウム、低分子量ヘパリン、ヘパリノイド、ヒルジン、アルガトロバン、ホルスコリン、バピプロスト、プロスタサイクリンおよびプロスタサイクリン類似体、デキストラン、D−phe−pro−arg−クロロメチルケトン(合成抗トロンビン物質)、ジピリダモール、糖蛋白IIb/IIIa血小板膜受容体拮抗薬抗体、組換えヒルジン、トロンビン阻害剤、例えばAngiomax a(マサチューセッツ州、CambridgeのBiogen,Inc.)、カルシウムチャネル遮断薬(例えば、ニフェジピン)、コルチシン、線維芽細胞成長因子(FGF)拮抗薬、魚油(ω3−脂肪酸)、ヒスタミン拮抗薬、ロバスタチン(HMG−CoAレダクターゼの阻害剤、コレステロール低下薬、ニュージャージー州、Whitehouse StationのMerck & Co.,Inc.からの商標名Mevacor(登録商標))、モノクローナル抗体(例えば、血小板由来増殖因子(PDGF)受容体に特異的なもの)、ニトロプルシド、ホスホジエステラーゼ阻害剤、プロスタグランジン阻害剤、スラミン、セロトニン遮断薬、ステロイド、チオプロテアーゼ阻害剤、トリアゾロピリミジン(PDGF拮抗薬)、窒素酸化物または窒素酸化物供与体、スーパーオキシドジスムターゼ、スーパーオキシドジスムターゼ模倣物、4−アミノ−2,2,6,6−テトラメチルピペリジン−1−オキシル(4−アミノ−TEMPO)、エストラジオール、抗癌剤、栄養補助食品、例えば様々なビタミン類、ならびにこれらの組み合わせが挙げられる。このような細胞増殖抑制物質の例としては、アンギオペプチン、アンギオテンシン変換酵素阻害剤、例えばカプトプリル(例えば、コネチカット州、StamfordのBristol−Myers Squibb Co.からのCapoten(登録商標)およびCapozide(登録商標))、シラザプリルまたはリシノプリル(例えば、ニュージャージー州、Whitehouse StationのMerck & Co.,Inc.からのPrinivil(登録商標)およびPrinizide(登録商標))が挙げられる。抗アレルギー薬の一例は、ペミロラストカリウムである。適切であり得る他の治療物質または治療薬としては、α−インターフェロンおよび遺伝子操作上皮細胞が挙げられる。上述の物質は、例として挙げたものであり、限定する意味はない。現在入手可能または将来開発され得る他の活性薬剤も同様に適用可能である。
抗増殖薬と抗炎症薬の両方を含む組成物を、任意のデリバリー様式によるデリバリーに適する任意の調合物に調合することができる。例えば、前記組成物を移植可能医療器具上のコーティングにして、抗増殖薬および抗炎症薬の制御放出をもたらすことができる。前記組成物を他の適する調合物、例えば、蛍光透視用色素を場合によっては伴うボーラス用量の遊離薬剤、ボーラス用量のゲル内包型薬剤、に調合することもできる。
1つの実施形態において、クロベタゾールなどの抗炎症薬は、蛍光透視用色素を場合によっては伴うボーラス用量の遊離薬剤に調合する。エベロリムスなどの抗増殖薬は、ポリマー材料とともにコーティング組成物に調合し、その後、移植可能器具(例えば、ステント)にコーティングすることができる。ボーラス用量の抗炎症薬を先ず投与し、その後、ドラッグデリバリーステントなどの移植可能器具からの放出により抗増殖薬を送達する。この組成物は、第三の薬剤、例えば、米国特許第6,367,479号に記載されているようなHDL(高密度リポタンパク質)模倣物をさらに含むことができる。あるいは、HDL模倣物は、ステントにより送達することができる。
一般に、ポリマーは、生体安定性、生体吸収性、生体分解性または生体侵食性であり得る。生体安定性は、生体分解性でないポリマーを指す。用語生体分解性、生体吸収性および生体侵食性、ならびに分解される、侵食されるおよび吸収されるは同義で用いており、血液などの体液に暴露されたときに完全に侵食または吸収され得、身体により徐々に再吸収、吸収および/または排除されるポリマーを指す。
本明細書に記載するコーティングは、スプレーコーティングまたは当分野において利用可能な他の任意のコーティングプロセスによって形成することができる。一般に、コーティングは、組成物またはその1つもしくはそれ以上の成分を溶媒または溶媒混合物に溶解または懸濁させて、前記組成物またはその1つ以上の成分の溶液、懸濁液または分散液を作ること、その溶液または懸濁液を移植可能器具に塗布すること、および溶媒または溶媒混合物を除去して、コーティングまたはコーティングの層を形成することを含む。本明細書に記載する組成物の懸濁液または分散液は、1ナノメートルから100ミクロンの間、好ましくは1ナノメートルから10ミクロンの間のサイズを有するマイクロ粒子のラテックスまたはエマルジョンの形態であり得る。ここに含まれる任意の段階に熱および/または加圧処理を適用することができる。加えて、所望される場合には、本明細書に記載するコーティングをさらなる熱および/または加圧処理に付すことができる。用いることができる移植可能器具のコーティングプロセスの幾つかの追加例は、例えば、Lambert TL,et al.Circulation,1994,90:1003−1011;Hwang CW,et al.Circulation,2001;104:600−605;Van der Giessen WJ,et al.Circulation,1996;94:1690−1697;Lincoff AM,et al.J Am Coll Cardiol 1997;29:808−816;Grube E.et al,J American College Cardiology Meeting,March 6 2002,ACCIS2002,poster 1174−15;Grube E,et al,Circulation,2003,107:1,38−42;Bullesfeld L,et al.Z Kardiol,2003,92:10,825−832;and Tanabe K,et al.Circulation 2003,107:4,559−64に記載されている。
本発明の実施形態に従って、様々な記載の実施形態のコーティングを、移植可能器具またはプロテーゼ、例えばステント上に形成することができる。1つ以上の活性薬剤を含むコーティングについては、薬剤は、医療器具(例えば、ステント)を送達および拡張している間はその器具の上に保持され、移植部位において所定の期間にわたって望ましい速度で放出される。好ましくは、前記医療器具は、ステントである。上記コーティングを有するステントは、一例として胆管、食道、気管/気管支および他の生物学的通路内の腫瘍に起因する閉塞の治療を含む、様々な医療処置に有用である。上記コーティングを有するステントは、平滑筋細胞の異常なまたは不適切な移動および増殖、血栓症ならびに再狭窄に起因する血管の閉塞領域の治療に特に有用である。ステントは、多種多様な血管(動脈と静脈の両方)に配置することができる。部位の代表例としては、腸骨動脈、腎動脈および冠動脈が挙げられる。
クロベタゾールのみのデリバリーステント、エベロリムスのみのステント、およびエベロリムス−クロベタゾール併用ドラッグデリバリーステントでの200μg/cm2用量Lemans試験と比較した28日ブタインプラント試験をこの実施例に記載する。この試験は、3つの異なるドラッグデリバリーステント、Arm 1、Arm 2およびArm 3を使用して行った。Arm 1は、Lemansステント(PVDF−co−HFPに基づく、Guidantから入手可能なステント)であり、これは、105μgのエベロリムスを含み、対照として使用した。Arm 2には185μgのクロベタゾールのみを負荷し、エベロリムスは負荷しなかった。Arm 3には105μgのエベロリムスおよび80μgのクロベタゾールを負荷する。
エベロリムスのみのステント、エベロリムス−クロベタゾール併用ドラッグデリバリーステント、およびクロベタゾールのみのステントを比較する、28日ブタインプラント試験をこの実施例に記載する。ニュージャージー州、ThorofareのSolvary Solexis PVDFから入手可能なSolefポリマーマトリックスに薬剤を分散させた。この試験は、3つの異なるドラッグデリバリーステント、Arm 1、Arm 2およびArm 3を使用して行った。Arm 1は、64μgのエベロリムスを含み、1:4.9の薬剤−ポリマー比を有するLemansステント(PVDF−co−HFPに基づく、Guidantから入手可能なステント)であり、これを対照として使用した。Arm 2には、1:4の薬剤−ポリマー比で64μgのエベロリムスおよび32μgのクロベタゾールを負荷する。Arm 3には、1:4の薬剤比で32μgのクロベタゾールのみを負荷し、エベロリムスは負荷しなかった。表5は、この試験で使用したステントのコーティングデザインを示す。
Claims (14)
- 再狭窄または脆弱性プラークの治療または予防用の、有効量のエベロリムスおよび有効量のクロベタゾールを含む移植可能医療器具の構造体上のコーティングであって、エベロリムスの含有量は、モルベースでエベロリムス及びクロベタゾールの総量の50〜75%である、コーティング。
- 前記移植可能医療器具の構造体がステントである、請求項1に記載のコーティング。
- 再狭窄の治療または予防用である、請求項1に記載のコーティング。
- 脆弱性プラークの治療または予防用である、請求項1に記載のコーティング。
- ポリマーをさらに含む、請求項1に記載のコーティング。
- 再狭窄または脆弱性プラークの治療または予防用のドラッグデリバリーシステムであって、有効量のエベロリムスと、移植可能医療器具の構造体と、前記器具の構造体内の有効量のクロベタゾールとを含み、エベロリムスの含有量は、モルベースでエベロリムス及びクロベタゾールの総量の50〜75%である、ドラッグデリバリーシステム。
- 前記器具が、ステントである、請求項6に記載のシステム。
- 前記構造体が、生体吸収性である、請求項6に記載のシステム。
- 前記構造体が、ポリマー製である、請求項6に記載のシステム。
- 少なくともエベロリムスの一部を含有する前記構造体上のコーティングをさらに含む、請求項6に記載のシステム。
- 前記コーティングが、生体吸収性である、請求項10に記載のシステム。
- クロベタゾールの少なくとも一部分を含有している少なくとも1つのデポーを前記構造体の表面の少なくとも一部分にさらに含む、請求項6に記載のシステム。
- 前記デポー内のクロベタゾールが、ポリマーマトリックスの中に混合または分散されている、請求項12に記載のシステム。
- クロベタゾールの少なくとも一部分が、前記構造体の中に混合または分散されている、請求項6に記載のシステム。
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US11/090,507 US7758881B2 (en) | 2004-06-30 | 2005-03-24 | Anti-proliferative and anti-inflammatory agent combination for treatment of vascular disorders with an implantable medical device |
PCT/US2005/022968 WO2006014270A2 (en) | 2004-06-30 | 2005-06-28 | Anti-proliferative and anti-inflammatory agent combination for treatment of vascular disorders |
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-
2005
- 2005-03-24 US US11/090,507 patent/US7758881B2/en not_active Expired - Fee Related
- 2005-06-28 JP JP2007519366A patent/JP5791221B2/ja not_active Expired - Fee Related
- 2005-06-28 ES ES05803287.1T patent/ES2529043T3/es active Active
- 2005-06-28 WO PCT/US2005/022968 patent/WO2006014270A2/en active Application Filing
- 2005-06-28 EP EP05803287.1A patent/EP1768718B1/en not_active Not-in-force
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WO2006014270A3 (en) | 2006-04-27 |
US20060002977A1 (en) | 2006-01-05 |
US7758881B2 (en) | 2010-07-20 |
EP1768718B1 (en) | 2014-10-29 |
WO2006014270A9 (en) | 2006-05-26 |
EP1768718A2 (en) | 2007-04-04 |
WO2006014270A2 (en) | 2006-02-09 |
ES2529043T3 (es) | 2015-02-16 |
JP2008505093A (ja) | 2008-02-21 |
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