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CN1420788A - 新血管形成的改进治疗方法 - Google Patents

新血管形成的改进治疗方法 Download PDF

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CN1420788A
CN1420788A CN01807144A CN01807144A CN1420788A CN 1420788 A CN1420788 A CN 1420788A CN 01807144 A CN01807144 A CN 01807144A CN 01807144 A CN01807144 A CN 01807144A CN 1420788 A CN1420788 A CN 1420788A
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R·K·布拉泽勒
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Abstract

本发明描述了用于治疗中央凹下脉络膜新血管形成(CNV)的改进的光动力学治疗方法。

Description

新血管形成的改进治疗方法
本发明涉及一种通过使用抗血管生成药作为光动力学疗法(也称作光动力学治疗方法)(PDT)的佐剂，来治疗中央凹下脉络膜新血管形成(CNV)的改进方法。
当前用应用合适光敏剂的光动力学疗法治疗老年黄斑变性(AMD)的方法时治疗CNV具有极佳的短期效果，并且与激光光凝固法相比具有显著的改善。然而，已经证实对用PDT治疗的患者中，在治疗区域内存在脉络膜新血管形成的复发和/或在最初的病变部位外形成新的病变(所谓进行性病变)，从而需要重复进行PDT。因此，可以与PDT联用并预防新血管生长的药物治疗方法是一大进步且有利于治疗CNV。对新的不需要的新血管结构的预防可以减少某些受试者所需的PDT治疗的次数。本技术还可以用于治疗其它类型的眼组织，诸如视网膜新血管损害。
因此，本发明在第一方面描述了一种对受试者体内因CNV而产生的不需要的血管结构的改进的治疗方法，该方法包括下列步骤：
(a)对所述的受试者施用有效量的抗血管生成药；
(b)对所述的受试者施用有效量的光敏剂；和
(c)用具有可由所述光敏剂吸收的波长的光照射所述的不需要的新血管结构。
本发明在进一步的方面涉及抗血管生成药的用途，其用于与光敏剂联合制备药物，以对受试者、优选人受试者因CNV而产生的不需要的新血管结构提供改进的光动力学治疗方法。
本发明在进一步的方面涉及抗血管生成药的用途，其用于与光敏剂联合制备药物，以对受试者、优选人受试者因CNV而产生的不需要的新血管结构提供改进的光动力学治疗方法，其中所述改进的光动力学治疗方法包括下列步骤：
(a)对所述的受试者施用有效量的抗血管生成药；
(b)对所述的受试者施用有效量的光敏剂；和
(c)用具有可由所述光敏剂吸收的波长的光照射所述的不需要的新血管结构。
现已发现抗血管生成药可与PDT联用，来治疗具有由CNV引起的不需要的眼部新血管结构的受试者。
PDT作为一种治疗方法在本领域内是所众所周知的，且一般涉及激光活化的光敏剂的应用。使用光敏剂和激光疗法的优选PDT治疗方法公开在已授权的欧洲专利EP 680′365 B1和国际申请WO 97/33619中。在PDT中，所述的光敏剂滞留在受CNV影响的眼组织(即靶眼组织)内，且被具有可由该光敏剂吸收的波长的激光所活化。在本发明中，所述的抗血管生成药在PDT治疗所用的光敏剂之前、之后和/或同时施用。PDT与抗血管生成药的联用称作辅助性PDT。
抗血管生成药可以与光敏剂依次施用，或与光敏剂同时施用，优选的方法是依次施用。因此，应将术语“与…联用”解释为本说明书公开内容中的定义。作为依次治疗的实例，可以在施用PDT光敏剂之前1-4周、更优选地0.5-1.5周施用抗血管生成药。在一个可选择的依次治疗方法中，可以在施用PDT光敏剂之后0-4周、更优选地0-1周施用所述的抗血管生成药。如果必要，可以按照上述方案在PDT之前和之后依次施用所述的抗血管生成药。另一方面，可以将该治疗方法看作是同时进行的，条件是将所述的抗血管生成药与所述的光敏剂一起施用。特定的受试者可能需要多次辅助性PDT疗法，或需要与抗血管生成药联用的辅助性PDT疗法，且特定的辅助性PDT疗法可能需要多次施用所述的抗血管生成药。
本文所用的术语抗血管生成药指的是通过公知的抗血管形成的方法预防、抑制或逆转新血管生长而起作用的药物。用于辅助PDT中的抗血管生成药的实例包括：星形孢菌素类(如N-苯甲酰基-星形孢菌素)、促生长素抑制素类(如奥曲肽(D)
Figure A0180714400051
醇)和类固醇类(如曲安奈德)。用于本发明的其它抗血管生成药为VEGF抑制剂，诸如CGP 79787D、CGP 57 148B或CGP 53 716等，它们的结构如下：
Figure A0180714400061
这些抗血管生成药特别用于抑制在脉络膜新血管形成过程中发生的血管生长的复发、再发、发展和/或进展，并在辅助性PDT中提供显著的有益作用。
优选的抗血管生成药选自蛋白激酶C抑制剂(PKC)(例如N-苯甲酰基-星形孢菌素)、生长激素和IGF-1抑制剂(例如奥曲肽)、血管内皮生长因子(VEGF)抑制剂(例如CGP 79787、N-苯甲酰基-星形孢菌素、CAM 781)、环加氧酶II抑制剂(例如双氯芬酸、COX 189)、血管紧张肽II抑制剂(例如缬沙坦)、NF-κB抑制剂和PLA2拮抗剂，更优选地选自PKC抑制剂、VEGF抑制剂以及选自生长激素和IGF-1抑制剂。
高度优选的抗血管生成药选自PKC和VEGF抑制剂，特别地选自PKC抑制剂。高度优选的抗血管生成药选自N-苯甲酰基-星形孢菌素、CGP79787和奥曲肽，且特别地选自N-苯甲酰基-星形孢菌素。
优选的光敏剂选自氯气、菌绿素、酞菁、卟啉、红紫素、部花青、脱镁叶绿甲酯一酸和补骨脂素。
高度优选的光敏剂选自卟啉类，且一般是所谓的绿卟啉或BPD-MA。
可以将上述任意的光敏性化合物用于本发明的方法。当然，也可以使用两种或多种光敏性化合物的混合物；不过，该治疗方法的有效性取决于光被所述光敏性化合物的吸收程度，因此如果使用混合物的话，那么优选具有相似最大吸收的组分。
用于转运抗血管生成药或光敏剂的制剂的性质将部分取决于施用方式以及所选择的抗血管生成药和光敏剂的性质。可以使用对特定活性化合物合适的任意可药用赋形剂或其组合。因此，可以将所述的光敏剂或抗血管生成化合物以含水组合物、以经粘膜或经皮组合物、用皮下或眼内注射剂或以口服制剂形式施用。其制剂还可以包括脂质体。尤其当光敏剂是绿卟啉时，特别优选脂质体组合物。优选通过含水载体施用抗血管生成药。
可以多种方式例如经口施用、肠胃外施用或直肠施用上述化合物，或可以将所述的化合物直接施用于眼内或眼上。就光敏剂而言，优选肠胃外施用，诸如静脉内施用、肌内施用或皮下施用。特别优选静脉内注射。优选经口施用或眼部施用来施用抗血管生成药。
上述化合物的剂量可以随施用方式、携带化合物的剂型(诸如脂质体形式的制剂)或化合物是否与诸如抗体或免疫活性片段这样的靶特异性配体偶联的不同而有大的变化。正如通常认识到的，在光敏剂类型、剂型、施用方式和剂量水平之间存在相关性。按照足以使药物与不需要的新血管结构发生相互作用的方式和用量施用抗血管生成药。按照使不需要的新血管结构闭合的有效用量施用光敏剂。
尽管各种光活性化合物需要不同的剂量范围，但是如果使用绿卟啉类，那么典型的剂量范围为0.1-50mg/m2体表面积，优选地为约1-10mg/m2体表面积，且甚至更优选地为约2-8mg/m2体表面积。
尽管不同的抗血管生成化合物需要不同的剂量范围，但是典型的剂量范围为1-500mg/kg(体重)、优选地为约10-250mg。
按照上述现有技术、例如按照WO 97/33619中公开的光治疗方案进行照射(激光能源、照射持续时间)。

Claims (10)

1.抗血管生成药的用途，其用于与光敏剂联合制备药物，用于对受试者因CNV而产生的不需要的新血管结构进行改进的光动力学治疗。
2.权利要求1的用途，其中所述改进的光动力学治疗方法包括下列步骤：
(a)对所述的受试者施用有效量的抗血管生成药；
(b)对所述的受试者施用有效量的光敏剂；和
(c)用具有可由所述光敏剂吸收的波长的光照射所述的不需要的新血管结构。
3.权利要求1或2的用途，其中在施用所述的光敏剂之前1-4周施用所述的抗血管生成药。
4.权利要求1或2的用途，其中同时施用所述的抗血管生成药和所述的光敏剂。
5.权利要求1或2的用途，其中在施用所述的光敏剂之后1-4周施用所述的抗血管生成药。
6.权利要求1的用途，其中所述的抗血管生成药选自：蛋白激酶C抑制剂、生长激素和IGF-1抑制剂、血管内皮生长因子抑制剂、环加氧酶II抑制剂、血管紧张肽II抑制剂、NF-κB抑制剂和PLA2拮抗剂。
7.权利要求6的用途，其中所述的抗血管生成药选自PKC和VEGF抑制剂，特别选自PKC抑制剂。
8.权利要求7的用途，其中所述的抗血管生成药选自N-苯甲酰基星形孢菌素、CGP 79787和奥曲肽，且特别选自N-苯甲酰基-星形孢菌素。
9.权利要求1的用途，其中所述的光敏剂选自卟啉和红紫素，且更优选地选自卟啉。
10.对受试者因CNV而产生的不需要的新血管结构的一种改进的光动力学治疗方法，该方法包括下列步骤：
(a)对所述的受试者施用有效量的抗血管生成药；
(b)对所述的受试者施用有效量的光敏剂；和
(c)用具有可由所述光敏剂吸收的波长的光照射所述的不需要的新血管结构。
CNB018071449A 2000-03-24 2001-03-22 抗血管生成药与光敏剂的联合制药用途 Expired - Fee Related CN100398153C (zh)

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IL151833A0 (en) 2003-04-10
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RU2271222C2 (ru) 2006-03-10
BR0109499A (pt) 2002-12-10
US8862224B2 (en) 2014-10-14
WO2001074389A2 (en) 2001-10-11
EE200200547A (et) 2004-02-16
JP2003528926A (ja) 2003-09-30
PL359027A1 (en) 2004-08-23
US20120203162A1 (en) 2012-08-09
EP1265636A2 (en) 2002-12-18
US20010039438A1 (en) 2001-11-08
US8158669B2 (en) 2012-04-17
MXPA02009351A (es) 2003-02-12
NO20024486D0 (no) 2002-09-19
CN100398153C (zh) 2008-07-02
US20060263392A1 (en) 2006-11-23
CA2403612A1 (en) 2001-10-11
KR20070114856A (ko) 2007-12-04
AU5040101A (en) 2001-10-15
ZA200207638B (en) 2003-10-16
HUP0300347A3 (en) 2005-03-29
NO20024486L (no) 2002-09-19
AR032151A1 (es) 2003-10-29
US20080096865A1 (en) 2008-04-24
WO2001074389A3 (en) 2002-07-11
AU2001250401B2 (en) 2005-08-11
UA75350C2 (en) 2006-04-17
CZ20023174A3 (cs) 2003-01-15

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