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Photosensitizer Radachlorin~?: Skin cancer PDT phase II clinical trials

机译：光敏剂Radachlorin〜?：皮肤癌PDT II期临床试验

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摘要

"Radachlorin"~?, also known in the EU as Bremachlorin, a composition of 3 chlorophyll a derivatives in an aqueous solution, was introduced into the Russian Pharmacopoeia. Its GMP (Good Manufacturing Practice) facility based manufacturing method was patented. Laboratory experiments and clinical phase I were performed. Protocols were designed for PDT of basal cell carcinoma of the skin to result in GCP (Good Clinical Practice)-conformed randomized phase II clinical studies. "Radachlorin"~? solution for intravenous infusions 0.35% 10 mL in the doses of 0.5-0.6 and 1.0-1.2mg/kg and a gel for topical application 0.1% 25 g in the dose of 0.1 g/cm2 were photoactivated by 2.5W 662 nm semiconductor laser "LAKHTA-MILON~?" (St. Petersburg, Russia) in light doses of 200, 300 (solution), 400, 600, 800 (gel) J/cm~2. Safety study showed no side effects and a good tolerability of "Radachlorin"~? by patients. There was no normal skin/subdermal tissue damage after both laser and sun light exposure. The main part (98%) of the drug was excreted or metabolized in the first 48 h. Drug administration at a dose of 1.0-1.2mg/kg and irradiation at 3h with 662±3nm light at a dose of 300 J/cm~2 (solution) and 4 PDT sessions at an interval of 1 week with 3 h gel exposure, followed by 400 J/cm2 light exposure (gel) were found to be the optimal treatment regimes. Having successfully passed clinical trials, "Radachlorin"~? achieved marketing authorization in Russia in 2009 and a conditional approval in South Korea in 2008. It is a candidate for phase III clinical trials in the EC and may be commercialized as a prospective second-generation photo- sensitizer.
机译：“ Radachlorin” ?，在欧洲也称为Bremachlorin，是在水溶液中由3种叶绿素a衍生物组成的组合物，已被引入俄罗斯药典。其基于GMP（良好生产规范）设施的制造方法已获得专利。进行了实验室实验和临床第一阶段。设计了针对皮肤基底细胞癌的PDT的方案，以进行GCP（良好临床实践）相关的随机II期临床研究。 “ Radachlorin”〜？用2.5W 662 nm半导体激光器将0.35％10 mL剂量为0.5-0.6和1.0-1.2mg / kg的静脉输注溶液和0.1％25 g剂量为0.1 g / cm2的局部用凝胶通过2.5W 662 nm半导体激光器进行光激活。 LAKHTA-MILON〜？” （俄罗斯圣彼得堡）的光剂量为200、300（溶液），400、600、800（凝胶）J / cm〜2。安全性研究表明，“瑞达霉素”没有副作用，并且具有良好的耐受性。由患者。激光和太阳光照射后均没有正常的皮肤/皮下组织损伤。药物的主要部分（98％）在最初的48小时内排泄或代谢。以1.0-1.2mg / kg的剂量给药，并以662±3nm的光以300 J / cm〜2的剂量（溶液）在3h照射，并在1周的间隔内进行4次PDT，并暴露3h的凝胶，其次是400 J / cm2的曝光量（凝胶）是最佳的治疗方案。成功通过临床试验的“ Radachlorin”〜？该产品于2009年在俄罗斯获得了销售授权，并于2008年在韩国获得了有条件的批准。它是EC中进行III期临床试验的候选人，并且可以作为有希望的第二代光敏剂商业化。

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  • 来源
    《Photodiagnosis and Photodynamic Therapy》 |2010年第4期|p.258-267|共10页
  • 作者

    Elena V. Kochneva; Elena V. Filonenko; Elena G. Vakulovskaya; Elena G. Scherbakova; Oleg V. Seliverstov; Nikolay A. Markichev; Andrei V. Reshetnickov;

  • 作者单位

    Municipal Healthcare Facility 'Chelyabinsk Municipal Clinical Hospital No. 1', 16 Vorovskogo Street, Chelyabinsk 454048 Russi;

    P.A.Gertsen Moscow Research Oncological Institute, 3 Vtoroy Botkinskii Proyezd, Moscow 125284, Russia;

    Russian Academy of Medical Sciences N.N.Blokhin Cancer Research Center, 24 Kashirskoye Shosse, Moscow 115478, Russia;

    RADA-PHARMA Ltd., 35, Perovskiy proezd, Moscow 111024, Russia;

    Municipal Healthcare Facility 'Chelyabinsk Municipal Clinical Hospital No. 1', 16 Vorovskogo Street, Chelyabinsk 454048 Russi;

    Russian Healthcare Ministry State Scientific Laser Medicine Centre, 40 Studencheskaya str., Moscow 121165, Russia;

    RADA-PHARMA Ltd., 35, Perovskiy proezd, Moscow 111024, Russia,RADA-PHARMA International B.V. 82, Westeinde, Noordwijkerhout 2211XR, The Netherlandsapp. 313, house 1, Chicherina str., Chelyabinsk 454100, Russia;

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  • 正文语种 eng
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  • 关键词

    carcinoma; skin; PDT; radachlorin; bremachlorin; laser;

    机译：癌;皮肤;太平洋夏令时;雷达霉素溴虫霉素激光;

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