29 november 2011: Bron: PDT journal

Hier de meest recente fase II studie publicatie over radachlorin gebruikt als photosynthesizer bij een PDT - Foto Dynamische Therapie behandeling plus referentielijst. Andrei Reshetnickov werkt dus nog steeds samen met de Nederlandse geldschieter en de studies zijn dus altijd doorgegaan. Hoe radachlorin werkt kunt u lezen in het ervaringsverhaal van Karen, een Nederlandse vrouw met borstkanker. In Nederland staat radachlorin bekend onder de naam bremachlorin. Of het ook nog te koop is weet ik niet maar kunt u navragen bij:

  • RADA-PHARMA Ltd., 35, Perovskiy proezd, Moscow 111024, Russia
  • RADA-PHARMA International B.V. 82, Westeinde, Noordwijkerhout 2211XR, The Netherlands
  • Tel.: +31 71 364 20 30.
  • Corresponding Author InformationCorresponding author at: app. 313, house 1, Chicherina str., Chelyabinsk 454100, Russia. Tel.: +7 925 509 40 31; fax: +7 495 600 07 52.

    • Onderaan ook referentielijst van studies met radachlorin 

    Photosensitizer Radachlorin®: Skin cancer PDT phase II clinical trials☆

       
    • Elena V. Kochneva

        Affiliations

      • Municipal Healthcare Facility “Chelyabinsk Municipal Clinical Hospital No. 1”, 16 Vorovskogo Street, Chelyabinsk 454048 Russia
      • Tel.: +7 3512 34 62 34.
      • ,
    • Elena V. Filonenko

        Affiliations

      • P.A.Gertsen Moscow Research Oncological Institute, 3 Vtoroy Botkinskii Proyezd, Moscow 125284, Russia
      • Tel.: +7 495 945 88 07.
      • ,
    • Elena G. Vakulovskaya

        Affiliations

      • Russian Academy of Medical Sciences N.N.Blokhin Cancer Research Center, 24 Kashirskoye Shosse, Moscow 115478, Russia
      • Tel.: +7 495 111 82 38.
      • ,
    • Elena G. Scherbakova

        Affiliations

      • RADA-PHARMA Ltd., 35, Perovskiy proezd, Moscow 111024, Russia
      • ,
    • Oleg V. Seliverstov

        Affiliations

      • Municipal Healthcare Facility “Chelyabinsk Municipal Clinical Hospital No. 1”, 16 Vorovskogo Street, Chelyabinsk 454048 Russia
      • ,
    • Nikolay A. Markichev

        Affiliations

      • Russian Healthcare Ministry State Scientific Laser Medicine Centre, 40 Studencheskaya str., Moscow 121165, Russia
      • Tel.: +7 495 146 85 64.
      • ,
    • Andrei V. Reshetnickov, PhD

        Affiliations

      • RADA-PHARMA Ltd., 35, Perovskiy proezd, Moscow 111024, Russia
      • RADA-PHARMA International B.V. 82, Westeinde, Noordwijkerhout 2211XR, The Netherlands
      • Tel.: +31 71 364 20 30.
      • Corresponding Author InformationCorresponding author at: app. 313, house 1, Chicherina str., Chelyabinsk 454100, Russia. Tel.: +7 925 509 40 31; fax: +7 495 600 07 52.

    published online 16 August 2010.

    Summary 

    “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% 10mL in the doses of 0.5–0.6 and 1.0–1.2mg/kg and a gel for topical application 0.1% 25g in the dose of 0.1g/cm2 were photoactivated by 2.5W 662nm semiconductor laser “LAKHTA-MILON®” (St. Petersburg, Russia) in light doses of 200, 300 (solution), 400, 600, 800 (gel) J/cm2.

    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 48h. Drug administration at a dose of 1.0–1.2mg/kg and irradiation at 3h with 662±3nm light at a dose of 300J/cm2 (solution) and 4 PDT sessions at an interval of 1 week with 3h gel exposure, followed by 400J/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 photosensitizer.

     

    References 

    1. Reshetnikov AV, et al. Photosensitizer, and method therefore. Russian patent No. 2183956 of March 30; 2001. South African patent 2003/8407 of 24 February 2005. United Kingdom patent GB2389531 of 13 March 2005. United States Patent US 6969765 of November 29; 2005. Chinese Patent No. 258833 of April 12; 2006. South Korean Patent No. 10-0628548 of September 19; 2006.
    2. Kochneva EV. Results of Phase II clinical trials of the photosensitizer Radachlorin in patients with cutaneous basal-cell carcinoma carried out at the Chelyabinsk municipal clinical hospital No. 1. Russian Biother J. 2005;4:92–95[in Russian]
    3. Vakulovskaya EG. Photodynamic therapy and fluorescence diagnostics of head and neck cancer using second-generation photosensitizers. In: Proc SPIE (laser use in oncology), 5973. 2005;p. 81–86
    4. Markichev NA, et al. Photodynamic therapy of cutaneous basal-cell carcinoma using photosensitizer from the chlorins family Radachlorin. Laser Med. 2004;8(3):144–145[in Russian]
    5. Privalov VA, et al. Five years’ experience of photodynamic therapy with new chlorin photosensitizer. In:  van den Bergh H,  Vogel A editor. Proceedings of SPIE, vol. 5863, “therapeutic laser applications and laser–tissue interactions, II. 2005;p. 186–198
    6. Privalov VA, et al. Clinical Trials of a New Chlorin Photosensitizer for Photodynamic Therapy of Malignant Tumors. In:  Dougherty TJ editors. Optical methods for tumor treatment and detection: mechanisms and techniques in photodynamic therapy XI, SPIE proceedings, vol. 4612. 2002;p. 178–190
    7. Vakulovskaya EG, Reshetnikov AV. Photodynamic therapy and fluorescent diagnostics with “Radachlorin®” in skin cancer patients. In: 10th congress of the European Society for photobiology. Vienna, Austria, September 6–11. 2003;p. 95
    8. Vakulovskaya EG, et al. Photodynamic therapy and fluorescent diagnosis of skin cancer patients using photosensitizer Radachlorin. Russian Biother J. 2004;1:77–82[in Russian]
    9. Non-clinical report of the study by LitePharmTech Ltd., South Korea. KFDA Radachlorin marketing authorization of 17.12.2008.
    10. Reshetnickov AV, et al. Evaluation of biological properties of novel chlorin-type photosensitizers. “Use of lasers for diagnosis and treatment of diseases. Sci Bul (Addendum to Bulletin “Laser-Inform”). 2001;3:34–40[in Russian]
    11. Reshetnickov AV, et al. Novel drug form of chlorin e6. In:  Dougherty TJ editors. Proceedings of SPIE, optical methods for tumor treatment and detection: mechanisms and techniques in photodynamic therapy IX, vol. 3909. 2000;p. 124–129
    12. Ivanov AV, et al. One more PDT application of chlorin e6. In:  Dougherty TJ editors. Proceedings of SPIE, optical methods for tumor treatment and detection: mechanisms and techniques in photodynamic therapy IX, vol. 3909. 2000;p. 131–137
    13. Uzdensky AB, et al. Photodynamic effect of novel chlorin e6 derivatives on a single nerve cell. Life Sci. 2004;74(17):2185–2197doi:10.1016/j.lfs.2003.09.053. See Elsevier site
    14. Reshetnickov AV, et al. Main results of laboratory studies of novel photosensitizer Radachlorin. Russian Biother J. 2002;1(2):141;[in Russian]
    15. Douillard S, et al. In vitro and in vivo evaluation of Radachlorin sensitizer for photodynamic therapy. Photochem Photobiol Sci. 2009;8:405–413

     

    radachlorin, photosynthesizer, Foto Dynamische Therapie, PDT


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