Photosensitizer Radachlorin®: Skin cancer PDT phase II clinical trials
Abstract
"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/cm(2) 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/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 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/cm(2) (solution) and 4 PDT sessions at an interval of 1 week with 3h gel exposure, followed by 400J/cm(2) 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.
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Chlorin has absorption at 662 nm and has been shown to be less painful to patients than MAL and ALA treatments.
“A further photosensitizing drug, chlorin, comprising of chlorin e6, chlorin p6, and purpurin 5, has been approved for use in Russia and Republic of Korea with absorption at 662 nm and has been shown to be less painful to patients than MAL and ALA treatments.66,67,114”
From Effect of skin color on optical properties and the implications for medical optical technologies: a review (2024) · cites this paper as [66]
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- Authors
- Kochneva, E. V., Filonenko, E. V., Vakulovskaya, E. G., Scherbakova, E. G., Seliverstov, O. V., Markichev, N. A., & Reshetnickov, A. V.
- Affiliations
- Russian Cancer Research Center NN Blokhin (RU)
- Municipal Autonomous Healthcare Institution (RU)
- Corresponding author
- Reshetnickov, Andrei V.
- Venue
- Photodiagnosis and Photodynamic Therapy
- Publisher
- Elsevier BV
- Published
- 2010-12
- Volume
- 7
- Issue
- 4
- Pages
- 258-267
- ISSN
- 1572-1000 (ISSN-L)
- OpenAlex
- W1965371367
- Cited by
- 71
- References
- 8
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 3 · 2023: 8 · 2022: 3 · 2021: 5 · 2020: 2 · 2019: 6 · 2018: 5 · 2017: 6 · 2016: 2 · 2015: 5 · 2014: 7 · 2013: 10 · 2012: 2
- FWCI
- 3.46
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Photodiagnosis and Photodynamic Therapy (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Photodynamic Therapy Research Studies
- Health Sciences › Medicine › Epidemiology › Nonmelanoma Skin Cancer Studies
- Physical Sciences › Engineering › Biomedical Engineering › Nanoplatforms for cancer theranostics
- Keywords
- Radachlorin, chlorophyll a derivatives, photosensitizers, photodynamic therapy, basal cell carcinoma, skin cancer, topical gel, intravenous infusion, treatment regimen optimization, drug safety and tolerability, drug metabolism
- MeSH terms
- Basal Cell Carcinoma, Chlorophyll, Dose-Response Relationship, Drug, Drug Combinations, Female, Humans, Male, Photochemotherapy, Porphyrins, Skin Neoplasms, Photosensitizing Agents
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