On October 18, 2022 Helsinn Group ("Helsinn"), a fully integrated global biopharma company with a diversified pipeline of innovative oncology assets, reported that research from an in vitro study of chlormethine gel has been published in the journal Dermatology and Therapy (Press release, Helsinn, OCT 18, 2022, View Source [SID1234622127]).

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This article, "Chlormethine Gel for the treatment of Mycosis Fungoides Cutaneous T-Cell Lymphoma: In Vitro Release and Permeation Testing", evaluated part of the mode of action of chlormethine (CL) gel once applied to the skin. In a preliminary, proof-of-concept, in vitro study, the release profile of 0.016% chlormethine gel was evaluated compared to an ointment-based formulation of CL. The absorption profile of the CL gel was also evaluated in ex vivo healthy human skin using in vitro permeation testing (IVPT).

Results from the study indicate that the rate of chlormethine release from the CL gel formulation was statistically higher in comparison to the ointment formulation. In addition, data indicate that only a minimal amount of the CL can pass through the epidermis reaching the dermis, suggesting that most of the applied CL reacted within the epidermal layer. This finding is consistent with the lack of evidence of systemic absorption seen with CL gel(1,2) and further supports the notion that drug-drug interactions are very unlikely.

Details of the publication:

Title: "Chlormethine Gel for the treatment of Mycosis Fungoides Cutaneous T-Cell Lymphoma: In Vitro Release and Permeation Testing."
Authors: Claudio Giuliano, Stefano Frizzarin, Alessandro Alonzi, Virginia Stimamiglio and Pablo L. Ortiz-Romero
Link: View Source
Chlormethine gel 0.016%, also known as mechlorethamine gel, is approved in multiple countries, including the EU and US, and is marketed under the trade names LEDAGA and VALCHLOR. The authorized use for each country varies based on the design of the registrational trial and the individual health authority requirements. For more details, please refer to the approved product information for each respective jurisdiction.

Dr. Silvia Sebastiani, Group Head of Medical Affairs, commented: "Chlormethine is a well-established and effective topical therapy for treating lesions in patients with MF-CTCL and is available in a variety of formulations. Understanding CL gel’s mode of action and how it permeates through the skin is extremely important for its use in clinical practice."