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MediWound Announces Initiation of U.S. Phase I/II Study of MW005 for the Treatment of Basal Cell Carcinoma
Data Expected End of 2021 Phase II Investigator-Initiated Trial in Non-Melanoma Skin Cancers Running in Parallel YAVNE, Israel, July 26, 2021 (GLOBE NEWSWIRE)
About this update from Mediwound Ltd.
[{"type":"text","content":"Data Expected End of 2021 Phase II Investigator-Initiated Trial in Non-Melanoma Skin Cancers Running in Parallel YAVNE, Israel, July 26, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced initiation of its phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be available by the end of 2021. The phase I/II open-label, randomized clinical study is designed to evaluate the safety and tolerability of MW005 in BCC using different schedules of administration, as well as to provide a preliminary evaluation of its efficacy, as measured by the percentage of target lesions with complete histological clearance. The study will enroll up to 32 patients with histologically confirmed superficial or nodular BCC and will be conducted at three leading clinical centers in the United States. The phase II investigator-initiated trial is an open-label study, designed to evaluate the safety and efficacy of MW005 in removing non-melanoma skin cancers and pre-cancerous lesions (e.g., actinic keratosis, BCC, and squamous cell carcinoma) in up to 50 patients. “Most low-risk BCCs are treated surgically. There is a clear unmet need for an effective, non-surgical, topically-applied, short duration treatment for low-risk BCC, with less severe local skin reactions associated with current topical therapies,” said Dr. Brian Berman, past president of American Dermatological Association, Professor Emeritus, University of Miami, and a lead principal investigator of the phase I/II study. “We are pleased to lead the clinical evaluation of MW005 as a potentially impactful topical therapy for low-risk BCC, given its pro-apoptotic mechanism of action and preliminary proof-of-concept efficacy.” “We are excited to initiate this U.S. phase I/II study of MW005, which is the first step in this important clinical development program. MW005 represents a meaningful progress in our strategy to leverage our innovative enzymatic technology platform to pioneer solutions for unmet medical needs,” said...