Mediwound Ltd (MDWD)

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MediWound Launches Clinical Development Program for Treatment of Non-Melanoma Skin Cancer


https://finance.yahoo.com/news/mediwound-launches-clinical-development-program-113000318.html

Phase I/II Clinical Study in Basal Cell Carcinoma Scheduled to Begin Second Quarter 2021, with Data Expected by the End of 2021

An Investigator-Initiated Trial Will Run in Parallel

YAVNE, Israel, Feb. 22, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced the initiation of a new clinical development program to evaluate its drug product candidate MWPC005 in patients with non-melanoma skin cancer. MediWound recently submitted a protocol to the FDA for a phase I/II clinical study of MWPC005 for the treatment of basal cell carcinoma (BCC) and is preparing to initiate this study in the United States in the second quarter of 2021. A phase II investigator-initiated trial of MWPC005 in non-melanoma skin cancer will be conducted in parallel at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be generated by the end of 2021.

MWPC005 is a topically applied biological drug candidate based on the same active ingredient as in the Company’s NexoBrid® and EscharEx® products, a concentrate of proteolytic enzymes enriched in bromelain. MediWound’s preclinical in-vitro research, combined with existing scientific evidence in a skin cancer model, demonstrated bromelain’s anti-cancer activity, and together with clinical case studies suggest that MWPC005 might have a role in treating low-risk non-melanoma skin malignancies.

“I am pleased to launch our new clinical development program for the treatment of non-melanoma skin cancers. MWPC005 represents an important step in our strategic evolution to leverage our innovative enzymatic platform technology to pioneer solutions for unmet medical needs,” said Sharon Malka, Chief Executive Officer of MediWound. “Non-melanoma skin cancers, including BCC, are by far the most common of all types of cancer and represent a significant potential market opportunity. We believe that MWPC005 has the potential to be an effective non-invasive treatment for BCC without the side effects associated with current topical therapies and their longer treatment duration. While MediWound remains focused on its continued growth and advancement of our NexoBrid and EscharEx programs, we are excited to add a synergistic drug product candidate to our pipeline portfolio.”

BCC is a non-melanoma skin cancer that arises from the basal layer of epidermis and its appendages. According to the American Cancer Society, BCC is the most diagnosed skin cancer in the United States with approximately 4.3 million diagnosed cases every year. The increasing number of diagnosed BCC is a result of better skin cancer detection, increased sun exposure, and greater life expectancy.

The phase I/II open-label, randomized clinical study of MWPC005 in BCC is designed to evaluate safety and tolerability using different schedules of administration, as well as provide a preliminary evaluation of efficacy as measured by the percentage of target lesion 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 U.S.

The phase II investigator-initiated trial is an open-label study, designed to evaluate the safety and efficacy of MWPC005 in removing non-melanoma skin cancer and pre-cancerous lesions (e.g. actinic keratosis, BCC and squama cell carcinoma) in up to 50 patients.

About MWPC005

MWPC005, is a topically applied biological product candidate based on the same active substance as in NexoBrid® and EscharEx® products, a concentrate of proteolytic enzymes enriched in Bromelain. MWPC005 is based on a proprietary formulation, designed to ease self-administration by the patients. The clinical development plan of MWPC005 is supported by the results from several toxicological and other preclinical studies, as well as the vast clinical experience from NexoBrid and EscharEx, which share the same active substance.