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) -- 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 Sharon Malka, Chief Executive Officer of MediWound. "We are encouraged by the interest expressed by the clinical community to participate in this study, and we look forward to working closely with practitioners and patients as we advance this program to potentially treat the most common form of human cancer.”
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 cases diagnosed every year. The increasing number of diagnosed BCC is a result of better skin cancer detection, increased sun exposure, and greater life expectancy.
MW005, a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development. MW005 is based on a proprietary formulation, designed to ease self-administration by the patients, and is based on the same active substance as in NxoBrid® and EscharEx®, a concentrate of proteolytic enzymes enriched in bromelain.
The clinical development program of MW005 is supported by results from several toxicological and other preclinical studies, as well as the vast clinical experience with NexoBrid and EscharEx. In addition, a recently-published case series, wherein MW005 (a concentrate of proteolytic enzymes enriched in bromelain) was used for destruction of basal cell carcinoma, provides a preliminary clinical proof-of-concept that MW005 may be a safe and effective treatment in this indication.
About MediWound Ltd.
MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burns, wound care and tissue repair.
NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).
EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications.
MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.
Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.
Cautionary Note Regarding Forward-Looking Statements
MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
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