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
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
BCC is a non-melanoma skin cancer that arises from the basal layer of epidermis and its appendages. According to the
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
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.
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.
NexoBrid, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the
EscharEx, our next-generation bioactive topical therapeutic under development in the
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.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future preclinical studies and clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
|Chief Financial Officer|
Source: MediWound Ltd.