MediWound, a biotech firm that makes burn and wound treatments, said Monday it will start a clinical trial in three US medical centers of a new drug candidate to treat non-melanoma skin cancer.
The phase I/II clinical trial , which is scheduled to start in the second quarter of the year, will study the safety, tolerability and efficacy of the drug product candidate MWPC005 for the non-invasive treatment of basal cell carcinoma (BCC), a non-melanoma skin cancer that arises from the basal layer of epidermis and its appendages. Results of the trial, which will evaluate the drug in patients with the disease, are expected by the end of the year, the company said in a statement, along with the results of a phase II trial of the drug candidate that will be conducted in parallel at the Soroka Medical Center in Israel.
The move represents a pivot from burn-related wounds, on which Mediwound has focused until now. The firm develops and produces therapies based on proteolytic enzymes which it extracts from the stem of the pineapple plant.
MediWound’s lead drug, NexoBrid, is a gel based on pineapple enzymes for the treatment of burns. The firm’s second product, EscharEx, is a topical biological drug being developed for debridement — the removal of dead or infected tissue — of chronic and other hard-to-heal wounds. EscharEx contains the same proteolytic enzyme technology as NexoBrid.
The new drug candidate, the MWPC005, is a topically applied biological product based on the same proteolytic enzymes that are used in NexoBrid and EscharEx, the company said, and once developed would be applied by the patients themselves.
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.
MediWound’s preclinical in-vitro research, combined with scientific evidence in a skin cancer model, demonstrated the anti-cancer activity of bromelain, which is the enzyme extract derived from the stems of pineapples, the statement said, and suggests that MWPC005 “might have a role in treating low-risk non-melanoma skin malignancies.”
The start of the MWPC005 trial is “an important step in our strategic evolution” to use the company’s “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.”
MediWound’s focus will remain on the growth and advancement of its NexoBrid and EscharEx programs, Malka said, but this synergistic drug product candidate will be added to the firm’s drug pipeline portfolio.
NexoBrid, the firm’s 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 European Union and other international markets, the statement said. EscharEx is still under development in the US, the statement said.