Trial Shows Gel Clears Common Skin Cancer Wounds

(Marco Verch, Flickr. https://flic.kr/p/2hf5q9E)

19 Dec. 2022. Results of a clinical trial indicate a gel applied to lesions caused by basal cell carcinoma is safe for patients and clears the cancerous skin tumors. Findings from the study were released today by MediWound Ltd. in Yavne, Israel, the developer of the treatment code-named MW005 tested in the trial, and are not peer-reviewed.

Basal cells are found in the outer layers of the skin that are shed as new cells form. Ultraviolet light from the sun or tanning beds, can damage DNA resulting in uncontrolled growth of basal cells, called basal cell carcinoma. Basal cell carcinoma or BCC is the most common form of skin cancer, affecting some 3.6 million people each year in the U.S., according to Skin Cancer Foundation. BCC lesions can appear as open sores, patches, growths, or bumps. While readily treated in their early stages, mainly with surgery, BCC lesions can grow and become disfiguring if not treated.

MediWound develops treatments for wounds and lesions with proteases, enzymes that break down other proteins into smaller peptides or amino acids, derived from the core of pineapples. Proteolytic enzymes from pineapple are known to have anti-inflammatory properties, which MediWound combines with bromelain, another anti-inflammatory enzyme derived from pineapples. The company develops NexoBrid as a treatment for burns and EscharEx for slow-healing skin wounds such as venous leg ulcers. Both therapies remove damaged or infected skin tissue from the wounds allowing for faster healing.

Skin tumors cleared after eight weeks

MW005 is MediWound’s experimental therapy for BCC that uses active ingredients in the company’s other products developed for treating slow-healing wounds. In this case, EscharEx compounds are dried and powdered, then mixed with water to form a gel. In the early- and mid-stage clinical trial, patients with BCCs at three sites in Florida and Texas apply MW005 gel to their lesions for eight to 12 hours, such as overnight, every other day for a total of seven applications in 14 days. The study team is looking primarily for adverse effects or patients dropping from the trial as a result of the treatments, but also the percentage of patients that clear their tumors, based on biopsies and microscopic tissue examination, after 13 weeks. The trial has no control or comparison group.

MediWound released results from 11 participants with BCCs enrolled in the trial; 32 participants are expected to take part by the end of the study. The company says MW005 treatments among all of the patients were safe and well-tolerated, but no details or statistics were given. And MediWound says in all 11 cases, biopsies and microscopic tissue examinations show the skin tumors were cleared after eight weeks.

A report of findings from three patients in the trial was published in The Open Dermatology Journal in April 2021, indicating local skin irritation and mild itching as a result of MW005 treatments, but also complete clearance of the tumors. The article says because of the Covid-19 pandemic, participants applied the gel ointment to their lesions at home, following directions via telehealth.

“Most low-risk BCCs are treated surgically,” says Brian Berman, lead investigator of the trial and emeritus professor of dermatology at University of Miami, in a MediWound statement. “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.”

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