AiViva Biopharma has begun dosing patients diagnosed with superficial or nodular basal cell carcinoma (BCC) with AIV001. AIV001 is AiViva’s novel intradermally administered product designed for local, prolonged treatment effect for dermatological conditions. This is the second clinical trial assessing AIV001 to address unmet needs of skin diseases building on the safety and exploratory efficacy of AIV001 in an earlier trial in wound healing from surgical incision.

This multicenter, open-label clinical trial is evaluating AIV001 in patients with biopsy-confirmed superficial or nodular BCC. The study is expected to enroll a total of 18 subjects who will be studied in two ascending dose cohorts. Subjects will receive two treatments during the course of the study and will be monitored to assess safety, tolerability, and efficacy measured by clearance of basal cells in the lesion. In preclinical xenograft studies, a single intratumoral treatment with AIV001 showed significant inhibition of skin tumor growth while maintaining high, local concentrations with minimal systemic exposure.

“We are very excited to be participating in AiViva’s BCC study as we believe, if efficacious, this product will provide a simple solution for patients seeking an effective nonsurgical treatment option,” said Dr. Navid Nami, Dermatology Clinical Trials, Newport Beach, CA.

The most common cancer worldwide is BCC that occurs in the skin. Millions of new cases are diagnosed every year in the U.S. alone due to the increase in sun exposure and aging population. Current treatment often requires surgery that can lead to scarring. Topical therapies are available but require patient compliance over an extended length of time to be effective.

“We believe that AIV001 has the potential to transform the treatment paradigm for BCC by offering a disease-modifying therapy providing physicians and patients with an effective treatment. We look forward to sharing data from our trial at its conclusion,” Dr. Diane Tang-Liu, President and CEO of AiViva said.