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Soo Park, MD
Soo Park, MD
Posted: Friday, December 27, 2024
An intradermal injection in facial skin of AIV001—the pan–tyrosine kinase inhibitor axitinib—has recently received clearance for testing by the U.S. Food and Drug Administration (FDA), according to the manufacturer AiViva Biopharma. This FDA clearance was supported by the company’s submission of safety data on nonfacial skin tolerability and efficacy as well as systemic exposure from 67 subjects treated with AIV001 in basal cell carcinoma and scar management.
To date, three clinical studies using intradermal injection of AIV001 have been completed. Subjects received one to three treatments, 3 weeks apart. According to the manufacturer, the potency of AIV001 and prolonged drug release in the skin provided clinical and histologic clearance of biopsied-confirmed basal cel carcinoma lesions in 26 patients. In addition, a total of 41 subjects were treated in two trials using scar models. Reduced fibrosis formation was observed after a single intradermal injection over the surgical incisional wounds.
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