FDA clears AIV001 for testing for mixed BCC lesions in facial skin

Key takeaways:

• AIV001 is a pan-tyrosine kinase inhibitor for the nonsurgical treatment of mixed basal cell carcinomas.
• Injected intradermally, AIV001 can now be tested in facial skin as well as non-facial skin.

The FDA has cleared AIV001 for testing for the treatment of facial skin with superficial and nodular superficial basal cell carcinoma, according to an AiViva Biopharma press release.

Injected intradermally, AIV001 is a pan-tyrosine kinase inhibitor formulated for prolonged drug release for the nonsurgical treatment of superficial basal cell carcinoma (sBCC) and nodular superficial basal cell carcinoma (nBCC).

While previously tested for non-facial skin, this new FDA clearance allows the company to now test the drug in facial skin affected by sBCC and nBCC.

“This agreement allows a clear path forward to develop AIV001 in cosmetically sensitive skin that includes the face, neck and scalp, and sets it on track to be the first therapeutic developed for facial skin areas having sBCC or nBCC lesions,” Diane Tang-Liu, PhD, president and CEO of AiViva, said in the press release. “We are excited about the product prospect of AIV001 using a focal delivery method that is supported by our strong intellectual property position.”

The company has completed three clinical studies of AIV001 intradermally to date. One study found that the potency and prolonged release of the drug provided clinical and histological clearance in mixed BCC lesions among 26 participants. In another study with 41 subjects, researchers observed reduced fibrosis formation after a single intradermal injection in surgical incision wounds, signaling the potential of AIV001 as a scar treatment as well.