AiViva Biopharma Receives FDA Clearance to Test AIV001 in Facial Skin

• AiViva Biopharma received FDA clearance to test AIV001 (axitinib) via intradermal injection in facial skin, marking a significant step in dermatological applications.
• AIV001, a pan-tyrosine kinase inhibitor with a proprietary formulation for prolonged drug release, has shown promise in treating BCC lesions and scar management.
• Clinical studies have demonstrated AIV001's efficacy in clearing biopsied-confirmed BCC lesions and reducing fibrosis formation in scar models, supporting its potential in dermatology.
• The FDA clearance allows AiViva to expand AIV001's evaluation to cosmetically sensitive areas like the face, neck, and scalp for conditions like sBCC or nBCC lesions.

AiViva Biopharma Inc. has announced FDA clearance to test AIV001 (axitinib) via intradermal injection in facial skin. This clearance paves the way for the development of AIV001 as a potential therapeutic for facial skin areas affected by conditions like superficial basal cell carcinoma (sBCC) or nodular basal cell carcinoma (nBCC).

AIV001 is a pan-tyrosine kinase inhibitor formulated for prolonged drug release. The FDA's decision was supported by safety data from 67 subjects treated with AIV001 in basal cell carcinoma (BCC) and scar management studies, demonstrating tolerability and efficacy in non-facial skin.

Clinical Data Supporting AIV001

AiViva has completed three clinical studies using intradermal injections of AIV001. Patients received one to three treatments, administered three weeks apart. The studies revealed clinical and histological clearance of biopsied-confirmed BCC lesions in 26 patients. Furthermore, two trials involving 41 subjects with scar models showed reduced fibrosis formation following a single intradermal injection over surgical incisional wounds, suggesting AIV001's potential in scar management.

"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," said Diane Tang-Liu, PhD, President and CEO of AiViva.

AIV001's Mechanism and Potential Applications

AIV001's mechanism of action, combined with its focal delivery method, is supported by AiViva's intellectual property. The drug's potency and prolonged release in the skin have demonstrated promising results in early clinical trials. AiViva is focusing on developing therapies that target diseases of neovascularization, abnormal cell proliferation, and fibrosis in dermatology, ophthalmology, urology, and oncology.

"This was an important achievement for the clinical development of AIV001 allowing us to expand our ability to evaluate AIV001’s utility in dermatological conditions," concluded Darlene Deecher, AiViva’s Vice President of Clinical Development.