Phase 1/2 trial of AiViva Biopharma’s intradermal basal cell carcinoma treatment complete

Key takeaways:

• AIV001 (Axitinib) is in development for the nonsurgical treatment of nonmelanoma skin cancers.
• Early data show good skin tolerability and a dose response.

AiViva Biopharma has completed a phase 1/2 trial of AIV001, a nonsurgical treatment for basal cell carcinoma, the company announced in a press release.

The open-label trial included 26 patients with modular, superficial and mixed nonmelanoma basal cell carcinoma (BCC) tumors who were randomly assigned into one of four ascending dose cohorts.

Each patient received up to three treatments of AIV001 (axitinib) intradermally and were evaluated for safety, skin tolerability and efficacy, which was defined as a “clinical and histological clearance of malignant basal cells in the lesions.”

“We are excited to have completed this safety study that is demonstrating excellent skin tolerability and a dose response,” Diane Tang-Liu, PhD, president and CEO of AiViva, said in the release. “This promising data allows AiViva multiple options to develop it further, including but not limited to seeking a strategic partner for this compound.”