AiViva Biopharma Completes Phase 1/2 Clinical Trial of AIV001 Administration in Patients with Nonmelanoma Skin Cancer

  • Novel Non-surgical Intradermal Treatment for Basel Cell Carcinoma

COSA MESA, Calif., Dec. 11, 2023 (GLOBE NEWSWIRE) — AiViva Biopharma Inc., a clinical-stage biotechnology company, announced completion of their first trial administering AIV001 (axitinib) to patients diagnosed with basal cell carcinoma (BCC) tumors. AIV001 is AiViva’s novel intradermally administered product designed for local, prolonged treatment effect for dermatological conditions.

The phase 1/2 multicenter, open-label clinical trial evaluated AIV001 in patients with superficial, nodular or mixed BCC tumors. The study enrolled a total of 26 subjects who were studied in four ascending dose cohorts. Subjects receive up to three treatments during the course of the study and monitored for safety, skin tolerability, and efficacy measured by 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. This promising data allows AiViva multiple options to develop it further, including but not limited to seeking a strategic partner for this compound,” said Diane Tang-Liu, PhD, President and CEO of AiViva.

The most common cancer worldwide is nonmelanoma skin cancer with the BCC subtype being the most prevalent 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. “It is exciting and important to have AiViva Biopharma develop a drug, with a new mechanism of action, that has the potential to treat BCC that avoids surgery,” said Brian Berman, MD, PhD, Professor Emeritus of Derma-tology and Dermatologic Surgery at The University of Miami Miller School of Medicine.

About AiViva Biopharma, Inc.

AiViva is a clinical stage biotech company led by a team of seasoned industry experts with proven track record in drug development and commercialization. AiViva has developed innovative approaches to address high unmet medical needs by transforming treatment paradigms through focal therapies that target diseases of neovascularization, abnormal cell proliferation, and fibrosis. Core competencies include development of novel drugs using proprietary technologies, including JEL™, in specialty therapeutic areas of dermatology, ophthalmology, urology and oncology. Please visit to learn more.

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