Vical Presents Case Study on Successful Design of Allovectin Phase 3 Melanoma Trial
Vical Incorporated (Nasdaq: VICL) announced today that the company will present a case study of its Allovectin® Phase 3 trial at the Phacilitate Cell & Gene Therapy Forum 2012 (Washington – January 30 - February 1). Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development, is scheduled to present on Monday, January 30, at 2:30 p.m.
Dr. Rolland's presentation reviews the company's success in designing and conducting its ongoing multinational pivotal Phase 3 melanoma trial through the Special Protocol Assessment process with the U.S. Food and Drug Administration (FDA), and outlines manufacturing and commercialization considerations in support of the possible licensure of Allovectin®.
The Phase 3 trial, initiated in January 2007, is evaluating Allovectin® as first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. Vical completed enrollment in February 2010 of 390 chemo-naive patients randomized on a 2:1 basis: 260 for treatment with Allovectin® and 130 for treatment with physician's choice of either dacarbazine or temozolomide. The company is projecting completion of the Phase 3 trial and release of top-line data in mid-2012.
Allovectin® is a novel gene-based immunotherapeutic with unique mechanisms of action fundamentally different from currently approved treatments. Vical estimates that the worldwide market for Allovectin® as a treatment for metastatic melanoma is between $500 million and $1 billion annually, and potential applications for other types of cancer could further expand its total use.
