Vical Incorporated (Nasdaq:VICL) today announced that an independent Safety Monitoring Board (SMB) for the company’s Phase 3 trial of Allovectin-7® in patients with metastatic melanoma has completed the trial’s fifth scheduled safety analysis and recommended that the trial continue per the protocol.
The Phase 3 trial, initiated in January 2007, is evaluating Allovectin-7® 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-7® and 130 for treatment with either dacarbazine or temozolomide. The company expects to complete patient follow-up and lock the Phase 3 clinical trial database in the second half of 2011.
Published results from a completed Phase 2 trial of Allovectin-7® in 127 chemo-refractory or chemo-intolerant patients with metastatic melanoma compare favorably with historical controls from other studies. Among the 15 responders (11.8%), 4 had complete responses and 11 had partial responses. The median duration of response was 13.8 months, and all responses were durable, lasting at least 6 months. The median survival for all patients was 18.8 months.
Allovectin-7® is a novel gene-based immunotherapeutic with a unique mechanism of action that is fundamentally different from currently approved treatments, and has the potential to be the first new primary treatment approved for metastatic melanoma in nearly 20 years. Vical estimates that the worldwide market for Allovectin-7® as a treatment for metastatic melanoma could exceed $500 million annually. The novel mechanism of action of Allovectin-7® gives it the potential to be successfully used in other types of solid tumors, which could further expand its total use.
Allovectin-7® has been granted orphan drug designation for the treatment of invasive and metastatic melanoma by the FDA’s Office of Orphan Products Development. Orphan drug designation provides U.S. marketing exclusivity for seven years if marketing approval is received from the FDA, in addition to certain tax benefits for qualifying expenses.