VICAL INITIATES TRIAL OF METASTATIC MELANOMA THERAPY

Vical has begun a Phase III pivotal trial of the company's Allovectin-7 cancer immunotherapeutic as first-line therapy in chemotherapy-naive patients with recurrent stage III or IV metastatic melanoma. The trial, known as AIMM, will be conducted in accordance with a special protocol assessment completed with the FDA at up to 50 clinical sites. AnGes MG will fund the clinical trial under a collaborative agreement with Vical.

Because of substantial unmet medical need, Allovectin-7 has been granted orphan drug designation for the treatment of invasive and metastatic melanoma, according to the company. Orphan drug designation provides U.S. marketing exclusivity for seven years upon marketing approval by the FDA, in addition to certain tax benefits for qualifying expenses.

The AIMM trial calls for enrollment of approximately 375 patients with recurrent metastatic melanoma. Patients may have been previously treated with surgery, adjuvant therapy and/or biotherapy, but cannot have been previously treated with chemotherapy. Approximately 250 patients will be treated with Allovectin-7 and approximately 125 will be treated with their physician's choice of either of two chemotherapy agents, dacarbazine or temozolomide. The primary endpoint is a comparison of objective response rates at six months or more after randomization. The study will also evaluate safety and tolerability as well as survival.

Allovectin-7 is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and beta-2 microglobulin, which together form a class I major histocompatibility complex, or MHC-I antigen. Injection of Allovectin-7 directly into tumors is designed to stimulate an immune response against both local and distant metastatic tumors. Vical has also conducted a large Phase II trial evaluating Allovectin-7 immunotherapeutic as a single agent for patients with stage III or IV metastatic melanoma.