Vical Licensee Sanofi-aventis Initiates Phase 3 Trial to Reduce A...( SAN DIEGO Sept. 20 /- Sanofi-aven...),Health

SAN DIEGO, Sept. 20 /PRNewswire-FirstCall/ -- Sanofi-aventis, a licensee of Vical Incorporated (Nasdaq: VICL), announced on Monday the initiation of a 500-patient Phase 3 clinical trial of its NV1FGF angiogenesis therapy, which is based on Vical's non-viral DNA delivery technology. Assuming successful completion of the trial, called TAMARIS, sanofi-aventis expects to file for marketing approval in 2010.

The plasmid DNA (pDNA) therapy encodes Fibroblast Growth Factor 1 (FGF-1), a growth factor that stimulates the growth of blood vessels, and is intended to reduce the need for amputations in patients suffering from critical limb ischemia. Sanofi-aventis previously reported results from a Phase 2 trial in 107 patients demonstrating a statistically significant reduction in the rate of both major amputations and all amputations in patients receiving NV1FGF compared with those receiving placebo.

"In addition to DNA vaccines for infectious diseases and cancer, angiogenesis is among the most promising applications of our DNA delivery technology," said Vijay B. Samant, Vical's President and Chief Executive Officer. "The ability of pDNA to induce production of a protein locally at the site of injection ideally matches the desired treatment profile for critical limb ischemia, and perhaps for earlier stages of peripheral vascular disease. We are pleased that sanofi-aventis, one of our two partners in this field, has advanced into Phase 3 testing of this novel therapy addressing a major unmet medical need, and we look forward to successful completion of the trial."

The TAMARIS study is a double-blind, placebo-controlled Phase 3 trial in approximately 500 patients with critical limb ischemia. Four doses of 4 mg ea
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