Sanofi-Aventis Starts Phase 3 Clinical Trial Of NV1FGF Angiogenesis Therapy

(RTTNews) - Thursday, Sanofi-Aventis (SNY, SNF.L), a licensee of Vical Inc. (VICL | charts | news | PowerRating), said it has initiated a Phase 3 clinical trial of its NV1FGF angiogenesis therapy, which is based on Vical's non-viral DNA delivery technology. The company expects to file for marketing approval in 2010, assuming successful completion of the trial, called Tamaris.

Tamaris study is a double-blind, placebo-controlled Phase 3 trial in about 500 patients with critical limb ischemia, while follow-up will continue for one year. The primary endpoint is the prevention of major amputation or of death.

The plasmid DNA or pDNA therapy encodes Fibroblast Growth Factor 1 (FGF-1 | charts | news | PowerRating), 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.

Previously, Sanofi-aventis said that the data from a Phase 2 trial in 107 patients demonstrated a statistically significant reduction in the rate of both major amputations and all amputations in patients receiving NV1FGF compared with those receiving placebo.

SNY is currently trading at $43.31, up 9 cents.

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