Vical licensee sanofi-aventis to launch phase 3 angiogenesis study for critical limb ischemia

By Lisa Kerner

Erie, Pa., March 13 - Vical Inc. said that its licensee, sanofi-aventis, plans to advance to phase 3 testing of angiogenesis product candidate NV1FGF in the fourth quarter of 2006 following encouraging phase 2b trial data.

The phase 2b data were released on Sunday at the 55th Annual Scientific Session of the American College of Cardiology in Atlanta by Sigrid Nikol, MD, a principal investigator on the trial. No specific trial results were detailed in the company news release.

The randomized, double-blind, placebo-controlled, parallel design trial of NV1FGF phase 3 trial will be conducted in patients with critical limb ischemia (CLI), an advanced form of peripheral arterial disease. The combined trial endpoint will be major amputation or death.

NV1FGF (XRP0038) contains DNA encoding Fibroblast Growth Factor 1 (FGF-1), a human protein that promotes the growth of blood vessels. When delivered by injection into a muscle in an area of restricted blood flow, NV1FGF is designed to be taken up by muscle cells and cause those cells to express the FGF protein, with the goal of promoting blood vessel growth near the injection site. This approach may be useful for peripheral arterial disease (PAD), in which blood flow to the extremities is restricted, including CLI, an advanced stage of PAD which frequently requires amputation of the affected limb.

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases, such as cancer.

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