Sanofi's NV1FGF "encouraging" in Ph II

French drug major Sanofi-Aventis has presented encouraging data from a Phase IIb trial of its angiogenesis product candidate NV1FGF, using US firm Vical's patented DNA delivery technology. Sanofi-Aventis has separately disclosed plans to advance to Phase III testing of the product candidate in the fourth quarter of 2006.

The Phase IIb data were released in a late-breaking clinical trials session presentation, Therapeutic Angiogenesis With Intramuscular NV1FGF Improves Amputation-Free Survival in Patients With Critical Limb Ischemia, at the 55th Annual Scientific Session of the American College of Cardiology in Atlanta, Georgia, by Sigrid Nikol, a principal investigator on the trial and professor of molecular cardiology and head of the Center of Angiology at the University Clinic in Munster, Germany. The Phase IIb trial was sponsored by Centelion, a wholly-owned subsidiary of Sanofi-Aventis.

In a presentation to analysts on February 24, Sanofi-Aventis announced plans to begin a Phase II, randomized, double-blind, placebo-controlled, parallel design trial of NV1FGF. The trial is designed to be conducted in patients with critical limb ischemia, with a combined trial endpoint of major amputation or death. Sanofi-Aventis also projected submission for regulatory approval of the product by 2009/2010.