The phase IIb data, which indicate that therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia (CLI), were released in a late-breaking clinical trials session presentation at the 55th annual scientific session of the American College of Cardiology in Atlanta, Georgia.
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 III, randomized, double-blind, placebo-controlled, parallel design trial of NV1FGF. The trial is designed to be conducted in patients with CLI, with a combined trial endpoint of major amputation or death. Sanofi-Aventis has also projected submission for regulatory approval of the product by 2009/2010.
NV1FGF, also called 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.
Sanofi-Aventis has licensed the rights to Vical’s core DNA delivery technology for cardiovascular applications using FGF-1.