Assuming successful completion of the trial evaluating NV1FGF, Sanofi-Aventis expects to file for marketing approval in 2010. In this study four doses of 4mg each will be administered by intramuscular injection at two-week intervals, and follow-up will continue for one year. The primary endpoint is the prevention of major amputation or of death.
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.
Vijay Samant, Vical's president and CEO, said: “In addition to DNA vaccines for infectious diseases and cancer, angiogenesis is among the most promising applications of our DNA delivery technology. 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.”