Sanofi-Aventis, has presented data from a Phase 2b trial of its angiogenesis product candidate NV1FGF, using Vical's patented DNA delivery technology. Sanofi- Aventis has separately disclosed plans to advance to Phase 3 testing of the product candidate in the fourth quarter of 2006, Vical Incorporated announced here.
Sanofi-Aventis announced plans to begin a Phase 3, randomized, double-blind, placebo-controlled, parallel design trial of NV1FGF. The trial is designed to be conducted in patients with Critical Limb Ischemia (CLI), with a combined trial endpoint of major amputation or death. Sanofi-Aventis 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. 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.
Sanofi-Aventis began testing the gene-based delivery of FGF-1 in 1999 in patients with PAD. In 2000, Sanofi-Aventis licensed the rights to Vical's core DNA delivery technology for cardiovascular applications using FGF-1. Published interim results from an open-label Phase 1 clinical trial indicated that the FGF-1 gene-based therapeutic was well-tolerated, with no serious adverse events considered related to the treatment, and demonstrated reduction in pain and evidence of newly visible blood vessels three months after treatment.
The Phase 2b 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 (ACC) 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 2b trial was sponsored by Centelion, a wholly-owned subsidiary of Sanofi-Aventis.