Healthcare Industry News: Sanofi-aventis
News Release - March 13, 2006
Vical Licensee sanofi-aventis Releases Phase 2b Angiogenesis Data and Plans for Phase 3SAN DIEGO, March 13 (HSMN NewsFeed) -- Vical Incorporated (Nasdaq: VICL ) announced today that its licensee, Sanofi-aventis, has presented encouraging 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.
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," on Sunday, March 12, at the 55th Annual Scientific Session of the American College of Cardiology (ACC) in Atlanta, Georgia, by Sigrid Nikol, M.D., 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.
In a presentation to analysts on February 24, 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.
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company has retained all rights to its internally developed product candidates. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and serve significant unmet medical needs. Additional information on Vical is available at http://www.vical.com.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether Sanofi-aventis will initiate a Phase 3 trial of NV1FGF in the fourth quarter of 2006, if at all; whether NV1FGF or any other product candidates will be shown to be safe and effective; whether Sanofi-aventis will submit Phase 3 results for regulatory approval by 2009/2010, if at all; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
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