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Vical Licensee Sanofi-aventis Initiates Phase 3 Trial to Reduce Amputations

Thursday, September 20, 2007 General News
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SAN DIEGO, Sept. 20 Sanofi-aventis, a licenseeof Vical Incorporated (Nasdaq: VICL), announced on Monday the initiation of a500-patient Phase 3 clinical trial of its NV1FGF angiogenesis therapy, whichis based on Vical's non-viral DNA delivery technology. Assuming successfulcompletion of the trial, called TAMARIS, sanofi-aventis expects to file formarketing approval in 2010.
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The plasmid DNA (pDNA) therapy encodes Fibroblast Growth Factor 1 (FGF-1),a growth factor that stimulates the growth of blood vessels, and is intendedto reduce the need for amputations in patients suffering from critical limbischemia. Sanofi-aventis previously reported results from a Phase 2 trial in107 patients demonstrating a statistically significant reduction in the rateof both major amputations and all amputations in patients receiving NV1FGFcompared with those receiving placebo.
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"In addition to DNA vaccines for infectious diseases and cancer,angiogenesis is among the most promising applications of our DNA deliverytechnology," said Vijay B. Samant, Vical's President and Chief ExecutiveOfficer. "The ability of pDNA to induce production of a protein locally at thesite of injection ideally matches the desired treatment profile for criticallimb ischemia, and perhaps for earlier stages of peripheral vascular disease.We are pleased that sanofi-aventis, one of our two partners in this field, hasadvanced into Phase 3 testing of this novel therapy addressing a major unmetmedical need, and we look forward to successful completion of the trial."

The TAMARIS study is a double-blind, placebo-controlled Phase 3 trial inapproximately 500 patients with critical limb ischemia. Four doses of 4 mgeach will be administered by intramuscular injection at two-week intervals,and follow-up will continue for one year. The primary endpoint is theprevention of major amputation or of death. Additional information on thetrial is available at http://en.sanofi-aventis.com/index.asp.

About Critical Limb Ischemia

Critical limb ischemia is a severe and costly condition. In the twelvemonths following the first episode of critical limb ischemia, 55% of patientseither require amputation or die. In the United States and Europe, there aremore than 150,000 amputations each year due to critical limb ischemia, with adirect cost of nearly $6 billion and a total cost of more than $8 billion. Nodisease-modifying therapy for critical limb ischemia is currently available.

About Vical

Vical researches and develops biopharmaceutical products based on itspatented DNA delivery technologies for the prevention and treatment of seriousor life-threatening diseases. Potential applications of the company's DNAdelivery technology include DNA vaccines for infectious diseases or cancer, inwhich the expressed protein is an immunogen; cancer immunotherapeutics, inwhich the expressed protein is an immune system stimulant; and cardiovasculartherapies, in which the expressed protein is an angiogenic growth factor. Thecompany is developing certain infectious disease vaccines and cancertherapeutics internally. In addition, the company collaborates with majorpharmaceutical companies and biotechnology companies that give it access tocomplementary technologies or greater resources. These strategic partnershipsprovide the company with mutually beneficial opportunities to expand itsproduct pipeline and address significant unmet medical needs. Additionalinformation on Vical is available at http://www.vical.com.

This press release contains forward-looking statements subject to risksand uncertainties that could cause actual results to differ materially fromthose projected, including: whether sanofi-aventis will continue developmentof NV1FGF as planned; whether NV1FGF or any other product candidates will beshown to be safe and effective in clinical trials; whether Phase 3 trialresults will support fili
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