Vical Licensee Sanofi-aventis Completes Enrollment in Phase 3 Angiogenesis Trial
- Category: DNA RNA and Cells
- Published on Monday, 28 September 2009 03:00
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Vical Incorporated announced that the company's licensee, sanofi-aventis, has confirmed the completion of enrollment in a multinational 500-patient pivotal Phase 3 clinical trial of its angiogenesis therapy based on Vical's non-viral DNA delivery technology
SAN DIEGO, CA USA | September 28, 2009 | Vical Incorporated (Nasdaq:VICL) announced today that the company's licensee, sanofi-aventis, has confirmed the completion of enrollment in a multinational 500-patient pivotal Phase 3 clinical trial of its angiogenesis therapy based on Vical's non-viral DNA delivery technology. Sanofi-aventis expects final data from this trial in late 2010.
"We are pleased that sanofi-aventis, one of our two partners in the angiogenesis field, has advanced according to plan with the Phase 3 testing of this novel therapy," said Vijay B. Samant, Vical's President and Chief Executive Officer, "and we would expect timely trial completion. Angiogenesis is among the most promising near-term human applications of our DNA delivery technology, and represents a substantial potential market for which there is no adequate therapy. The ability of plasmid DNA to induce production of angiogenesis protein locally at the site of injection ideally matches the desired treatment profile for peripheral vascular disease."
The NV1FGF therapy contains DNA encoding 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. Sanofi-aventis previously reported results from a Phase 2 trial in 107 patients demonstrating a statistically significant reduction in the rate of both major amputations and all amputations in patients receiving NV1FGF compared with those receiving placebo.
The TAMARIS study is a double-blind, placebo-controlled Phase 3 trial in approximately 500 patients with critical limb ischemia. Four doses of 4 mg each are administered by intramuscular injection at two-week intervals, and follow-up continues for one year. The primary objective of the study is to demonstrate the superiority of NV1FGF treatment over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia patients with skin lesions. Additional information on the trial is available at www.clinicaltrials.gov/ct2/show/NCT00566657.
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 is developing certain infectious disease vaccines and cancer therapeutics internally. 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 address significant unmet medical needs. Additional information on Vical is available at www.vical.com.
SOURCE: Vical Incorporated