SAN DIEGO, March 28 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced the company's licensee, AnGes MG, Inc., reported submission on March 27, 2008, of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare for its angiogenesis product candidate, Collategene, for treatment of critical limb ischemia. The treatment uses Vical technology to deliver a gene encoding hepatocyte growth factor (HGF), a human protein that causes growth of blood vessels in areas of restricted blood flow.
"The Japanese NDA filing positions Collategene to be the first product based on our DNA delivery technology with the potential to be approved for human use," said Vijay B. Samant, President and Chief Executive Officer of Vical. "In the United States, where it is estimated that more than 10 million people have peripheral arterial disease (PAD), AnGes already has completed two Phase 2 clinical trials of Collategene in PAD patients. This product candidate offers a novel approach to addressing an important, unserved medical need in the Japanese market, and has the potential to expand into the much larger markets worldwide. This NDA filing by AnGes is an important milestone in advancing nonviral gene therapy toward regulatory and commercial acceptance."
The NDA submission follows positive results announced in June 2007
following interim analysis of data from the first 41 subjects to complete a
Phase 3 trial of Collategene. Based on the findings that the primary
efficacy endpoint in the trial had been achieved with statistical
significance and that there were no major safety concerns related to
treatment, an Independent Data Monitoring Committee recommended stopping
the trial early to prevent potential e
|SOURCE Vical Incorporated|
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