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news.Vical's licensee AnGes has reported the submission of new drug application to the Japanese ministry of health, labor and welfare for its angiogenesis product candidate, Collategene, for treatment of critical limb ischemia.
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The treatment uses Vical technology to deliver a gene encoding hepatocyte growth factor, a human protein that causes growth of blood vessels in areas of restricted blood flow.
The new drug application (NDA) submission follows positive results announced in June 2007 following interim analysis of data from the first 41 subjects to complete a phase III 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 ethical issues against the placebo group subjects.
Vijay Samant, president and CEO of Vical, said: “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. This NDA filing by AnGes is an important milestone in advancing nonviral gene therapy toward regulatory and commercial acceptance.”