Vical Incorporated has announced that the company's licensee, AnGes MG, Inc. reported positive results following interim analysis of data from the first 41 subjects to complete a phase III trial of an angiogenesis product candidate using Vical's DNA delivery technology.
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 (IDMC) recommended stopping the trial early to prevent potential ethical issues against the placebo group subjects. AnGes is ending the trial and preparing to file an application for Japanese marketing approval.
"The successful phase III results from our Japanese licensee position the AnGes product candidate to be the first approved for human use based on our DNA delivery technology and provide proof of concept for DNA delivery in the treatment of disease," said Vijay B Samant, president and chief executive officer of Vical. "This novel approach has the potential to address an important, unserved medical need in a significant commercial market. We look forward to further updates from AnGes as they advance through the regulatory approval process."
The treatment uses Vical technology to deliver a gene encoding Hepatocyte Growth Factor (HGF), a human protein that causes angiogenesis (growth of blood vessels) in areas of ischemia (restricted blood flow). In the trial, 40 subjects with critical limb ischemia (advanced peripheral arterial disease) were evaluated for efficacy. The primary endpoints, improvement of rest pain ((VAS (Visual Analog Scale)) or ischemic ulcer size, at 12 weeks post dosing, showed 30.8 per cent improvement in the placebo group and 70.4 per cent improvement in the treatment group, a statistically significant difference.