Shares of Vical Inc. (Nasdaq: VICL) were trading up $1.16 (23 percent) to $6.15 per share on volume of 1,341,835. Positive Phase III results announced earlier this morning were the driving force behind VICL’s run up the charts today.
The company announced its 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 VICL’s DNA delivery technology.
“The successful Phase 3 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 CEO of VICL – in a press release.
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. AnGes is ending the trial and preparing to file an application for Japanese marketing approval.
The treatment uses VICL 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).
“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,” concluded Samant.
VICL researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.