In the trial 140 patients were randomized to receive either VLTS 934 or a saline placebo. The primary endpoint of the trial is improvement in exercise tolerance 90 days after treatment. Valentis anticipates that it will have efficacy results from the trial in July 2006.
“Based on VLTS 934’s prior safety data, the significant improvements from baseline in all efficacy measures in the prior phase IIa trial and the favorable results observed in the phase IIb interim analysis, we believe the phase IIb trial will be successful,” commented Benjamin McGraw, III, chairman of Valentis.
The market for a safe and efficacious product to treat intermittent claudication has been estimated to be in excess of $1 billion. According to the company, approximately 5% of adults in the US over age of 55 suffer from the intermittent claudication.