Valentis Initiates Phase IIb Trial of VLTS-934 in Peripheral Arterial Disease
Valentis has initiated patient dosing on schedule in a Phase IIb clinical trial to evaluate the safety and efficacy of VLTS-934 in patients with peripheral arterial disease.
VLTS-934 is a nonionic, block copolymer known as a poloxamer, which appears to produce a therapeutic benefit in ischemic tissue.
In this randomized, double-blinded and placebo-controlled trial, approximately 148 patients with peripheral arterial disease, specifically intermittent claudication, will receive either VLTS-934 or a saline placebo. The primary endpoint of the trial is improvement in exercise tolerance. Valentis plans to complete enrollment in the first quarter of 2006 and data are expected mid-2006.
This VLTS-934 Phase IIb trial follows a previously completed 105-patient Phase IIa clinical trial that compared VLTS-934 to an investigational angiogenic agent. In that trial, VLTS-934 demonstrated a statistically significant improvement in exercise tolerance and ankle-brachial index compared to baseline. The Phase IIb trial has a virtually identical design to the Phase IIa trial but includes a comparison to patients treated with a saline placebo.