On July 11, 2006 Valentis announced that no statistically significant difference was seen in the primary endpoint or any of the secondary endpoints in its Phase IIb clinical trial of VLTS
934 in PAD.
After 90 days, there was no statistically significant change in exercise in the 78 patients receiving VLTS 934 versus the 79 patients receiving placebo.
What: Valentis VLTS 934 Phase IIb results and future plans for the company When: Tuesday, July 11, 2006 @ 1:00 p.
Further, there can be no assurance that Valentis will be able to develop commercially viable therapeutics for peripheral arterial disease, that any of Valentis' programs will be partnered with pharmaceutical partners, that necessary regulatory approvals will be obtained or that any clinical trial including Valentis' Phase IIb VLTS 934 trial, will be successful.
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 F.
VLTS 934 is a nonionic block copolymer known as a poloxamer.
VLTS 934, the company's lead product, is an anti-inflammatory drug in Phase II testing.
Patients with PAD, specifically intermittent claudication, which is leg pain during walking, were randomized to receive either VLTS
934 or a saline placebo.
announced today favorable interim results in its VLTS 934 Phase IIb clinical trial in peripheral arterial disease (PAD).
The trial is a randomized, double-blind, placebo-controlled Phase IIb trial of VLTS 934 versus a saline placebo in patients with the intermittent claudication form of peripheral arterial disease.
Factors that could cause actual results to differ include risks regarding Valentis' ability to develop potential products based on VLTS
934 for treatment of peripheral arterial disease and the potential therapeutic benefit, safety and efficacy of VLTS