Valentis interim phase 2b analysis, efficacy results on course

By Lisa Kerner

Erie, Pa., Jan. 10 - Valentis, Inc. said interim results of its VLTS 934 phase 2b clinical trial in peripheral arterial disease are favorable. An interim analysis, conducted by independent statisticians, confirmed the VLTS 934 phase 2b placebo group assumptions.

Valentis anticipates completing the trial by mid-year, according to a company news release.

The trial is a randomized, double-blind, placebo-controlled phase 2b trial of VLTS 934 versus a saline placebo in 148 patients with the intermittent claudication form of peripheral arterial disease.

The disease is a result of atherosclerosis in patients' legs. Atherosclerosis is an inflammatory disorder of blood vessels leading to the formation of atheroma or plaque in large blood vessels and impeding blood flow.

The primary efficacy endpoint in the trial is improvement in exercise tolerance after 90 days with VLTS 934 versus a saline placebo. VLTS 934 appears to have a direct effect on repairing compromised cell membranes and reduces levels of specific mediators of inflammation.

Valentis reported that in its phase 2a trial, which used a virtually identical patient population and dosing as the phase 2b trial, VLTS 934 showed promising results. The company plans to secure a development and marketing partner by the end of this year.

Valentis will be hosting a conference call and web cast on Jan. 11 at 4 p.m. ET to discuss the interim results of the phase 2b clinical trial of VLTS 934.

Valentis is a Burlingame, Calif.-based biotechnology company engaged in the development of innovative products for peripheral arterial disease

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.