Valentis completes dosing in trial of VLTS 934 for peripheral arterial disease

By E. Janene Geiss

Philadelphia, Feb. 13 - Valentis, Inc. said Monday that it has completed the dosing on schedule in its VLTS 934 phase 2b trial for the treatment of patients suffering with peripheral arterial disease.

The efficacy results are on course for July 2006, according to a company news release.

The 140-patient, randomized, double-blind and placebo-controlled phase 2b trial began in March 2005 throughout the United States.

Patients with peripheral arterial disease, specifically intermittent claudication, which is leg pain during walking, 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 the efficacy results from the phase 2b trial will be on schedule in July 2006.

"Based on VLTS 934's prior safety data, the significant improvements from baseline in all efficacy measures in the prior phase 2a trial and the favorable results observed in the phase 2b interim analysis, we believe the phase 2b trial will be successful," Benjamin F. McGraw, chairman, president and chief executive officer of Valentis, said in the release.

The market for a safe and efficacious product to treat intermittent claudication has been estimated to be in excess of $1 billion, officials said.

About 5% of adults in the United States over age 55 suffer from the intermittent claudication, a form of peripheral arterial disease. Symptoms include leg pain during exercise due to a lack of adequate blood flow.

VLTS 934 is a nonionic block copolymer known as a poloxamer. It appears to have a direct effect of repairing compromised cell membranes and improving cell function, which may have a therapeutic benefit in ischemic tissue.

Valentis is a Burlingame, Calif., biotechnology company engaged in the development of innovative products for peripheral arterial disease, a large and unsatisfied market.

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