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Phase 2 Trial of VLTS-934 Initiated in Peripheral Arterial Disease

BURLINGAME, Calif., March 31 /PRNewswire-FirstCall/ -- Valentis, Inc. (NASDAQ:VLTS) announced today it initiated patient dosing on schedule in a Phase IIb clinical trial to evaluate the safety and efficacy of VLTS-934. VLTS-934 is a non-ionic, 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.

The estimated market for a safe and efficacious product to treat intermittent claudication is in excess of $1 billion. Approximately five percent of adults in the United States over the age of 55 suffer from the intermittent claudication, a form of peripheral arterial disease. Symptoms of intermittent claudication include leg pain during exercise due to a lack of adequate blood flow.

Source: Valentis, Inc.

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