Valentis announces VLTS 934 phase 2b trial does not meet endpoints; company assessing strategic options

By Jennifer Lanning Drey

Eugene, Ore., July 11 - Valentis, Inc. is weighing its options following the company's announcement that no statistically significant difference was seen in the primary or secondary endpoints in its phase 2b clinical trial of VLTS 934 for peripheral arterial disease (PAD), according to Benjamin F. McGraw III, chairman, president and chief executive officer of Valentis.

"The company is assessing strategic opportunities, which include the sale or merger of the business, the sale of certain assets and other actions," McGraw said Tuesday during a company conference call.

Valentis has no plans for further development of the VLTS 934, McGraw said.

The primary efficacy endpoint in the study was improvement in exercise tolerance on an escalating grade treadmill after 90 days in patients receiving VLTS 934 versus patients receiving placebo, according to a company news release.

Valentis will provide detailed results of the phase 2b clinical trail at a scientific meeting, McGraw said.

However, the company did report Tuesday that after 90 days there was no significant change in exercise in the 78 patients receiving VLTS 934 versus the 79 patients receiving placebo.

The company said there were also no significant differences in any of the secondary endpoints of exercise tolerance at 30 days, ankle-brachial index at 30 and 90 days, total work capacity at 30 and 90 days and quality of life at 90 days, according to the news release.

"There have been multiple drug failures in PAD over the years. This is a very large market opportunity but it is clearly a very difficult disease for drug development," said McGraw during Tuesday's call.

The company expected the phase 2b clinical trial results to be positive, based on promising results demonstrated in its phase 2a clinical trial of VLTS 934, which it said used a virtually identical protocol.

"We decided to run the phase 2b trial because of the promising results in the phase 2a trial," McGraw said.

The company could not find an explanation for the difference in performance between the two trials, he said.

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

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