West Coast Editor

Less than a month after disclosing a delay in the regulatory filing for its stroke drug Cerovive, Renovis Inc. reported another setback, this time with REN-1654, which missed its primary endpoint in a Phase II trial against sciatica.

Since safety might be an issue at higher doses, Renovis is stopping work on the oral version of REN-1654, an inhibitor of tumor necrosis factor-alpha, and will explore different routes of administration.

Wall Street took the failure in stride. Renovis' stock (NASDAQ:RNVS) closed Friday at $12.56, down 14 cents. Company officials could not be reached.

In the trial, REN-1654 showed a positive trend in pain relief but fell short of statistical significance in its primary endpoint of change as measured by average daily spontaneous pain ratings at the end of a three-week treatment period, compared to placebo.

A planned analysis of secondary endpoints in the study showed a statistically significant reduction in maximum daily leg pain at the end of weeks one and two in subjects treated with REN-1654, compared with placebo, but here, too, the reduction in maximum daily leg pain was not statistically significant after three weeks.

The Phase II study enrolled 74 patient-volunteers who had developed leg pain due to lumbosacral radiculopathy of no more than 12 weeks before they signed up for the trial. After a baseline week of no treatment, study subjects were randomized into two double-blind groups and got single daily oral doses of placebo or 100-mg REN-1654 for 21 days.

In late July, Renovis said the regulatory filing for the neuroprotectant Cerovive could be delayed for as long as one year because of the company's decision to nearly double the number of patients enrolled in SAINT II, the second of two Phase III studies in ischemic stroke. (See BioWorld Today, July 29, 2005.)

In May, Renovis' shares skyrocketed on Phase III data from the first trial, showing Cerovive reduced disability in stroke patients. The drug was licensed to London-based AstraZeneca plc for development and commercialization in exchange for milestone and royalty payments.

The company said in June that it was ending development of REN-850, its leukocyte-traffic inhibitor for multiple sclerosis, because of what Renovis described as "unexpected pharmacokinetics" in a Phase Ia trial. Better news came earlier in the summer, when Renovis nailed down a preclinical research deal with Pfizer Inc. worth up to $187 million or more for products that inhibit the vanilloid receptor (VR1). (See BioWorld Today, June 1, 2005, and June 14, 2005.)

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