TorreyPines Therapeutics Initiates Clinical Trial to Evaluate Analgesic Effect of Oral Prodrug of ...( LA JOLLA Calif. June 4 /- TorreyP...),Health

LA JOLLA, Calif., June 4 /PRNewswire-FirstCall/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced it has initiated a clinical trial to evaluate the analgesic effect of NGX426, the oral prodrug of its lead product candidate, tezampanel.

The randomized, double-blind, placebo-controlled Phase I trial will enroll 18 healthy volunteers at a single center in the United States. The trial is designed to evaluate the compound's safety and tolerability and to assess the time of onset, magnitude and duration of its analgesic effect. Specifically, the study will evaluate the effect of NGX426 on hyperalgesia, an abnormally increased pain state, and allodynia, pain resulting from normally non-painful stimuli to the skin, induced by intradermal injections of capsaicin. The primary endpoint is subject self-report of spontaneous pain following the injection of capsaicin.

"We believe there is a substantial commercial opportunity for NGX426 as a novel, oral analgesic," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines Therapeutics. "Data we have obtained in our ongoing Phase I maximum tolerated dose study demonstrate that the drug is well-tolerated at single doses up to and including 210 mg and that NGX426 is rapidly converted to tezampanel. Moreover, this capsaicin study, if successful, will enable us to further take advantage of the versatility of NGX426 and the overall tezampanel franchise."

Subjects in the trial, which involves the recognized and validated capsaicin-induced pain model, will receive single doses of 90 mg and 150 mg of NGX426 versus placebo in a three-way crossover design.

Tezampanel is the first AMPA/kainate-type glutamate receptor antagonist to be studied in clinical t
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