TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migrain...( - Top Line Results Expected...),Health

- Top Line Results Expected to Be Reported in 4Q 2007 -

LA JOLLA, Calif., Aug. 6 /PRNewswire-FirstCall/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that it has completed enrollment in its Phase IIb clinical trial of tezampanel for the treatment of acute migraine headache. Tezampanel is an AMPA/kainate (AK) receptor antagonist that offers a non-opioid, non-vascular and non-serotonergic approach to the management of pain and represents a potentially new and promising alternative to current migraine treatments.

The clinical trial is a double-blind, placebo-controlled, multi-center trial that reached its targeted enrollment of 300 patients suffering a single migraine attack, with or without aura. Patients are randomized to one of four arms and receive a 40 mg, 70 mg, or 100 mg single, subcutaneous dose of tezampanel or placebo. The purpose of the trial is to identify a dose, or a range of doses, that could be used in a Phase III development program for tezampanel in acute migraine. The primary efficacy endpoint for the trial is headache pain relief at two hours post-dose. Secondary efficacy endpoints include pain free status at two hours, sustained pain relief and sustained pain free at 24 hours, and headache recurrence and relapse. Additional measures include assessments of functional disability and patient satisfaction, relief of migraine-associated symptoms such as nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound), as well as various assessments that characterize speed of treatment onset. Safety, tolerability and plasma pharmacokinetic data will also be evaluated.

"Completing enrollment in our Phase IIb trial with tezampanel is an i
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SOURCE TorreyPines Therapeutics, Inc. Copyright©2007 PR Newswire.

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