Data Presented at American Headache Society's Annual Scientific Meeting Show Primary Endpoint Met as Well as Improvement on Important Secondary Endpoints in Phase IIb Acute Migraine Trial of TorreyPines Therapeutics' ...( Company's End-of-Phase II Mee...),Health

Company's End-of-Phase II Meeting with FDA Set for Sept. 29

LA JOLLA, Calif., June 30 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that data presented at the 50th Annual Scientific Meeting of the American Headache Society showed that, in addition to meeting the primary endpoint of headache pain relief at two hours, the company's lead AMPA/kainate-type glutamate receptor antagonist, tezampanel, demonstrated improvement on important secondary endpoints in a 306-patient Phase IIb clinical trial in acute migraine headache. Specifically, tezampanel demonstrated improvement in the following secondary endpoints: sustained headache response, absence of nausea or vomiting, absence of phonophobia and absence of photophobia.

"This is our second positive study in acute migraine with tezampanel," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines Therapeutics, who presented the data. "In both studies, we have shown improvement in all of the endpoints that the FDA has indicated will be required for the drug's approval. Earlier this year we conducted a clinical guidance call with the FDA in which the agency said it has no objection with us moving forward with a Phase III study of the 40 mg dose of tezampanel. We have scheduled an end-of-Phase II meeting to discuss the entire Phase III program with the agency on Sept. 29."

In the Phase IIb clinical trial, tezampanel was well tolerated with no reports of serious or medically important adverse events. At the 40 mg dose, the most commonly reported adverse events compared to placebo were injection site pain (5.1 percent vs. 20 percent), injection site burning (3.8 percent vs. 6.7 percent), dizziness (6.4 percent vs. 5.3 percen
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