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TorreyPines' NGX426, an Oral AMPA/Kainate Receptor Antagonist, Meets Primary Endpoints in Reducing Capsaicin-Induced Pain in Healthy Subjects
Date:12/1/2008

rended toward statistical significance on reduction in spontaneous pain. In addition, a statistically significant pain-reducing effect was observed for the 150 mg dose through 4.5 hours post-dosing.

NGX426 was well tolerated and all subjects completed the three treatment periods. There were no serious or medically important adverse events or changes on laboratory or ECG parameters. The most common adverse events associated with NGX426 administration were mild somnolence and dizziness.

"We are very encouraged by these results that show an analgesic effect for NGX426 in this well-accepted pain model," said Ev Graham, Chief Executive Officer of TorreyPines. "As an oral, non-opioid pain agent, NGX426 could address the significant and documented unmet needs in treating a range of chronic pain conditions including neuropathic pain and acute or prophylactic treatment of migraine. These data, as well as data from our on-going Phase I multiple dose trial, will help us structure our Phase II development plan for NGX426."

NGX426, an ester prodrug, is an oral form of tezampanel, TorreyPines most advanced product candidate. Pharmacokinetic analyses from two Phase I studies confirmed that when given to humans, NGX426 is rapidly converted to tezampanel, the active moiety. Six Phase II, double-blind, placebo-controlled trials have demonstrated that tezampanel, administered either subcutaneously or intravenously, was more effective than placebo in relieving pain across migraine, nociceptive and neuropathic pain models, including a capsaicin-induced pain model.

In order to pursue the Phase II clinical development of NGX426 TorreyPines intends to explore both strategic and financing initiatives.

About TorreyPines Therapeutics, Inc.

TorreyPines Therapeutics, Inc. is a biopharmaceutical company committed to providing patients with better alternatives to existing therapies through
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SOURCE TorreyPines Therapeutics, Inc.
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