TorreyPines Therapeutics, Inc. Initiates Phase I Clinical Trial For NGX424, A First-In-Class Compound For Severe Pain

SAN DIEGO, Nov. 14 /PRNewswire/ -- TorreyPines Therapeutics, Inc. today announced that it has initiated a Phase I clinical trial for NGX424, a novel therapeutic for the treatment of severe migraine and other persistent, intractable pain states. An AMPA/kainate (AK) receptor antagonist, NGX424 offers a non-opioid, non-vascular approach to the management of severe pain.

"We're pleased to initiate clinical trials with NGX424, which could offer a better safety profile and more effective pain relief to sufferers worldwide," said Neil Kurtz, M.D., Chief Executive Officer at TorreyPines. "We believe NGX424, and its follow-on compound NGX426, an oral prodrug, may effectively relieve severe and persistent pain through a novel mechanism, without having a negative impact on the cardiovascular system or imparting side effects and risks that may be associated with prolonged use of some pain relief medications."

The Phase I trial with NGX424 will enroll approximately 90 healthy male volunteers at one center in the U.S. The single, ascending, fixed-dose, study will evaluate the local and systemic tolerability, safety and pharmacokinetics of the drug, as well as the maximum tolerated dose of a subcutaneous formulation.

In previously conducted placebo-controlled, Phase II, proof of concept trials, an intravenous formulation of NGX424 achieved positive data in five pain models. In a placebo and active-controlled trial in migraine, NGX424, administered intravenously, achieved statistical significance in all primary and secondary endpoints traditionally required for regulatory approval. These included pain relief at two hours, pain-free at two hours, sustained pain-free state at 24 hours and relief of nausea, photophobia (sensitivity to light) and phonophobia (sensitivity to sound).

TorreyPines licensed NGX424 and its oral prodrug NGX426 from Eli Lilly & Co. in 2003. In addition to a subcutaneous route of administration, the company intends to continue development of the intravenous formulation, as well as develop intrathecal and epidural formulations. These multiple dosing forms permit development across a range of indications including severe migraine, epilepsy, neuropathic pain, spinal cord injury and other intractable pain states.

"With NGX424 and NGX426, we have the potential to address unmet needs in virtually every segment of the pain market," said Dr. Kurtz.

About AK Receptor Antagonists

AK receptor antagonists selectively block transmission of pain signals mediated through the activation of glutamate receptors. These receptors play a critical role in the development of central sensitization phenomena -- a key component of many pain syndromes, including migraine and persistent pain states such as chronic neuropathic pain. Because they do not block opioid receptors, constrict blood vessels or interact with systems external to the central nervous system at dosages that are therapeutically relevant, the safety profile of AK antagonists may offer important advantages over existing drugs.

About TorreyPines

TorreyPines Therapeutics, Inc. is a biopharmaceutical company that discovers and develops breakthrough small molecule drugs to treat diseases and disorders of the central nervous system. Led by an accomplished management team, the company is leveraging novel drug targets and technologies to deliver new therapies for Alzheimer's disease, severe migraine and neuropathic pain. Its breakthrough therapies are intended to offer significant advantages over current therapies. Further information is available at www.torreypinestherapeutics.com.

This news release contains certain forward-looking statements that involve risk and uncertainties. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials and the risk that the company will not obtain approval to market its products.

TorreyPines Therapeutics, Inc.

CONTACT: Evelyn Graham of TorreyPines Therapeutics, Inc., +1-858-623-5665,ext. 118, egraham@torreypinestherapeutics.com; or Patricia Garrison,+1-917-322-2567, pgarrison@RxIR.com, or Rhonda Chiger, +1-917-322-2569,rchiger@RxIR.com, both of Rx Communications for TorreyPines Therapeutics,Inc.

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