TorreyPines Therapeutics Initiates Second Phase I Clinical Trial Of NGX426, A Potential Novel Oral Treatment For Chronic Pain Conditions

Main Category: Pain / Anesthetics
Also Included In: Headache / Migraine;  Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 27 Feb 2007 - 0:00 PDT

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TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that it has initiated a second Phase I clinical trial of NGX426, a novel product candidate intended to treat chronic pain conditions such as migraine and neuropathic pain. NGX426 is an oral prodrug of tezampanel, the company's parenteral product candidate currently in a Phase IIb clinical trial for acute migraine.

The double-blind, placebo-controlled, clinical trial will evaluate the safety, tolerability and pharmacokinetics of NGX426 to determine the maximum safe and well-tolerated oral dose. Approximately 60 healthy adult volunteers, enrolled in sequential, dose-escalating cohorts, will receive placebo or a single dose of NGX426. The trial is intended to evaluate doses of NGX426 ranging from 40 mg up to the maximum tolerated dose. In a previous Phase I trial, completed in November 2006, NGX426 was well tolerated at doses up to 30 mg and pharmacokinetic analyses confirmed that it was rapidly converted to tezampanel.

"This second Phase I trial for NGX426 is an important next step in establishing the safety and tolerability of this potential new treatment for chronic pain conditions such as migraine," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines. "As an oral prodrug of tezampanel, NGX426 broadens our portfolio by providing an additional route of administration to potentially address the varied and unmet needs of pain sufferers. We look forward to moving ahead with our clinical program."

Tezampanel and NGX426 are AMPA/kainate (AK) receptor antagonists that potentially offer a non-narcotic, non-vascular approach to the treatment of chronic pain, including migraine. 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 chronic pain conditions, including migraine and neuropathic pain. As AK receptor antagonists, tezampanel and NGX426 may effectively relieve severe and persistent pain through a novel mechanism of action without imparting the side effects and risks associated with currently available treatment options for chronic pain, including migraine. Five Phase IIa, double-blind, placebo-controlled trials have demonstrated that tezampanel, administered intravenously, was more effective than placebo in relieving pain symptoms across multiple pain models, including migraine.

About TorreyPines Therapeutics, Inc.

TorreyPines Therapeutics, Inc. is a clinical stage biopharmaceutical company that discovers and develops small molecule drugs to treat diseases and disorders of the central nervous system (CNS). Led by an accomplished management team, TorreyPines is leveraging novel drug targets and technologies to potentially deliver new CNS therapies for chronic pain, including migraine and neuropathic pain; and cognitive disorders, including cognitive impairment associated with schizophrenia and Alzheimer's disease. TorreyPines' common stock is traded on the NASDAQ Global Stock Market under the symbol "TPTX." For detailed company information, including copies of this and other press releases, please visit TorreyPines' website at http://www.torreypinestherapeutics.com/.

This press release contains forward-looking statements or predictions. Such forward-looking statements include, but are not limited to, statements regarding the potential of NGX426 and tezampanel to treat chronic pain, including migraine and neuropathic pain and the potential for NGX426 and tezampanel to have reduced side-effects and risks compared to currently available treatment option. Such statements are subject to numerous known and unknown risks, uncertainties and other factors, which may cause TorreyPines' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. In particular there is no guarantee that NGX426 or tezampanel will be safe and efficacious, that NGX426 or tezampanel will actually treat chronic pain or that TorreyPines will be able to complete the necessary development work and receive regulatory approval for NGX426 or tezampanel. These and other risks which may cause results to differ are described in greater detail in the registration statement on Form S-4, as amended, as filed with the Securities and Exchange Commission and the "Risk Factors" section of TorreyPines' Form 10-Q for the quarter ended September 30, 2006 and TorreyPines other SEC reports. The forward-looking statements are based on current information that is likely to change and speak only as of the date hereof.

TorreyPines Therapeutics, Inc.
http://www.torreypinestherapeutics.com/