LA JOLLA, Calif., Nov. 2 /PRNewswire-FirstCall/ -- TorreyPines Therapeutics, Inc. today announced findings from a Phase I clinical trial for NGX426, a novel oral therapy intended for the treatment of acute migraine and chronic pain conditions, such as neuropathic pain. The compound, an oral prodrug of the company’s lead compound, tezampanel, was found to be well-tolerated and rapidly converted to tezampanel at all doses tested.
This Phase I study enrolled 30 healthy adult male volunteers at one center in the U.S. The double blind, placebo-controlled, ascending-dose, sequential cohort study was designed to evaluate the safety, tolerability and pharmacokinetics of NGX426, as well as to determine the rate and extent of conversion of the prodrug, NGX426, to the active drug tezampanel. In this study, volunteers were randomized to receive single oral doses of 10 mg, 20 mg and 30 mg of NGX426 or placebo. There were no dose-limiting or dose-related increases in adverse events. Reported adverse events were generally mild in intensity and similar to those previously reported for tezampanel. In addition, there were no drug-related laboratory abnormalities or clinically important changes in cardiovascular parameters. Furthermore, pharmacokinetic analyses suggest rapid conversion of NGX426 to tezampanel.
“With these promising results, TorreyPines is one step closer to confirming that NGX426 is essentially an oral form of tezampanel, our lead compound currently in Phase IIb development for acute migraine,” said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines. “As an oral product candidate for pain, NGX426 broadens and diversifies our pain pipeline and allows for potentially multiple commercialization opportunities.”
As AMPA/kainite (AK) receptor antagonists, NGX426 and tezampanel offer a unique mechanism of analgesia that is non-narcotic and non-vascular in approach. As such, both compounds may effectively relieve severe and persistent pain without imparting the risks and side effects associated with currently available treatments. Importantly, neither compound shows any clinically relevant effects on the cardiovascular system in animal models or in man, nor demonstrates interaction with serotonin receptors, so these compounds may offer an effective alternative for migraine sufferers for whom triptans, the current treatment standard, are contraindicated. Tezampanel, delivered subcutaneously, is currently in a Phase IIb clinical trial for acute migraine. NGX426 will be studied initially for acute migraine and then for chronic pain conditions such as neuropathic pain.
About AK Receptor Antagonists
AK receptor antagonists selectively block transmission of pain signals mediated through the activation of a subtype 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 Therapeutics
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 migraine; chronic pain, including neuropathic pain; and cognitive disorders, including Alzheimer’s disease and cognitive impairment associated with schizophrenia. Further information is available at www.torreypinestherapeutics.com.
This press release contains forward-looking statements or predictions. Such forward-looking statements include statements regarding the potential for tezampanel and NGX426 as treatments for migraine and other pain indications, the potential for these compounds to effectively relieve severe and persistent pain without imparting the risks and side effects associated with currently available treatments, and the potential for multiple commercialization opportunities from the company’s pipeline of pain compounds. Such statements are subject to numerous factors, risks, and uncertainties regarding development, regulatory approval and commercialization that may cause actual events or results to differ materially from the company’s current expectations, including whether clinical trials of NGX426 will show that it acts in a way comparable to tezampanel, whether any preclinical studies or clinical trials, either ongoing or conducted in the future, will prove successful, and if successful, whether the results can be replicated; whether safety and efficacy profiles of any of its drug candidates will be established, or if established, will remain the same, be better or worse in future clinical trials, if any; whether pre-clinical or early clinical results will be substantiated by ongoing or future clinical trials, if any, or whether any of its drug candidates will be able to improve the signs or symptoms of their respective clinical indication; whether any of its drug candidates will support an NDA filing, will be approved by the FDA or its equivalent, or if approved, will prove competitive in the market; or whether the necessary financing to support its drug development programs will be available. Actual results may differ materially from the above forward-looking statements due to a number of other important factors including that TorreyPines Therapeutics may not be able to execute its integration strategies or realize the expected benefits of its recently completed merger with Axonyx, Inc. These and other risks which may impact management’s expectations are described in greater detail in the registration statement on Form S-4, as amended, as filed with the Securities and Exchange Commission and Axonyx’s other SEC reports. TorreyPines Therapeutics undertakes no obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
TorreyPines Therapeutics, Inc.
CONTACT: Evelyn Graham of TorreyPines Therapeutics, Inc., +1-858-623-5665,ext. 118, egraham@torreypinestherapeutics.com; or Media, Patricia Garrison,+1-917-322-2567, pgarrison@RxIR.com, or Investors, Rhonda Chiger,+1-917-322-2569, rchiger@RxIR.com, both of Rx Communications, forTorreyPines Therapeutics, Inc.
Web site: http://www.torreypinestherapeutics.com/
