SAN DIEGO, May 15 /PRNewswire/ -- TorreyPines Therapeutics, Inc. today announced the completion of a Phase I clinical trial for tezampanel (NGX424), a first-in-class compound in development for the treatment of acute migraine, and plans to move forward with a Phase II clinical trial during the second half of this year. An AMPA/kainate (AK) receptor antagonist, tezampanel offers a non-opioid, non-vascular approach to the management of migraine and other persistent pain states and represents a promising alternative to current treatments.
The single, ascending, fixed-dose, double-blind and placebo-controlled trial enrolled 110 healthy adult males at one center in the U.S. The primary purpose of the study was to investigate the safety, tolerability and pharmacokinetics of tezampanel in healthy volunteers. Tezampanel, administered subcutaneously, was well tolerated at single doses up to and including 100 mg and pharmacokinetic findings showed the compound was rapidly and completely absorbed.
“We are pleased with the results of our Phase I study and we look forward to initiating a Phase II program evaluating subcutaneous administration of tezampanel in the treatment of acute migraine,” said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines. “With its previously established efficacy when given intravenously, this compound has the potential to offer migraine sufferers the first novel alternative to their pain management in more than a decade.”
In five Phase II, placebo-controlled trials, tezampanel demonstrated positive proof of concept in multiple pain models. In a placebo and active-controlled trial in migraineurs, the compound, administered intravenously, achieved statistical significance in all primary and secondary endpoints traditionally required for regulatory approval. These endpoints include pain relief at two hours, pain-free at two hours and relief of nausea, photophobia (sensitivity to light) and phonophobia (sensitivity to sound).
The company also plans to file an Investigational New Drug Application with the U.S. Food and Drug Administration this year for its follow-on compound NGX426, an oral prodrug of tezampanel. Both compounds may effectively relieve severe and persistent pain through a novel mechanism that does not impart the side effects and risks associated with currently available migraine and other pain treatments.
“With these compounds, TorreyPines looks forward to meeting the growing and unmet need for non-narcotic pain management that is highly effective and without significant side effects,” said Dr. Kurtz. “The company intends to continue development of the intravenous route of administration, as well as to develop intrathecal and epidural formulations. These multiple dosing routes permit development across a range of indications including migraine, epilepsy, neuropathic pain, spinal cord injury and other intractable pain states.”
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 Media, 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.
Web site: http://www.torreypinestherapeutics.com//
