LA JOLLA, Calif., Aug. 27 /PRNewswire-FirstCall/ -- TorreyPines Therapeutics, Inc. today announced that it has initiated a Phase I multiple dose clinical trial to evaluate the safety, tolerability and pharmacokinetics of tezampanel given as a subcutaneous injection to healthy male and female volunteers once-daily for four consecutive days. Tezampanel, an AMPA/kainate (AK) receptor antagonist that selectively binds to certain AK receptors to potentially block the transmission of pain signals, has been administered in single doses to more than 300 patients and healthy adults. Data from this multiple dose trial will support the continued development of tezampanel for the treatment of migraine as well as allow TorreyPines to consider expanding the development of tezampanel into additional chronic pain conditions.
The double-blind, placebo-controlled, multiple-dose trial will be conducted at one center in the United States. Approximately 30 healthy male and female volunteers, between the ages of 21 and 55, will be enrolled in sequential, dose-escalating cohorts and receive once-daily subcutaneous doses of placebo or 40 mg, 70 mg or 100 mg of tezampanel for four consecutive days. These same dose strengths, given as a single dose subcutaneous injection, are currently being evaluated by TorreyPines in a Phase IIb clinical trial of tezampanel for acute migraine.
"We are pleased with our development progress for tezampanel," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines. "Our Phase IIb trial in migraine has completed enrollment and we are on track to announce top line results in the fourth quarter of this year. We believe tezampanel represents a potentially new and promising alternative to current treatments for not only migraine but also other pain conditions. Obtaining multiple dose safety and tolerability data will allow us to plan future studies in those chronic painful conditions."
In five Phase IIa, placebo-controlled trials, tezampanel demonstrated proof of concept in multiple pain models. In a placebo and active-controlled clinical trial in patients with acute migraine, the compound, administered intravenously, achieved statistical significance on all primary and secondary endpoints traditionally required for regulatory approval. These endpoints included pain relief at two hours, pain-free at two hours and relief of nausea, photophobia and phonophobia.
About AK Receptor Antagonists
AK receptors are part of the glutamate biological pathway that transmits pain signals to the brain. In addition, 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. AK receptor antagonists selectively bind to certain AK receptors to block transmission of pain signals mediated through the activation of a subtype of glutamate receptors. Because they do not block opioid receptors or constrict blood vessels, the safety profile of AK antagonists may offer important advantages over existing drugs to treat migraine and other pain conditions.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel small molecules 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. Further information is available 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 anticipated timing for reporting clinical trial results for tezampanel, the potential for tezampanel as a treatment for migraine and other pain indications and the potential of TorreyPines Therapeutics' product candidates to treat certain diseases and disorders. Such statements are subject to numerous factors, risks, and uncertainties that may cause actual events or results to differ materially from the combined company's current expectations. Statements regarding TorreyPines Therapeutics' product candidates are subject to risks and uncertainties regarding development, regulatory approval and commercialization, including 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 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. These and other risks which may impact management's expectations are described in greater detail in the TorreyPines Therapeutics' annual report on Form 10-K for the year ended December 31, 2006 as well as TorreyPines Therapeutics' subsequent filings with the Securities and Exchange Commission. 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/
