TorreyPines Therapeutics, Inc. Initiates Phase I Multiple Dose Clinical Trial of NGX267, a Selective M1 Agonist for the Potential Treatment of Cognitive Impairment Associated With Schizophrenia
LA JOLLA, Calif., March 12 /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 NGX267 when given once-daily for four days to healthy male volunteers. NGX267, a potential treatment for cognitive impairment associated with schizophrenia (CIAS), is a functionally selective muscarinic (M1) receptor agonist. In a previous Phase I trial, NGX267 was well-tolerated at single doses believed to be effective for treating memory and cognitive disturbances.
This double-blind, placebo-controlled, multiple-dose trial will enroll 90 healthy males, between the ages of 18 and 55, in sequential cohorts at one center in Belgium. Doses of 10, 20, 30, and 35 mg will be evaluated. The highest planned dose represents the maximum tolerated single dose of NGX267 from an earlier Phase I study. In that previous study, evidence of cholinergic stimulation, as measured by increase in salivary flow, was detected and there were no clinically notable adverse events. Evaluation of drug-related increases in salivary flow is included in this study as a secondary objective.
"We are pleased with our development progress for NGX267," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines. "Our two previous Phase I studies demonstrated that the drug is well-tolerated and has excellent pharmaceutical properties. The development of NGX267 as a potential adjunctive therapy to antipsychotics may lead to an exciting new approach to improve the lives of patients with CIAS."
The National Institute of Mental Health estimates that approximately 2.4 million adults in the U.S., or about 1.1 percent of the population, suffer from schizophrenia -- a chronic, severe and disabling brain disorder. Up to 70 percent of schizophrenia patients may have cognitive impairment. While currently approved antipsychotics are effective in the core symptoms of schizophrenia, there are no approved therapies to improve the associated cognitive impairment.
About TorreyPines Therapeutics, Inc.
TorreyPines Therapeutics 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 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 for NGX267 to treat symptoms of CIAS. 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 NGX267 will successfully treat symptoms of CIAS, or that TorreyPines will be able to complete the necessary development work and receive regulatory approval for NGX267. 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.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/