TorreyPines Therapeutics Completes Phase I Multiple Dose Clinical Trial of NGX267, a Selective M1 Agonist for the Potential Treatment of Cognitive Impairment Associated with Sch...( LA JOLLA Calif. Sept. 10 /- Torre...),Health

LA JOLLA, Calif., Sept. 10 /PRNewswire-FirstCall/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced completion of its third Phase I clinical trial for NGX267, in clinical development for the treatment of cognitive impairment associated with schizophrenia (CIAS). The compound, a functionally selective muscarinic (M1) agonist, was found to be safe and well-tolerated when given orally to healthy male volunteers once-daily for four consecutive days. In two previous Phase I trials, NGX267, administered as single oral doses, was shown to be well-tolerated in healthy young adult males, as well as in healthy elderly males and females.

The purpose of the Phase I trial was to investigate the safety, tolerability and pharmacokinetics of multiple doses of NGX267 and to confirm data from previous studies in which NGX267 demonstrated evidence of muscarinic receptor stimulation as measured by increases in salivary flow. A total of 60 healthy males, between the ages of 18 and 55, were enrolled in the double-blind, placebo-controlled trial conducted at one center in Belgium. In a series of sequential dosing cohorts, subjects received a single oral dose of either 10, 20, 30 or 35 mg of NGX267 once-daily for four consecutive days. NGX267 was well tolerated at doses up to and including 30 mg, a dose range believed to be effective for treating memory and cognitive disturbances. TorreyPines plans to initiate a Phase II dose-ranging trial in CIAS during the first half of 2008.

A secondary objective was to obtain quantitative measures of salivary flow, prior to and at multiple time points post-dosing, as a peripheral biomarker for stimulation of the muscarinic receptor. In the study, increases in peak and total sal
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