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Executive Summary

THA CLINICAL HALT: WARNER-LAMBERT TO MEET WITH FDA THE WEEK OF NOV. 2 to discuss the possible resumption of THA clinical trials in Alzheimer's disease, Warner-Lambert told "The Pink Sheet." The company suspended studies on Oct. 23 when elevated liver enzyme levels appeared in certain patients. Warner-Lambert explained that liver toxicity was discovered in some patients taking the second-highest out of a total of four THA (tetrahydroaminoacridine) dosing regimens. The firm at this point feels the incidents were dose related. W-L said it will present all relevant data to FDA at the upcoming meeting. Approximately 40-50 patients at 12 centers have been enrolled in the trial during its first month, Warner-Lambert noted. Announced Aug. 6, the two-year program to test the safety and efficacy of THA in Alzheimer's Disease is expected to include about 300 patients at 17 centers. Warner-Lambert is supplying the drug along with $3 mil. in funding. An additional $1.9 mil. of funding comes from the National Institute on Aging, with another $250,000 donated from the Alzheimer's Disease and Related Disorders Association. At the time of the August announcement, HHS said that while the cooperatively funded trial has a two-year time frame, the study would "be monitored periodically to look for any beneficial or adverse effects of the drug." At the time, the department said that it expects to know "within a year" whether the drug might benefit Alzheimer's patients.

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