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Enrollment Closed in Phase 3 Trial with Phenserine for Alzheimer's Disease
"This is an important milestone for Axonyx as it solidifies our timeline to clinical results in the first randomized, placebo-controlled trial with Phenserine in Alzheimer's disease," said Gosse B. Bruinsma, M.D., President and Chief Operating Officer of Axonyx. "Investigators have demonstrated their support for our therapeutic approach by fully enrolling this late-stage trial within one year's time."
Results of the Company's ongoing Phase IIB study are also expected during the first quarter of 2005. The study is evaluating Phenserine's ability to lower levels of beta-amyloid precursor protein (B-APP) and beta-amyloid (AB) in the plasma and cerebrospinal fluid (CSF) of mild to moderate Alzheimer's disease patients. Beta-amyloid precursor protein and beta-amyloid are well established markers, and potential causes, in the development of Alzheimer's disease.
"We believe analysis of the beta amyloid data from the Phase IIB trial will provide early, valuable information on the potential of Phenserine to modify disease progression," continued Dr. Bruinsma.
The Company's second Phase III pivotal study is currently enrolling 450 patients. The randomized, placebo controlled trial will evaluate 10 mg and 15 mg tablets of Phenserine, administered twice daily.
About The Phase III Trial
Axonyx's first Phase III trial testing Phenserine is a randomized, placebo-controlled double-blind trial evaluating the safety and efficacy of two different dosages of Phenserine in 375 mild to moderate Alzheimer's disease (AD) patients following a six-month treatment period. Patients were randomly assigned to receive either Phenserine 15mg twice daily, Phenserine 10mg twice daily, or placebo. Patients in this trial undergo testing with the standard memory and cognition tests that are the required efficacy endpoints by the United States FDA and European regulatory authorities.
Source: Axonyx Inc.