Alzheimer's
Phenserine may Reduce Progression of Alzheimer's Disease
By Axonyx Inc.
Jul 27, 2005, 13:35

Axonyx Inc. (NASDAQ: AXYX) announced today that it conducted a second interim statistical analysis of 59 patients in an ongoing Phase IIb double-blind placebo-controlled clinical trial (designated AX-CL-06a) designed to evaluate the effects of Phenserine tartrate (PT) treatment for 6 months on plasma and cerebrospinal fluid (CSF) levels of beta-amyloid (AB 1- 42) and other biomarkers in mild to moderate Alzheimer's Disease (AD) patients.

This analysis, which follows the first interim analysis reported on March 11, 2005, was undertaken to assess the benefit of continuing enrollment. Pre-defined criteria for the interim analysis were based on beta amyloid 1 - 42 levels in patients who completed the study according to the clinical trial protocol.

These interim analyses, with small patient numbers, are intended to guide the Company in conducting the trial and are rarely statistically significant.

An additional 22 patients were added to the 37 patients analyzed in the first interim analysis for a total of 59 patients. While this second interim analysis appears to again confirm that Phenserine may have an impact on the levels of beta amyloid, there is still insufficient evidence due to the variability of the data to draw definitive conclusions. Further detailed analyses as well as additional laboratory bio-assay activities are being undertaken by the Company, its scientific advisors and biostatisticians to investigate the variability in the data. Meanwhile, the enrollment in the Phase IIb trial will continue at the 15mg dose level and placebo.

The presence of toxic beta-amyloid in the brains of AD patients is considered by many experts to be a key pathological event in the causation as well as the progression of AD. A reduction of beta-amyloid levels could correlate to a reduced progression of AD. The interim data is comprised of patients who received Phenserine 10mg or 15mg twice daily or placebo for a period of 6 months.

About Phenserine

Phenserine is a highly selective acetylcholinesterase (AChE) inhibitor that binds with an enzyme that is responsible for the breakdown of a neurotransmitter important in memory and cognition. Unlike other AChE inhibitors, which only suppress the activity of this enzyme,

Phenserine has been shown to have two mechanisms of action: (1) the inhibition of the AChE enzyme, and
(2) in preclinical studies, the inhibition of the synthesis of AB, the protein in the brain that is thought to be a cause of brain cell death in Alzheimer's disease.

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