New York-based Axonyx Inc?s Phenserine is in late stage Phase IIb and two Phase III clinical trials in Europe. The results of the Phase IIb and first Phase III trials are expected out in the first quarter of 2005. Over 450 patients are currently involved in the Phase IIb and the first Phase III trials (IIb contains 75 patients, the first Phase III trial contains 375 patients). The second Phase III trial is currently enrolling 450 patients.

Preclinical studies with the drug indicate that it may have the potential to MODIFY the progression of the disease. The Phase IIb trial is intended to substantiate the in-vitro and in-vivo preclinical data that has consistently shown that Phenserine can reduce the levels of beta-amyloid precursor protein and beta amyloid levels. The Phase III trial will examine the safety in and efficacy of Phenserine to improve memory and cognition, in which early studies found the drug to be well tolerated and have less severe side effects than treatments currently available on the market. (See the enclosed slide)

Steven H. Ferris, Ph.D., is the Friedman Professor of the Alzheimer?s Disease Center at New York University (NYU) School of Medicine, Executive Director of NYU?s Silberstein Institute for Aging and Dementia and Principal Investigator of their National Institute on Aging-supported Alzheimer?s Disease Center, is available to speak with you about Phenserine and other on-going research activities in the field of Alzheimer?s disease. He has been studying brain aging and Alzheimer?s disease for more than three decades and is a neuropsychologist, psychopharmacologist, and gerontologist specialist.

Phenserine is targeted to the Amyloid Plaque theory, but Dr. Hausman, the CEO of Axonyx Inc., also believes that oxidative stress may play a role in the development of Alzheimer?s disease. Per your request, I can send a number studies that you might find of particular interest including:

-- Phenserine: A Selective, Long-Acting and Brain Directed Acetylcholinesterase Inhibitor Affecting Cognition and ?-APP Processing

-- Do Acetylcholinesterase Inhibitors Boost Synaptic Scaling in Alzheimer?s Disease

-- The Safety and Side Effect Profile of Phenserine Tartrate Following 12 Weeks of Treatment in Alzheimer?s Disease Patients

-- The Efficacy of Phenserine Tartrate Following Twelve Weeks of Treatment in Alzheimer?s Disease Patients

-- A Double blind, Randomized, Sequential Group, Multiple Oral Dose Study of the Safety, Tolerance and Anticholinesterase Profile of Phenserine Tartrate in Healthy Human Subjects

-- Anticholinesterase Profile of Phenserine in Healthy Elderly Human Subjects

-- The Experimental Alzheimer Drug Phenserine: Preclinical Pharmacokinetics and Pharmacodynamics

If you are interested in learning more Andria Arena can put you in touch with Dr. Ferris and/or Dr. Hausman at your earliest convenience. Please feel free to contact her at (USA) 212-370-4500, ext. 26 or andria@wolfeaxelrod.com.

http://www.axonyx.com