AXONYX COMPLETES ALL TREATMENT PERIODS OF PHASE III TRIAL WITH PHENSERINE FOR ALZHEIMER'S DISEASE

AXONYX has completed the last six-month patient treatment period in its Phase III double-blind placebo-controlled clinical trial with Phenserine for Alzheimer's disease (AD).

Axonyx initiated this Phase III trial in June 2003, and the last recruited patients have now successfully completed the study's six-month treatment period; this completion puts Axonyx on target to announce the study's results by the end of March 2005.

More than 375 mild-to-moderate AD patients were randomly assigned to receive either Phenserine 15 mg twice daily, or Phenserine 10 mg twice daily, or placebo. Patients were tested with the standard memory and cognition tests that are the required efficacy endpoints by the FDA and European regulatory authorities.

The company will spend the next several weeks carefully ensuring that the database is accurate and complete. Once this has been accomplished, the database will be locked and the statistical analyses of the efficacy and safety endpoints will follow.

Phenserine is a dual action acetylcholinesterase and beta-APP inhibitor that is being developed by Axonyx for the treatment of mild-to-moderate AD patients. Two additional Phase III clinical trials were initiated in the latter half of 2004.