Alzheimer's Club

Axonyx Inc. (NASDAQ: AXYX) reports today the results of an additional analysis of a subgroup of patients from its two curtailed Phase III clinical trials (AX-CL-09/010) with Phenserine, in development for mild to moderate Alzheimer's disease (AD). The subgroup of patients, who received Phenserine 15mg twice daily, demonstrated a statistically significant benefit over placebo as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), when treated for more than 12 weeks. Additionally, this subgroup showed a positive trend towards improvement in the Clinical Interview Based Impression of Change (CIBIC+) test, which approached statistical significance. There were no unexpected safety or tolerability concerns associated with Phenserine treatment. This analysis was undertaken in addition to the previously announced results of the primary pre-defined statistical analysis.
While additional clinical trials would be required to further confirm the results of this additional analysis, the Company believes that they support its stated position that higher doses of Phenserine could potentially be efficacious in treating the signs and symptoms of mild to moderate AD in future potential Phase III trials of 26 weeks duration.

On September 20, 2005, the Company announced the top line results from its primary efficacy analysis of all patients that participated in the curtailed Phase III clinical trials; this analysis did not demonstrate a statistically significant benefit associated with Phenserine over placebo after 12 weeks of treatment in either the ADAS-cog or CIBIC+, the primary efficacy endpoints for the study. At that time, the Company indicated that it would continue to evaluate the Phenserine program. On November 7, 2005, the Company indicated it would not commit further resources to the development of Phenserine and would seek a partner for the compound.

This additional analysis was recently completed as part of the program to identify a partner for the further development of Phenserine. The analysis included 182 patients who received Phenserine treatment or placebo for more than 12 weeks and up to 26 weeks of treatment. The statistically significant benefit was based on the ADAS-cog test; one of the FDA approved measurements of efficacy in Alzheimer's disease clinical trials. The improvement in the CIBIC+ test, another approved efficacy endpoint, for the 15mg twice daily group approached statistical significance compared to the placebo group. The patients who received Phenserine 10mg twice daily did not show a statistically significant benefit compared to placebo..." [Read Full Article at Genetic & Engeneering News, 29 Nov 2005]