This excerpt taken from the TPTX 8-K filed Mar 14, 2005.
Data Meet Pre-defined Criteria for Continuing Trial Enrollment in Top Dose Group
NEW YORK, NY March 11, 2005 Axonyx Inc. (NASDAQ: AXYX) announced today
interim results from the first 37 patients in a Phase IIb double-blind placebo-controlled clinical trial (designated AX-CL-06a) designed to evaluate the effects of Phenserine tartrate (PT) on cerebrospinal fluid (CSF) levels of beta-amyloid (A( 1- 42) and other biomarkers in mild to moderate Alzheimers Disease (AD) patients. 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. Patients received Phenserine 10mg or 15mg twice daily or placebo for a period of 6 months.
Results from this Phase IIb clinical trial will be presented on Saturday, March 12, 2005, at the 7Th International Conference on Alzheimers and Parkinsons disease in Sorrento, Italy.
The Company scheduled this interim analysis 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 successfully and referred to as the per protocol population (PP).
The changes in CSF Aß 1-42 are summarized in the following table:
CSF Aß 1- 42 Mean Changes from Baseline in pg/ml (picograms per milliliter) (SE)
The Phenserine 15mg BID dose showed approximately a 58 pg/ml difference from placebo following 6 months of treatment. The interim analysis demonstrated that none of the numerical differences between the treatment groups achieved statistical significance. However, there was sufficient information to conclude that enrollment to the 15mg dose group was justified, but not to the 10mg group. Completion of patient enrollment of this trial is expected in the second quarter 2005 with final results in the last quarter 2005.
While these results met the predefined criteria for continuing enrollment at the higher dose and we believe are encouraging, further data are required before definitive conclusions can be drawn, stated Gosse Bruinsma, M.D., President and Chief Executive Officer of Axonyx. Successful completion of this trial will remain a priority for the Company.