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Neurochem Announces results from Tramiprosate (ALZHEMED(TM)) North American Phase III Clinical Trial
Neurochem Announces results from Tramiprosate (ALZHEMED(TM)) North American Phase III Clinical Trial.
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nNeurochem will host a conference call tomorrow August 27, 2007, at 8:30 AM\nEDT.\n\n\nLAVAL, QC, Aug. 26 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)\nannounces today top-line results from the North American Phase III clinical\ntrial designed to assess the safety, efficacy and disease modification effect\nof tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease (AD).\nFollowing a recent meeting with the U.S. Food and Drug Administration (FDA)\nand subsequent statistical analyses, the Company announces that the North\nAmerican Phase III clinical trial for tramiprosate (ALZHEMED(TM)), despite the\ndescriptive data showing numerical differences, did not demonstrate a\nstatistically significant difference in favor of tramiprosate (ALZHEMED(TM))\nwith respect to the primary endpoints over 18 months of treatment. However, a\nsubstantial difference observed in hippocampal volume did approach statistical\nsignificance. Due to significant interference from high between-site\nvariations that complicated the statistical analyses beyond expectations, it\nis not possible to draw definitive conclusions with respect to the treatment\neffect of tramiprosate (ALZHEMED(TM)).\n\n\nAt the recent FDA meeting, Neurochem sought feedback on appropriate next\nsteps, especially with respect to the statistical models and the detailed\nanalysis of potential confounding factors. The agency recognized the difficult\nissues surrounding a trial of this magnitude, with its significant site effect\nand the large number of covariates identified during the modeling process, and\nadvised that neither the proposed adjusted models nor any further adjustments\ncould be used for this trial to provide results in support of a claim of\nclinical efficacy. The agency recognized that it might be possible to utilize\nthe findings of the North American Phase III study to potentially revise the\nstatistical analysis plan and/or modify the study design of the ongoing\nEuropean Phase III clinical trial.\n\n\nNeurochem will continue to evaluate the treatment effect of tramiprosate\n(ALZHEMED(TM)) with post-hoc evaluations to facilitate its understanding of\nthe data and assess any treatment effect from the North American trial.\n\n\nNeurochem has established a Special Advisory Board, chaired by Dr.\nRachelle S. Doody, M.D., Ph.D., the Effie Marie ...