Business
Neurochem Update on the North American Phase III Clinical Trial for Tramiprosate (ALZHEMED(TM)) for the Treatment of Alzheimer's Disease
Neurochem Update on the North American Phase III Clinical Trial for Tramiprosate (ALZHEMED(TM)) for the Treatment of Alzheimer's Disease.
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nLAVAL, QC, April 19 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX:\nNRM) announces that the database for the North American Phase III clinical\ntrial for tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease\nhas been locked. The analysis is ongoing and entails employing an accurate\nstatistical model that appropriately describes the data and provides accurate\nresults. Neurochem has been advised by its external team of statisticians that\nadjustment to the initial statistical model, as set out in the statistical\nplan, would be necessary to provide accurate results. The procedure to arrive\nat a reliable model involves a detailed analysis of potential confounding\nfactors such as the effect of concomitant medications, baseline\ncharacteristics of the study population or differences in clinical sites.\nNeurochem points out that potential refinement of the statistical model was\ndiscussed with the U.S. Food and Drug Administration before filing with the\nAgency and was anticipated in the plan filed.\n\n\nThe Company notes that in a clinical trial of the size, duration and\ncomplexity of the tramiprosate (ALZHEMED(TM)) Phase III study, such a process\nis not uncommon. The Company has been informed that it could take several\nweeks, perhaps longer, before the results are known. Neurochem continues to\nexpect to announce these results during the second quarter of this year.\n\n\nAbout Neurochem\n\n\nNeurochem Inc. is focused on the development and commercialization of\ninnovative therapeutics to address critical unmet medical needs. Eprodisate\n(KIACTA(TM) - formerly FIBRILLEX(TM)) is currently being developed for the\ntreatment of Amyloid A (AA) amyloidosis, and is under regulatory review for\nmarketing approval by the United States Food and Drug Administration and\nEuropean Medicines Agency. Tramiprosate (ALZHEMED(TM)), for the treatment of\nAlzheimer's disease, has completed a Phase III clinical trial in North America\nand is currently in a Phase III clinical trial in Europe, while tramiprosate\n(CEREBRIL(TM)), for the prevention of Hemorrhagic Stroke caused by Cerebral\nAmyloid Angiopathy, has completed a Phase IIa clinical trial.\n\n\nTo Contact Neurochem\n\n\nFor additional information on Neurochem and its drug development\nprograms, please call the North American toll-free number 1 877 680-4500 or\nv...