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Tramiprosate (ALZHEMED(TM)) North American Phase III clinical trial progress update
Tramiprosate (ALZHEMED(TM)) North American Phase III clinical trial progress update.
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nLAVAL, QC, June 22 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)\nhas issued an update on the progress made since announcing in April 2007 that\nadjustments would be required to arrive at a reliable statistical model for\nthe North American Phase III clinical trial for tramiprosate (ALZHEMED(TM))\nfor the treatment of Alzheimer's disease (AD). Neurochem has been advised by\nits external team of statisticians that they have made progress adjusting the\nstatistical model, reaching an acceptable level of validity for the disease\nmodification endpoint, as measured by magnetic resonance imaging (MRI).\nHowever, further work is required to reach a reliable model particularly for\nthe co-primary clinical efficacy endpoint composed of ADAS-cog(1) and\nCDR-SB(2). Therefore, the Company expects the results to be available later in\n2007.\n\n\nSince April, Neurochem has provided regular updates on the program,\nincluding preliminary data and reports on the model. Certain of the\nconfounding factors identified by the statisticians and included so far in\nadjustments to the model are the use of concomitant drugs, including change in\nmemantine use and dose, change in vitamin E use and dose, change in\nanti-depressant use, and change in acetylcholinesterase inhibitor dose.\n\n\nTo date, Neurochem has invested significant human and financial resources\nin this program. The Company is committed to continuing its efforts to adjust\nthe model in order to evaluate the significance of the data and remains\nhopeful that the results will prove valuable in the development of the first\npotential disease-modifying treatment for this terrible disease. Given the\nmagnitude and duration of this trial, the size of the patient population, and\nthe challenge of testing a first-in-class product candidate, which is\nhypothesized to target the underlying pathology of AD, Neurochem will need\nmore time to work with experts in the field, including the trial's\ninvestigators and the regulatory authorities.\n\n\nThe Company has been also advised by its statistical team that refinement\nof the statistical model needs further adjustments. In view of the continuing\ncomplexities of the trial, which involves the first attempt to employ these\nparticular primary outcome measures across multiple clinical sites for a\npotential disease modification effec...