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Neurochem receives recommendations from data safety monitoring boards to continue phase III clinical trials for tramiprosate (ALZHEMED(TM))
Neurochem receives recommendations from data safety monitoring boards to continue phase III clinical trials for tramiprosate (ALZHEMED(TM)).
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[{"type":"text","content":"\n\n\n\n\nLAVAL, Nov. 6 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM),\nannounces that it has received recommendations from both the North American\nand European Data Safety Monitoring Boards (DSMB) to continue its two Phase\nIII clinical trials currently ongoing for tramiprosate (ALZHEMED(TM)),\nNeurochem's investigational product candidate for the treatment of Alzheimer's\ndisease (AD).\nThe two DSMBs are made up of independent clinical experts who monitor and\nevaluate the safety of patients taking part in the tramiprosate (ALZHEMED(TM))\nPhase III clinical trials. In North America, this fifth recommendation by the\nDSMB was based on the recent review of the available safety data from 1,052\npatients who have been on study medication for an average of 12.9 months. The\nCompany announced previous recommendations by the North American DSMB in\nFebruary 2006, and April, June and October 2005.\nIn Europe, this first recommendation by the DSMB members was based on\ntheir recent review of the available safety data from 333 patients who have\nbeen on study medication for an average of 1.8 months.\nTramiprosate (ALZHEMED(TM)) is a small, orally-administered molecule\nknown as an amyloid (B) antagonist, which crosses the blood-brain-barrier,\nbinds to soluble A(B) peptide and interferes with the amyloid cascade that is\nassociated with amyloid deposition and the toxic effects of A(B) peptide in\nthe brain.\n\nAbout the Phase III Clinical Trials for tramiprosate (ALZHEMED(TM))\n\nNeurochem is currently conducting a multi-center, randomized,\ndouble-blind, placebo-controlled and parallel-designed, 18-month Phase III\nclinical trial in 1,052 mild-to-moderate AD patients, which is being carried\nout at close to 70 clinical sites across the United States and Canada. The\ntrial is scheduled to be completed in January 2007. To date, 542 patients have\ncompleted 18 months on study medication. All patients who complete the North\nAmerican Phase III clinical trial are eligible to receive tramiprosate\n(ALZHEMED(TM)) in an open-label extension study.\nNeurochem is also actively advancing an 18-month Phase III clinical trial\nfor tramiprosate (ALZHEMED(TM)) in Europe, which was initiated in September\n2005. The ongoing European Phase III clinical trial, an international,\nmulti-center, randomized, double-blind, placebo-controlled and\npa...