Business
Neurochem receives second recommendation from European Data Safety Monitoring Board to continue Phase III clinical trial for tramiprosate (ALZHEMED(TM))
Neurochem receives second recommendation from European Data Safety Monitoring Board to continue Phase III clinical trial for tramiprosate (ALZHEMED(TM)).
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nLAVAL, QC, Feb. 13 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)\nannounces that it has received a second recommendation from the European Data\nSafety Monitoring Board (DSMB) to continue its ongoing European Phase III\nclinical trial for tramiprosate (ALZHEMED(TM)), Neurochem's investigational\nproduct candidate for the treatment of Alzheimer's disease (AD). Neurochem\nrecently completed its North American Phase III clinical trial involving\n1,052 patients at 67 sites. For the North American trial, Neurochem received\nfive consecutive recommendations from the North American DSMB to proceed.\n\n\nEach DSMB is 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 Europe, this second recommendation by the DSMB\nmembers was based on their recent review of the available safety data from\n491 patients who have been on study medication for an average of 3.6 months.\n\n\nThe North American Phase III clinical trial was a multi-center,\nrandomized, double-blind, placebo-controlled, three-armed and parallel-\ndesigned, 18-month Phase III clinical trial. All patients who completed the\nNorth American Phase III clinical trial were eligible to receive tramiprosate\n(ALZHEMED(TM)) in an open-label extension study.\n\n\nNeurochem is progressing with its 18-month Phase III clinical trial for\ntramiprosate (ALZHEMED(TM)) in Europe. This trial was initiated in September\n2005 and is of a design similar to the North American trial. Some 930 mild-to-\nmoderate AD patients at close to 70 sites across ten countries are expected to\ntake part and enrollment is expected to be completed in early 2007.\n\n\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\n\nAbout Alzheimer's Disease\n\n\nAD is a leading cause of death in older people. The disease is\ncharacterized by the progressive death of nerve cells in the brain, making it\ndifficult for the brain's signals to be transmitted properly. A person with\nAD experiences problems with memory, judgment, thinking, and e...