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Neurochem granted Fast Track designation from U.S. FDA for tramiprosate (ALZHEMED(TM))
Neurochem granted Fast Track designation from U.S. FDA for tramiprosate (ALZHEMED(TM)).
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nNeurochem to meet with FDA to discuss statistical models for the\n\n\ncompleted North American Phase III clinical trial\n\n\nLAVAL, QC, July 24 /CNW Telbec/ - Neurochem Inc. (NASDAQ: NRMX; TSX: NRM)\nannounces that the U.S. Food and Drug Administration (FDA) has designated the\ninvestigational product candidate, tramiprosate (ALZHEMED(TM)), as a Fast\nTrack Product for the treatment of Alzheimer's disease.\n\n\nUnder the FDA Modernization Act of 1997, the Fast Track designation\nprogram is intended to facilitate the development and expedite review of drugs\ndeveloped for the treatment of serious or life-threatening conditions and that\ndemonstrate the potential to address an unmet medical need for such a\ncondition.\n\n\nAs previously announced, Neurochem requested a meeting with the FDA,\nwhich is now scheduled for August 2007 with the Division of Neurology\nProducts. The goal of this meeting is to have a discussion on the tramiprosate\n(ALZHEMED(TM)) Phase III program and present an update on the work\naccomplished to date on the North American Phase III clinical trial. Neurochem\nwill also seek FDA's feedback and validation on the next steps that would be\nacceptable to the agency especially with respect to the statistical models. In\nrelation to the ongoing European Phase III clinical trial, patient screening\nactivities will stop in August as Neurochem has exceeded its original patient\nenrolment objectives. However, in light of the information and experience\ngained from the North American Phase III clinical trial, Neurochem is\npresently considering modifications that would need to be made to the design\nof the European trial.\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 AD\nexperiences problems with memory, judgment, thinking, and eventually with\nmotor functions, all of which make it difficult for the person to participate\nin daily activities.\n\n\nAccording to the U.S. Alzheimer Association (2007), there are now more\nthan five million people in the United States living with Alzheimer's disease.\nThis number includes 4.9 million people aged 65 and older. It also includes at\nleast 200,000 individuals you...