Neurochem announces important initiatives to provide medical and health benefits to patients
"Our goal is to provide innovative health solutions to patients sufferingfrom serious diseases as soon as possible," said Dr. Francesco Bellini,Chairman, President and CEO of Neurochem. "With the strategy unveiled today,the Company plans to make tramiprosate available to consumers. As well,Neurochem is confirming its commitment to developing new drugs for AD byadvancing into preclinical development a prodrug which improves tramiprosateconcentration in the brain several fold, thus leveraging the wealth ofknowledge the Company has gained from the work accomplished to date in thisfield. Neurochem will be dedicating its resources to building a strong anddiversified pipeline of product candidates, which could potentially providecash flow in the near term. As a result, our business model is expandingbeyond the traditional biopharmaceutical strategy to one that embraces shorterterm projects. These projects should fund research and development activities,while complementing our longer term prescription drug programs geared atsustaining the Company's future growth," he concluded.
As part of the initiatives announced today, Neurochem will leverage thenumerous years of accumulated knowledge and the experience it has gained indeveloping tramiprosate (ALZHEMED(TM)) for AD, and will prioritize andaccelerate the development of its next generation lead compound NRM-8499, anew chemical entity (NCE) and a prodrug(1) of tramiprosate for the treatmentof AD. Pharmacokinetic studies performed in mice with NRM-8499 have alreadydemonstrated greater than five-fold increases in brain concentration ascompared to the original tramiprosate molecule.
As announced previously, descriptive data from the North American PhaseIII clinical trial shows numerical differences in favor of tramiprosate on theprimary clinical endpoints. The descriptive data also shows by magneticresonance imaging differences between groups on the primary diseasemodification endpoint of change in the volume of the hippocampus, a structureof the brain that is considered to be important in memory function.
Additional findings obtained from a preliminary post-hoc analysisperformed by the Company's external team of statisticians that allowedadjustment for potential confounding factors showed a dose-dependent reductionin hippocampal atrophy in patients treated with tramiprosate. When compared toplacebo, patients treated with 200 mg of tramiprosate per day experiencedsignificantly less atrophy (relative difference of 65%; P = 0.036) andpatients treated with tramiprosate with 300 mg of tramiprosate per daypresented no atrophy (P = 0.003).
The Company is committed to analyzing and understanding the wealth of datagenerated by the Phase III clinical trials. It is pursuing several post-hocanalyses which are revealing promising preliminary results. Neurochem iscurrently working to submit results for publication in a peer-reviewedjournal.
In view of these results, coupled to the large number of physicians andfamilies requesting access to the compound, and given that tramiprosate occursnaturally in certain foods, Neurochem is planning to provide commercial accessto tramiprosate as a branded nutraceutical product, potentially as early as2008, via the creation of a new self-sustaining company. This decision wastaken in view of the fact that AD is a devastating disease and remains anunmet medical need.
Early discontinuation of Phase III Tramiprosate Clinical Trial in Europe
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