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November 6, 2006
Neurochem receives recommendations from Data Safety Monitoring Boards to continue Phase III clinical trials for
tramiprosate (ALZHEMED™) About the Phase III Clinical Trials for tramiprosate (ALZHEMED™)
Neurochem is currently conducting a multi-center, randomized, double-blind, placebo-controlled and parallel-designed,
18-month Phase III clinical trial in 1,052 mild-to-moderate AD patients, which is being carried out at close to 70
clinical sites across the United States and Canada. The trial is scheduled to be completed in January 2007. To date, 542
patients have completed 18 months on study medication. All patients who complete the North American Phase III clinical
trial are eligible to receive tramiprosate (ALZHEMED™) in an open-label extension study. About Alzheimer's Disease
Alzheimer's disease (AD), associated with specific brain pathologies, is a progressive form, and the most common cause, of
dementia. It impairs a person's cognitive and motor functions, affects their ability to undertake basic daily activities,
alters their behavior and gradually destroys their brain. About Neurochem
Neurochem Inc. is focused on the development and commercialization of innovative therapeutics to address critical
unmet medical needs. Eprodisate (KIACTA™) is currently being developed for the treatment of AA amyloidosis, and is
under regulatory review for marketing approval by the U.S. Food and Drug Administration and European Medicines Agency.
Tramiprosate (ALZHEMED™), for the treatment of Alzheimer's disease, is currently in Phase III clinical trials in
both North America and Europe and tramiprosate (CEREBRIL™), for the prevention of Hemorrhagic Stroke caused by
Cerebral Amyloid Angiopathy, has completed a Phase IIa clinical trial. To Contact Neurochem
For additional information on Neurochem and its drug development programs, please call the North American toll-free number
1 877 680-4500 or visit our Web Site at: www.neurochem.com.
This news release contains forward-looking statements regarding tramiprosate (ALZHEMED™) as well as regarding
continuing and further development efforts. These statements are based on the current analysis and expectations of
management. Drug development necessarily involves numerous risks and uncertainties, which could cause actual results to
differ materially from this current analysis and these expectations. Analysis regarding the results of clinical trials
may not provide definitive results regarding safety, tolerability or therapeutic benefits. Even if all the endpoints
sought in the clinical trials were met (which is not certain), there is no certainty that regulators would ultimately
approve tramiprosate (ALZHEMED™) for sale to the public. Risks and uncertainties may include: failure to demonstrate
the safety, tolerability and efficacy of our product, the expense and uncertainty of obtaining regulatory approval, including
from the FDA, and the possibility of having to conduct additional clinical trials. Further, even if regulatory approval
is obtained, therapeutic products are generally subject to: stringent on-going governmental regulation, challenges in
gaining market acceptance, and competition. Neurochem does not undertake any obligation to publicly update its
forward-looking statements, whether as a result of new information, future events, or otherwise. Please see the Annual
Information Form for further risk factors that might affect the Company and its business.
For further Information, please contact: |
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