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May 30, 2006
Tramiprosate (Alzhemed™) preclinical results published in Neurobiology of Aging
The presence of amyloid in the brain is one of the major histopathological characteristics of AD. The amyloid cascade
hypothesis proposes that certain forms of Aß peptide are toxic and causally related to the severity of AD. The
Aß-peptide is one of the most promising targets for the development of AD therapies. About tramiprosate (Alzhemed™)
Tramiprosate (Alzhemed™) is a small, orally-administered molecule known as an amyloid ß antagonist, designed
to cross the blood-brain-barrier, bind to soluble Aß peptide and interfere with the amyloid cascade, thereby
leading to the prevention or inhibition of amyloid deposition and the toxic effects of Aß peptide in the brain. 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. To date, 600 patients have already completed 12 months on study
medication and the trial is scheduled to be completed by January 2007. All patients who complete the North American
Phase III clinical trial will be offered the opportunity to receive tramiprosate (Alzhemed™) in an open-label
extension study. About Alzheimer's disease
Alzheimer's disease (AD) is a progressive form of dementia associated with specific brain pathologies. It impairs a
person's cognitive and motor functions, their activities of daily living, alters the behaviour and gradually destroys
the brain. About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics to address critical unmet medical
needs. Eprodisate (Fibrillex™) is designated as an orphan drug, is a Fast Track product candidate and is also part
of the U.S. Food and Drug Administration (FDA) Continuous Marketing Application Pilot 1 and Pilot 2 programs. In April
2006, the FDA filed and granted the eprodisate (Fibrillex™) new drug application for priority review. 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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