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November 22, 2005
Neurochem enrolls first patient in Phase III clinical trial for Alzheimer's disease in Europe North American Phase III Clinical Trial On-going
Neurochem continues its North American Phase III clinical trial for Alzhemed™ following a third consecutive
recommendation from its Independent Safety Review Board on the safety and tolerability of the product candidate. The
Company recently completed the enrolment of 1,052 patients with mild-to-moderate AD for the trial being conducted in
51 U.S. and 17 Canadian clinical centers across North America, over a period of 18 months. Both the European and North
American trials are designed to demonstrate the disease-modifying potential of Alzhemed™. About Alzhemed™
Alzhemed™ is an orally administered, small organic molecule that has been designed to modify the course of AD
through its anti-amyloid activity. As part of a novel "disease modifying" class of product candidates,
Alzhemed™ is thought to act at two levels: by preventing and slowing the formation and the deposition of amyloid
fibrils in the brain and by binding to soluble Aß protein to reduce the amyloid-induced toxicity on neuronal and
brain inflammatory cells. About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics principally for neurological
disorders. The Company's pipeline of proprietary, disease-modifying oral products addresses critical unmet medical
needs. 1,3-propanedisulfonate (1,3PDS; Fibrillex™) is designated as an orphan drug, is a Fast Track product
candidate and is also part of an FDA Continuous Marketing Applications Pilot 2 program. The Phase II/III clinical trial
of Fibrillex™ for the treatment of AA Amyloidosis was concluded in April 2005. The Company is in the process of
submitting a New Drug Application (NDA) for Fibrillex™ on a "rolling" basis that the FDA has agreed
to file and review. 3-amino-1-propanesulfonic acid (3APS; Alzhemed™), for the treatment of Alzheimer's disease, is
currently in Phase III clinical trials in both North America and Europe and 3APS (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 Alzhemed™ (3-amino-1-propanesulfonic acid, 3APS),
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 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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