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April 26, 2004
Neurochem receives fourth consecutive positive recommendation from Data Safety Monitoring Board to
continue Phase II/III Clinical Trial for Fibrillex™ About Fibrillex™
The Phase II/III clinical trial for Fibrillex is a two-year, international, multicenter, randomized,
double-blind, placebo-controlled, and parallel-designed trial to evaluate the safety and efficacy of
Fibrillex™ in patients suffering from AA Amyloidosis. Neurochem has successfully completed the
enrollment of 183 patients for this Phase II/III trial, which is being conducted at 27 sites located
across North America, Europe and Israel. This trial is planned to end in January 2005. After two years
of treatment patients are invited to participate in a two-year open-label study with Fibrillex™.
Fibrillex™ has received orphan drug designation in the United States and Europe, which normally
entails market exclusivity on this product candidate for seven years and ten years respectively, once
it is approved. It has also received Fast Track Product designation by the U.S. Food and Drug
Administration (FDA) which will make it eligible for priority reviews by the FDA. About AA Amyloidosis
AA Amyloidosis is a progressive and fatal condition that occurs in a proportion of patients with
chronic inflammatory diseases, including RA, ankylosing spondylitis, juvenile rheumatoid arthritis,
and Crohn's disease. The disease also occurs in patients suffering from many other conditions ranging
from chronic infections to inherited inflammatory diseases such as Familial Mediterranean Fever. The
most common clinical presentation of AA Amyloidosis is kidney malfunction such as proteinuria. The
gastrointestinal system is also frequently involved, with patients experiencing chronic diarrhea,
gastrointestinal bleeding, abdominal pain and malabsorption. Enlargement of the liver and the spleen
may also occur in some patients. Patients suffering from AA Amyloidosis have a poor prognosis with
five- to 15-year survival rates of 50% and 25%, respectively. End-stage renal failure is the cause
of death in 40% to 60% of cases. There is currently no specific therapy for the treatment of AA
Amyloidosis. About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics for
neurological disorders. The Company's pipeline of proprietary, disease-modifying, oral products
addresses critical unmet medical needs. Fibrillex™, designated an orphan drug and a Fast Track
Product candidate, is in a Phase II/III clinical trial for AA amyloidosis. Alzhemed™ and
Cerebril™ have completed a Phase II clinical trial for Alzheimer's Disease and for the prevention
of Hemorrhagic Stroke caused by Cerebral Amyloid Angiopathy, respectively. For additional information
on Neurochem, please visit our website at : (www.neurochem.com).
All of the statements contained in this news release, other than statements of fact that are
independently verifiable at the date hereof, are forward-looking statements. Such statements, based
as they are on the current expectations of management, inherently involve numerous risks and
uncertainties, known and unknown. Some examples of known risks are: the impact of general
economic conditions, general conditions in the pharmaceutical industry, changes in the
regulatory environment in the jurisdictions in which Neurochem does business, stock market
volatility, fluctuations in costs, and changes to the competitive environment due to consolidation
or otherwise. Consequently, actual future results may differ materially from the anticipated
results expressed in the forward-looking statements.
For further Information, please contact: |
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