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June 9, 2005
New Fibrillex™ data presented at the meeting of the European League Against Rheumatism (EULAR). Poster Presentation
A poster was also presented at EULAR today by Bouke P.C. Hazenberg, MD, an investigator in the Phase II/III trial,
Division of Rheumatology, Department of Medicine, University Hospital Groningen, Netherlands. Professor Hazenberg
presented results of a sub-study of the Phase II/III trial to assess the presence/absence of AA amyloid in abdominal
fat tissue in the two treatment groups during the two year trial. The results suggest that detection of AA amyloid in
fat aspirates in patients with symptomatic AA Amyloidosis is an easy and sensitive method to confirm a diagnosis of
AA Amyloidosis but does not appear to be useful in monitoring the progression of the disease. About Fibrillex™
Fibrillex™ is an oral investigational product candidate for the treatment of AA Amyloidosis through the prevention
of amyloid fibril formation. It has received Orphan Drug Status designation in the United States and Orphan Medicinal
Product designation in Europe. About AA Amyloidosis
AA Amyloidosis is a progressive and fatal condition that occurs in a proportion of patients with chronic
inflammatory diseases, including rheumatoid arthritis, 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 renal dysfunction. Involvement of the gastrointestinal system is also frequent and is usually
manifested as chronic diarrhea, gastrointestinal bleeding, abdominal pain and malabsorption. Enlargement of the
liver and the spleen may also occur in some patients. End-stage renal failure is the main cause of death in 40-60%
of cases. The median survival time from diagnosis varies from 2 to 10 years depending on the stage of the disease at
the time of diagnosis. No specific treatment is currently available for this orphan disease. 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.
1,3-propanedisulfonate (1,3PDS; Fibrillex™) is designated as an orphan drug and 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 recently concluded and preliminary results have been issued
in April 2005. 3-amino-1-propanesulfonic acid (3APS; Alzhemed™), for the treatment of Alzheimer's Disease, is in
a Phase III clinical trial 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 Fibrillex™, 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 Fibrillex™ 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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