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January 18, 2001
Neurochem receives approval to begin phase II/III clinical trials for
Fibrillex™
Neurochem Inc. (TSX : NRM) has received approval from the Clinical Trials Unit of the
Medicines Control Agency in the United Kingdom for the initiation of a pivotal Phase
II/III clinical study for Fibrillex™, an anti-amyloid drug expected to treat
patients suffering from Secondary Amyloidosis.
Fibrillex™ has also recently been granted Investigational New Drug (IND) status
for the initiation of the same pivotal Phase II/III clinical study in the United States
by the Food and Drug Administration (FDA). Fibrillex™ was previously granted
Orphan Drug Designation (ODD) by the FDA, which will give Neurochem a 7-year market
exclusivity in the U.S. upon product approval. In addition, an application for Orphan
Medicinal Products (OMP) has been filed with the European Agency for the Evaluation of
Medicinal Products (EMEA) in October 2000 which, if approved, could allow for a 10-year
market exclusivity in the 15 Member States of the European Community.
Secondary Amyloidosis is a systemic and fatal form of amyloidosis due to the deposition of
amyloid A (AA) protein mainly in the kidneys, the spleen, the liver and the adrenals
leading to organ failure. This disease is associated with chronic inflammatory
conditions such as rheumatoid arthritis, chronic infections and Familial Mediterranean
Fever.
"The study will evaluate the efficacy and safety of the orally active anti-amyloid
treatment, Fibrillex™, on patients suffering from Secondary Amyloidosis,"
said Dr. Denis Garceau, Vice-President, Drug Development at Neurochem. "A total of
150 patients will be randomly divided into two arms of equal size (Fibrillex™;
placebo) and treated over a period of 24 months."
The Phase II/III clinical trial has been designed as a multicenter, multinational,
randomized, double-blind, placebo-controlled, and parallel-design trial.
About Neurochem
Neurochem is a leader in the development of novel, proprietary compounds that inhibit
the formation, deposition and toxic effects of amyloid fibrils associated with the
development of amyloidosis. Neurochem's research team has been working with international
amyloid experts on the development of therapeutic cures to amyloid-related diseases,
including Alzheimer's Disease, Secondary Amyloidosis, Diabetes Type II and Hemorrhagic
Stroke due to Cerebral Amyloid Angiopathy. Neurochem has advanced three drug candidates to
clinical trials : Alzhemed™, for Alzheimer's Disease, Fibrillex™,
in a pivotal Phase II/III clinical trial, for Secondary Amyloidosis and Cerebril™,
for Hemorrhagic Stroke.
At present, the Company employs over 60 people and is located in Saint-Laurent, Canada
(www.neurochem.com).
All of the statements contained in this news release, other than statements of fact which
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:
Dr. Lise Hébert
Vice President, Corporate Communications
lhebert@neurochem.com
275 Armand-Frappier
Laval (Quebec)
H7V 4A7
Tel: (450) 680-4500
Fax: (450) 680-4501
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