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November 8, 2000
Neurochem files a request to begin phase II/III clinical trials in U.K. for
Fibrillex™
Neurochem Inc. (TSX : NRM) has submitted an application to the Clinical Trials Unit of
the Medicines Control Agency in the United Kingdom for initiation of a pivotal Phase
II/III clinical study for Fibrillex™, an anti-amyloid drug for the treatment of
patients suffering from Secondary Amyloidosis.
Fibrillex™ has 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 it a 7-year market exclusivity in the U.S.
upon product approval. Additionally 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 typically allows a 10-year market exclusivity in the 15 Member States
of the European Community.
The Phase II/III clinical trial has been designed as a randomized, multinational,
double-blind, placebo-controlled, and parallel-design trial. "The study will evaluate
the efficacy and safety of the orally active anti-amyloid treatment, Fibrillex™,
in 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."
Secondary Amyloidosis is a systemic and fatal form of amyloidosis. The disease is caused
by the deposition of amyloid A (AA) protein mainly in the kidneys, the spleen, the liver
and the adrenals causing severe dysfunction. It is associated with chronic inflammatory
conditions such as rheumatoid arthritis, chronic infections and Familial Mediterranean Fever.
It is estimated that more than 500,000 patients in industrialized countries are presently
suffering from Secondary Amyloidosis, with no treatment available.
Neurochem is an industry leader in the development of a novel, proprietary series of
compounds that inhibit the formation, deposit and toxic effects of amyloid fibrils on
cells within the body. 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 the treatment of Alzheimer's disease,
Fibrillex™, for Secondary Amyloidosis, and Cerebril™, for
Hemorrhagic Stroke. At present, the Company employs over 50 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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