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October 11, 2000
FDA grants Investigational New Drug (IND) status to Neurochem for
Fibrillex™ pivotal phase II/III on schedule
Neurochem Inc. (TSX : NRM) announced today that it received Investigational New Drug (IND)
status for its lead drug candidate Fibrillex™ from the United States
Food and Drug Administration (FDA). Neurochem can now proceed to a pivotal Phase II/III
clinical trial of Fibrillex™, its orally active anti-fibrillary agent for adult
patients suffering from Secondary Amyloidosis. The FDA conferred to Fibrillex™
in 1999 Orphan Drug Designation granting 7 years of market exclusivity in the United States,
upon product approval.
" Neurochem has achieved a major milestone in the drug development process of
Fibrillex™," said Dr. Louis R. Lamontagne, President and
Chief Executive Officer of Neurochem Inc. "With the IND approval of
Fibrillex™ we can now move to the pivotal Phase II/III trial
stage. We have met the target as presented to our shareholders for the expected
development of this important therapeutic treatment for patients suffering from
Secondary Amyloidosis."
Secondary Amyloidosis is a systemic and fatal form of amyloidosis associated with
chronic diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing
spondylitis, Crohn's disease 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. The market potential for this treatment is
projected to exceed US $ 500 million per year.
The Phase II/III clinical trial of Fibrillex™ will be a randomized, double-blind,
placebo-controlled, and parallel-design trial, which will be conducted in multiple centers
internationally. The trial will begin in the United States within the coming weeks. It will
evaluate the efficacy and safety of the anti-amyloid treatment Fibrillex™ in
150 patients suffering from Secondary Amyloidosis using a composite assessment of clinical
improvement or worsening of both renal and gastrointestinal functions. Subjects will be
randomly divided into two arms of equal size (Fibrillex™; placebo) and treated
over a period of 24 months.
It will also re-confirm the good safety, tolerability and pharmacokinetic profile of
Fibrillex™ as indicated in the four clinical Phase I studies conducted
previously. A total of 80 healthy volunteers and 16 subjects with impaired renal
function have received Fibrillex™ in the Phase I studies. "No subjects
were withdrawn prematurely due to an adverse event in any of the four phase I studies",
said Dr. Denis Garceau, Vice-President, Drug Development, at Neurochem.
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).
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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