ECUBLENS, SWITZERLAND, June 7 /CNW Telbec/ - Neurochem (International)
Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ:
NRMX; TSX: NRM), announces that the New England Journal of Medicine (NEJM)
published the results of the "Eprodisate For AA Amyloidosis Trial" (EFAAT),
recognized as a landmark clinical trial in the search for a treatment of AA
amyloidosis. The results of the Phase II/III clinical trial for eprodisate
(KIACTA(TM)) demonstrate that this product candidate offers important clinical
benefits to patients by reducing the progression of AA amyloidosis-associated
renal disease. The results from the EFAAT have been submitted to the U.S. Food
and Drug Administration, the European Medicines Agency and Swissmedic in
support of applications for marketing approval of eprodisate (KIACTA(TM)) for
the treatment of AA amyloidosis, a disease which remains today without a
The print issue of the publication will be available in the June 7, 2007
issue of the NEJM. The article entitled "Eprodisate for the Treatment of Renal
Disease in AA Amyloidosis" is accessible online, and can be found at
www.nejm.org under the "Current Issue" section of the Web site.
"These results show clinically important benefits for patients suffering
from this disabling and potentially fatal disease," said Dr. Laura Dember,
nephrologist and Associate Professor of Medicine, Boston University School of
Medicine, and the lead author of the New England Journal of Medicine article
reporting the results of the Phase II/III clinical trial for eprodisate
(KIACTA(TM)). "Our treatment approach, up to this point, has been limited to
controlling the inflammatory condition that underlies the development of AA
amyloidosis. However, for many patients such efforts are unsuccessful and
amyloid formation continues. KIACTA(TM) is the first product candidate
designed to target amyloid formation and represents a truly novel strategy for
treating nephropathy associated with AA amyloidosis," she concluded.
Findings about eprodisate (KIACTA(TM)) reported in the article include:
- At the end of the 24-month period, the disease had worsened in 24 of
89 patients assigned to eprodisate (KIACTA(TM)) (27%), and 38 of
94 patients given placebo (40%, p=0.06)(1).
- Eprodisate (KIACTA(TM)) decreased the risk of the primary endpoint, a
composite of worsening of renal function or death, by 42%
(HR 0.58, p=0.02)(2).
- Eprodisate (KIACTA(TM)) significantly reduced the risk of the doubling
of serum creatinine, the risk of 50% reduction in creatinine clearance
and the slope of decline in creatinine clearance.
- Eprodisate (KIACTA(TM)) treatment was associated with a reduction in
the risk of developing end-stage renal disease, one of the clinical
measures of the composite primary endpoint that was not statistically
significant at the two-year time point.
- There was no significant difference between the two groups in the risk
- Eprodisate (KIACTA(TM)) did not affect proteinuria, amyloid content in
abdominal fat and, as expected, did not change the blood level of serum
amyloid A protein.
- The frequency and types of adverse events and death were similar in the
treated and placebo groups. The most frequent adverse events (as
categorized by common terms) were diarrhea, headaches and nausea.
About Eprodisate (KIACTA(TM))
Eprodisate (KIACTA(TM)) was investigated in a landmark international,
randomized, double-blind, placebo-controlled, and parallel-designed clinical
trial in which 183 AA amyloidosis patients were enrolled at 27 sites around
the world. Patients who completed the clinical trial were eligible for
enrollment in an ongoing open-label extension study, some of whom have now
been receiving eprodisate (KIACTA(TM)) for more than five years.
Eprodisate (KIACTA(TM)) has received orphan drug designation in the U.S.,
the European Union and in Switzerland.
About Amyloid A (AA) Amyloidosis
A progressive and potentially fatal condition, AA amyloidosis occurs in a
proportion of patients with chronic inflammatory disorders, chronic infections
and inherited diseases such as Familial Mediterranean Fever. The kidney is the
organ most frequently affected and progression to dialysis/end-stage renal
disease is the most common clinical manifestation of this disease. Currently,
there is no approved therapy to treat AA amyloidosis and about half of all
patients diagnosed with the disease die within five years of diagnosis.
The EFAAT study was sponsored by Neurochem Inc., and in part by a
CDN$1.4 million grant from the U.S. Food and Drug Administration.
Neurochem Inc. is focused on the development and commercialization of
innovative therapeutics to address critical unmet medical needs. Eprodisate
(KIACTA(TM)) is currently being developed for the treatment of Amyloid A (AA)
amyloidosis, and is under regulatory review for marketing approval by the U.S.
Food and Drug Administration, the European Medicines Agency and Swissmedic.
Tramiprosate (ALZHEMED(TM)), for the treatment of Alzheimer's disease, has
completed a Phase III clinical trial in North America and is currently in a
Phase III clinical trial in Europe, while tramiprosate (CEREBRIL(TM)), 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.
(1) Cochran-Mantel-Haenszel row mean-scores test
(2) Cox proportional-hazards analysis.
This news release contains forward-looking statements regarding
eprodisate (KIACTA(TM)), 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. There is no certainty that
regulators will ultimately approve eprodisate (KIACTA(TM)) for sale to the
public. Risks and uncertainties may include: failure to demonstrate the
safety, tolerability and efficacy of our product, that actual results may vary
once the final and quality-controlled verification of data and analyses has
been completed, 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. Neither Neurochem
Inc., nor Neurochem (International) Limited undertake any obligation to
publicly update any forward-looking statements, whether as a result of new
information, future events, or otherwise. Please see Neurochem Inc.'s Annual
Information Form for further risk factors that might affect Neurochem Inc.,
Neurochem (International) Limited and their respective businesses.
For further information:
For further information: Lise Hébert, PhD, Vice President, Corporate
Communications, (450) 680-4572, firstname.lastname@example.org