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Idenix Pharmaceuticals Completes Enrollment of Valopicitabine
(NM283) Phase IIb Trial in Treatment Refractory Hepatitis C Genotype 1 Patients
- First Hepatitis C Antiviral Drug to Reach This Stage of Development -
CAMBRIDGE, Mass., May 31 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals,
Inc. (NASDAQ:IDIX), a biopharmaceutical company engaged in the discovery,
development and commercialization of drugs for the treatment of human viral and
other infectious diseases, today announced that it has completed enrollment of
its phase IIb clinical trial of valopicitabine (NM283) with more than 170
treatment refractory hepatitis C genotype 1 patients. The company believes that
this is the first time a direct antiviral drug has reached this stage of
clinical testing for this patient population.
"Today, there are very limited treatment options for treatment refractory
hepatitis C patients, or patients that have failed prior treatment with
existing hepatitis C therapies. Among this patient population, approximately 10
percent respond to retreatment with the current standard of care, pegylated
interferon plus ribavirin," said Jean-Pierre Sommadossi, Ph.D., Idenix's
chairman and chief executive officer. "Since standard treatment is only
effective in about half of genotype 1 patients, it is estimated that 30,000 -
40,000 patients in the U.S. will fail treatment each year. Our development
program for valopicitabine is seeking first to address this major, growing,
unmet need."
Phase IIb Trial Design
Valopicitabine is being evaluated in a phase IIb clinical trial in patients who
have previously failed treatment with pegylated interferon plus ribavirin. This
six-month head-to-head trial, comparing the combination of valopicitabine plus
Pegasys(R) to ribavirin plus Pegasys(R), is evaluating more than 170 hepatitis
C genotype 1 patients who have previously failed at least 3 months of treatment
with pegylated interferon plus ribavirin, the current standard therapy. Idenix
expects to report initial clinical data from this phase IIb trial in the fall
of 2005. Currently, the company anticipates initiating a phase III clinical
trial in this patient population in the first half of 2006.
About Valopicitabine (NM283)
Valopicitabine (NM283) is an oral, novel nucleoside analog that was co-
discovered by Idenix and the University of Cagliari through a cooperative
laboratory agreement under the direction of Dr. Paolo LaColla, Director of the
Department of Biomedical Sciences and Technologies of the University.
Valopicitabine (NM283) is currently being developed in combination with
pegylated interferon for use in both treatment refractory and treatment naive
patient populations.
About Hepatitis C
There are approximately 170 million people worldwide with chronic hepatitis C
virus (HCV) infection, of which approximately 2.7 million are in the United
States. Chronic HCV infection accounts for 40 percent of end-stage cirrhosis,
60 percent of liver cancer and 30 to 40 percent of liver transplants in the
United States and other industrialized countries. Responses to current
treatment options are frequently inadequate due to the inability of some
patients to tolerate these treatments and by their limited effectiveness,
particularly in patients infected with HCV genotype 1. The genotype 1 strain of
HCV is the most treatment-resistant HCV genotype and is estimated to cause more
than 70 percent of the reported cases of hepatitis C in the U.S. and Japan, and
more than 65% of the reported cases of hepatitis C in Western Europe.
About Idenix
Idenix Pharmaceuticals, Inc. (NASDAQ:IDIX) is a biopharmaceutical company
engaged in the discovery, development and commercialization of drugs for the
treatment of human viral and other infectious diseases. Idenix's current focus
is on the treatment of infections caused by hepatitis B virus, hepatitis C
virus and human immunodeficiency virus (HIV). Idenix's headquarters are located
in Cambridge, Massachusetts. The company also has drug discovery and
development operations in Montpellier, France and drug discovery operations in
Cagliari, Italy. For further information about Idenix, please refer to
http://www.idenix.com/ .
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of
The Private Securities Litigation Reform Act of 1995. Statements in this press
release other than those that are historical in nature are "forward-looking
statements." Forward-looking statements, which include statements with respect
to the potential therapeutic benefits and successful development of the
company's product candidates and the company's drug discovery and research,
regulatory approval processes and commercialization activities, are subject to
numerous factors, risks and uncertainties that may cause actual events or
results to differ materially from the company's current expectations. These
risks and uncertainties relate to the results of clinical trials and other
studies with respect to the product candidates that the company has under
development; the timing and success of submission, acceptance and approval of
regulatory filings; the company's dependence on its collaboration with Novartis
Pharma AG; the company's ability to obtain additional funding required to
conduct its research, development and commercialization activities; the ability
of the company to attract and retain qualified personnel and the company's
ability to obtain, maintain and enforce patent and other intellectual property
protection for its product candidates and its discoveries. These and other
risks are described in greater detail under the caption "Factors That May
Affect Future Results" in the company's quarterly report on Form 10-Q for the
quarter ended March 31, 2005 and filed with the Securities and Exchange
Commission and other filings that the company makes with the Securities and
Exchange Commission.
All forward-looking statements reflect the company's expectations only as of
the date of this release and should not be relied upon as reflecting the
company's views, expectations or beliefs at any date subsequent to the date of
this release. Idenix anticipates that subsequent events and developments may
cause these views, expectations and beliefs to change. However, while Idenix
may elect to update these forward-looking statements at some point in the
future, it specifically disclaims any obligation to do so.
Pegasys(R) is a registered trademark of Hoffmann-La Roche.
Contact:
Idenix Pharmaceuticals, Inc.
Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838
DATASOURCE: Idenix Pharmaceuticals, Inc.
CONTACT: Media, Teri Dahlman, +1-617-995-9905, or Investors, Amy
Sullivan, +1-617-995-9838, both of Idenix Pharmaceuticals, Inc.
Web site: http://www.idenix.com/