Idenix Pharmaceuticals Completes Enrollment of Valopicitabine (NM283) Phase IIb Trial in Treatment Refractory Hepatitis C Genoty
31 May 2005 - 11:30PM
PR Newswire (US)
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/
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