Partial 24-Week Data Demonstrate Valopicitabine (NM283) Combined with Pegylated Interferon Continues to Produce Greater Viral Su
December 14 2005 - 8:56AM
PR Newswire (US)
CAMBRIDGE, Mass. and KOHALA COAST, HI, Dec. 14
/PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc.
(NASDAQ:IDIX) announced partial 24-week data today from an ongoing
phase IIb clinical trial evaluating valopicitabine combined with
pegylated interferon in treatment-refractory patients with chronic
hepatitis C. These 24-week data demonstrate continued increased
viral suppression in patients treated with the combination of
valopicitabine plus pegylated interferon compared to patients
retreated with ribavirin plus pegylated interferon. All patients
enrolled in this clinical trial are chronically infected with the
genotype 1 strain of hepatitis C and have previously failed to
respond to treatment with pegylated interferon plus ribavirin. Dr.
Christopher O'Brien, Professor of Clinical Medicine at the
University of Miami and a principal investigator in the trial,
presented these data at the Hep DART meeting in Hawaii. This
48-week phase IIb clinical trial is evaluating three dosing
regimens of valopicitabine, administered once-daily, in combination
with pegylated interferon compared to retreatment with combination
therapy of pegylated interferon plus ribavirin. Valopicitabine
combination dosing regimens include: valopicitabine 400 mg;
valopicitabine ramping from 400 mg to 800 mg during Week 1 and
continuing thereafter with 800 mg; and valopicitabine 800 mg. In
all three arms, valopicitabine is given in combination with
pegylated interferon alfa-2a (Pegasys(R)) 180 �g with the initial
dose of pegylated interferon administered on Day 8. The partial
24-week data for 162 patients out of 178 patients in the intent to
treat population demonstrated that the two higher-dose arms of
valopicitabine plus pegylated interferon produced greater
suppression of serum HCV RNA compared to the ribavirin plus
pegylated interferon retreatment control arm. At Week 24, mean HCV
RNA reductions in the two high-dose arms of valopicitabine plus
pegylated interferon were 3.01 log10 and 3.32 log10, with 11
percent and 25 percent of patients achieving undetectable levels of
virus. In comparison, patients in the pegylated interferon plus
ribavirin retreatment control arm showed a mean HCV RNA reduction
of 2.31 log10, with 19 percent of patients achieving undetectable
levels of virus. Patients in valopicitabine-containing arms also
demonstrated a more consistent response than patients in the
retreatment control arm. At Week 24, the median HCV RNA reduction
in the control arm was 1.21 log10, compared to median HCV RNA
reductions of 3.01 log10 and 3.29 log10 in the two high-dose
valopicitabine combination arms. Correspondingly, patients in the
retreatment control arm had much higher residual viral levels at
Week 24, with a median residual viral load (HCV RNA level) of 5.35
log10 copies/mL in the control arm, compared to residual HCV RNA
levels of 3.81 log10 and 3.57 log10 copies/mL in the two high-dose
valopicitabine combination arms. "It is encouraging that we
continue to see substantial viral reductions out to week 24 with
the valopicitabine and pegylated interferon combination treatment
arms in this refractory patient population," said Dr. O'Brien. "The
consistency of response seen in the individual patient data in the
valopicitabine combination arms compared to the control arm
suggests that the differential in viral load reductions may
continue to widen in favor of the valopicitabine combination arms
as treatment progresses," he said. In this phase IIb clinical
trial, valopicitabine has demonstrated satisfactory safety and
tolerance overall. To date, in this ongoing clinical trial, a low
percentage of patients on valopicitabine have discontinued due to
adverse events. Four serious adverse events, diverse in nature,
were considered attributable to combination treatment with
valopicitabine plus pegylated interferon and all cases resolved
after discontinuation of treatment. The company anticipates
presenting the complete 24-week data from this phase IIb clinical
trial at scientific conferences in the spring of 2006. About
Valopicitabine Valopicitabine, which is administered orally once a
day, is intended to block HCV replication by specifically
inhibiting the HCV RNA polymerase, the enzyme that makes new copies
of HCV viral chromosome inside infected cells. Initial phase I
clinical trials sponsored by Idenix showed that valopicitabine is
active in patients infected with the genotype 1 strain of HCV, the
strain that infects the majority of patients in North America,
Europe, and Japan. The ongoing clinical trials are designed to
evaluate the combination of valopicitabine and pegylated interferon
in hepatitis C genotype 1 patients who previously failed to respond
to antiviral treatment, as well as in genotype 1 patients who have
not been treated previously. Preliminary results from phase II
clinical trials to date have demonstrated that the antiviral effect
of valopicitabine is enhanced when this agent is used in
combination with pegylated interferon. About Hepatitis C Hepatitis
C is an infectious liver disease caused by the hepatitis C virus.
The World Health Organization estimates that 170 million
individuals worldwide carry chronic HCV infection, with 3 to 4
million new infections occurring globally each year. It is the most
common chronic blood-borne infection in the United States with 2.7
million chronically infected. Chronic HCV infection causes
inflammation of the liver, which may cause progressive liver damage
that can lead to cirrhosis (liver scarring), hepatocellular
carcinoma (liver cancer), liver failure, and death. Patients
infected with HCV genotype 1 are difficult to treat, with half or
fewer such patients achieving sustained responses to current
standard treatment regimens involving a combination of pegylated
interferon plus ribavirin. These "non-responders" or
treatment-refractory patients comprise a growing patient
population, who have no proven alternative treatments available and
who are at risk for progressive HCV-associated liver disease. As
the prevalence of severe liver disease attributable to chronic
hepatitis C rises, deaths due to complications from hepatitis C
infection, currently 8,000 to 10,000 per year in the United States,
are expected to increase dramatically over the next 15 to 20 years.
About Idenix Idenix Pharmaceuticals, Inc. is a biopharmaceutical
company engaged in the discovery and development 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 and
it 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. Such forward-
looking statements can be identified by the use of forward-looking
terminology such as, "it is encouraging," "suggests,"
"anticipates," "may," or similar expressions or by express or
implied discussions regarding the potential therapeutic benefits
and successful development of valopicitabine, or regarding any
potential future revenues from valopicitabine. Such forward-
looking statements are subject to numerous factors, risks and
uncertainties that may cause actual events or results to differ
materially from the company's current expectations. There can be no
guarantee that valopicitabine will be successfully developed or
approved for sale in any market, or that it will reach any
particular level of revenue. In particular, management's
expectations regarding valopicitabine could be affected by risks
and uncertainties relating to the results of clinical trials and
other studies with respect to valopicitabine, including further
analysis of existing clinical data, additional data from the
ongoing phase IIb clinical trials and data from any subsequent
phase III clinical trials; the timing, acceptance and approval, if
any, of regulatory filings submitted to the FDA or other regulatory
bodies around the world, 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; competition in
general; and the company's ability to obtain, maintain and enforce
patent and other intellectual property protection for
valopicitabine. These and other risks which may impact management's
expectations regarding valopicitabine 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 September 30, 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, Inc. Idenix
Pharmaceuticals' Contact: Teri Dahlman: 617-995-9905 DATASOURCE:
Idenix Pharmaceuticals, Inc. CONTACT: Teri Dahlman of Idenix
Pharmaceuticals, Inc., +1-617-995-9905 Web site:
http://www.idenix.com/
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