Idenix Pharmaceuticals Initiates Phase II Clinical Trial of IDX184 in Combination With Pegylated Interferon and Ribavirin for th
November 03 2009 - 7:00AM
PR Newswire (US)
CAMBRIDGE, Mass., Nov. 3 /PRNewswire-FirstCall/ -- Idenix
Pharmaceuticals, Inc. (NASDAQ:IDIX), a biopharmaceutical company
engaged in the discovery and development of drugs for the treatment
of human viral diseases, announced today that it has initiated a
Phase II clinical trial evaluating IDX184, a liver-targeted
nucleotide prodrug candidate for the treatment of HCV, in
combination with pegylated interferon and ribavirin, in
treatment-naive hepatitis C genotype 1-infected patients. Antiviral
activity, safety and tolerability of the triple combination will be
assessed at 14 days. Patients will continue on treatment with
pegylated interferon and ribavirin for 14 days and Rapid Viral
Response (RVR), the proportion of patients with undetectable virus
at week 4, will be determined at Day 28. "IDX184 was well tolerated
and exhibited favorable antiviral activity in the initial 3-day,
proof-of-concept study," said Douglas Mayers, M.D., chief medical
officer of Idenix. "We look forward to evaluating IDX184 over a
longer treatment period and as a component of combination therapy.
This trial will also help us determine the optimal doses for
broader clinical development." The clinical trial is a Phase II,
randomized, double-blind, placebo-controlled, sequential
dose-escalation study evaluating the safety, tolerability,
pharmacokinetics and antiviral activity of IDX184 in combination
with pegylated interferon and ribavirin in treatment-naïve HCV
genotype 1-infected patients. Patients will receive a daily dose of
IDX184 or placebo plus pegylated interferon and ribavirin for 14
days and then continue on pegylated interferon and ribavirin for an
additional 14 days. Antiviral activity will be assessed at the
14-day and 28-day timepoints. All patients in the study will have
the option to continue pegylated interferon and ribavirin for up to
48 weeks. Four doses of IDX184 ranging from 50 to 200 mg per day
will be evaluated. Each cohort of the study will evaluate twenty
patients randomized 16 to IDX184 and 4 to placebo. This study is
being conducted at multiple centers in the United States and
Argentina. About IDX184 IDX184 is a novel, liver-targeted
nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's
proprietary liver-targeting technology. This technology enables the
delivery of nucleoside monophosphate to the liver, leading to the
formation of high levels of nucleoside triphosphate, thus
potentially maximizing drug efficacy and limiting systemic side
effects. About Idenix Idenix Pharmaceuticals, Inc., headquartered
in Cambridge, Massachusetts, is a biopharmaceutical company engaged
in the discovery and development of drugs for the treatment of
human viral diseases. Idenix's current focus is on the treatment of
infections caused by the hepatitis C virus. 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 "expect," "plans," "anticipates," "will,"
"expects," "goal" or similar expressions, or by express or implied
statements with respect to the company's clinical development
programs or commercialization activities in hepatitis C, or any
potential pipeline candidates, including any expressed or implied
statements regarding the efficacy and safety of IDX184, the
likelihood and success of any future clinical trials involving
IDX184 or successful development of novel combinations of
direct-acting antivirals for the treatment of hepatitis C. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or
achievements expressed or implied by such statements. There can be
no guarantees that the company will advance any clinical product
candidate or other component of its potential pipeline to the
clinic, to the regulatory process or to commercialization. In
particular, management's expectations could be affected by
unexpected regulatory actions or delays; uncertainties relating to,
or unsuccessful results of, clinical trials, including additional
data relating to the ongoing clinical trials evaluating its product
candidates; the company's ability to obtain additional funding
required to conduct its research, development and commercialization
activities; changes in the company's business plan or objectives;
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 its product candidates and its discoveries. These
and other risks which may impact management's expectations are
described in greater detail under the caption "Risk Factors" in the
company's annual report on Form 10-K for the year ended December
31, 2008 and the Quarterly Report on Form 10-Q for the quarter
ended September 30, 2009, as filed with the Securities and Exchange
Commission (SEC) and other filings that the company makes with the
SEC. 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.
Idenix Pharmaceuticals Contact: Teri Dahlman (617) 995-9905
DATASOURCE: Idenix Pharmaceuticals, Inc. CONTACT: CONTACT: Teri
Dahlman of Idenix Pharmaceuticals, +1-617-995-9905 Web Site:
http://www.idenix.com/
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