Idenix Announces Data Presentations at the 2005 56th Annual Meeting of the American Association for the Study of Liver Diseases
October 03 2005 - 1:03PM
PR Newswire (US)
-Idenix to Webcast Conference Call Regarding the Accepted Abstracts
at 2:00 p.m. ET on October 3, 2005- CAMBRIDGE, Mass., Oct. 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 and other
infectious diseases, announced today that five abstracts have been
accepted for presentation at the 56th annual meeting of the
American Association for the Study of Liver Diseases (AASLD), to be
held in San Francisco, CA, from November 11-15, 2005. Full
abstracts can now be viewed on the AASLD website at
http://www.aasld.org/. Hepatitis B treatment abstracts: Dr.
Ching-Lung Lai, Professor of Medicine and Hepatology, Department of
Medicine, University of Hong Kong will present, "Telbivudine (LdT)
vs. Lamivudine for Chronic Hepatitis B: First-Year Results from the
International Phase III GLOBE Trial" in the late-breaker session on
Monday, November 14 at 3:00 p.m. Pacific Standard Time (PST). Dr.
Lai, a principal investigator in the trial, will present first-year
efficacy and safety results from the ongoing two-year phase III
GLOBE trial of the investigational agent telbivudine in
HBeAg-positive and HBeAg-negative chronic hepatitis B patients.
After 1 year of treatment, telbivudine, compared with lamivudine,
demonstrated statistically significantly greater efficacy on all
virologic endpoints in both HBeAg-positive and HBeAg-negative
patients. Telbivudine met superiority criteria for the primary
clinical efficacy endpoint of Therapeutic Response in
HBeAg-positive patients and met non-inferiority criteria on the
Therapeutic Response endpoint in HBeAg-negative patients. Both
treatments were well tolerated, however telbivudine showed
significantly less resistance and fewer ALT flares as compared to
lamivudine. Transient creatine kinase (CK) elevations, not
requiring treatment modification, were more common with telbivudine
compared to lamivudine. In the GLOBE trial, the most frequently
reported adverse events, regardless of attributability to study
treatment, were upper respiratory infection and fatigue, which were
equally common for telbivudine and lamivudine. Additionally, Dr.
Lai will present, "Maximal Early HBV Suppression is Predictive of
Optimal Virologic and Clinical Efficacy in Nucleoside-Treated
Hepatitis B Patients: Scientific Observations from A Large
Multinational Trial" in a Presidential Plenary session on Monday,
November 14 at 8:15 a.m. (PST). Dr. Lai will present an analysis of
the results from the 1,367 patients from the ongoing phase III
GLOBE trial of telbivudine that evaluates the potential link
between rapid and profound viral suppression and subsequent
clinical benefits in patients with chronic hepatitis B. This
analysis suggests that after 1 year of treatment with anti-HBV
nucleosides, the highest rates of clinical efficacy outcomes are
associated with maximal reduction of HBV DNA levels early in the
course of therapy (at six months). Idenix is developing its
hepatitis B clinical drug candidates in collaboration with Novartis
Pharma AG under a license granted by Idenix and a development and
commercialization arrangement established in May 2003. Idenix and
Novartis are currently evaluating telbivudine in the largest
hepatitis B registration trial to date (the GLOBE study). Idenix
and Novartis anticipate using one-year data from the GLOBE study as
the basis for regulatory filings expected to be submitted beginning
in late 2005. Hepatitis C treatment abstracts: Dr. Christopher
O'Brien, Clinical Associate Professor of Medicine at the University
of Miami, will present "Randomized Trial of Valopicitabine (NM283),
Alone or with Peg-interferon, vs. Retreatment with Peg-interferon
Plus Ribavirin (PegIFN/RBV) in Hepatitis C Patients with Previous
Non-response to PegIFN/RBV: First Interim Results" in a
Presidential Plenary session on Monday, November 14 at 9:00 a.m.
(PST). Dr. O'Brien, a principal investigator in the trial, will
present 12-week interim findings from this phase IIb clinical
trial, which is evaluating the therapeutic potential of
valopicitabine (NM283), a novel investigational treatment for
chronic hepatitis C, in patients who previously failed treatment
with pegylated interferon plus ribavirin. Both 4-week and 12-week
data demonstrate that valopicitabine combined with Pegasys(R)
produces statistically significantly greater suppression of HCV
replication, resulting in a statistically significantly greater
proportion of patients achieving early viral response, defined as
greater than or equal to a 2 log reduction from baseline, as
compared to retreatment with Pegasys(R) and ribavirin. In this
trial, valopicitabine has demonstrated satisfactory safety and
tolerance overall, to date. A low percentage of patients have
discontinued due to adverse events (approx. 6% by week 12). Two
discontinuations due to serious adverse events were considered
attributable to study treatment (anemia and dehydration) and both
resolved. To date, there is no predominant treatment-limiting
adverse event or laboratory abnormality. Two posters will be
presented during the hepatitis C session on Monday, November 14
from 1:45-3:00 p.m. PST: * Dr. Vadim Bichko, Idenix's Associate
Director, Research, will present "Characterization of NM283
(valopicitabine) Resistance Profile Using Bovine Viral Diarrhea
Virus." The study evaluated the potential for the development of
resistance to valopicitabine in an in vitro infection model that
uses bovine viral diarrhea virus (BVDV), a pestivirus related to
the hepatitis C virus. In this study, an NM283-related resistant
mutation in BVDV was identified. However BVDV containing this
mutation demonstrated a reduced capacity to replicate and increased
sensitivity to inhibition by interferon alpha. * Dr. Xiao-Jian
Zhou, Idenix's Associate Director, Clinical Pharmacology, will
present "Absence of Effect of Pegylated Interferon alfa-2b on the
Pharmacokinetics of Valopicitabine (NM283) in Patients with Chronic
Hepatitis C." Dr Zhou will present pharmacokinetic findings from an
ongoing phase IIb trial of valopicitabine in patients with chronic
hepatitis C. The results of this analysis suggest that the
pharmacokinetics of valopicitabine and pegylated interferon a-2b
are not altered when these two agents are administered in
combination. Conference Call Information Idenix will hold a
conference call at 2:00 p.m. ET. Company management will review
one-year data from the ongoing phase III GLOBE trial of telbivudine
as well as preliminary 12-week data from the phase IIb trial of
valopicitabine in patients who have previously failed treatment
with pegylated interferon plus ribavirin. Please log in
approximately 10 minutes before the call to ensure a timely
connection. An archived webcast will be available on the Idenix
website for two weeks after the call. A replay of the call will
also be available from 8:00 p.m. ET on October 3, 2005 until 8:00
p.m. ET on October 17, 2005. To access the replay, please dial
(800) 642-1687 or (706) 645-9291 (international), and provide the
access code 1132843. 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 "anticipate" or similar
expressions or by express or implied discussions regarding
potential therapeutic benefits and successful development of
telbivudine and valopicitabine and the anticipated regulatory
filings required for the registration of telbivudine. 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. These risks and
uncertainties relate to the results of clinical trials and other
studies with respect to telbivudine, valopicitabine and the other
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 telbivudine and valopicitabine. 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 June 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. Idenix
Pharmaceuticals' Contact: Amy Sullivan 617-995-9838 DATASOURCE:
Idenix Pharmaceuticals, Inc. CONTACT: Amy Sullivan of Idenix
Pharmaceuticals, +1-617-995-9838 Web site: http://www.idenix.com/
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