Indenix Announces Data Presentations at
the 57th Annual Meeting of the American Association for the Study of Liver Diseases
(AASLD)
CAMBRIDGE, Mass., Oct. 2 -- Idenix Pharmaceuticals, Inc. (Nasdaq:
IDIX - News), a biopharmaceutical company engaged in the discovery, development
and commercialization of drugs for the treatment of human viral and other infectious
diseases, announced today that seven abstracts have been accepted for presentation
at the 57th Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD) to be held in Boston, MA, October 27 to October 31, 2006. Full
abstracts can now be viewed at the AASLD website at http://www.aasld.org.
Hepatitis
B Abstracts
Dr. Ching-Lung Lai, Professor of Medicine and Hepatology, Department of Medicine,
University of Hong Kong, will present "Two-Year Results from the GLOBE Trial
in Patients with Hepatitis B: Greater Clinical and Antiviral Efficacy for Telbivudine
(LdT) vs. Lamivudine" in a Presidential Plenary session on Monday, October,
30, 2006 at 8:00 a.m. EST.
Dr.
Adrian DiBisceglie, Associate Chairman, Department of Internal Medicine, Saint
Louis University School of Medicine, will present
Telbivudine
GLOBE Trial: Maximal Early HBV Suppression is Predictive of Optimal Two-Year Efficacy
in Nucleoside-Treated Hepatitis B Patients" in an oral session on Monday,
October 30, 2006 at 3:45 p.m. EST.
Dr.
Edward Gane, Associate Professor of Gastroenterology and Hepatology, Middlemore
Hospital in Auckland, New Zealand, will present "A Randomized Trial of Telbivudine
(LdT) vs. Lamivudine in Lamivudine Experienced Patients - Week 24 Primary Analysis"
in a poster session on Monday, October 30, 2006.
Dr.
Natalie Bzowej, Director of Clinical Hepatology Research at California Pacific
Medical Center, will present "A Randomized Trial of Telbivudine (LdT) vs.
Adefovir for HBeAg-Positive Chronic Hepatitis B: Final Week 52 Results" in
a poster session on Monday, October 30, 2006.
Dr.
Nikolai Naoumov, Consultant Physician at the Institute of Hepatology, University
College London, England, will present "Impact Of Nucleoside Treatment On
Antiviral T-Cell Reactivity In Chronic Hepatitis B: Major Differences Depending
On Early Viral Suppression, HBeAg Status And HBV Genotype" in a poster session
on Monday, October 30, 2006.
Dr.
David Standring, Idenix's Senior Vice President, Biology, will present "Telbivudine
Phosphorylation by Three Enzymes: Implications for Anti-Hepatitis B Virus Activity
In Vitro and in the Clinic" in a poster session on Monday, October, 30, 2006.
About
Telbivudine
Telbivudine, an investigational agent for the treatment
of hepatitis B, is currently under review for marketing approval by the U.S. Food
and Drug Administration. [Editor's note: the press release was issued before
the drug's approval on October 26.] Idenix has evaluated telbivudine in a
two-year international phase III clinical trial referred to as the GLOBE study.
The GLOBE study, in which 1,367 chronic hepatitis B patients were enrolled, compared
600 mg dose of telbivudine orally administered once a day to treatment once a
day with 100 mg of lamivudine. Safety Information About Telbivudine
The
diverse nature and rate of occurrence of adverse events were similar between telbivudine-treated
patients and lamivudine-treated patients. The most common adverse events for telbivudine
and lamivudine, regardless of attributability, were upper respiratory infection,
headache, fatigue, and nasopharyngitis.
Grade 3-4 serum ALT elevations
were more common in lamivudine-treated patients compared to telbivudine after
week 24. Grade 3-4 creatine kinase (CK) elevations were more common with telbivudine
compared to lamivudine by week 52.
Severe acute exacerbations of hepatitis
B have been reported in patients who have discontinued anti-hepatitis B therapy.
Hepatic function should be monitored closely with both clinical and laboratory
follow-up for at least one year in patients who discontinue anti-hepatitis B therapy.
If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Idenix/Novartis
Collaboration
Idenix is developing its hepatitis B product candidates,
telbivudine and valtoricitabine, and its hepatitis C clinical product candidate,
valopicitabine, in collaboration with Novartis Pharma AG. The collaboration arrangement
provides that, upon successful development and approval, Idenix and Novartis will
co-promote licensed products in the United States, France, Germany, Italy, Spain
and the United Kingdom. Novartis holds the exclusive license to commercialize
licensed products in the rest of the world.
10/27/06
Source Idenix
Announces Data Presentations at the 57th Annual Meeting of the American Association
for the Study of Liver Diseases (AASLD). Press Release. October 2, 2006.
Earlier
this month, Idenix Pharmaceuticals offered a preview of several studies of 
Dr. Ching-Lung Lai, Professor of Medicine and Hepatology, Department of Medicine,
University of Hong Kong, will present "Two-Year Results from the GLOBE Trial
in Patients with Hepatitis B: Greater Clinical and Antiviral Efficacy for Telbivudine
(LdT) vs. Lamivudine" in a Presidential Plenary session on Monday, October,
30, 2006 at 8:00 a.m. EST.
