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HCV Drug NM283 Trial Fully Enrolled
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Idenix sent out this press release today.
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, MA, May 31, 2005 - 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 to ribavirin plus Pegasys, 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 naïve 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 is a registered trademark of Hoffmann-La Roche.
Contact:
Idenix Pharmaceuticals, Inc.
Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838
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