Idenix Pharmaceuticals, Inc. Release: Valopicitabine (NM283) Combined With Pegylated Interferon Demonstrated Significantly Greater Suppression Of Hepatitis C Virus (HCV) Replication In Treatment-Refractory Patients Compared To Retreatment With Ribavirin P
SAN FRANCISCO, Nov. 11 /PRNewswire-FirstCall/ -- Valopicitabine combined with pegylated interferon demonstrated significantly greater viral suppression after 12 weeks of treatment compared to retreatment with ribavirin plus pegylated interferon in chronic hepatitis C, genotype 1 patients who were non- responders to previous therapy. Dr. Christopher O'Brien, Professor of Clinical Medicine at the University of Miami and a principal investigator in an ongoing phase IIb clinical trial of valopicitabine, will present 12-week data from this phase IIb clinical trial on Monday, November 14, 2005 at 9:00 a.m. (PST) at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) held in San Francisco. Valopicitabine, a novel polymerase inhibitor, is being developed by Idenix Pharmaceuticals, Inc. , a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases.
"At 12 weeks, the combination of valopicitabine plus Pegasys(R) produced a statistically significant improvement in suppression of hepatitis C virus (HCV) replication and a significantly higher proportion of patients achieving an early virologic response (EVR) compared to patients retreated with Pegasys(R) and ribavirin," said Dr. O'Brien. "These are promising results, particularly for the many treatment-refractory patients in urgent need of new therapeutic options," he said.
The phase IIb clinical trial in treatment-refractory patients is designed to evaluate different dosing regimens of valopicitabine in combination with pegylated interferon and to compare this combination with the combination therapy of pegylated interferon plus ribavirin. At 12 weeks of treatment, the two higher-dose arms of valopicitabine plus Pegasys(R) showed significantly greater suppression of serum HCV RNA compared to the ribavirin plus Pegasys(R) retreatment arm (p = 0.01). At week 12, mean HCV RNA reductions in the two high-dose arms of valopicitabine plus Pegasys(R) were 2.5 log10 and 2.8 log10, with 63 percent and 71 percent of patients achieving an EVR. In comparison, patients in the Pegasys(R) plus ribavirin retreatment control arm showed a mean HCV RNA reduction of 1.9 log10, with 41 percent of patients achieving an EVR. EVR is defined as a greater than 2 log10 reduction in viral load from baseline.
"These encouraging data support continued evaluation of combination treatment with valopicitabine and pegylated interferon in both treatment- refractory and treatment-naive hepatitis C patients," commented Nathaniel Brown, M.D., executive vice president of clinical development and chief medical officer of Idenix. "We look forward to initiating our phase III program for valopicitabine in treatment-refractory patients in early 2006."
In the phase IIb clinical trial, valopicitabine has demonstrated satisfactory safety and tolerance overall. A low percentage of patients on valopicitabine have discontinued due to adverse events. Two serious adverse events were considered attributable to combination treatment with valopicitabine plus pegylated interferon (anemia and dehydration) and both resolved. To date, there has been no predominant treatment-limiting adverse event or laboratory abnormality observed for combination treatment with valopicitabine and pegylated interferon.
Idenix's Hepatitis C Clinical Development Program
At the end of November, Idenix anticipates reviewing with the FDA the available data from the valopicitabine clinical development program, including data from this phase IIb clinical trial during an end-of-phase II meeting. This meeting will help the company define the optimal protocol for the phase III program for valopicitabine in treatment-refractory patients. Idenix currently anticipates initiating a multinational phase III program in treatment-refractory patients in the first quarter of 2006. A 48-week phase IIb clinical trial evaluating valopicitabine in treatment-naive patients is currently ongoing and enrollment is expected to be completed by year end 2005.
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 the 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. The Centers for Disease Control and Prevention estimates that 4 million Americans have been infected with HCV, and 2.7 million of these persons have chronic HCV infections. 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 "promising," "encouraging," "look forward to," "anticipate" or similar expressions or by express or implied discussions regarding potential therapeutic benefits and successful development of valopicitabine, or 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 approved for sale in any market, or that it will reach any particular level of revenue. 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, 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; 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 office: 617-995-9905 or cell: 617-817-8655 Amy Techtmann office: 617-995-9004 or cell: 267-240-8389 (please call cell numbers from 11/11/05 - 11/15/05)
Idenix Pharmaceuticals, Inc.CONTACT: Teri Dahlman, +1-617-995-9905 or +1-617-817-8655, or AmyTechtmann +1-617-995-9004 or +1-267-240-8389, both of IdenixPharmaceuticals, Inc.
Web site: http://www.idenix.com//