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ViroPharma Announces Start of HCV-796 Phase 1 Program
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Press Release Source: ViroPharma Incorporated
Monday February 14, 2005
EXTON, Pa., Feb. 14, 2005 (PRIMEZONE) -- ViroPharma Incorporated (NasdaqNM:VPHM - News) today announced that dosing has begun in the Phase 1 clinical trial for HCV-796, a novel polymerase inhibitor being developed as a potential new product to treat hepatitis C. ViroPharma is conducting this Phase 1 clinical trial with its partner in the development of antiviral compounds targeting hepatitis C (HCV), Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE - News). Preclinical studies have shown that HCV-796 may be more potent than other anti-HCV compounds developed to date between the two companies.
HCV-796 represents an exciting opportunity for us, as this non-nucleoside, based on preclinical tests, is the most potent of all of the molecules targeting HCV that we have brought into clinical trials,'' commented Dr. Colin Broom, ViroPharma's chief scientific officer. ``For the first time in the history of this collaboration, we with our partners at Wyeth Pharmaceuticals have two promising anti-hepatitis C compounds in humans. With the first compound, HCV-086, we remain on track to have proof of concept antiviral data available from the ongoing Phase 1b trial later this quarter. We hope to initiate a similarly designed Phase 1b proof of concept studies with HCV-796 in HCV-positive adults during the second quarter of 2005, with data available from that trial in the fourth quarter of 2005.''
The current Phase 1a study is an ascending single dose, placebo-controlled trial designed to assess the safety and tolerability of HCV-796 in healthy adult volunteers, as well as to gather pharmacokinetic data. The study is being conducted at a leading clinical research facility in the United States. Should those data support further advancement of the product, the companies plan to initiate a Phase 1b multiple dose study in patients with chronic HCV infection to assess the antiviral activity, safety, tolerability and pharmacokinetic profile of HCV-796 during the second quarter of 2005.
About Hepatitis C
Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.
About ViroPharma Incorporated
ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(r) Pulvules(r), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at http://www.viropharma.com.
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties, including those relating to the company's anticipated schedule relating to its HCV clinical development program as well as its ability to find an effective small molecule antiviral treatment for HCV disease. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. Conducting clinical trials for investigational pharmaceutical products is subject to risks and uncertainties. There can be no assurance that ViroPharma's studies as part of the HCV program can be conducted within the timeframe that the company expects, that such studies will yield positive results, or that ViroPharma will be successful in gaining regulatory approval of any of its HCV product candidates. These factors, and other factors, including, but not limited to those described in ViroPharma's quarterly report on Form 10-Q for the quarter ended September 30, 2004 filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
Contact:
ViroPharma Incorporated
Will Roberts
Director, Corporate Communications
(610) 321-6288
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