EXTON, Pa., June 8, 2004 (PRIMEZONE) -- ViroPharma Incorporated (Nasdaq:VPHM) today announced the initiation of a proof of concept clinical study with HCV-086, a hepatitis C antiviral compound that the company is co-developing with Wyeth (NYSE:WYE). HCV-086 is an orally dosed molecule that has the potential to interfere with the replication of hepatitis C virus (HCV).
"We are excited to initiate this important study with this promising and unique molecule," said Dr. Colin Broom, ViroPharma's chief scientific officer. "With our partners at Wyeth, we have made significant progress with the HCV-086 program this year. We now have agreement from the FDA that the data from the first Phase 1 trial in healthy volunteers allow us to progress to a repeat dose study, in which we will determine the activity of the molecule in HCV-positive patients. We expect to start dosing in this trial in early July, and have proof of concept data for the molecule by the end of the fourth quarter. If positive, these data should support the initiation of Phase 2 clinical testing in 2005."
This clinical trial is a randomized, double blind, multiple ascending dose, placebo controlled study at a leading clinical research facility in the United States involving 96 patients with chronic HCV infection. In the study, patients will be given multiple ascending oral doses of HCV-086 once or twice daily for fourteen days. The study will assess the antiviral activity, safety, and pharmacokinetic profile of the drug compared to placebo. In February of 2004, ViroPharma and Wyeth initiated the first Phase 1 trial with HCV-086, a single dose, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of the compound administered orally to healthy volunteers. Preliminary data from this single dose trial suggest that HCV-086 is well tolerated, with a favorable pharmacokinetic profile.
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.
ViroPharma and Wyeth are engaged in a collaboration to develop and commercialize antiviral compounds to treat hepatitis C. In addition to HCV-086, the companies are continuing to advance an additional, next-generation HCV antiviral compound through preclinical testing.
ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma is currently focused on drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV).
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties, including those relating to:
-- ViroPharma's belief that HCV-086 has the potential to interfere
with the replication of hepatitis C virus (HCV); and
-- ViroPharma's plans to begin dosing in early July and expectation
of receiving proof of concept, antiviral data from its current
Phase 1 HCV studies in the fourth quarter of 2004; and
-- ViroPharma's plans to initiate Phase 2 testing in 2005
Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. There can be no assurance that that any of the forward-looking statements identified in this press release will occur. Conducting clinical trials for investigational pharmaceutical products are subject to risks and uncertainties. There can be no assurance that planned clinical trials can be initiated, that planned or ongoing clinical trials can be successfully concluded or concluded in accordance with ViroPharma's anticipated schedule, or that HCV-086 will achieve proof of concept. These factors, and other factors, including, but not limited to those described in ViroPharma's most recent annual report on Form 10-K and registration statements on Forms S-3 and S-4 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.