Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study ...(sient in some patients. The U.S. Food an...),Health

"While substantial efforts are ongoing to continue analysis of these data, we consider it to be in the best interests of patients to discontinue dosing with HCV-796 at this time," commented Dr. Colin Broom, ViroPharma's chief scientific officer. "We and Wyeth are focused on patient safety. We are acting quickly and with the best interests of patients in mind. "

"This is a clear disappointment in light of the exciting antiviral activity observed to date in this study. Although this represents a potential setback for hepatitis C patients, we are committed to the health and safety of patients, and this decision was absolutely the right thing to do," commented Michel de Rosen, ViroPharma's president and chief executive officer. "We are committed to understanding the observations that led to this decision in the hope of advancing this potential therapeutic agent in the future."

Clinical trial investigators are being notified of the current data and the change in clinical plans. ViroPharma and Wyeth will continue to analyze the efficacy and safety data from this ongoing study in order to make a benefit risk assessment for the future development of HCV-796.

Phase 2 Preliminary Antiviral Data

All patients currently in the study have received at least 8 weeks of dosing. We have not completed a full analysis of all data, including discontinuations and withdrawals. Preliminary analysis of antiviral data has been performed on patients who have completed 4 weeks and a portion of patients who have completed 12 weeks of therapy. Not all patients who have completed 12 weeks of therapy have data available at this time.

For Patients On-therapy at Week 4:

Treatment Naive Patients Null Respo
'/>"/>

SOURCE ViroPharma Incorporated Copyright©2007 PR Newswire.

0 GOOD