Schering-Plough To Initiate Phase III Studies With HCV Protease Inhibitor Boceprevir in Previously Untreated Hepatitis C Patients and Those Who Failed Prior...( KENILWORTH N.J. May 21 /- Scherin...),Health

KENILWORTH, N.J., May 21 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP), a leader in hepatitis research, today announced that it is initiating two large Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, in patients chronically infected with hepatitis C virus (HCV) genotype 1. One study will be in previously untreated (naive) patients and the other in patients who failed prior treatment (relapsers and nonresponders), an area of great unmet medical need. The two randomized, double-blind, placebo-controlled studies will evaluate the efficacy of boceprevir in combination with PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) compared to standard of care with PEGINTRON and REBETOL alone. The Company said the two pivotal studies will run concurrently and are projected to enroll a total of more than 1,400 patients at U.S. and international sites.

"We are excited to advance to Phase III clinical studies with boceprevir in combination with PEGINTRON and REBETOL," said Fred Poordad, M.D., chief of hepatology in the division of gastroenterology at Cedars-Sinai Medical Center, associate professor of medicine at the David Geffen School of Medicine, University of California, Los Angeles (UCLA), and co-principal investigator of the Phase III study in naive patients. "These studies are designed to demonstrate that this combination therapy has the potential to benefit a broad range of patients by significantly increasing sustained response rates with a potentially shorter course of treatment."

In both Phase III clinical studies, patients will receive 4 weeks of treatment with PEGINTRON and REBETOL prior to the addition of boceprevir. The rationale for this novel tr
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