Schering-Plough Corporation reaffirms its commitment to advancing the science and treatment of chronic hepatitis C virus (HCV) infection with several key data presentations at the European Association for the Study of the Liver (EASL) 42nd annual meeting in Barcelona, Spain, April 11-15. A total of 38 data presentations highlighting Schering-Plough hepatitis medications will be presented at EASL 2007.
Among these are several studies with Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin) combination therapy, a current standard of care in the treatment of chronic hepatitis C, evaluating how results at important treatment milestones can help physicians make informed treatment decisions.
Schering-Plough also is exploring novel therapeutic approaches, both through targeted internal research programs and strategic collaborations. chief among these efforts is boceprevir (SCH 503034), Schering-Plough's investigational oral HCV protease inhibitor currently in phase II clinical development for treating chronic hepatitis C. Individual in vitro studies of boceprevir in combination with investigational oral HCV polymerase inhibitors from Wyeth/ViroPharma and Idenix/Novartis have been completed and will be presented at EASL.
"Schering-Plough is proud of its long-term role in introducing innovative treatments to the field of hepatitis," said Robert J. Spiegel, chief medical officer and senior vice president, Schering-Plough Research Institute. "Our vision with Pegintron, our cornerstone HCV therapy, and ongoing work with boceprevir, our investigational oral HCV protease inhibitor, is to continue to advance the science and deliver additional treatment options for patients with hepatitis C infection."
Numerous studies with Pegintron will be presented at EASL evaluating patient response to therapy at certain treatment milestones, an approach that is aimed at individualising treatment for patients.
Schering-Plough also is exploring novel therapeutic approaches with Pegintron in combination with investigational antiviral agents to optimise treatment for patients with more difficult-to-treat forms of the disease, such as those with HCV genotype 1 and nonresponders to previous therapy.
Schering-Plough is undertaking a large, fully integrated clinical development program for its oral HCV protease inhibitor boceprevir (SCH 503034), with the goal of developing new strategies for improving treatment outcomes for patients with hepatitis C.
As part of this effort, Schering-Plough has collaborated with Wyeth/ViroPharma and Idenix/Novartis to conduct separate in vitro studies of boceprevir in combination with their respective investigational HCV polymerase inhibitors, HCV-796, a non-nucleoside polymerase inhibitor, and NM107 (the active moiety of NM283, valopicitabine), a nucleoside polymerase inhibitor. These in vitro experiments suggest that the combination of boceprevir and either one of these polymerase inhibitors achieves additive antiviral activity and a complementary resistance profile; the combination of two agents increases the barrier for developing resistance to either drug alone.
In addition, Schering-Plough has initiated the HCV Sprint-1 study (HCV Serine Protease Inhibitor Therapy-1), a large phase II study that is currently enrolling 400 HCV genotype 1, treatment-naAve patients in sites across the United States, Canada and Europe. The primary objective of the study is to evaluate the safety and efficacy of boceprevir 800 mg TID in combination with Pegintron and Rebetol in the treatment-naAve patient population.
Schering-Plough also is conducting a large phase II study evaluating the safety and efficacy of boceprevir 800 mg TID in combination with Pegintron and Rebetol in patients chronically infected with HCV genotype 1 who were nonresponders to previous peginterferon and ribavirin combination therapy.