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Final Results of PEGINTRON(R) Combination Therapy Studies Also Presented
KENILWORTH, New Jersey, November 7/PRNewswire/ -- Important new data on Schering-Plough's investigational oral protease inhibitor in development for treating hepatitis C virus (HCV) infection will be presented for the first time at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) at the Moscone West Convention Center, San Francisco, Calif., November 11-15, 2005.
Study investigators will report Phase I clinical study results with protease inhibitor SCH 503034 capsules, both as monotherapy and in combination therapy with PEGINTRON(R) (peginterferon alfa-2b), in patients with chronic hepatitis C genotype 1 who were nonresponders to previous therapy, including previous peginterferon combination therapy. Currently, there are no products approved for treating patients who failed previous therapies, representing an area of great unmet medical need.
Investigators also will present final results of major clinical studies with PEGINTRON and REBETOL(R) (ribavirin, USP) combination therapy in patients with HCV, as well as results of large-scale prospective and retrospective analyses of "real-world" treatment data with PEGINTRON combination therapy. Pharmacoeconomic analyses of the cost-effectiveness of PEGINTRON combination therapy also will be presented.
In total, 67 abstracts involving Schering-Plough hepatitis therapies will be presented at AASLD, including eight oral presentations.
Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including 5 million in Europe. It is a leading cause of chronic liver disease and one of the most common reasons for liver transplant in Europe.
HCV Protease Inhibitor (SCH 503034)
Oral Presentations
Anti-Viral Activity of SCH 503034, a HCV Protease Inhibitor, Administered as Monotherapy in Hepatitis C Genotype-1 (HCV-1) Patients Refractory to Pegylated Interferon (Peg-IFN-a), Zeuzem S. et al. Presidential Plenary I, Moscone West General Session Room, Monday, Nov. 14, 8:45-9:00 am.
Combination Therapy with the HCV Protease Inhibitor, SCH 503034, plus PEGINTRON in Hepatitis C Genotype-1 PEGINTRON Nonresponders: Phase Ib Results, Zeuzem S. et al. Parallel Session 29, Moscone West Rooms 3016/3018/3020, Tuesday, Nov. 15, 11:45-12:00 pm.
Poster Presentations
Single Dose Pharmacokinetics of a Novel Hepatitis C Protease Inhibitor, SCH 503034, in an Oral Capsule Formulation, Zhang J. et al. Moscone West Exhibit Hall, Monday, Nov. 14, 8:00 am-6:30 pm.
SCH 503034, a Mechanism-Based Inhibitor of Hepatitis C virus (HCV) NS3 Protease Suppresses Polyprotein Maturation and Enhances the Antiviral Activity of Interferon alfa-2b (INF), Malcolm B.A. et al. Moscone West Exhibit Hall, Monday, Nov. 14, 8:00 am-6:30 pm.
Modeling of Hepatitis C Viral Dynamics During Combination Therapy with Peginterferon alfa-2b (PEGINTRON) and the NS3 Protease Inhibitor SCH 503034, Malcolm B.A. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am-12:30 pm.
PEGINTRON and REBETOL Combination Therapy
Oral Presentations
Weight-Based Ribavirin Dosing (WBD) Increases Sustained Viral Response (SVR) in Patients with Chronic Hepatitis C (CHC): Final Results of the WIN-R Study, a US Community Based Trial, Jacobson I. et al. Parallel Session 33, Moscone West General Session Room, Monday, Nov. 14, 3:00-4:45 pm.
Double-Dose Peginterferon Alfa-2b with Weight-Based Ribavirin Improves Response for Interferon/Ribavirin Nonresponders with Hepatitis C: Final Results of "RENEW", Gross J. et al. Parallel Session 08, Moscone West General Session Room, Sunday, Nov. 13, 6:00-6:15 pm.
Poster Presentations
PEG-INF alfa-2b (1.5 mcg/kg/wk) + ribavirin (800-1400 mg daily) is Significantly More Effective than PEG-INF alfa-2b (1.0 mcg/kg/wk) + ribavirin (800-1400 mg daily) in men with G1 and women with G2/3: Final Results of a Prospective, Randomized, Controlled Trial, Flamm S.L. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am-12:30 pm.
Efficacy of PEG-IFN Alfa-2b vs. PEG-IFN Alfa-2a + Ribavirin Regimens in Treatment-Naïve Chronic HCV Patients: A Cumulative Meta-Analysis of Retrospective Data from 6 Clinic Sites, Almasio P. and the HCV Meta-Analysis Working Group. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am-12:30 pm.
PEGINTRON Prospective Optimal Weight-Based Dosing Response Program (POWER): Preliminary Results, Abadir N. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am-12:30 pm.
A Pharmacoeconomic Analysis of the Registration Trials: Peginterferon Alfa-2a plus Ribavirin versus Peginterferon Alfa-2b plus Ribavirin for Treatment of Genotype 1 Chronic Hepatitis C, Kamal A. et al. Moscone West Exhibit Hall, Saturday, Nov. 12, 2:00-8:00 pm.
Cost-Effectiveness of Peginterferon Alfa-2b plus Ribavirin for Chronic Hepatitis C in HIV/HCV Co-Infected Patients, Wong, J.B. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am-12:30 pm.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company's Web site is www.schering-plough.com.
Web site: http://www.schering-plough.com
Source: Schering-Plough
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