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Schering-Plough Statement on Status of SCH 503034 Clinical Development Plans
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(3/7/06) Schering Plough issued this statement regarding the study of the HCV protease inhibitor SCH503034
Schering-Plough's HCV protease inhibitor SCH 503034 is currently being studied in an ongoing Phase II dose-finding study in HCV patients who were nonresponders to previous peginterferon and ribavirin combination therapy.
The company has written an amendment to the protocol to add a higher-dose (800 mg TID) cohort with up to 65 patients to this ongoing Phase II study. This cohort will include African American patients. Study investigators in the United States and Europe have been advised of the protocol amendment and can begin identifying potential patients for the amendment.
Previous studies have shown that African American patients are "hard to treat" for HCV. In designing a comprehensive clinical development program for SCH 503034, pharmacokinetic and pharmacodynamic data in African American patients are needed to assess safety before initiating larger trials. We also want to have a better understanding of dosing and thus are evaluating the potential for using higher daily doses of SCH 503034 than were used in our Phase I studies or are being used currently in our ongoing Phase II study in combination with PEG-Intron (400 mg TID).
We believe this plan is both responsible and prudent at this stage of clinical development, and will lead to the best possible study designs for evaluating SCH 503034 in the treatment of African Americans in future Phase III studies.
A similar approach is being taken to studying SCH 503034 in other hard-to-treat HCV patient populations, including cirrhotic patients, HIV/HCV coinfected patients, liver transplant patients and patients with renal or hepatic impairment.
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