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ViroPharma Announces Completion of Enrollment in Phase 3 Study of Maribavir in Stem Cell Transplant Patients
Date:5/29/2008

e-blind, placebo-controlled, multicenter pivotal Phase 3 study in 681 patients who have undergone allogeneic stem cell transplantation. Following transplantation and transplant engraftment, eligible patients have been randomized to receive maribavir or matching placebo in a 2:1 randomization ratio. All patients will receive maribavir 100 mg BID or placebo for a maximum duration of 12 weeks, and will then be followed for an additional 12 weeks to reach the 6-month post-transplant analyses for regulatory filing purposes. All patients will then be followed for an additional 24 weeks.

Enrolled subjects will undergo testing for CMV infection at least weekly. CMV surveillance includes weekly testing at a central laboratory for the presence of CMV pp65 antigenemia and for the presence of CMV DNA in plasma using a polymerase chain reaction (PCR). If CMV infection is detected during the study drug administration period (or if CMV organ disease is diagnosed), study drug will be discontinued and the subject will be managed according to standard CMV treatment practices at the transplant center.

The primary efficacy endpoint will be the incidence of CMV disease within six months post-transplant, which is predicted to be approximately nine percent in the placebo (current standard of care) arm based on data from the Phase 2 study, data from published literature, and information from transplant center databases. Following extensive dialogue with FDA, a number of key secondary endpoints associated with CMV infection have been identified and assessment of these endpoints will be essential in assessing the clinical benefit of maribavir. These key secondary endpoints include incidence of initiation of preemptive anti-CMV therapy, incidence of graft-versus-host disease, mortality and CMV disease-free survival.

About maribavir

Maribavir is a potent and selective, orally bioavailable Phase 3 antiviral drug with a unique mechanism of action against cytomegalovir
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SOURCE ViroPharma Incorporated
Copyright©2008 PR Newswire.
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