ViroPharma has completed enrollment in a Phase II clinical study for maribavir, an oral antiviral drug that inhibits cytomegalovirus (CMV), in allogeneic bone marrow (stem cell) transplant patients.
The trial is a randomized, double-blind, placebo-controlled, dose-ranging study at 13 transplant centers across the U.S. involving CMV-seropositive subjects who have undergone allogeneic stem cell transplantation. At least 36 subjects have been randomized into three ascending-dose groups, with a total of 108 patients. The primary objective of this study is to evaluate the safety and tolerability of maribavir administered orally for up to 12 weeks. The secondary objectives are to evaluate the prophylactic activity of maribavir in preventing CMV reactivation in CMV seropositive recipients of allogeneic stem cell transplants, to evaluate the pharmacokinetics of maribavir in this subject population, and to select a dose or doses of maribavir to be used in the Phase III program.