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ViroPharma Incorporated has announced that it completed enrollment in its pivotal phase III study of maribavir in stem cell transplant patients.
This international phase III study is evaluating the efficacy, safety and tolerability of prophylactic use of maribavir administered orally for up to 12 weeks for the prevention of cytomegalovirus (CMV) disease in recipients of allogeneic stem cell transplants (SCT).
The study also will evaluate the pharmacokinetics of maribavir in this subject population. It is being conducted in 90 transplant centres in the US, Canada, and Europe.
“Maribavir may mark the first new advancement in CMV therapeutics for transplant recipients in many years,” stated Stephen Villano, MD, vice president, clinical research and development at ViroPharma.
“CMV can cause significant and potentially deadly clinical manifestations among transplant recipients, and maribavir represents the opportunity for a shift in CMV treatment paradigm toward prophylaxis against CMV, thus preventing CMV viral infection and disease and allowing for enhanced focus on other aspects of patient outcome following transplantation.”
“These are significant milestones for the development of this important drug, and we are excited by the global interest and support for maribavir among transplant physicians throughout the US, Europe and Canada,” commented Vincent Milano, ViroPharma’s president and chief executive officer.