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news.ViroPharma, a biopharmaceutical company, has announced that its Phase III trial evaluating maribavir used as prophylaxis in allogeneic stem cell, or bone marrow, transplant patients did not achieve its primary endpoint.
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In the primary analysis, there was no statistically significant difference between maribavir and placebo in reducing the rate of cytomegalovirus (CMV) disease. In addition, the study failed to meet its key secondary endpoints. Maribavir was generally well tolerated in this clinical study, the company said.
The primary endpoint of this Phase III study was the incidence of CMV disease, confirmed by an independent endpoint committee, within six months post-transplant. The incidence of CMV disease within six months was 4.4% for maribavir compared to 4.8% for placebo (P=0.79).
The first of four key secondary endpoints was the rate of initiation of anti-CMV treatment within six months, which was 37.9% for maribavir compared to 40.5% for placebo (P=0.49). In addition, the incidence of graft-versus-host disease, mortality and CMV disease-free survival was comparable between the groups.
Vincent Milano, president and CEO of ViroPharma, said: We are extremely disappointed by the outcome of this pivotal study. We just received these data and there are far more questions than answers; we still have a significant amount of work to do to fully understand this outcome and its impact on the overall program.