Chimerix Inc. announced positive results from a Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV) disease in hematopoietic stem cell transplant (HCT) recipients.

In CMX001 Study 201, a double-blind, placebo-controlled trial that enrolled 230 HCT recipients, CMX001 had a statistically significant benefit versus placebo in preventing CMV viremia and/or CMV disease 13 weeks post-transplant.

Results from subjects receiving 100 mg twice weekly of CMX001 met the primary endpoint, a statistically significant reduction in CMV viremia or disease at the end of treatment in CMX001-treated subjects versus those who received placebo. The study showed that three different doses of CMX001 demonstrated statistically significant reductions in the proportion of subjects with CMV viremia at any time during treatment when compared to placebo. In subjects who were CMV viremia negative prior to treatment, four different CMX001 dose regimens demonstrated statistically significant reduction versus placebo.

There was no difference versus placebo across CMX001 treatment groups in measurements of renal function and hematologic parameters. Diarrhea was the most common adverse event seen in the CMX001 treatment groups and was dose-limiting at the highest dose of CMX001 (200 mg twice weekly).

The trial was a randomized, double-blind, placebo-controlled, dose-escalation, multi-center trial evaluating the safety, tolerability, and ability of CMX001 to prevent or control CMV disease in 230 evaluable CMV seropositive allogeneic stem cell transplant recipients. Following engraftment, subjects were stratified based on the presence or absence of acute GVHD requiring systemic therapy and the presence or absence of CMV DNA in plasma and randomized into five sequential, dose-escalating cohorts. Subjects were treated once or twice weekly for 9 to 11 weeks through post-transplant, after which subjects were followed for an additional 4 to 8 weeks. Placebo patient results were pooled for endpoint analysis.

Release Date: Jan. 25, 2012
Source: Chimerix Inc.