ViroPharma phase 2 study shows maribavir has prophylactic properties in cytomegalovirus

By Lisa Kerner

Erie, Pa., March 29 - ViroPharma Inc. announced positive preliminary results from a phase 2 study of maribavir, an oral antiviral drug candidate being developed to inhibit cytomegalovirus reactivation in transplant patients.

Cytomegalovirus, a member of the herpes virus group, has the ability to remain dormant in the body for long periods of time, according to a company news release.

The data from this study demonstrate that prophylaxis with maribavir displays strong antiviral activity, as measured by reduction in the rate of reactivation of cytomegalovirus in recipients of allogeneic stem cell (bone marrow) transplants.

Additionally, the administration of maribavir for up to 12 weeks has a favorable tolerability profile.

The maribavir phase 2 clinical trial was a randomized, double blind, placebo-controlled, dose-ranging study at 13 U.S. transplant centers, the company said.

A total of 111 cytomegalovirus seropositive subjects that had undergone bone marrow transplant were randomized to receive maribavir or placebo in each of three ascending dose groups (100 mg BID, 400 mg QD, 400 mg BID).

ViroPharma said the study objectives included an evaluation of the safety and tolerability of maribavir administered orally and the prophylactic activity of maribavir in preventing cytomegalovirus reactivation.

"With these new data now in hand, we can move forward toward pivotal phase 3 studies," said chief scientific officer Colin Broom in a news release.

"Our plan is to meet with the Food and Drug Administration as soon as possible to discuss the data and reach agreement on the phase 3 program. Our goal is to initiate a pivotal phase 3 study in allogeneic stem cell transplant patients mid-year and a subsequent phase 3 study in solid organ transplant patients by year end."

ViroPharma is a biopharmaceutical company currently focusing its drug development activities in viral diseases including cytomegalovirus and hepatitis C. The company is located in Exton, Pa.

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