ViroPharma completes enrollment for phase 2 maribavir study in bone marrow transplant patients

New York, Nov. 28 - ViroPharma Inc. said it has completed enrollment of patients for its phase 2 clinical study of maribavir, an oral antiviral drug that inhibits cytomegalovirus in allogeneic bone marrow (stem cell) transplant patients.

The Exton, Pa., biopharmaceutical company said it expects to have preliminary data from phase 2 by the end of the first quarter of 2006. If the results are positive then ViroPharma expects to start phase 3 trials in the middle of next year.

"CMV [cytomegalovirus] infection and associated disease is a significant cause of morbidity and mortality for patients undergoing hematopoietic stem cell and solid organ transplant," said Colin Broom, ViroPharma's chief scientific officer, in a news release.

"Due to potential toxicities associated with current treatments, anti-CMV therapy is often initiated only when there is clear evidence of CMV infection; however, it would be preferable to administer anti-CMV therapy as prophylaxis to prevent CMV infection altogether. Our hope is that maribavir may offer transplant patients an effective option to prevent CMV infection with an improved safety profile compared to currently available therapies."

The phase 2 trial is a randomized, double blind, placebo-controlled, dose-ranging study at 13 transplant centers in the United States. Patients are cytomegalovirus-seropositive subjects who have undergone allogeneic stem cell transplantation. At least 36 subjects have been randomized 3:1 (ratio of maribavir to placebo) into each of three ascending dose groups for a total of at least 108 patients.

The primary objective of the 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 cytomegalovirus reactivation in cytomegalovirus 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 3 program.

Maribavir is a member of a new class of drugs called benzimidazole ribosides, ViroPharma said. Unlike currently available anti- cytomegalovirus agents that inhibit cytomegalovirus DNA polymerase, maribavir inhibits viral DNA assembly and inhibits egress of viral capsids from the nucleus of infected cells.

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