Fortress Biotech, Inc. announced that the first patient was dosed in a multi-center, placebo-controlled, randomized Phase 2 study of Triplex, a vaccine for control of cytomegalovirus (?CMV?), in patients undergoing liver transplantation. The trial is funded by a grant from the National Institutes of Health?s National Institute of Allergy and Infectious Diseases (?NIH/NIAID?) to University of Washington Seattle. This grant has provided $9.0 million to date with an estimated additional $12 million over the next four years in support of the Phase 2 clinical trial.

The trial will be conducted in up to 20 nationally recognized transplant centers in the United States. Triplex was initially developed by City of Hope, a world-renowned cancer treatment and research organization, and exclusively licensed to Helocyte. COLT is a multi-center, randomized, placebo-controlled, double-blinded clinical trial in up to 416 CMV seronegative prospective liver transplant recipients to determine the safety and efficacy of two doses of Triplex, a Modified Vaccinia Ankara-vectored CMV vaccine, administered to participants anticipated to receive transplant within one to twelve months after study enrollment.

The primary objective of the trial is to assess the effect of pre-transplant Triplex vaccination on the duration of CMV antiviral therapy within the first 100 days post-transplant in CMV seronegative liver transplant recipients whose liver donor is CMV seropositive. Secondary endpoints relate to the development of CMV disease by six months post-transplant as well as time to onset.