Fortress Biotech Announces First Patient Dosed in Multi-Center Phase 2 Study of Triplex for Control of CMV in Patients Undergoing Liver Transplantation

Helocyte, a majority-owned subsidiary of Fortress Biotech, is developing Triplex for the prevention and treatment of cytomegalovirus in multiple transplant indications, as well as HIV

Clinical trial funded by a NIAID grant to a multi-center university consortium

Study is evaluating whether Triplex is safe and effective in improving the outcomes of liver transplant recipients

MIAMI, May 14, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, and its majority-owned subsidiary, Helocyte, Inc. (“Helocyte”), today 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.

Ajit Limaye, M.D., Professor of Medicine and Director of the Solid Organ Transplant Infectious Disease Program at the University of Washington and Principal Investigator of the “CMV vaccine in Orthotopic Liver Transplant” (“COLT”, see NCT06075745) trial, said, “The first dosing in this multi-center Phase 2 clinical trial is a major milestone and the culmination of years of effort to advance Triplex. There remains a significant unmet medical need to develop new therapies that can reduce the frequency and severity of CMV events in the organ transplant setting, where CMV continues to present life-threatening complications that directly impact patient outcomes and survival.”