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Fortress Biotech Announces First Patient Dosed in Phase 2 Clinical Trial of Triplex Vaccination in Stem Cell Donors to Reduce CMV Events in Recipients of HSCT
Study is the first randomized, controlled trial examining a vaccine’s effectiveness in controlling CMV in recipients of HSCT from vaccinated donors
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"Study is the first randomized, controlled trial examining a vaccine’s effectiveness in controlling CMV in recipients of HSCT from vaccinated donors Encouraging pilot study results demonstrated the benefit of vaccinating donors with Triplex to convey protective CMV-specific T cell immunity to allogeneic HSCT recipients at risk for CMV reactivation MIAMI, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), and its majority-owned subsidiary, Helocyte, Inc. (“Helocyte”), today announced that the first patient was dosed in a multicenter, placebo-controlled and randomized Phase 2 clinical trial to evaluate Triplex, a cytomegalovirus (“CMV”) vaccine, when administered to human leukocyte antigen (“HLA”) matched related stem cell donors to reduce CMV events in patients undergoing hematopoietic stem cell transplantation (“HSCT”). The Phase 2 clinical trial is funded by a grant from the National Cancer Institute (“NCI”). Triplex is anticipated to induce a CMV-specific immune response in the donor’s body who then conveys that virus-specific immunity to the intended recipient of the stem cell transplant through the concept of adoptive immunity. Vaccination of donors with Triplex prior to stem cell harvest and transplant is believed to introduce virus-specific immunity sooner, and in turn, reduce CMV events in patients undergoing stem cell transplantation. The objective of the trial is to determine whether Triplex is safe and effective in reducing CMV events in recipients of HSCT from vaccinated donors. CMV reactivation is one of the most common and life-threatening complications following allogeneic HSCT. The virus reactivates in an estimated 60-70% of CMV-seropositive recipients of HSCT with primary CMV infection occurring in 20-30% of CMV-seronegative recipients of HSCT from CMV-seropositive donors. “CMV frequently affects patients undergoing transplants, posing significant risks to their recovery and survival. In this Phase 2 clinical trial, we are testing a new treatment approach, offering promise for better CMV management in HSCT recipients. This approach transfers CMV immunity from donors to transplant recipients, thereby potentially reducing the need for antiviral medications that can delay reconstitution of virus-specific immunity,” said Don J. Diamond, Ph.D., Professor, Hematology & Hematopoietic Ce...