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Fortress Biotech Announces Initiation of Phase 2 Clinical Trial of Triplex for Adults Co-Infected with HIV and CMV
Helocyte, Inc., a partner company of Fortress Biotech, is developing Triplex for the treatment of cytomegalovirus Clinical trial will evaluate whether
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"Helocyte, Inc., a partner company of Fortress Biotech, is developing Triplex for the treatment of cytomegalovirus Clinical trial will evaluate whether Triplex, which was developed by City of Hope, is safe and effective in eliciting a CMV-specific immune response in people living with HIV and is thus able to reduce CMV replication NEW YORK, Dec. 16, 2021 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, and its partner company, Helocyte, Inc., (“Helocyte”) today announced that a Phase 2 double-blind, randomized, placebo-controlled clinical trial has been initiated to evaluate the safety and efficacy of Triplex, a cytomegalovirus (“CMV”) vaccine, in eliciting a CMV-specific immune response and reducing CMV replication in people living with HIV. Triplex was developed by City of Hope, a world-renowned cancer treatment and research organization. Most people living with HIV are co-infected with CMV, and there is strong evidence that CMV is associated with chronic inflammation and potentially other significant co-morbidities, including cardiovascular disease, neurological complications, and metabolic disease. Triplex is a modified vaccinia ankara (MVA)-based vaccine, which encodes three full-length CMV antigens [pp65 (UL83), IE1-exon4 (UL123), and IE2-exon5 (UL122)]. Triplex was demonstrated to be safe, well-tolerated, immunogenic and effective in multiple Phase 1 and 2 studies involving over 100 subjects. The Phase 2, double-blind, randomized, placebo-controlled study is evaluating the safety and immunogenicity of two injections of Triplex in adults aged 18 to 65 co-infected with HIV and CMV. Upon enrollment in the study, 60 participants will be randomized to receive Triplex and 30 participants will be randomized to receive placebo, both through two intramuscular deltoid injections on Day 0 and Day 28 following enrollment. Participants will be followed for 92 weeks after the last scheduled vaccination at Day 28, for a total study duration of 96 weeks. At least 25 percent of participants will be cisgender or transgender women and all subjects must have undetectable HIV on antiretroviral therapy. Lindsay A. Rosenwald, M.D., Chairman,...