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Longeveron Announces Successful Completion of Phase 1 Clinical Study of Lomecel-B Intramyocardial Injection in Hypoplastic Left Heart Syndrome Patients
Intramyocardial injection of Lomecel-B well-tolerated, with no major cardiac events, and no serious adverse events related to Lomecel-B reported Full results
About this update from Longeveron Inc.
[{"type":"text","content":"Intramyocardial injection of Lomecel-B well-tolerated, with no major cardiac events, and no serious adverse events related to Lomecel-B reported Full results of the Phase 1 clinical trial expected to be released in Q2 2021 Phase 2 trial expected to commence in Q3 2021 MIAMI, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (\"Longeveron\" or \"Company\"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, is pleased to announce completion of the Company’s Phase 1 clinical study of Lomecel-B in Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell product manufactured under cGMP in Longeveron’s cell processing facility in Miami. The study was conducted by a consortium of leading pediatric cardiac surgeons at centers that included the University of Maryland Medical Center, University of Cincinnati/Children’s Hospital Medical Center and University of Utah Primary Children’s Hospital, and was supported in part by a Maryland Stem Cell Research Fund TEDCO Grant. The Phase 1, open-label single arm study was designed to assess safety and tolerability of intramyocardial injection of Lomecel-B administered to 10 children with HLHS during the Stage 2 bidirectional cavopulmonary anastomosis (BDCPA, or “Glenn procedure”) surgery. HLHS is a rare congenital heart defect that effects approximately 1,000 babies per year in the U.S. Babies with HLHS are born with an underdeveloped left ventricle, which impairs the heart’s ability to pump adequate amounts of blood throughout the body. Without a three-staged reconstructive surgery, the condition is often fatal. Even with surgery, HLHS is still associated with high mortality. Intramyocardial injection of Lomecel-B at doses of 2.5 × 105 cells/kg of body weight was shown to be well-tolerated, with no major cardiac events, and no serious adverse events reported that were considered to be related to the investigational therapy. The Phase 1 safety results have enabled Longeveron to advance its HLHS program into a Phase 2 multi-center trial, with a randomized, double-blind, placebo-controlled trial scheduled to begin in the third quarter of 2021. The Phase 2 trial which will study 32 patients nationwide is being funded by a $5.6M grant from the National In...