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Longeveron Announces Publication of Final Data from ELPIS I Trial of Lomecel-BTM for Hypoplastic Left Heart Syndrome in Peer-Reviewed Journal
-- Full results published in European Heart Journal Open -- -- Study met primary safety endpoint -- -- All patients alive, transplant-free, and maintained
About this update from Longeveron Inc.
[{"type":"text","content":"-- Full results published in European Heart Journal Open -- -- Study met primary safety endpoint -- -- All patients alive, transplant-free, and maintained expected rate of growth one year after treatment -- -- Data supports ongoing clinical development of Lomecel-BTM for HLHS, currently being evaluated in a Phase 2a trial -- MIAMI, Jan. 19, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (\"Longeveron\" or \"Company\"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced the publication of the full results from the Company’s ELPIS I trial of Lomecel-BTM for hypoplastic left heart syndrome (HLHS) in the European Heart Journal Open. In the uncontrolled open-label Phase 1b study entitled “Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: The ELPIS phase I trial,” patients (n=10) underwent the Glenn Procedure (an open heart surgery) at approximately 4-5 months old, and received intracardiac injections of Lomecel-BTM. “We are pleased that the data from the ELPIS I trial have been published in European Heart Journal Open,” said Chris Min, M.D., Ph.D., Interim Chief Executive Officer and Chief Medical Officer. “This data supports our conviction that Lomecel-BTM has the potential to alter the treatment landscape for patients with HLHS, a rare and life-threatening congenital heart disease. Notably, the procedure appeared to be generally safe and well-tolerated in the babies undergoing heart surgery in the first 6 months of life. The study provisionally shows suggestions of possible improvement in measures of cardiac function, findings that are presently being tested in our ongoing controlled and randomized Phase 2 study.” The ELPIS I study was conducted by a consortium of leading pediatric cardiac surgeons led by Sunjay Kaushal, M.D., Ph.D., currently Division Head of Cardiovascular-Thoracic Surgery at Lurie Children’s and principal investigator of the ELPIS I study. Dr. Kaushal said, “On behalf of the families affected with this devastating condition and my surgical colleagues, we are thrilled to publish these results. We are hopeful we may be able to add this therapy to the armamentarium for managing babies with HLHS.” The findings of the study included: None of the children experienc...