LGVN - Longeveron completes early-stage Lomecel-b heart defect study

Longeveron (LGVN) announces completion of its Phase 1 clinical study of Lomecel-B in Hypoplastic Left Heart Syndrome ((HLHS)), a rare congenital heart defect that effects about 1,000 babies per year in the U.S.Shares up nearly 8% premarket.Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell product manufactured under cGMP in Longeveron’s cell processing facility in Miami.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 surgery. The full results of the Phase 1 clinical trial are expected to be released in Q2 2021.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 Q3 2021.

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Longeveron completes early-stage Lomecel-b heart defect study