Business
Longeveron Inc. Provides Corporate Update and Reports First Quarter 2022 Financial Results
Conference call scheduled for 8:30 a.m. ET today MIAMI, May 13, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a
About this update from Longeveron Inc.
[{"type":"text","content":"Conference call scheduled for 8:30 a.m. ET today\nMIAMI, May 13, 2022 (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, today provided a business update and reported its financial results for the first quarter ended March 31, 2022. First Quarter Business Updates: Lomecel-B for Alzheimer’s Disease: In January 2022, we initiated enrollment in a 48-patient, 4-arm, parallel design, randomized (1:1:1:1) Phase 2a clinical trial of Lomecel-B infusion in patients with mild Alzheimer’s disease. The Phase 2a study is intended to evaluate the safety of single and multiple infusions of two different dose levels of Lomecel-B compared to placebo. Other endpoints include brain volumetry by MRI, biomarkers relevant to inflammation and endothelial/vascular systems, and measures of cognitive function. On March 31st, 2022, Longeveron announced the publication of a manuscript in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association® detailing the previously completed and announced Phase 1 Alzheimer’s disease trial results. Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS): The ELPIS II trial (Phase 2a) continues to enroll infants. EPLIS II is a 38-patient, randomized (1:1), blinded, controlled Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial injection of Lomecel-B in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery. The trial is partially funded by a grant from the National Institute of Health’s National Heart, Lung, and Blood Institute (NHLBI; Grant number 1UG3HL148318). All seven planned clinical sites have been activated for enrollment, and additional sites are being considered. Lomecel-B for HLHS has been granted both Rare Pediatric Disease and Orphan Drug Designations by the United States Food and Drug Administration (FDA). The Company expects to submit the full Phase 1 (“ELPIS I”) trial results for publication in a peer-reviewed journal, with acceptance and publication currently anticipated in 2022. Longeveron previously announced top-line data from ELPIS I on September 9th, 2021. Lomecel-B for Aging Frailty: A planned Japanese Aging Frailty Phase 2 trial is currently on track to initiate in the first ...