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Longeveron Announces New Long-Term Survival Data from ELPIS I Trial of Lomecel-B™ for Hypoplastic Left Heart Syndrome
- Children in the ELPIS I trial had 100% survival up to 5 years of age after receiving Lomecel-BTM compared to 20% mortality rate observed from historical
About this update from Longeveron Inc.
[{"type":"text","content":"- Children in the ELPIS I trial had 100% survival up to 5 years of age after receiving Lomecel-BTM compared to 20% mortality rate observed from historical control data - - Data reinforce potential survival benefit of Lomecel-BTM for patients with hypoplastic left heart syndrome (HLHS) - - Enrollment ongoing in Phase 2a ELPIS II trial - - Lomecel-BTM has Rare Pediatric Disease Designation, Fast Track Designation, and Orphan Drug Designation for HLHS Indication - MIAMI, May 09, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (\"Longeveron\" or \"Company\"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced new long-term follow-up data from the Company’s ELPIS I trial of Lomecel-BTM for patients with hypoplastic left heart syndrome (HLHS). The data showed that 100% of the 10 patients who participated in the ELPIS I trial survived and remained heart transplant-free for up to 5 years of age after receiving Lomecel-BTM during their Stage 2 surgery. To-date All 10 patients enrolled in the study have been monitored for at least 3.5 years after treatment with Lomecel-BTM. All patients are more than 4 years of age, with 2 being 5 years of age, and additional long-term follow-up is ongoing in the ELPIS I participants. Historical results have shown that children with HLHS have approximately 20% mortality by 5 years. In addition, about three years after the Stage 2 surgery, most of these patients undergo the third palliative surgery, which is the last of the standard sequence of surgeries that comprises the current standard of care for HLHS. To-date, 5 of 5 of the eligible patients from the ELPIS I trial have already undergone this third surgery. The Company expects to present these updated data at a scientific conference later in 2023. “We are pleased to share additional long-term follow-up data demonstrating the continued survival of the ELPIS I trial participants,” said Joshua M. Hare, M.D., co-founder of Longeveron, Chief Science Officer, and Chairman of the Board of Directors. “Previously, we disclosed the participants had 100% survival rate for up to 3.5 years post-administration of Lomecel-BTM. These data represent an additional 2 years of follow-up data, reinforcing our enthusiasm for Lomecel-BTM in this indication, and providing support for the ongoing ELPIS II ...