Longeveron Inc. (NASDAQ: LGVN) announced that its data on Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS) has been selected for oral presentation at the Congenital Heart Surgeons’ Society (CHSS) 51st Annual Meeting in Chicago, Illinois, October 27-28, 2024. The presentation will highlight 5-year long-term transplant-free survival data from the ELPIS I follow-on study, showcasing the potential of cell-based therapy in improving outcomes for HLHS patients.
Long-Term Outcomes with Lomecel-B
The study, titled "Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy," provides evidence of the sustained benefits of Lomecel-B in HLHS patients. HLHS is a rare congenital heart defect affecting approximately 1,000 infants per year in the U.S. These infants are born with an underdeveloped left ventricle, leading to the heart's inability to pump adequate blood throughout the body. Current treatment involves a complex three-stage heart reconstruction surgery within the first five years of life. However, only 50% to 60% of these infants survive to adolescence due to right ventricular failure, highlighting a critical unmet medical need.
Ongoing Clinical Trial
"We are extremely excited to share this 5-year long-term survival data from our ELPIS I follow-on study at the CHSS meeting this year," said Wa’el Hashad, CEO of Longeveron. "Based on the strength of the ELPIS I data, we are currently conducting the ELPIS II Phase 2b clinical trial, which is evaluating our cellular therapy Lomecel-B™ as a potential adjunct therapy for treating HLHS, and which, if positive, may serve as the foundation for a BLA submission for potential approval of Lomecel-B™."
About Lomecel-B
Lomecel-B™ is an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. It has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects. Longeveron is also investigating Lomecel-B™ for Alzheimer’s disease (AD) and Aging-related Frailty. The Lomecel-B™ development programs have received several U.S. FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for the HLHS program, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the AD program.
