The Food and Drug Administration (FDA) has granted Fast Track designation to Lomecel-B™, an investigational allogeneic, bone marrow-derived medicinal signaling cell product for treatment of hypoplastic left heart syndrome (HLHS) in infants.
Lomecel-B is derived from culture-expanded medicinal signaling cells that are sourced from the bone marrow of young, healthy adult donors, and is delivered via intramyocardial injection. In the phase 1 ELPIS trial (ClinicalTrials.gov Identifier: NCT03525418), Lomecel-B was well tolerated with no major adverse cardiac events 1-year post-surgery, and/or treatment-related infections.
The Company is currently evaluating the efficacy and safety of Lomecel-B in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery in the ongoing phase 2a ELPIS II trial (ClinicalTrials.gov Identifier: NCT04925024).
The FDA previously granted Orphan Drug and Rare Pediatric Disease designations to Lomecel-B for HLHS.
“Fast Track Designation represents a significant milestone in our efforts to develop Lomecel-B™ as a treatment for infants with HLHS,” said Chris Min, MD, PhD, Longeveron’s Interim Chief Executive Officer and Chief Medical Officer. “Fast Track Designation underscores the urgent need in HLHS, and we look forward to continuing to work closely with the FDA to bring this potential new therapy to infants as expeditiously as possible.”
US Food and Drug Administration (FDA) grants Fast Track designation for Longeveron’s Lomecel-B™ product for treatment of hypoplastic left heart syndrome (HLHS) in infants. News release. Longeveron Inc. Accessed August 31, 2022. https://www.globenewswire.com/news-release/2022/08/31/2507637/0/en/U-S-Food-and-Drug-Administration-FDA-Grants-Fast-Track-Designation-for-Longeveron-s-Lomecel-B-Product-for-Treatment-of-Hypoplastic-Left-Heart-Syndrome-HLHS-in-Infants.html