Benzinga | Jul 6, 2021 08:13AM EDT

Longeveron Announces First Patient Treated In Phase 2b Hypoplastic Left Hearth Syndrome Clinical Study

Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, announced today that the first patient has been enrolled and treated in the Phase 2b clinical study evaluating Lomecel-B intraventricular injection in infants with Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured in Longeveron's cell processing facility in Miami, Florida.

Longeveron' s HLHS program has transitioned to Phase 2, with a randomized, double-blind, controlled trial titled: Evaluation of Lomecel-B(tm) Injection in Patients with Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial. (ELPIS II). The trial is being funded by a grant from the National Institute of Health's National Heart, Lung and Blood Institute (NHLBI), in collaboration with Longeveron, and is led by Principal Investigator, Sunjay Kaushal, MD, PhD, Division Head Cardiovascular Thoracic Surgery, Ann and Robert H. Lurie Children's Hospital of Chicago. With a target enrollment of 38 infants, the trial will be enrolling in 7 children's hospitals in major metropolitan centers located throughout the U.S. For more information regarding the trial design and location of clinical sites please visit www.elpistrial.org hosted by the University of Texas Health Sciences Center which serves as the data coordinating center.

"After demonstrating safety and feasibility in the successfully completed Phase 1 ELPIS trial, we are now embarking upon the next phase of development, which importantly includes a control arm for comparison against babies treated with Lomecel-B injection," remarked Dr. Kaushal. "Our hypothesis is that transplanted Lomecel-B medicinal signaling cells into the right ventricle as an adjunct to HLHS surgery will improve right ventricle structure and performance compared with surgery alone, potentially leading to a clinical benefit. We feel that this trial is a crucial step forward for developing cell-based therapy as an adjunct for surgery in HLHS."