Benzinga | Feb 24, 2021 09:23AM EST

Longeveron Announces Completion Of Phase 1 Clinical Study Of Lomecel-B Intramyocardial Injection In Hypoplastic Left Heart Syndrome Patients

Intramyocardial injection of Lomecel-B well-tolerated, with no major cardiac events, and no serious adverse events related to Lomecel-B reported

Full results of the Phase 1 clinical trial expected to be releasedIntramyocardial injection of Lomecel-B well-tolerated, with no major cardiac events, and no serious adverse events related to Lomecel-B reported



Full results of the Phase 1 clinical trial expected to be released in Q2 2021

Phase 2 trial expected to commence in Q3 2021

MIAMI, Feb. 24, 2021 (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, is pleased to announce completion of the Company's Phase 1 clinical study of Lomecel-B in Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell product manufactured under cGMP in Longeveron's cell processing facility in Miami.

The study was conducted by a consortium of leading pediatric cardiac surgeons at centers that included the University of Maryland Medical Center, University of Cincinnati/Children's Hospital Medical Center and University of Utah Primary Children's Hospital, and was supported in part by a Maryland Stem Cell Research Fund TEDCO Grant.

The Phase 1, open-label single arm study was designed to assess safety and tolerability of intramyocardial injection of Lomecel-B administered to 10 children with HLHS during the Stage 2 bidirectional cavopulmonary anastomosis (BDCPA, or "Glenn procedure") surgery. HLHS is a rare congenital heart defect that effects approximately 1,000 babies per year in the U.S. Babies with HLHS are born with an underdeveloped left ventricle, which impairs the heart's ability to pump adequate amounts of blood throughout the body. Without a three-staged reconstructive surgery, the condition is often fatal. Even with surgery, HLHS is still associated with high mortality. Intramyocardial injection of Lomecel-B at doses of 2.5 ? 105 cells/kg of body weight was shown to be well-tolerated, with no major cardiac events, and no serious adverse events reported that were considered to be related to the investigational therapy.

The Phase 1 safety results have enabled Longeveron to advance its HLHS program into a Phase 2 multi-center trial, with a randomized, double-blind, placebo-controlled trial scheduled to begin in the third quarter of 2021. The Phase 2 trial which will study 32 patients nationwide is being funded by a $5.6M grant from the National Institute of Health's National Heart, Lung and Blood Institute (NHLBI), and is led by Sunjay Kaushal, MD, PhD, Division Head Cardiovascular Thoracic Surgery at Lurie Children's Hospital of Chicago.

The full results of the Phase 1 clinical trial are expected to be released in Q2 2021.

"We are extremely excited and gratified to have completed Phase 1 and to be able to transition so efficiently to phase 2 for this program," stated Dr. Kaushal. "Babies with HLHS are very seriously ill and require multiple open-heart operations. This program is designed around helping their hearts recover from this complicated congenital heart disease. We are excited about moving this program forward and potentially adding a key therapeutic in the recovery of these kids."