Longeveron Exceeds 50% Enrollment in Lomecel-B™ Study for Hypoplastic Left Heart Syndrome

14 August 2023 | Monday | News

Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, announced today the Phase 2 ELPIS II trial, funded by the National Heart, Lung, and Blood Institute (NHLBI) and using the Company’s Lomecel-B™ asset in Hypoplastic Left Heart Syndrome (HLHS), has surpassed the 50% enrollment threshold. Additionally, the trial has activated its eighth clinical site location – one additional site beyond the seven originally planned -- in order to try to expedite the completion of the trial enrollment.
Image Source | Public Domain

Image Source | Public Domain

Company Activates Additional Study Location to Expedite Enrollment Completion

HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, babies born with this condition have severely diminished systemic blood flow (blood circulation throughout the body), which requires children to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. While these children can now live into adulthood, early mortality is still extremely high in this population due to right ventricle failure, which is not meant for the increased load demanded by the systemic circulation. As such, there is an important unmet medical need to improve right ventricular function in these patients to improve both short-term and long-term outcomes.

“Surpassing the 50% enrollment threshold is a significant milestone for the trial and more importantly for HLHS patients who are in such critical need of new therapeutic options to improve outcomes in this rare and life-threatening indication,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We look forward to continuing to execute on our clinical program for Lomecel-B™ and to do all possible to expedite completing enrollment in the ELPIS II trial.”

Key Opinion Leader Webinar to be Held Wednesday, August 16, 2023 at 10:00 AM ET

Longeveron will host a virtual webinar to discuss the unmet medical need and current standard of care for patients suffering from HLHS, as well as the potential of medicinal signaling cells, such as those making up Lomecel-B™ for injection, in improving outcome for these patients. The event will feature Sunjay Kaushal, MD, PhD and Ram Kumar Subramanyan, MD, PhD.

For more information and to register for the event, click here.

ELPIS II (NCT04925024) is a 38-participant, randomized (1:1) blinded, controlled Phase 2 clinical trial evaluating the safety and efficacy of intramyocardial injection of Lomecel-B™ in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery. Lomecel-B™ for HLHS has previously received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA). ELPIS II is being funded by grants from the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI; Grant numbers UG3HL148318, U24HL148316), in collaboration with Longeveron.


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