LGVN - Long-term Survival Data from Longeveron's ELPIS 1 Trial Presented at the 2023 Scientific Sessions of the American Heart Association | Benzinga
Extended Follow Up Data Show Continued, Transplant Free Survival of All Patients
Results Support Continued Investigation of Lomecel-BTM As Adjunct to Stage II Surgery in HLHS
- Enrollment ongoing in Phase 2 ELPIS II trial -
MIAMI, Nov. 11, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN, NASDAQ:LGVNR) ("Longeveron" or "Company"), a clinical-stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer's disease and Aging-related Frailty, announced today that extended long-term follow-up data from the Company's ELPIS I trial of Lomecel-BTM for patients with hypoplastic left heart syndrome (HLHS) is being presented as a poster at the annual Scientific Sessions of the American Heart Association (AHA), being held in Philadelphia, PA on November 11-13, 2023.
The poster, titled Long-term Transplant-free Survival Is Improved in Hypoplastic Left Heart Syndrome with Cell-based Therapy (Sunjay Kaushal, et al), showed that 100% of the 10 patients who participated in the ELPIS I trial survived and remained heart transplant-free for up to 5 years of age after receiving Lomecel-BTM during their Stage II surgery. The extended follow-up data on all patients enrolled in the study now includes monitoring for up to 5 years following treatment with Lomecel-BTM. The average age at the time of the last follow-up visit was 4.5 years, with 2 patients being 5 years of age. Additional long-term follow-up is ongoing in the ELPIS I participants. Historical results from outside studies have shown that children with HLHS have approximately 20% mortality by 5 years.
"Long-term follow-up data from our ELPIS I trial demonstrate the continued survival of the participants, and reinforce potential survival benefit of Lomecel-BTM for patients with HLHS," said Joshua M. Hare, M.D., Longeveron's Co-founder, Chief Science Officer, and Chairman of the Board of Directors. "These data represent an additional up to 2 years of follow-up data, which point to the potential of Lomecel-BTM in this indication and provide support for our ongoing ELPIS II study, which has exceeded its 50% enrollment threshold. We anticipate completing enrollment in this trial in 2024. There is an unmet need to improve the transplant-free survival for patients with HLHS, and we hope Lomecel-BTM can significantly improve the treatment landscape for this patient population."
"These results are encouraging, as patients with HLHS have progressive time-dependent increases in mortality and need for transplantation," added Sunjay Kaushal, M.D., Ph.D., principal investigator of the ELPIS I study. "Historical data ...