Longeveron Inc.’s (NASDAQ: LGVN) Long-Term Follow-Up Data from Its ELPIS I Clinical Trial Presented at the 2023 Annual Scientific Sessions of the American Heart Association
- A poster about Longeveron’s long-term follow-up data from its ELPIS I clinical trial was presented at the 2023 Scientific Sessions of the American Heart Association in November 2023
- The poster showed that 100% of the 10 patients enrolled in the study survived and remained heart transplant-free for up to 5 years of age after receiving Lomecel-B(TM) during their Stage II surgery
- The data supports Longeveron’s ongoing ELPIS II study, which has exceeded its 50% enrollment threshold
- The company believes the long-term follow-up data underscore the potential for Lomecel-B(TM) as a much-needed therapeutic innovation for HLHS patients
- Historical results from outside studies have shown that children with HLHS who are undergoing Stage II surgery have approximately 20% mortality by 5 years of age
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions including hypoplastic left heart syndrome (“HLHS”), Alzheimer’s disease and Aging-related Frailty has evaluated – and still is evaluating – its lead investigational therapeutic candidate Lomecel-B(TM), an allogeneic, bone marrow-derived medicinal signaling cell (“MSC”) therapy product, in multiple clinical trials.
One of these trials, titled ELPIS I, was a Phase 1, open-label single-arm study whose final results Longeveron announced in September 2021 (https://nnw.fm/e7lGw). ELPIS I was designed to assess the safety and potential efficacy as of intramyocardial injection of Lomecel-B(TM) administered to 10 infants with HLHS during Stage II surgeries at approximately 4 months of age. The study met the primary safety endpoint: no major adverse cardiac events or any treatment-related infections during the first month post-treatment were reported. Moreover, secondary endpoints measured per protocol suggested Lomecel-B(TM) injection may improve patient long-term clinical outcome post-surgery.
While the positive results permitted the transition to a Phase 2 randomized, double-blind, controlled trial, ELPIS II, with enrollment commencing in July 2021 (https://nnw.fm/68Ukl), investigators elected to extend follow-up of the 10 infants after ELPIS I came to its planned end for a total period of five years. More than two years later, at the annual Scientific Sessions of the American Heart Association (“AHA”) held November 11-13, 2023, in Philadelphia, Pennsylvania, a poster about Longeveron’s extended long-term follow-up data was presented. (Additional long-term follow-up is still ongoing in the ELPIS I children.)
The poster, titled Long-term Transplant-free Survival Is Improved in Hypoplastic Left Heart Syndrome with Cell-based Therapy and authored by Sunjay Kaushal, M.D., Ph.D., the principal investigator of the ELPIS I study, and colleagues, showed that all the 10 children survived and remained heart transplant-free for up to 5 years of age after receiving Lomecel-B(TM) during their Stage II surgery.
The transplant-free survival follow-up on all patients enrolled in the study is ongoing. Moreover, the average age at the time of the last follow-up visit was 4.5 years, with 2 patients being 5 years of follow-up, according to the company.
“Long-term follow-up data from our ELPIS I trial demonstrate the continued survival of the participants, and reinforce potential survival benefit of Lomecel-B(TM) for patients with HLHS,” commented Joshua M. Hare, Longeveron’s Co-Founder, Chief Science Officer, and Chair 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-B(TM) 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.”
FDA granted Rare Pediatric Disease Designation (“RPD”), Orphan Drug Designation, and Fast Track designation to Longeveron’s Lomecel-B(TM) for treatment of HLHS.
HLHS refers to cardiac malformations characterized by underdevelopment or absence of the left ventricle. Before the 1980s, HLHS was associated with 95% mortality within the first month of life. But in the last two decades of the 20th century, there was remarkable progress in the management of children born with HLHS, thanks to the introduction and successful implementation of operative reconstructive procedures, according to a 2000 study (https://nnw.fm/VoLEP).
These procedures, which are still used to date, are performed in three stages. The final result is a reconstructed heart in which the right ventricle – which ordinarily pumps deoxygenated (venous) blood to the lungs – is now responsible for pumping oxygenated blood to the body through a reconstructed aorta, with venous blood returning directly to the lungs without going through the heart chambers.
While the operative procedures have helped lower mortality, some patients who have undergone surgeries still succumb to HLHS. According to a 2015 study (https://nnw.fm/SJgT8), “The highest mortality for infants with HLHS undergoing surgical intervention is with Stage 1 palliation and the interstage period between Stage I and Stage II surgery, both done in the first year of life.”
Furthermore, Kaushal explained, “Historical data collected by the National Heart, Lung, and Blood Institute (‘NHLBI’) has shown that more than 15% of HLHS patients either required a heart transplant or died from their illness 12 months after having undergone Stage 2 surgery. Additional historical data from the NHLBI-sponsored Single Ventricle Reconstruction (‘SVR’) trial – the largest HLHS trial to date, with enrollment of more than 500 patients – shows that patients undergoing Stage II surgery have approximately 15% mortality by year 3 after surgery, which increased to approximately 20% mortality by 5 years.”
These statistics underscore the high unmet need among children with HLHS. Fortunately, the extended follow-up data, which show the 100% survival rate of ELPIS I patients up to 5 years post-treatment, highlight the opportunity for Lomecel-B(TM) as a much-needed therapeutic innovation for this patient group.
Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com
For more information, visit the company’s website at www.Longeveron.com.
NOTE TO INVESTORS: The latest news and updates relating to LGVN are available in the company’s newsroom at https://nnw.fm/LGVN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
- A poster about Longeveron’s long-term follow-up data from its ELPIS I clinical trial was presented at the 2023 Scientific Sessions of the American Heart Association in November 2023
- The poster showed that 100% of the 10 patients enrolled in the study survived and remained heart transplant-free for up to 5 years of age after receiving Lomecel-B(TM) during their Stage II surgery
- The data supports Longeveron’s ongoing ELPIS II study, which has exceeded its 50% enrollment threshold
- The company believes the long-term follow-up data underscore the potential for Lomecel-B(TM) as a much-needed therapeutic innovation for HLHS patients
- Historical results from outside studies have shown that children with HLHS who are undergoing Stage II surgery have approximately 20% mortality by 5 years of age
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions including hypoplastic left heart syndrome (“HLHS”), Alzheimer’s disease and Aging-related Frailty has evaluated – and still is evaluating – its lead investigational therapeutic candidate Lomecel-B(TM), an allogeneic, bone marrow-derived medicinal signaling cell (“MSC”) therapy product, in multiple clinical trials.
One of these trials, titled ELPIS I, was a Phase 1, open-label single-arm study whose final results Longeveron announced in September 2021 (https://nnw.fm/e7lGw). ELPIS I was designed to assess the safety and potential efficacy as of intramyocardial injection of Lomecel-B(TM) administered to 10 infants with HLHS during Stage II surgeries at approximately 4 months of age. The study met the primary safety endpoint: no major adverse cardiac events or any treatment-related infections during the first month post-treatment were reported. Moreover, secondary endpoints measured per protocol suggested Lomecel-B(TM) injection may improve patient long-term clinical outcome post-surgery.
While the positive results permitted the transition to a Phase 2 randomized, double-blind, controlled trial, ELPIS II, with enrollment commencing in July 2021 (https://nnw.fm/68Ukl), investigators elected to extend follow-up of the 10 infants after ELPIS I came to its planned end for a total period of five years. More than two years later, at the annual Scientific Sessions of the American Heart Association (“AHA”) held November 11-13, 2023, in Philadelphia, Pennsylvania, a poster about Longeveron’s extended long-term follow-up data was presented. (Additional long-term follow-up is still ongoing in the ELPIS I children.)
The poster, titled Long-term Transplant-free Survival Is Improved in Hypoplastic Left Heart Syndrome with Cell-based Therapy and authored by Sunjay Kaushal, M.D., Ph.D., the principal investigator of the ELPIS I study, and colleagues, showed that all the 10 children survived and remained heart transplant-free for up to 5 years of age after receiving Lomecel-B(TM) during their Stage II surgery.
The transplant-free survival follow-up on all patients enrolled in the study is ongoing. Moreover, the average age at the time of the last follow-up visit was 4.5 years, with 2 patients being 5 years of follow-up, according to the company.
“Long-term follow-up data from our ELPIS I trial demonstrate the continued survival of the participants, and reinforce potential survival benefit of Lomecel-B(TM) for patients with HLHS,” commented Joshua M. Hare, Longeveron’s Co-Founder, Chief Science Officer, and Chair 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-B(TM) 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.”
FDA granted Rare Pediatric Disease Designation (“RPD”), Orphan Drug Designation, and Fast Track designation to Longeveron’s Lomecel-B(TM) for treatment of HLHS.
HLHS refers to cardiac malformations characterized by underdevelopment or absence of the left ventricle. Before the 1980s, HLHS was associated with 95% mortality within the first month of life. But in the last two decades of the 20th century, there was remarkable progress in the management of children born with HLHS, thanks to the introduction and successful implementation of operative reconstructive procedures, according to a 2000 study (https://nnw.fm/VoLEP).
These procedures, which are still used to date, are performed in three stages. The final result is a reconstructed heart in which the right ventricle – which ordinarily pumps deoxygenated (venous) blood to the lungs – is now responsible for pumping oxygenated blood to the body through a reconstructed aorta, with venous blood returning directly to the lungs without going through the heart chambers.
While the operative procedures have helped lower mortality, some patients who have undergone surgeries still succumb to HLHS. According to a 2015 study (https://nnw.fm/SJgT8), “The highest mortality for infants with HLHS undergoing surgical intervention is with Stage 1 palliation and the interstage period between Stage I and Stage II surgery, both done in the first year of life.”
Furthermore, Kaushal explained, “Historical data collected by the National Heart, Lung, and Blood Institute (‘NHLBI’) has shown that more than 15% of HLHS patients either required a heart transplant or died from their illness 12 months after having undergone Stage 2 surgery. Additional historical data from the NHLBI-sponsored Single Ventricle Reconstruction (‘SVR’) trial – the largest HLHS trial to date, with enrollment of more than 500 patients – shows that patients undergoing Stage II surgery have approximately 15% mortality by year 3 after surgery, which increased to approximately 20% mortality by 5 years.”
These statistics underscore the high unmet need among children with HLHS. Fortunately, the extended follow-up data, which show the 100% survival rate of ELPIS I patients up to 5 years post-treatment, highlight the opportunity for Lomecel-B(TM) as a much-needed therapeutic innovation for this patient group.
Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com
For more information, visit the company’s website at www.Longeveron.com.
NOTE TO INVESTORS: The latest news and updates relating to LGVN are available in the company’s newsroom at https://nnw.fm/LGVN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
