Longeveron Inc. (NASDAQ: LGVN) Eyeing Global HLHS,
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Posted On: 09/27/2023 5:10:42 PM
Longeveron Inc. (NASDAQ: LGVN) Eyeing Global HLHS, in addition to Alzheimer’s Disease, and Aging-Related Frailty Treatment Markets with Lomecel-B(TM), its Lead Investigational Product
- Longeveron’s study ELPIS I demonstrated 100% survival and heart transplant-free for up to 5 years of age
- All ten patients enrolled in the study were monitored for at least 3.5 years after treatment with Lomecel-B(TM), the company’s lead investigational product
- Longeveron’s study results show Lomecel-B(TM)’s potential, not just for the potential treatment of HLHS but also for Alzheimer’s disease and Aging-related Frailty
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, recently posted promising results from its ELPIS I clinical trial. Of note was data that showed that 100% of the ten patients who participated in the trial survived and remained heart transplant-free for up to 5 years of age after receiving the company’s lead investigational product, Lomecel-B(TM) (https://nnw.fm/cC9cX ).
This study explored Lomecel-B(TM)’s potential to address hypoplastic left heart syndrome (“HLHS”), a congenital disability affecting normal blood flow through the heart. Historical results have shown that children with the condition have approximately 20% mortality by five years, with as many as 1,025, or one out of every 3,841 babies in the U.S. born with the condition (https://nnw.fm/Cn9Da ).
From the ELPIS I trial, all ten patients enrolled were monitored for at least 3.5 years after treatment with Lomecel-B(TM). To date, 5 out of the 5 eligible patients from the trial have already undergone the last of the three surgeries required to treat the condition, with Longeveron expected to present updated data from this process later in 2023.
“We are pleased to share additional long-term follow-up data demonstrating the continued survival of the ELPIS I trial participants,” noted Joshua M. Hare, M.D., Co-Founder, Chief Science Officer, and Chairman of the Board of Directors at Longeveron (https://nnw.fm/A1UJp ).
ELPIS I is an open-label, Phase 1b trial specifically designed to evaluate the safety of Lomecel-B(TM) in patients with HLHS. Initial results demonstrated that the study met its primary safety endpoint and that all patients were alive, transplant-free, and maintained their expected growth rate one year after treatment. With these promising results, Longeveron is optimistic about the results to be shared later in the year. In addition, its management is excited for the next steps in the study, particularly as the company continues to enroll patients at the eight sites in the ELPIS II trial, a 38-patient, randomized (1:1) blinded, controlled Phase 2 clinical trial designed to evaluate the safety and efficacy of intramyocardial injection of Lomecel-B(TM) in infants with HLHS undergoing the Glenn Procedure.
“There is a major unmet need among children with HLHS, and today’s data highlighting the 100% survival rate of ELPIS I patients up to 5 years post-treatment underscore the potential opportunity for Lomecel-B(TM) as a much-needed therapeutic innovation for this patient group,” noted Sunjay Kaushal, M.D., Ph.D. Principal Investigator of the ELPIS I trial.
There is no FDA-approved medical treatment for HLHS, leaving a vast untapped market for Longeveron. So far, the product has received Fast Track Designation, Rare Pediatric Disease Designation, and Orphan Drug Designation from the United States Food and Drug Administration (“FDA”), which represent significant milestones for the company as it continues its work towards seeking FDA approval of Lomecel-B(TM) for HLHS.
With these studies, the company looks to tap into several market opportunities, projecting that the potential market size for its Lomecel-B(TM) in treating HLHS could be up to $1 billion annually, globally. In addition, the company is investigating Lomecel-B(TM) to address Alzheimer’s disease, which represents a market between $5 billion to $10 billion annually, as well as Aging-related Frailty, which represents a market between $4 billion and $8 billion globally per year.
For more information, visit the company’s website at www.Longeveron.com
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
- Longeveron’s study ELPIS I demonstrated 100% survival and heart transplant-free for up to 5 years of age
- All ten patients enrolled in the study were monitored for at least 3.5 years after treatment with Lomecel-B(TM), the company’s lead investigational product
- Longeveron’s study results show Lomecel-B(TM)’s potential, not just for the potential treatment of HLHS but also for Alzheimer’s disease and Aging-related Frailty
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, recently posted promising results from its ELPIS I clinical trial. Of note was data that showed that 100% of the ten patients who participated in the trial survived and remained heart transplant-free for up to 5 years of age after receiving the company’s lead investigational product, Lomecel-B(TM) (https://nnw.fm/cC9cX ).
This study explored Lomecel-B(TM)’s potential to address hypoplastic left heart syndrome (“HLHS”), a congenital disability affecting normal blood flow through the heart. Historical results have shown that children with the condition have approximately 20% mortality by five years, with as many as 1,025, or one out of every 3,841 babies in the U.S. born with the condition (https://nnw.fm/Cn9Da ).
From the ELPIS I trial, all ten patients enrolled were monitored for at least 3.5 years after treatment with Lomecel-B(TM). To date, 5 out of the 5 eligible patients from the trial have already undergone the last of the three surgeries required to treat the condition, with Longeveron expected to present updated data from this process later in 2023.
“We are pleased to share additional long-term follow-up data demonstrating the continued survival of the ELPIS I trial participants,” noted Joshua M. Hare, M.D., Co-Founder, Chief Science Officer, and Chairman of the Board of Directors at Longeveron (https://nnw.fm/A1UJp ).
ELPIS I is an open-label, Phase 1b trial specifically designed to evaluate the safety of Lomecel-B(TM) in patients with HLHS. Initial results demonstrated that the study met its primary safety endpoint and that all patients were alive, transplant-free, and maintained their expected growth rate one year after treatment. With these promising results, Longeveron is optimistic about the results to be shared later in the year. In addition, its management is excited for the next steps in the study, particularly as the company continues to enroll patients at the eight sites in the ELPIS II trial, a 38-patient, randomized (1:1) blinded, controlled Phase 2 clinical trial designed to evaluate the safety and efficacy of intramyocardial injection of Lomecel-B(TM) in infants with HLHS undergoing the Glenn Procedure.
“There is a major unmet need among children with HLHS, and today’s data highlighting the 100% survival rate of ELPIS I patients up to 5 years post-treatment underscore the potential opportunity for Lomecel-B(TM) as a much-needed therapeutic innovation for this patient group,” noted Sunjay Kaushal, M.D., Ph.D. Principal Investigator of the ELPIS I trial.
There is no FDA-approved medical treatment for HLHS, leaving a vast untapped market for Longeveron. So far, the product has received Fast Track Designation, Rare Pediatric Disease Designation, and Orphan Drug Designation from the United States Food and Drug Administration (“FDA”), which represent significant milestones for the company as it continues its work towards seeking FDA approval of Lomecel-B(TM) for HLHS.
With these studies, the company looks to tap into several market opportunities, projecting that the potential market size for its Lomecel-B(TM) in treating HLHS could be up to $1 billion annually, globally. In addition, the company is investigating Lomecel-B(TM) to address Alzheimer’s disease, which represents a market between $5 billion to $10 billion annually, as well as Aging-related Frailty, which represents a market between $4 billion and $8 billion globally per year.
For more information, visit the company’s website at www.Longeveron.com
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
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