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Longeveron Said ELPIS I Met Its Primary Endpoint Of Safety Through 1-year Post-treatment, With 100% Survival Rate

Longeveron Said ELPIS I Met Its Primary Endpoint Of Safety Through 1-year Post-treatment, With 100% Survival Rate

Longeveron表示,ELPIS在1年后治疗的主要终点安全性方面已达到,生存率为100%
Benzinga ·  10/27 16:48

Longeveron Inc. (NASDAQ:LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that its positive long-term transplant-free survival data from a multi-year follow-on study to the ELPIS I Phase 1 clinical trial were featured in an oral presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting taking place October 27-28, 2024 in Chicago, Illinois.

纳斯达克股票代码为LGVN的Longeveron Inc.(Longeveron公司)是一家临床阶段的生物技术公司,致力于开发再生医学,今天宣布其来自ELPIS I阶段1临床试验的多年追踪研究中的正面长期无移植生存数据被特色板块在芝加哥伊利诺伊州举办的先天性心脏外科医师学会(CHSS)第51届年会上口头演示。会议日期为2024年10月27-28日。

  • Oral presentation highlights findings that patients treated with Lomecel-BTM in ELPIS I, in an open-label follow-on study, experienced 5-year survival after stage 2 Glenn surgery of 100% with none requiring heart transplant; this compared to the largest data set from the Single Ventricle Reconstruction Trial which showed 83% survival, with a 5.2% heart transplantation rate
  • ELPIS I met its primary endpoint of safety through 1-year post-treatment, with 100% survival rate, 100% transplant-free and patients maintained expected rate of growth one year after treatment
  • Findings support cell based therapy as a potential adjunct to HLHS reconstruction surgery to improve clinical benefits and reduce the need for subsequent heart transplantation
  • ELPIS II Phase 2b clinical trial is currently ongoing, further evaluating Lomecel-BTM as a potential adjunct therapy for HLHS versus standard of care alone
  • 口头演示强调了在ELPIS I的Lomecel-BTm治疗,进行开放性追踪研究的患者在接受格伦第2阶段手术后的5年存活率为100%,无需心脏移植;相比之下,单心室重建试验的最大数据集显示83%的存活率,心脏移植率为5.2%。
  • ELPIS I通过了其通过1年后治疗的安全主要终点,具有100%的存活率,100%无需移植,并且患者在治疗后一年后保持了预期的生长速度。
  • 研究结果支持基于细胞的疗法作为HHLH重建手术的潜在辅助疗法,以改善临床效益,减少随后心脏移植的需求。
  • ELPIS II第20亿临床试验目前正在进行,进一步评估Lomecel-BTm作为HHLH潜在辅助疗法与仅采用标准治疗的比较。
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