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在治療後的1年內達到了安全性的主要終點,存活率達到100%
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.
納斯達克股票代碼爲LGVN的Longeveron Inc.(Longeveron公司)是一家臨床階段的生物技術公司,致力於開發再生醫學,今天宣佈其來自ELPIS I階段1臨床試驗的多年追蹤研究中的正面長期無移植生存數據被特色板塊在芝加哥伊利諾伊州舉辦的先天性心臟外科醫師學會(CHSS)第51屆年會上口頭演示。會議日期爲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
- 口頭演示強調了在ELPIS I的Lomecel-BTm治療,進行開放性追蹤研究的患者在接受格倫第2階段手術後的5年存活率爲100%,無需心臟移植;相比之下,單心室重建試驗的最大數據集顯示83%的存活率,心臟移植率爲5.2%。
- ELPIS I通過了其通過1年後治療的安全主要終點,具有100%的存活率,100%無需移植,並且患者在治療後一年後保持了預期的生長速度。
- 研究結果支持基於細胞的療法作爲HHLH重建手術的潛在輔助療法,以改善臨床效益,減少隨後心臟移植的需求。
- ELPIS II第20億臨床試驗目前正在進行,進一步評估Lomecel-BTm作爲HHLH潛在輔助療法與僅採用標準治療的比較。
譯文內容由第三人軟體翻譯。
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