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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年後治療的主要終點安全性方面已達到,生存率爲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.

開發再生藥物的臨床階段生物技術公司Longeveron Inc.(納斯達克股票代碼:LGVN)今天宣佈,在2024年10月27日至28日在伊利諾伊州芝加哥舉行的先天性心臟外科醫生協會(CHSS)第51屆年會上,其來自ELPIS I一期臨床試驗多年後續研究的積極長期無移植存活率數據已在2024年10月27日至28日在伊利諾伊州芝加哥舉行的先天性心臟外科醫生協會(CHSS)第51屆年會上做了口頭報告。

  • 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
  • 口頭陳述強調了以下發現:在一項開放標籤的後續研究中,在ELPIS I中接受Lomecel-btm治療的患者在第二階段格倫手術後的5年存活率爲100%,無需進行心臟移植;相比之下,單心室重建試驗的最大數據集顯示存活率爲83%,心臟移植率爲5.2%
  • ELPIS I 在 1 年的後期治療中達到了其主要安全終點,存活率爲 100%,100% 無需移植,患者在治療一年後保持預期的生長率
  • 研究結果支持以細胞爲基礎的療法作爲HLHS重建手術的潛在輔助手術,以提高臨床療效並減少後續心臟移植的需求
  • ELPIS II 20期臨床試驗目前正在進行中,進一步評估了Lomecel-BTM作爲HLHS的潛在輔助療法與單獨使用標準治療的比較
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