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ProKidney公布治疗糖尿病CKD的肾自体细胞疗法(REACT®)RMCL-002的2期临床试验中期阳性数据

ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT®) for Diabetic CKD and Provides Corporate Updates

GlobeNewswire 等信源发布 2023-11-14 06:02

可切换为仅中文


Updated positive interim Phase 2 data demonstrate potential efficacy of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients Focusing Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure and need for renal replacement therapy Dr.

更新的阳性中期2期数据显示REACT®在中度和高危糖尿病CKD患者中保留肾功能的潜在功效,重点关注3b期和4期糖尿病CKD患者进展为肾功能衰竭的最高风险的3期开发计划,需要肾脏替代疗法Dr。

Bruce Culleton appointed ProKidney CEO following Dr. Tim Bertram’s transition to advisory role Sufficient capital to fund operations into fourth quarter 2025 ProKidney to host conference call and webcast tomorrow at 8:00 a.m. ET WINSTON-SALEM, N.C., Nov. 13, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp.

布鲁斯·卡勒顿(Bruce Culleton)任命了ProKidney首席执行官,原因是蒂姆·伯特拉姆(Tim Bertram)博士过渡到咨询职位-足够的资金资助业务进入第四季度2025年ProKidney明天上午8:00召开电话会议和网络广播-新罕布什尔州WINSTON-SALEM,2023年11月13日(GLOBE NEWSWIRE)-ProKidney Corp。

(Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced updated positive interim diabetic CKD data from its RMCL-002 Phase 2 study that support the Company’s evolution into late-stage development and position the Company to change the treatment paradigm in high-risk diabetic CKD patients with its REACT® (rilparencel) renal autologous cell therapy.

(纳斯达克股票代码:PROK)(“ProKidney”)是一家专注于慢性肾病(CKD)的领先的晚期临床细胞治疗公司,今天宣布其RMCL-002 2期研究更新了积极的中期糖尿病CKD数据,支持该公司发展为晚期发展,并使该公司通过其REACT®(rilparencel)肾脏改变高危糖尿病CKD患者的治疗模式自体细胞疗法。

Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients. Updated interim REACT RMCL-002 study data support continued investigation of REACT’s potential to benefit patients with moderate and high-risk diabetic CKD. The updated data include information from 83 patients enrolled in the RMCL-002 study.

阳性中期2期数据显示REACT®在中高危糖尿病CKD患者中保留肾功能的潜力。更新的中期REACT RMCL-002研究数据支持继续调查REACT有利于中高危糖尿病CKD患者的潜力。更新的数据包括来自RMCL-002研究的83名患者的信息。

All patients had Stage 3 or 4 CKD caused by type 2 diabetes. The ongoing Phase 2 clinical study assessed adverse events and changes in kidney function as measured by estimated glomerular filtration rate (eGFR), as primary study endpoints. The dataset revealed a safety profile in line with previous Phase 1 & 2 REACT trials, with REACT showin.

所有患者均有2型糖尿病引起的3或4期CKD。正在进行的2期临床研究评估不良事件和肾功能的变化,通过估计的肾小球滤过率(eGFR)测量,作为主要研究终点。该数据集显示了与之前的1期和2期REACT试验一致的安全性,并显示了REACT。