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Enlivex在评估Allocetra™治疗膝关节骨性关节炎的I/II期试验中开始给最初两名患者用药

Enlivex Initiates Dosing of Initial Two Patients in Phase I/II Trial to Evaluate Allocetra™ for Knee Osteoarthritis

PHARMA FOCUS ASIA | 2024-04-23 | 翻译由动脉网AI生成,点击反馈

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Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has commenced dosing for the initial two patients in its Phase I/II trial evaluating AllocetraTM for moderate to severe knee osteoarthritis. This multi-country trial aims to enroll up to 160 patients.The trial consists of two stages: an initial safety run-in phase and a subsequent randomized, controlled phase.

Enlivex Therapeutics Ltd.(纳斯达克股票代码:ENLV)在其评估AllocetraTM治疗中度至重度膝关节骨性关节炎的I/II期试验中,已开始为最初的两名患者服用药物。这项多国试验旨在招募多达160名患者。该试验包括两个阶段:初始安全磨合阶段和随后的随机对照阶段。

The safety run-in phase, focusing on dose escalation and open-label administration, will determine the appropriate dosage and injection schedule for the randomized phase. Following the safety run-in, a double-blind, placebo-controlled stage will assess both safety and efficacy, with primary endpoints centered on joint-pain and joint-function compared to placebo at three, six, and twelve months post-treatment.Dr.

安全磨合阶段侧重于剂量递增和开放标签给药,将确定随机阶段的适当剂量和注射时间表。在安全性磨合之后,双盲,安慰剂对照阶段将评估安全性和有效性,主要终点集中在治疗后三个月,六个月和十二个月的关节疼痛和关节功能上,与安慰剂相比。博士。

Einat Galamidi, Vice President of Medical at Enlivex, expressed satisfaction with the trial's progress, highlighting the enrollment and dosing of the initial participants. This phase is crucial in establishing the groundwork for the subsequent randomized stage.Osteoarthritis, affecting millions worldwide, represents a significant unmet medical need, with current treatments primarily focused on symptom management.

Enlivex医学副总裁Einat Galamidi对试验的进展表示满意,并强调了初始参与者的注册和剂量。这一阶段对于为随后的随机阶段奠定基础至关重要。骨关节炎影响着全球数百万人,是一种尚未得到满足的医疗需求,目前的治疗主要集中在症状管理上。

AllocetraTM, designed to reprogram macrophages into their normal state, offers a promising therapeutic approach for various diseases, including knee osteoarthritis, where macrophage dysfunction plays a significant role in disease severity.This milestone marks a step forward in Enlivex's mission to address critical medical needs through innovative immunotherapy approaches. Source: globenewswire.com.

AllocetraTM旨在将巨噬细胞重新编程为正常状态,为包括膝关节骨关节炎在内的各种疾病提供了一种有前途的治疗方法,其中巨噬细胞功能障碍在疾病严重程度中起着重要作用。这一里程碑标志着Enlivex通过创新的免疫治疗方法解决关键医疗需求的使命向前迈出了一步。来源:globenewswire.com。

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