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Enlivex Receives Regulatory Authorization to Expand its Phase II Sepsis Trial into Greece
Nes-Ziona, Israel, Dec. 07, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming
About this update from Enlivex Ltd.
[{"type":"text","content":"Nes-Ziona, Israel, Dec. 07, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that, following a review of the Company’s preclinical and clinical data, study design, and manufacturing process, Greece’s National Organization of Medicines has authorized the expansion of the Company’s Phase II trial of AllocetraTM in patients with pneumonia-associated sepsis to sites in the country. The placebo-controlled trial, which has multiple sites currently open for enrollment in Israel and was recently cleared to expand into Spain, is expected to enroll 120 to 160 patients across four cohorts receiving varying doses of AllocetraTM or placebo, all in addition to standard-of-care therapy. The trial's two primary endpoints are safety (number and severity of adverse events and severe adverse events) and efficacy (change from baseline in sequential organ failure (SOFA) score), which will be assessed throughout a 28-day follow-up period. Additionally, the trial’s secondary endpoint is 28-day all-cause mortality. The trial is supported by previously reported positive results from a Phase Ib trial that demonstrated a positive safety profile and vastly improved clinical outcomes, including SOFA scores, duration of hospitalization, and mortality, in Allocetra-treated sepsis patients compared to a group of matched historical controls that received standard-of-care therapy. Interim results from the Phase II trial are expected in the first half of 2022, and top-line data are expected by year-end 2022. Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, “Receiving clearance to expand our sepsis trial into Greece is an important accomplishment that we believe demonstrates our ability to efficiently execute on our regulatory strategy. It also underscores the strength of our datasets and the rigor of our study design and manufacturing process. Looking ahead, we will continue our efforts to efficiently advance this trial, including working with additional regulatory agencies to further expand the trial throughout Europe.” ABOUT ALLOCETRATM AllocetraTM is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram ...