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Enlivex Therapeutics Announces Positive Interim Safety and Efficacy Data From Ongoing Trial of Off-The-Shelf Allocetra in Patients with Severe Sepsis
-- Interim Analysis Comparing Allocetra-Treated Patients with 37 Severe Sepsis Patients with Equivalent Source of Infection and Disease Severity Who Were
About this update from Enlivex Ltd.
[{"type":"text","content":"-- Interim Analysis Comparing Allocetra-Treated Patients with 37 Severe Sepsis Patients with Equivalent Source of Infection and Disease Severity Who Were Hospitalized at the Same Hospital, Demonstrates Potential of Allocetra as Therapy for Prevention of Sepsis-Associated Organ Failure and Mortality --\nNes Ziona, Israel, Nov. 04, 2019 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today announced positive interim efficacy data from the Company’s ongoing Phase Ib clinical trial in patients with severe sepsis. The interim analysis is based on a dataset of 43 patients with severe sepsis, all hospitalized at Hadassah Medical Center, which is one of the largest and most prestigious hospitals in Israel. Six patients admitted to Hadassah’s intensive care unit with sepsis have been administered with off-the-shelf Allocetra (“OTS Allocetra”) upon their admission, while 37 patients were matched controls that received standard of care treatment during 2016-2019 but did not receive OTS Allocetra.\n The primary safety parameter was 28 days mortality. None (0 of 6) of the OTS Allocetra -treated patients died during this period, compared to 11 of 37 (29%) in the matched control group who died during this period. OTS Allocetra treatment resulted in improved efficacy in all analyzed parameters, which included the sequential organ failure assessment (SOFA) score (the higher the score, the worse the clinical condition of various organs), as well as recovery from sepsis, number of days of hospitalization in the intensive care unit, and others. The interim and efficacy data are as follows: Sepsis OutcomesMatched Untreated GroupOTS Allocetra Treated Group % of patients that recovered from sepsis within 28 days Significant increase in recovery from sepsis in patients that were treated with Allocetra-OTS48%100% % mortality of patients 29%0% Average organ failure score (SOFA) at admission vs maximal reached during hospitalization OTS Allocetra substantially prevents organ failure in severe sepsis patientsAvg. at admission: 3.98 Avg. maximal: 8.11Avg. at admission: 4.5 Avg. maximal: 4.5 Median organ failure score (SOFA) at admission vs maximal reached during hospitalization Median at admission: 4 Median maximal: 8Median at admission: 4.5 Median maximal: 4.5 % of patients with organ failure score (SOF...