Enlivex announces interim safety, efficacy data from ongoing Allocetra trial
Enlivex Therapeutics 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 upon their admission, while 37 patients were matched controls that received standard of care treatment during 2016-2019 but did not receive OTS Allocetra. The primary safety parameter was 28 days mortality. None of the OTS Allocetra -treated patients died during this period, compared to 11 of 37 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 score, as well as recovery from sepsis, number of days of hospitalization in the intensive care unit, and others. The matching of the 37 patients to the OTS Allocetra-treated group was based on similar organ failure clinical SOFA score at admission, overall clinical state, age group, sex, and source of severe sepsis. All matched patients were treated at the same hospital as the Allocetra-treated group.