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Enlivex Announces Positive Final Safety and Efficacy Data From Clinical Trial of Off-The-Shelf Allocetra in Patients with Severe Sepsis
– Final Analysis Comparing 10 AllocetraTM-Treated Patients with 37 Matched Controls Showed Significant Positive Responses in State of Organ Failure, ICU
About this update from Enlivex Ltd.
[{"type":"text","content":"– Final Analysis Comparing 10 AllocetraTM-Treated Patients with 37 Matched Controls Showed Significant Positive Responses in State of Organ Failure, ICU Hospitalization and Mortality in a Highly Fragile and Extremely Difficult to Treat Population with Severe Sepsis –\n Nes Ziona, Israel, March 18, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today announced positive final safety and efficacy data from the Company’s completed Phase Ib clinical trial in patients with severe sepsis. The final analysis compared the clinical data of 10 patients admitted to the intensive care unit with sepsis who were administered off-the-shelf AllocetraTM (“Allocetra-OTS”) upon their admission, with 37 patients who were matched controls (matched by age, gender, Sequential Organ Failure Assessment (SOFA) score, and infection source) who received only the standard of care treatment at the same hospital during 2014-2019 but did not receive Allocetra-OTS. The clinical trial was conducted at Hadassah Medical Center, which is one of the largest and most prestigious hospitals in Israel (“Haddasah”). The primary aim of the clinical trial was to determine the safety profile and tolerability of . In addition, effects on, mortality, organ dysfunction and number of hospitalization days in general and in the intensive care unit (ICU) were measured. MortalityThe Acute Physiology and Chronic Health Evaluation (APACHEII) score of the Allocetra OTS-treated group was 12.3, and the corresponding probability of mortality of at least one patient in that group was predicted at 85% based on the hospital’s ICU staff’s clinical assessment of each patient’s overall condition at admission. However, none (0%) of the Allocetra-OTS-treated patients died during the 28-day study period, as compared to 27% 28-day mortality in the matched controls group. Sepsis & Organ FailureEach of the 10 Allocetra-OTS-treated patients had between 2 to 5 dysfunctional organ systems upon admission to the ICU. All (100%) of the Allocetra-OTS-treated patients had rapid and complete recovery from their septic conditions and of any organ dysfunction that was present upon admission to the ICU. Despite the similarity of organ-failure state (SOFA) at entry between the Allocetra-OTS-treated patients and the matched controls group (average of 3.4 ...