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Enlivex Reports Positive Interim Results From Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients
Nes Ziona, Israel, Dec. 03, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage immunotherapy company, today
About this update from Enlivex Ltd.
[{"type":"text","content":"Nes Ziona, Israel, Dec. 03, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage immunotherapy company, today reported positive interim results of an investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients. The interim clinical results relate to eight COVID-19 patients who were treated with AllocetraTM in the Phase II clinical trial , six of whom were in severe condition and two of whom were in critical condition. Key results and conclusions from both the ongoing Phase II clinical trial, as well as a previously-reported investigator-initiated Phase Ib study include: Seven out of seven (100%) patients treated through November 26, 2020 had complete recovery from their respective severe/critical condition and were discharged from the hospital, after an average of 4.7 days following AllocetraTM administration. Taken together with previously-treated patients in the concluded Phase Ib study, twelve out of twelve patients (100%) through November 26, 2020 had complete recovery from their respective severe/critical condition and were discharged from the hospital, after an average of 5.5 days following AllocetraTM administration. The eighth treated patient in the Phase II study (and 13th treated patient overall), who enrolled in the Phase II study in critical condition on November 27, 2020, has experienced a clinical improvement following treatment with AllocetraTM and is classified as moderate/severe condition on the date of this press release. The patient remains hospitalized six days after treatment (results from patients enrolled in the prior Phase Ib investigator-initiated study showed an average of nine days to hospital discharge following AllocetraTM administration to critical patients). AllocetraTM treatment has been well tolerated with no treatment-related serious adverse events. Data from both the previously-reported investigator-initiated Phase Ib study and the ongoing investigator-initiated Phase II COVID-19 trials are shown below: Clinical Trial# Patients enrolledDisease SeverityClinical OutcomeHospitalizationPost Administration of AllocetraTMRecoveredMortalityDischargedDuration (days, avg.)Phase Ib PatientsPhase Ib3Severe3/3 (100%)0/3 (0%)3/3 (100%)5Phase Ib2Critical2/2 (100%)0/2 (0%)2/2 (100%)9Total5 5/5 (100%)0/5 (0%)5/5 (1...