Enlivex Therapeutics reported that the Israeli Ministry of Health authorized the initiation of a proposed investigator-initiated Phase II clinical trial evaluating Allocetra in severe and critical COVID-19 patients.
The planned COVID-19 study is a multi-center investigator-initiated, Phase II clinical trial. The trial is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition, and is designed to assess Allocetra in combination with standard of care treatment. The trial plans to evaluate safety, tolerability, cytokine profile and efficacy parameters.
Enlivex recently reported positive top-line results of a previously announced Phase Ib investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe and critical condition in Hadassah Hospital, one of the largest hospitals in Israel. Enlivex was scheduled to provide the Israeli Ministry of Health with a full summary of the completed Phase Ib study following a 28-day observational period for each of the five patients treated in that study, which period is scheduled to lapse in late October.
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However, based on the positive Phase Ib top-line results and the release from the hospital of all patients treated in that study, after having tested negative for COVID-19, the Israeli Ministry of Health requested expedited submission by Enlivex of its COVID-19 Allocetra Phase Ib clinical trial summary prior to the completion of the full 28-day period for the last patient in order to expedite the regulatory review process.
The Phase Ib clinical trial included five COVID-19 patients, three in severe condition and two in critical condition. All five patients completely recovered from their respective severe/critical condition and were released from the hospital after an average of 5 days (severe) and 9 days (critical), following administration of Allocetra, at which time they were all COVID-19 PCR negative. There were no reported severe adverse events relating to the administration of Allocetra in the patients, and the therapy was well-tolerated.