Benzinga | Oct 22, 2020 08:46AM EDT

Enlivex Therapeutics Reports Dosing Of First 2 Patients In Phase 2 Trial Evaluating Allocetra In Severe, Critical COVID-19 Patients

Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the &ldquo, Company&rdquo, ))), a clinical-stage immunotherapy company, today reported that the first two patients have been dosed in an investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients.

This COVID-19 study is designed as 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 AllocetraTM in combination with standard of care treatment. The trial plans to evaluate safety, tolerability, cytokine profile and efficacy parameters. Each patient in the clinical trial will be observed for 28 days following administration of AllocetraTM.

The newly initiated Phase II study follows recently reported positive top-line results from a Phase Ib investigator-initiated clinical trial of AllocetraTM in COVID-19 patients in severe and critical condition. The Phase Ib study took place in Hadassah Hospital, one of the largest hospitals in Israel, and 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 AllocetraTM, at which time they were all COVID-19 PCR negative. There were no reported severe adverse events relating to the administration of AllocetraTM in the patients, and the therapy was well-tolerated.