Enlivex announces recommendation, IMOH clearance for Phase I/II trial

Enlivex Therapeutics announced that an independent Data and Safety Monitoring Board, DSMB, has completed its prespecified data review for the first cohort of patients in the Company’s ongoing Phase I/II cell therapy clinical trial of Allocetra in patients with advanced-stage solid tumors. The Israeli Ministry of Health, IMOH, also reviewed the data and provided regulatory clearance to continue the study and open the study’s additional cohorts. The DSMB based its review on available safety data for the three enrolled patients in the first cohort in which three, once-weekly, low starting doses of AllocetraTM were administered as monotherapy. The dose-limiting toxicity period extended for one week following the last administration with an overall follow-up of 21 days. There were no mortalities nor DSMB-identified safety signals in the first cohort, and the DSMB recommended that the study continue as designed. Following the DSMB recommendation, the IMOH reviewed the safety data for the first cohort and provided a regulatory clearance to initiate the recruitment of patients into the two following cohorts in the study, both of which will be administered higher AllocetraTM doses – one as monotherapy and the other in combination with anti-PD1 therapy. Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, "We are pleased with the safety profile of AllocetraTM as demonstrated in the first three patients in this trial. We look forward to initiating the next two cohorts in which higher doses of AllocetraTM will be administered in patients, allowing Enlivex to obtain additional safety data as well as a potential indication of effect."