Enlivex receives IMOH clearance for Phase I/II trial of Allocetra

Enlivex Therapeutics announced that an independent Data and Safety Monitoring Board, DSMB, has completed an interim data review for the first cohort of patients in the Company’s ongoing Phase I/II clinical trial of Allocetra in patients with advanced-stage peritoneal metastasis arising from solid tumors as an add-on to the standard of care, SoC, chemotherapy administered via Pressurized Intraperitoneal Aerosol Chemotherapy. The Israeli Ministry of Health, IMOH, also reviewed the interim data and provided regulatory clearance to continue the study and open the study’s next cohort. In addition, the safety profile supported a protocol amendment to start new patients in the second cohort with higher initial doses of Allocetra. This IMOH clearance follows a previously-reported IMOH clearance to the Company’s second Phase I/II clinical trial, which is evaluating Allocetra as monotherapy and in combination with anti-PD1 checkpoint inhibitors in patients with advanced-stage solid tumors. The DSMB based its review on available safety data for the three enrolled patients in the first cohort, in which two patients received three escalating doses of Allocetra, and one received two escalating doses of Allocetra, once every six weeks as an add-on to SoC chemotherapy delivered to the peritoneum.