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Enlivex Receives Israeli Ministry of Health Authorization for the Initiation of a Phase I/II Trial Evaluating Allocetra Combined with Chemotherapy in Patients with Peritoneal Metastases Arising from Solid Cancers
Trial will be the first clinical study of Allocetra™ in patients with cancer, following encouraging preclinical data presented at the International Society
About this update from Enlivex Ltd.
[{"type":"text","content":" Trial will be the first clinical study of Allocetra™ in patients with cancer, following encouraging preclinical data presented at the International Society for Gene and Cell Therapy 2022 conference, and preclinical data in ovarian cancer presented at the American Society of Clinical Oncology 2022 conference Nes-Ziona, Israel, June 06, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, today announced that the Israeli Ministry of Health (MOH) authorized the initiation of a company-sponsored Phase I/II clinical trial evaluating Allocetra™ combined with chemotherapy in patients with peritoneal metastases arising from solid cancer. Peritoneal cancer, whether originating from a primary tumor within the peritoneum or from a metastatic tumor elsewhere in the body, is a terminal disease with a poor prognosis. Patients with peritoneal metastases are in urgent need of novel treatment options, as standard-of-care (SOC) chemotherapy provides only modest survival benefits. The median survival of patients with peritoneal metastases differs based on the location of the primary tumor but is frequently poor, with survival rates of 2.9 months, 6.5 months, and 6.9 months reported for cancers of pancreatic, gastric, and colorectal origins, respectively. The planned Phase I/II trial is an open-label dose escalation and expansion trial that is expected to enroll a total of approximately 12 patients across four cohorts. It is designed to evaluate the safety and potential preliminary efficacy of Allocetra™ combined with SOC chemotherapy in patients with peritoneal metastases arising from solid cancer. The study will begin with two cohorts of intra-patient and intra-cohort dose escalation to determine the maximum feasible dose (MFD) of Allocetra™ in this population, followed by two additional cohorts comparing administration of Allocetra™ at the selected dose either before or after administration of SOC via a pressurized intraperitoneal aerosol chemotherapy procedure (PIPAC; a technique applied when patients are not eligible to receive the standard treatment due to a considerable tumor load, or large quantities of persistent ascites and other circumstances). Intraperitoneally delivered A...