Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage company pioneering macrophage reprogramming immunotherapy, has announced great news for their Phase II trial evaluating Allocetra™ in patients with sepsis: the first patient was dosed under the recently amended protocol – allowing for a higher SOFA score inclusion range and two cohort (treatment and placebo) structure instead of the original four-cohort structure. This is a major step forward for the Company’s journey to provide improved care for septic patients.
We are delighted to announce that the amended protocol for our Phase II trial of AllocetraTM has been approved in France, Belgium, and the Netherlands, enabling us to follow the planned timeline for initiating recruitment. This means that we are on track for top-line data readout from the trial to take place in Q1 2024, just as we had previously announced.
Oren Hershkovitz, CEO of Enlivex, commented: “We are pleased that the approval of the amended protocol aligns with the planned timeline for the initiation of recruitment as per the amended protocol.”
ABOUT ALLOCETRA™
Allocetra™ is a revolutionary cell therapy that is poised to revolutionize how we treat deadly conditions such as solid cancers, sepsis, and many others. By using the power of reprogramming macrophages into their homeostatic state, Allocetra™ could provide an unprecedented immunotherapeutic mechanism to combat life-threatening conditions that have been defined as “unmet medical needs”, either on its own or as part of a combination with existing treatments.
This groundbreaking technology is poised to change the landscape of healthcare, providing hope to those afflicted with debilitating diseases.
ABOUT ENLIVEX
Enlivex is revolutionizing the immunotherapy landscape with its macrophage reprogramming therapy, Allocetra™. By reprogramming macrophages into their homeostatic state, Allocetra™ aims to restore balance to an overactive immune system, allowing for resolution of life-threatening conditions. This revolutionary ‘off-the-shelf’ cell therapy is set to provide a much-needed advance in the field of immunotherapy.