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Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra™ In Patients With Sepsis
Nes-Ziona, Israel, July 31, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming
About this update from Enlivex Ltd.
[{"type":"text","content":"Nes-Ziona, Israel, July 31, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed under the amended protocol for the Company’s Phase II trial evaluating Allocetra™ in patients with sepsis. As previously announced, the amended protocol allows a higher SOFA score inclusion range, which allows the recruitment of patients with higher levels of sepsis severity. Additionally, the amended protocol provides for two cohorts (treatment and placebo) rather than the prior protocol’s four-cohort structure. “We are pleased that the approval of the amended protocol in France, Belgium and Netherlands aligns with the Company’s planned timeline for the initiation of recruitment as per the amended protocol,” stated Oren Hershkovitz, CEO of Enlivex. “Therefore, we believe that the top-line data readout from the Phase II trial will be in Q1 2024, which is consistent with our previously announced timeline.” ABOUT ALLOCETRA™ Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as \"unmet medical needs\", as a stand-alone therapy or in combination with leading therapeutic agents. ABOUT ENLIVEX Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “...