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Enlivex Announces Regulatory Clearance in Multiple Countries for Integration of Frozen Allocetra Formulation and Expansion of Patient Population in its Sepsis Phase II Clinical Trial
Sepsis Phase II protocol amendments have been cleared by regulatory authorities in Israel, Spain, and Greece. In addition to these clearances, Enlivex plans
About this update from Enlivex Ltd.
[{"type":"text","content":"Sepsis Phase II protocol amendments have been cleared by regulatory authorities in Israel, Spain, and Greece. In addition to these clearances, Enlivex plans to obtain clearances for these protocol amendments in additional jurisdictionsDevelopment of frozen Allocetra™ formulation, a primary cornerstone of Enlivex’s R&D efforts during the last two years, was successfully completed in Q1 2022, twelve months ahead of schedule, following which Enlivex filed the Sepsis Phase II protocol amendment The shelf life of frozen Allocetra™ formulation is expected to be vastly superior to that of its liquid formulation, leading to anticipated improvements in manufacturing scalability and shipping logistics, which is expected to lower production costs and increase profitability upon potential commercializationIn addition to utilization of the frozen Allocetra™ formulation, the protocol amendments allow expansion of the study population, which was originally limited to patients with pneumonia-associated sepsis, to include patients whose septic condition stems from biliary, urinary tract, or abdominal infections. Nes-Ziona, Israel, Aug. 24, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that regulatory authorities in Israel, Spain, and Greece have cleared amendments to the protocol of the Company’s Phase II trial evaluating Allocetra™ in patients with sepsis. The amendments enable the treatment of newly recruited patients with a frozen Allocetra™ formulation and allow expansion of the study population, which was originally limited to patients with pneumonia-associated sepsis, to include patients whose septic condition stems from biliary, urinary tract, or abdominal infections. Enlivex also intends to submit the same protocol amendments to regulators in additional jurisdictions. Enlivex expects that broad acceptance of the proposed amendments will shorten the timeline for potential regulatory approval of frozen Allocetra™ formulation in sepsis and its associated commercial launch. In addition, the frozen formulation of Allocetra™ is expected to have a shelf-life spanning multiple years, versus a shelf life of 96 hours for the previously used liquid formulation. This is expected to dramatically improve manufacturing scalability and sh...