Enlivex’s forecast is that approval in the various countries of the updated protocol will shorten the timeline for potential regulatory approval of the frozen formulation of Allocetra for the treatment of sepsis and related commercial launch. In addition, the frozen formulation of Allocetra is expected to have a shelf life of several years, compared to the 96-hour shelf life of the liquid formulation previously used. This is expected to dramatically improve production expansion, shipping logistics and production costs.
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“The approval of the protocol update in key geographies is a significant milestone for Enlivex. We are better positioned to promote our positive results from phase Ib and accelerate the progress of the sepsis program,” noted Dr. Oren Hershkovich, CEO of Enlivex. “The sepsis clinical program is designed to address a high and urgent medical need that remains unanswered, as there are currently no treatments approved by the FDA for the millions of patients diagnosed with sepsis every year. We thank the regulators in Israel, Spain and Greece for their work to approve the amendments.”
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Each year, more than 1.7 million adults in the US develop sepsis, and more than 270,000 die from the disease. Enlivex’s sepsis program is backed by previously reported positive results from a phase Ib trial, which demonstrated a good safety profile for Allocetra and showed improved clinical outcomes, including SOFA (Systems Collapse Index) scores, length of hospital stay and mortality between patients treated with Allocetra and a matched control group who received standard care.
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