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Enlivex Therapeutics (NASDAQ:ENLV) has announced data from its ongoing Phase 1b clinical trial in patients with severe sepsis in addition to a recommendation to regulatory authorities to keep enrolling patients in the study. As quoted in the press release: Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated immune response to infection. …
Enlivex Therapeutics (NASDAQ:ENLV) has announced data from its ongoing Phase 1b clinical trial in patients with severe sepsis in addition to a recommendation to regulatory authorities to keep enrolling patients in the study.
As quoted in the press release:
Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated immune response to infection. Sepsis has been identified by the World Health Organization as a global health priority, and currently has no FDA-approved pharmacologic treatment. Sepsis is the third leading cause of mortality in the United States after cardiovascular and cancer diseases and affects approximately 1.7 million adults in the United States each year. Various studies have estimated that up to 50% of severe sepsis hospitalizations culminate in death.
The ongoing Phase Ib study is the first clinical trial of off-the-shelf AllocetraTM (“OTS Allocetra”) in human subjects. Enlivex developed OTS Allocetra as a second-generation cell therapy to the matched-donor Allocetra product, which has demonstrated a robust safety and clinical efficacy profile in a Phase IIa clinical trial for the prevention of graft-versus-host disease in patients post bone-marrow transplantations. Enlivex has designed the off-the-shelf product to eliminate the need to find matched donors as the source of the therapeutic cells. Following regulatory approval, if obtained, OTS Allocetra would allow Enlivex to manufacture therapeutic product inventory that could be used for additional clinical indications that require swift infusion of the product to patients. The first such indication Enlivex is targeting is prevention of cytokine storms and organ dysfunction associated with sepsis.
The six patients in the Phase Ib clinical trial of OTS Allocetra had severe sepsis at the time of OTS Allocetra infusion. All six patients tolerated the infusion without serious adverse events, demonstrated swift clinical improvement after administration of the standard of care treatment combined with OTS Allocetra, and were released from the hospital after the condition of severe sepsis had been eliminated.