Enlivex Therapeutics’ Phase 1b clinical trial is evaluating the company’s Allocetra in patients with severe sepsis.
Enlivex Therapeutics (NASDAQ:ENLV) has announced it has completed patient enrollment in its Phase 1b clinical trial in patients with sepsis.
As quoted in the press release:
The study was designed to recruit ten patients, including six treated with a single dose of Allocetra, and four patients treated with two doses of Allocetra.
Enlivex announced on November 4, 2019 positive interim safety and efficacy data from an ongoing trial of off-the-shelf universal Allocetra in patients with severe sepsis. The interim analysis comparing the first six Allocetra-treated patients with 37 severe sepsis patients with equivalent source of infection and disease severity who were hospitalized at the same hospital, demonstrated the potential of single dose Allocetra infusion as therapy for prevention of sepsis-associated organ failure and mortality.
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.
ALLOCETRATM by Enlivex was designed to provide a novel immunotherapy mechanism of action that targets life-threatening clinical indications that are defined as “unmet medical needs”, including prevention or treatment of complications associated with bone marrow transplantations (BMT) and/or hematopoietic stem cell transplantations (HSCT); organ dysfunction and acute multiple organ failure associated with sepsis; and enablement of an effective treatment of solid tumors via immune checkpoint rebalancing.