Allocetra™ for the treatment of sepsis.
Enlivex is developing Allocetra™ as an adjunctive immunomodulating cell therapy platform to potentially prevent organ failure caused by sepsis. Following a sepsis diagnosis, the drug would be administered intravenously to patients alongside standard of care treatment.
Sepsis, a heterogeneous and life-threatening syndrome, is defined as organ dysfunction resulting from a dysregulated host response to an infection. A common mechanism driving the severity of sepsis is a cytokine storm, a severe immune response characterized by the rapid and excessive release of cytokines into the bloodstream.
While a disproportionate inflammatory response to invasive infection was long considered the central driver of sepsis, it is now understood that the host response is far more complex, involving both sustained excessive inflammation and immune suppression, resulting in a failure to return to normal homeostasis.
We believe that many of the outcomes, specifically organ damage and failure, could be prevented, thereby significantly increasing a patient’s chance of survival with reduced morbidity
OUR CLINICAL TRIALS
Sepsis imposes a substantial global burden in terms of morbidity and mortality.
Nearly all patients with severe sepsis require treatment in an intensive care unit.
Sepsis, identified by the World Health Organization as a global health priority, has no proven pharmacologic treatment other than select antibiotic agents, fluids, and vasopressors. According to the CDC, at least 1.7 million adults in the United States develop sepsis each year, with approximately 270,000 dying of the disease.
Among all sepsis cases, up to an estimated 31% are urosepsis, representing up to 9.8 million cases and up to 1.6 million deaths worldwide, annually (G. Bonkat et. al; 2018). Various studies estimate that sepsis is present in 30% to 50% of hospitalizations that culminate in death (Rhee et al; 2019).