Enlivex Therapeutics completes recruitment in Phase Ib trial of Allocetra
Enlivex Therapeutics reported completion of patient recruitment into the Company's Phase Ib clinical trial in patients with severe sepsis. 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. ALLOCETRA 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 and/or hematopoietic stem cell transplantations; organ dysfunction and acute multiple organ failure associated with sepsis; and enablement of an effective treatment of solid tumors via immune checkpoint rebalancing.