RevImmune, a privately held biotech company based in Paris, France and Bethesda, MD, developing CYT107 (recombinant human Interleukin-7) for infectious diseases, sepsis and cancer, announced today that its "ILIAD-7" international randomized controlled Phase 2 trial in patients critically ill with COVID-19, is now enrolling patients at 5 sites in the U.S. The trial has already been under way for some time in the U.K. and France and is about to start in Brazil.
This ILIAD-7 trial has started enrolling patients at Barnes Jewish Hospital-Missouri Baptist Medical Center and Washington University in St. Louis, and 4 additional sites: the Cleveland Clinic, Stony Brook University Hospital, the University of Florida Medical Center, and Rutgers New Brunswick Medical Center. Additional sites are in process.
Dr. Kenneth Remy, physician-scientist at Washington University in St. Louis explains, "data over the past few months from our laboratory and a growing body of literature from others regarding COVID-19 has demonstrated that patients have a sustained and severe loss of lymphocytes with a profound immune suppression rather than exclusively a cytokine storm. Patients who succumb to COVID-19 have the most severe loss of lymphocytes and have a high incidence of developing secondary hospital-acquired infections."
Dr. Vidula Vachharajani, Professor of Medicine, Cleveland Clinic Lerner College of Medicine, stated that "IL-7 offers a potential new way to restore immunity in COVID-19 patients and may reduce the incidence of secondary hospital acquired infections."
To date, CYT107 has been administered in clinical trials to over 500 patients with diverse infectious diseases, sepsis and cancers, with an excellent safety profile and encouraging results. The primary mechanism of action of CYT107 works to restore lymphocyte function and increase lymphocyte proliferation of lymphocytes thereby aiding in the elimination of invading pathogens.
Early success with CYT107 in critically ill COVID-19 patients, published in the Journal of American Medical Association (JAMA) Open Network in August, showed that CYT 107 improved absolute lymphocyte counts in 12 compassionate use patients with COVID-19.
The CYT107 treatment being tested in the current phase 2 randomized controlled trial is designed to improve survival in critically ill patients with hypoxemia and severe lymphopenia (low lymphocyte counts). The study is currently enrolling at 5 sites in the U.S., and is expected to continue through December.
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