Sepsis

Agennix is preparing to initiate an NIH-funded, randomized, double-blind, placebo-controlled, multi-center, Phase II trial in patients with severe sepsis. A total of 190 patients admitted to a hospital intensive care unit (ICU) with severe sepsis will receive standard therapy plus either oral talactoferrin or placebo. The primary endpoint of the trial will be 28-day all-cause mortality. Secondary endpoints will include number of ICU days, shock-free days, incidence and severity of organ failure/dysfunction, and circulating levels of pro-inflammatory cytokines. The study is expected to start in early 2008. The trial will be funded by a $3 million Phase I/II Fast-Track Small Business Innovative Research (SBIR) grant from the National Institutes of Health (NIH).

Sepsis is a major and increasing cause of multi-organ failure and death throughout the world. There are approximately 750,000 cases of sepsis each year in the U.S., with roughly 500,000 ICU admissions and 210,000 deaths, making sepsis a leading cause of death. Sepsis is a multi-factorial disease. Multi-organ damage from high levels of circulating cytokines originating from the gut is an important contributor to sepsis-induced morbidity and mortality. Talactoferrin modulates these gut-induced cytokine surges through its effects on the Gut Associated Lymphoid Tissue. In preclinical experiments, oral talactoferrin significantly reduced mortality from endotoxin- and bacterially-induced sepsis, and reduced the systemic cytokine surge induced by endotoxin. Successful development of oral talactoferrin for the treatment of sepsis would satisfy a significant unmet medical need, and address a potential annual market of over $2 billion.