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Agennix Initiates A Randomized Double-Blind, Placebo-Controlled Phase 2 Study of Oral Talactoferrin in Severe Sepsis
Date:4/22/2008

nt funding.

"The SBIR grant for sepsis, with its $3 million budget, will allow us to conduct the study with enough patients to provide an answer regarding talactoferrin's activity in the clinical setting," said Robert Lodato, M.D., Associate Professor of Medicine, University of Texas Health Science Center, and Medical Monitor for the study.

About the Phase 2 Study

The double-blind, placebo-controlled Phase 2 study of talactoferrin will enroll 190 patients who have a diagnosis of sepsis with at least one organ dysfunction due to sepsis. Patients will receive standard therapy (including, at the discretion of the primary physician, drotrecogin alfa activated, marketed as Xigris(R)(1), and will be randomly assigned (1:1) to receive either talactoferrin (1.5 g) or placebo three times a day for up to 28 days or until discharge from the intensive care unit (ICU), whichever occurs first. The primary efficacy endpoint of the trial is 28-day all-cause mortality. Secondary endpoints include number of ICU days, shock-free days, incidence and severity of organ failure/dysfunction and circulating levels of pro- inflammatory cytokines. Safety will be monitored and patients will be followed for survival at three and six months post-randomization.

About Sepsis

Sepsis is a clinical syndrome consisting of known or suspected infection and associated inflammatory response. Severe sepsis is defined as the presence of sepsis with dysfunction of one or more organs. The incidence of sepsis in the United States is estimated to be approximately 750,000 cases per year, with an annual increase of approximately 1.5%, and estimated mortality due to sepsis of 210,000 deaths each year. According to the Centers for Disease Control and Prevention, sepsis is among the top 10 leading causes of death in the United States.

Treatment for sepsis consists of eradicating the underlying infection and providing supportive care for any associated organ dysfunction. In N
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SOURCE Agennix, Inc.
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