Agennix AG has announced that new data from a Phase II trial evaluating talactoferrin in the treatment of patients with severe sepsis were presented at the American Thoracic Society International Conference in Denver, Colorado.
The double-blind, placebo-controlled trial evaluated talactoferrin versus placebo in 190 adult patients with severe sepsis enrolled at 24 leading centers across the U.S.
As previously reported, the Phase II trial achieved its primary endpoint of a reduction in 28-day all-cause mortality (12.5% absolute reduction, 46.5% relative reduction).
The analysis presented at the conference evaluated the differences in a variety of cytokines and chemokines (proteins that help to regulate the immune system) in patients receiving talactoferrin versus placebo.
The proteins that were measured play an important role in the initiation and propagation of the damaging inflammatory response in severe sepsis.
The data were discussed in an oral presentation entitled, "Reduction in Cytokines/Chemokines in Severe Sepsis: Results from a Phase II Randomized Placebo-Controlled Double Blind Trial of Talactoferrin Alfa in Severe Sepsis," given by Kalpalatha Guntupalli, M.D., Professor and Chief, Pulmonary Critical Care and Sleep Medicine, Baylor College of Medicine and principal investigator of the talactoferrin Phase II trial.
Dr. Guntupalli said, "The exploratory analyses we conducted suggest that talactoferrin may be effective in reducing the levels of certain cytokines and chemokines that are important in the initiation and propagation of the inflammatory response in severe sepsis. This provides preliminary evidence of an immunomodulatory effect of talactoferrin in this clinical setting."