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Results From Phase II Trial in Critical Care Medicine Showed Eritoran Tetrasodium (E5564) To Be Well Tolerated in Patients with Severe Sepsis
Date:12/22/2009

WOODCLIFF LAKE, N.J., Dec. 22 /PRNewswire/ -- The investigational compound, eritoran tetrasodium ("eritoran," also known as E5564) appeared to be well tolerated in patients with severe sepsis in a Phase II trial published in the January issue of Critical Care Medicine, the official journal of the Society of Critical Care Medicine, the largest multiprofessional organization dedicated to ensuring excellence and consistency in the practice of critical care.

The trial evaluated two doses of eritoran, low-dose (45mg given every 12 hours for six days) and high-dose (105mg given every 12 hours for six days), along with a placebo group. Additionally, the trial, although not powered for statistical significance, evaluated the efficacy (reduction in 28-day all-cause mortality) of eritoran versus placebo.

"Currently, limited treatment options exist for severe sepsis. In this Phase II study, eritoran was well tolerated, and the adverse events were not surprising, given the significant co-morbidities commonly seen in patients with severe sepsis," said lead investigator Mark Tidswell, MD, Director, ICU Research, Baystate Medical Center, Adult Critical Care Division, in Springfield, Mass. "Although this Phase II trial was not sized to demonstrate a reduction in mortality and the observed 26.6% mortality rate for high-dose eritoran versus 33.3% for placebo (p=0.34) was not statistically significant, the data warrant further investigation of eritoran."

About the Phase II Trial

This trial of eritoran tetrasodium (E5564) was a Phase II, randomized, double-blind, placebo-controlled, multi-center, ascending-dose trial evaluating the safety and efficacy of eritoran in patients with severe sepsis. The trial, conducted in intensive care units (ICUs) in the United States and Canada, involved 300 patients randomized to three groups: 96 received placebo, 103 received eritoran low-dose (45mg given every 12 hours for si
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