Spectral's EAA Used In Study For Sepsis Anti-Endotoxin Therapy
Spectral Diagnostics's Endotoxin Activity Assay (EAA), an FDA cleared diagnostic for risk of sepsis, will be used to measure endotoxin levels during the enrolment of patients in a Phase III sub study, part of a multinational clinical trial evaluating the safety and effectiveness of a treatment for severe sepsis.
"Spectral is pleased that a major international pharmaceutical company is using the EAA in a proportion of patients in its study," said Dr. Paul Walker, President and CEO of Spectral Diagnostics. "We are optimistic that the data from this sub study will promote subsequent use of the EAA to identify patients most likely to benefit from specific anti-endotoxin therapy."
Currently, in North America, there is no available drug to directly counter the effects of endotoxin. The Phase III sub study will explore the utility of partnering a reliable measurement of endotoxin, the EAA, with a targeted anti-endotoxin treatment aimed at reducing mortality rates for patients with severe sepsis. Spectral's unique assay helps identify endotoxin levels in patients and enables appropriate and rapid application of therapeutics.
Spectral has a contractual agreement to supply EAA equipment, test kits and technical expertise for use in the study that is expected to run until mid 2010.