"The initiation of our EUPHRATES trial is a major milestone for the Company. This is a step closer to providing U.S. patients the opportunity to access this unique therapeutic device," said Dr. Paul Walker, President and CEO of Spectral. "In part due to the few therapeutic options available to treat the more than 250,000 patients diagnosed with severe sepsis in the U.S. each year, this disease remains a leading cause of mortality. Toraymyxin™ has been used safely on more than 70,000 patients worldwide and, when guided by our EAA™ diagnostic, has the potential to address this large unmet medical need. We are now qualifying additional sites and, following the upcoming investigators meeting, anticipate that all 15 sites should be active within the next three months."
The EUPHRATES trial is expected to enroll approximately 360 patients at 15 sites throughout the U.S. and will have a primary end point of 28 day mortality. About Spectral Diagnostics Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment for severe sepsis and septic shock. Toraymyxin™ is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the detection of endotoxin. Spectral's EUPHRATES trial is the world's first theranostics trial in the area of sepsis.
Toraymyxin™ has been approved for
|SOURCE Spectral Diagnostics Inc.|
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