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SPECTRAL INITIATES U.S. PIVOTAL TRIAL OF TORAYMYXIN¿ IN SEPTIC SHOCK
SPECTRAL INITIATES U.S. PIVOTAL TRIAL OF TORAYMYXIN¿ IN SEPTIC SHOCK
About this update from Spectral Medical Inc
[{"type":"text","content":"\n\n\n\n Oct. 19, 2010 (Canada NewsWire Group) -- \n\n#ReleaseContent TABLE\n{\n BORDER-COLLAPSE: collapse\n}\nTR.cnwUnderlinedCell TD\n{\n BORDER-BOTTOM: #000000 1px solid\n}\nTR.cnwDoubleUnderlinedCell TD\n{\n BORDER-BOTTOM: #000000 3px double\n}\nTR.cnwBoldUnderlinedCell TD\n{\n BORDER-BOTTOM: #000000 3px solid\n}\nTD.cnwUnderlinedCell\n{\n BORDER-BOTTOM: #000000 1px solid\n}\nTD.cnwDoubleUnderlinedCell\n{\n BORDER-BOTTOM: #000000 3px double\n}\nTD.cnwBoldUnderlinedCell\n{\n BORDER-BOTTOM: #000000 3px solid\n}\n#ReleaseContent TABLE.cnwBorderedTable TD\n{\n BORDER-RIGHT: black 1px solid;\n PADDING-RIGHT: 2px;\n BORDER-TOP: black 1px solid;\n PADDING-LEFT: 2px;\n PADDING-BOTTOM: 2px;\n BORDER-LEFT: black 1px solid;\n PADDING-TOP: 2px;\n BORDER-BOTTOM: black 1px solid;\n BORDER-COLLAPSE: collapse\n}\n#ReleaseContent TABLE TD\n{\n PADDING-RIGHT: 2px;\n PADDING-LEFT: 2px;\n PADDING-BOTTOM: 2px;\n PADDING-TOP: 2px\n}\n\n\nCombination of Toraymyxin™ and EAA™ represents first theranostic trial\n in sepsis\n\n\nTORONTO, Oct. 19 /CNW/ - Spectral Diagnostics Inc. (TSX:SDI), a Phase III company seeking FDA approval for its lead theranostics\n product for the treatment severe sepsis and septic shock, today\n announced initiation of its U.S. pivotal trial of Toraymyxin™, a\n therapeutic hemoperfusion device that removes endotoxin from the\n bloodstream, for patients with severe sepsis. The Cooper Health System,\n in Camden, New Jersey, which also acts as the coordinating centre for\n the EUPHRATES trial, has been screening patients using the FDA approved\n protocol for inclusion and exclusion criteria. After determining the\n suitability of the protocol, patients have now been enrolled in the\n trial.\n\n\nThe EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a\n Randomized controlled trial of Adults Treated for Endotoxemia and\n Septic shock) trial is a randomized, double-blinded control trial of\n standard of care versus standard of care and Toraymyxin™ directed by\n Spectral's Endotoxin Activity Assay (EAA™), an FDA cleared assay for\n use in sepsis. This is the first theranostics trial, a combination\n therapeutic and diagnostic, in the area of sepsis.\n\n\n"The initiation of our EUPHRATES trial is a major milestone for the\n Company. This is a step closer to providing U.S. patients ...