Spectral Granted IDE Approval by U.S. FDA to Conduct Pivotal Trial for Toraymyxin™
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Spectral Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for Toraymyxin™, a therapeutic hemoperfusion device that removes endotoxin from the bloodstream, allowing the Company to conduct a pivotal trial in the United States.
The EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock) trial is a randomized, double-blinded control trial of standard of care versus standard of care and Toraymyxin™ directed by Spectral's Endotoxin Activity Assay (EAA™), an FDA cleared assay for use in sepsis. The 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.
"The FDA's approval of our IDE is a major step forward in the development of Toraymyxin™ for the U.S. market. We are on track to start the pivotal trial in the first half of 2010, using the EAA™ guided approach to endotoxin removal by Toraymyxin™ hemoperfusion in patients with septic shock. This theranostics approach, a combination of a therapeutic and diagnostic, is included in the design of our EUPHRATES trial," said Dr. Paul Walker, President and CEO of Spectral. "Also incorporated in the trial design is clinical information already available on the use of the Toraymyxin™ column from many previously conducted positive trials completed internationally. We look forward to confirming these findings."
Dr. Walker continued: "This theranostics strategy should address a major unmet need for more than 250,000 patients per year in the United States alone who suffer from severe sepsis and are at high risk of dying."
The EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock) trial is a randomized, double-blinded control trial of standard of care versus standard of care and Toraymyxin™ directed by Spectral's Endotoxin Activity Assay (EAA™), an FDA cleared assay for use in sepsis. The 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.
"The FDA's approval of our IDE is a major step forward in the development of Toraymyxin™ for the U.S. market. We are on track to start the pivotal trial in the first half of 2010, using the EAA™ guided approach to endotoxin removal by Toraymyxin™ hemoperfusion in patients with septic shock. This theranostics approach, a combination of a therapeutic and diagnostic, is included in the design of our EUPHRATES trial," said Dr. Paul Walker, President and CEO of Spectral. "Also incorporated in the trial design is clinical information already available on the use of the Toraymyxin™ column from many previously conducted positive trials completed internationally. We look forward to confirming these findings."
Dr. Walker continued: "This theranostics strategy should address a major unmet need for more than 250,000 patients per year in the United States alone who suffer from severe sepsis and are at high risk of dying."
