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Spectral Demonstrate Toraymyxin™ Significantly Reduces Mortality from Sepsis in Prospective Controlled Trial
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Spectral Diagnostics Inc. has announced that findings demonstrating the Toraymyxin™ cartridge, a blood purification device that absorbs endotoxin from the bloodstream, when added to conventional therapy, significantly improved hemodynamics and organ dysfunction and reduced 28-day mortality in patients with severe sepsis and septic shock.
The article entitled “Early Use of Polymyxin B Hemoperfusion in Abdominal Septic Shock: The EUPHAS Randomized Controlled Trial,” was published in the Journal of the American Medical Association (JAMA). Spectral has exclusive rights to Toraymyxin™ in the United States and plans to initiate a trial in the U.S. in the latter half of 2009.
“The degree of reduction in mortality demonstrated by Toraymyxin™ in the EUPHAS trial is an unprecedented result for sepsis therapies and indicates that this product has the potential to fulfill an unmet need for the approximately 100,000 patients that develop severe sepsis or septic shock in the U.S. each year,” said Dr. Paul Walker, President and CEO of Spectral Diagnostics.
“Our Endotoxin Activity Assay (EAA™) has the ability to identify patients who could benefit from this therapy and monitor its effect. Together, this diagnostic and therapeutic have the potential to provide a more effective treatment for patients with severe sepsis and septic shock caused by endotoxemia.”
The Company says that the objective of this study was to determine whether Toraymyxin™, when added to conventional medical therapy, improves clinical outcomes and mortality compared with conventional therapy alone, in a targeted patient population with severe sepsis and/or septic shock associated with intra-abdominal infections.
The article entitled “Early Use of Polymyxin B Hemoperfusion in Abdominal Septic Shock: The EUPHAS Randomized Controlled Trial,” was published in the Journal of the American Medical Association (JAMA). Spectral has exclusive rights to Toraymyxin™ in the United States and plans to initiate a trial in the U.S. in the latter half of 2009.
“The degree of reduction in mortality demonstrated by Toraymyxin™ in the EUPHAS trial is an unprecedented result for sepsis therapies and indicates that this product has the potential to fulfill an unmet need for the approximately 100,000 patients that develop severe sepsis or septic shock in the U.S. each year,” said Dr. Paul Walker, President and CEO of Spectral Diagnostics.
“Our Endotoxin Activity Assay (EAA™) has the ability to identify patients who could benefit from this therapy and monitor its effect. Together, this diagnostic and therapeutic have the potential to provide a more effective treatment for patients with severe sepsis and septic shock caused by endotoxemia.”
The Company says that the objective of this study was to determine whether Toraymyxin™, when added to conventional medical therapy, improves clinical outcomes and mortality compared with conventional therapy alone, in a targeted patient population with severe sepsis and/or septic shock associated with intra-abdominal infections.
