Spectral Diagnostics Inc. 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. Spectral has exclusive rights to Toraymyxin in the US and plans to initiate a trial in the US 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 US 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 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.
• 28 day mortality was 32% (11/34 patients) in the Toraymyxin group and 53% (16/30 patients) in the conventional therapy group.
• Mean Arterial Pressure (MAP) increased (76 to 84 mm Hg; P = 0.001) in the
Toraymyxin group but not in the conventional therapy group (MAP, 74 to 77 mm Hg; P = 0.37).
• Vasopressor requirement decreased (inotropic score, 29.9 to 6.8; P < 0.001) at
72 hours in the Toraymyxin group but not in the conventional therapy group (inotropic score, 28.6 to 22.4; P = 0.14).
• Sequential Organ Failure Assessment scores improved in the Toraymyxin group but not in the conventional therapy group (change in SOFA, –3.4 vs –0.1; P < 0.001).