Sepsis is a life threatening condition caused by the body's response to bacterial products such as endotoxin. Sepsis is a challenging disease affecting millions worldwide, and if not recognized early and treated promptly, sepsis can lead to multiple organ failure, shock and death.
The syndrome of sepsis is difficult to diagnose. Currently, physicians diagnose sepsis based on the signs and symptoms of inflammation in the context of a suspicion of infection. However these signs are common in critically ill patients and may be present for many reasons. Therefore there is a pressing need for a biomarker that is associated with causality of sepsis, correlates with severity of illness, and can monitor the effects of an intervention.
Endotoxin is an important pathogenic trigger of sepsis. Humans are extremely sensitive to endotoxin and a significant invasion into the blood stream triggers a systemic inflammatory response of fever, tachycardia, and leukocytosis. For well over a century, controlled endotoxin infusion is the most widely used and commonly accepted method to produce sepsis in experimental models.
Spectral’s EAA™ is a novel method to measure endotoxin. Numerous previous attempts to develop a reliable and accurate assay for endotoxin have been unsuccessful, mainly due to the complexity of the interaction of endotoxin with other elements in the blood such as binding proteins. Scientists at Spectral have incorporated the body’s natural mechanisms of endotoxin detection and adapted them into a system that provides an accurate endotoxin measurement within 30 minutes.
The EAA™ is now being used to direct an innovative therapeutic called Toraymyxin. Toraymyxin is an extracorporeal hemoperfusion device which is composed of polymyxin B covalently immobilized to polystyrene fibers. Polymyxin B is an antibiotic that is well known to bind endotoxin selectively and neutralize its toxicity. Toraymyxin use reduces blood endotoxin level and may improve hemodynamics in patients with sepsis.
Toraymyxin, directed by the EAA™, is currently undergoing a U.S. Phase III randomized, blinded, clinical trial (EUPHRATES Trial) for the treatment of severe sepsis and septic shock.
EUPHRATES is a randomized, double-blind controlled, clinical trial that compares standard of care versus standard of care and Toraymyxin, directed...more >>
Q. What is the trial endpoint?
A. The primary endpoint is 28 day mortality...more >>
For more information on sepsis...more >>
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