Toraymyxin is a Polymyxin B extracorporeal direct hemoperfusion adsorption column which is highly effective in removing endotoxin in the bloodstream. Toraymyxin has been approved and marketed by Toray Industries in Europe and Japan since 2002 and 1994 respectively, and has been used safely on more than 100,000 patients. Spectral holds the exclusive rights for Toraymyxin in the U.S. and Canada, and is currently conducting a Phase III clinical trial for severe sepsis and septic shock. Toraymyxin has the potential to meet the needs of the more than 250,000 U.S. patients diagnosed with severe sepsis and septic shock each year.
How is Toraymyxin used?
Toraymyxin is a therapeutic hemoperfusion device that requires a pump capable of circulating at 100 ml/min. Hemoperfusion is a medical process to remove a toxic substance from a patient’s blood by pumping the blood over an absorbent surface. In this case, this toxic substance is endotoxin. By passing an endotoxemic patient’s blood through the device, endotoxin, a major cause of sepsis, is removed from the bloodstream. The standard dose is to administer two columns over a 24-hour period.
The inside of a Toraymyxin column is packed with polystyrene fibers coated with the antibiotic Polymyxin B. This material has a high affinity for endotoxin and as blood passes through the column, endotoxin is tightly adsorbed onto the Polymyxin B coated fibers. Testing using Spectral’s EAA™ has shown that Toraymyxin can remove 90% of an endotoxemic patient’s circulating endotoxin within a 48-hour period.
Were there previous Toraymyxin trials and what were the results?
Toraymyxin has been used in more than 100,000 patients in markets outside of the U.S. and has been tested in more than 90 published studies.
The most recent results of a randomized controlled trial (the EUPHAS - Early use of polymyxin B hemoperfusion in abdominal sepsis (surgery) trial) were published in the Journal of the American Medical Association (JAMA. 2009; Vol. 301 No. 23, 2445-2452) . The results demonstrated that Toraymyxin adsorbs endotoxin from the bloodstream, and when added to conventional therapy, significantly improved hemodynamics and organ function. Toraymyxin reduced 28-day mortality in patients with severe sepsis and septic shock in comparison to those patients in the conventional therapy group.