Disappointing results have been reported from a pivotal phase 3 trial of the Toraymyxin therapeutic hemoperfusion device (Spectral Medical Inc.), which removes sepsis-causing endotoxin from the bloodstream. A total of 450 patients were treated with either two Toraymyxin columns or two shams. The study did not achieve its primary endpoint of an absolute reduction in mortality at four weeks.
The results showed, however, that the mortality benefit of the system significantly increased as a function of the amount of endotoxin removed, as measured by the Endotoxin Activity Assay, according to Spectral Medical. In addition, cardiovascular function improved and the use of vasopressors decreased. Based on these outcomes, the company intends to meet with the FDA to discuss the regulatory pathway for its sepsis treatment.
The Toraymyxin technology has been in use in Japan and parts of Europe for years but has never been approved for wide use in the United States because, in the view of the FDA, it has never been tested in trials large enough to prove its effectiveness and safety.
Spectral Medical, a Canadian company, holds the North American rights to the system, which was developed in Japan by Toray Industries to restore blood pressure and to correct organ dysfunction by using an antibiotic to detoxify the blood. Once the patient’s blood has been extracted, it is passed through a column to remove endotoxins, which are believed to be a major trigger for sepsis.
Even though the Toraymyxin system has been used in Japan since 1994 and in Europe since 2002, the clinical data supporting the use of the device are still intensely debated. In addition to the latest findings, trials conducted outside of Japan and Italy have failed to prove its effectiveness, according to a Reuters report issued in July.
Meanwhile, the FDA has approved “compassionate use” of the system in select hospitals.