BioMS Medical has reported that Spectral Diagnostics has received Investigational Device Exemption (IDE) approval from FDA for Toraymyxin, a blood purification medical device for endotoxin removal.
Spectral Diagnostics and BioMS have entered into a service agreement whereby BioMS will assist Spectral, as required, in its commercialization of Toraymyxin, a therapeutic hemoperfusion device for the treatment of severe sepsis. The approval permits Spectral to initiate its planned pivotal trial for Toraymyxin in the US.
The EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock) trial is a randomized, double-blinded control trial of standard of care versus standard of care and Toraymyxin.
The use of Toraymyxin will be directed by Spectral’s Endotoxin Activity Assay (EAA), an FDA cleared assay for use in sepsis. The trial is expected to enroll approximately 360 patients at 15 sites throughout the US and will have a primary end point of 28 day mortality.
Spectral has obtained exclusive rights for the Toraymyxin device in the US from Toray Industries of Japan, in March of 2009 and anticipates initiating a pivotal US clinical trial in the first half of 2010. Toraymyxin has been used in more than 70,000 patients globally and has demonstrated in clinical trials that it safely and effectively removes endotoxin and reduces mortality in patients with severe sepsis.
Kevin Giese, president and CEO of BioMS Medical, said: “Securing FDA approval to conduct this pivotal US trial is a major milestone in the advancement of Toraymyxin, a product with blockbuster potential and a track record of safety and efficacy in the treatment of severe sepsis. In addition, Spectral now has suitable resources in place to proceed with this pivotal trial and is on track to initiate patient enrolment in the first half of this year.”