BioMS Medical Corp. (TSX: MS) today reported that Spectral Diagnostics (TSX: SDI) has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for Toraymyxin(TM). Spectral Diagnostics and BioMS have entered into a services agreement whereby BioMS will assist Spectral, as required, in its commercialization of Toraymyxin(TM), a therapeutic hemoperfusion device for the treatment of severe sepsis. This approval permits Spectral to initiate its planned pivotal trial for Toraymyxin(TM) in the United States.
Spectral also reported that it has closed its previously announced private placement of 48,750,000 units of the Company for gross proceeds of $19.5 million. BioMS subscribed to 30,000,000 of the units.
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(TM). The use of Toraymyxin(TM) will be directed by Spectral's Endotoxin Activity Assay (EAA(TM)), an FDA cleared assay for use in sepsis. The trial is expected to enroll approximately 360 patients at 15 sites throughout the U.S. and will have a primary end point of 28 day mortality.
"Securing FDA approval to conduct this pivotal US trial is a major milestone in the advancement of Toraymyxin(TM), a product with blockbuster potential and a track record of safety and efficacy in the treatment of severe sepsis," said Kevin Giese, President and CEO of BioMS Medical Corp. "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."
Spectral obtained exclusive rights for the Toraymyxin(TM) device in the US from Toray Industries Inc., of Japan, in March of 2009 and anticipates initiating a pivotal US clinical trial in the first half of 2010. Toraymyxin(TM) 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. There are over 250,000 patients who develop severe sepsis in the US each year and who currently face a high risk of mortality with limited treatment options, representing a potential market opportunity in excess of $1 billion per annum.
SOURCE BioMS Medical Corp.