Combination of Toraymyxin™ and EAA™ represents first theranostic trial in sepsis
TORONTO, Oct. 19 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. (TSX:SDI), a Phase III company seeking FDA approval for its lead theranostics product for the treatment severe sepsis and septic shock, today announced initiation of its U.S. pivotal trial of Toraymyxin™, a therapeutic hemoperfusion device that removes endotoxin from the bloodstream, for patients with severe sepsis. The Cooper Health System, in Camden, New Jersey, which also acts as the coordinating centre for the EUPHRATES trial, has been screening patients using the FDA approved protocol for inclusion and exclusion criteria. After determining the suitability of the protocol, patients have now been enrolled in the trial.
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™ directed by Spectral's Endotoxin Activity Assay (EAA™), an FDA cleared assay for use in sepsis. This is the first theranostics trial, a combination therapeutic and diagnostic, in the area of sepsis.
"The initiation of our EUPHRATES trial is a major milestone for the Company. This is a step closer to providing U.S. patients the opportunity to access this unique therapeutic device," said Dr. Paul Walker, President and CEO of Spectral. "In part due to the few therapeutic options available to treat the more than 250,000 patients diagnosed with severe sepsis in the U.S. each year, this disease remains a leading cause of mortality. Toraymyxin™ has been used safely on more than 70,000 patients worldwide and, when guided by our EAA™ diagnostic, has the potential to address this large unmet medical need. We are now qualifying additional sites and, following the upcoming investigators meeting, anticipate that all 15 sites should be active within the next three months."
The EUPHRATES 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. About Spectral Diagnostics Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment for severe sepsis and septic shock. Toraymyxin™ is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the detection of endotoxin. Spectral's EUPHRATES trial is the world's first theranostics trial in the area of sepsis.
Toraymyxin™ has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively in more than 70,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin™. More than 250,000 patients are diagnosed with severe sepsis and septic shock in the U.S. each year, representing a greater than $1 billion market opportunity for Spectral.
Spectral is listed on the Toronto Stock Exchange under the symbol SDI. Forward-looking statement Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of our future operating results and economic performance and anticipated events or results, are assumptions based on beliefs of our senior management as well as information currently available to it. These assumptions, although considered reasonable by us at the time of preparation, may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, our ability to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected. For more exhaustive information on these risks and uncertainties you should refer to our most recently filed annual information form which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time.
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|SOURCE Spectral Diagnostics Inc.|
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