TORONTO, ONTARIO--(Marketwired - June 20, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT) (OTCQX:EDTXF), a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from septic shock due to endotoxemia, today announced that patient enrollment has been completed for the Company's pivotal Phase III EUPHRATES clinical trial.
The clinical trial is intended to demonstrate the safety and efficacy of Toraymyxin™, an investigational device that removes endotoxin from the bloodstream. Over 900 patients who met clinical entry criteria for septic shock were evaluated using the Company's proprietary Endotoxin Activity Assay, which measures the level of endotoxin in the bloodstream. This lead to a total of 446 evaluable patients who were enrolled and randomized into the trial at 42 hospitals in the United States and Canada. The primary endpoint of the trial is a reduction in 28 day mortality in patients treated with Toraymyxin™.
"The EUPHRATES trial is a randomized, prospective, blinded trial evaluating a novel approach to the treatment of septic shock, combining a targeted diagnostic and therapeutic. This protocol required tremendous dedication and hard work from clinical research staff at each of the hospitals," stated Debra Foster, VP Clinical Development for Spectral. "We also thank the many patients and their loved ones who consented to be part of this trial."
"The completion of patient enrollment in the EUPHRATES trial is an important step in our mission to commercialize a treatment that addresses an enormous unmet medical need," said Dr. Paul Walker, President and CEO of Spectral. "Over the coming months, we will collect and analyze all required data with the expectation of announcing primary outcome results in September. We remain fully on-track to complete our PMA application with the FDA by year's end."
A novel therapy for certain patients in septic shock, Toraymyxin™ is specifically targeted at those with elevated levels of endotoxin in the blood. Toraymyxin™ is a direct hemoperfusion adsorption column that has been shown to be highly effective in removing endotoxin. Studies have shown that this medical device can remove up to 90 percent of an endotoxemic patient's circulating endotoxin when administered twice within a 24 hour period.
About Spectral Medical Inc.
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of endotoxemic septic shock. Toraymyxin™ (PMX) is a therapeutic hemoperfusion device that removes endotoxin, a main trigger of sepsis and septic shock, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis, Spectral's EUPHRATES trial is the world's only active and most innovative Phase III study for a medical device in the area of septic shock.
PMX has been approved for therapeutic use in Japan and Europe, and has been used on more than 150,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Over 350,000 patients are diagnosed with septic shock in North America each year, representing a greater than $3 billion market opportunity for Spectral.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT, and on the OTCQX under the symbol EDTXF. For more information, please visit www.spectraldx.com.
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 the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they 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, the ability of Spectral to commercialize its products, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities, the ability of Spectral to complete the Offering as expected as well as general economic, market and business conditions, and could differ materially from what is currently expected.
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