SPECTRAL ACHIEVES IMPORTANT MILESTONE IN ITS PIVOTAL U.S. CLINICAL TRIAL FOR SEPSIS

- All 15 sites for the EUPHRATES trial are operational and enrolment is underway -

TORONTO, May 5 /CNW/ - Spectral Diagnostics Inc., (TSX: SDI), a Phase III company developing the first theranostic treatment for  septic shock, today announced that the 15 carefully chosen clinical sites for its EUPHRATES trial are all screening and able to enrol patients.

"The successful enrolment of patients within these outstanding hospitals is indicative of the support for our trial and of the participating clinicians' commitment to our novel trial protocol," said Dr. Paul Walker, CEO of Spectral Diagnostics. "Once patients have met clinical entry criteria, they are tested using Spectral's EAA™ diagnostic and, then, those shown to be endotoxemic are treated with a targeted therapeutic, Toraymyxin. This is the first time that a theranostics approach has been used in a sepsis trial. Having achieved this significant milestone, we are looking forward to the interim trial results, which we anticipate by the end of the first half of 2012."

EUPHRATES is a randomized, double-blind clinical trial that compares standard of care versus standard of care and Toraymyxin, directed by Spectral's EAA™ Endotoxin Activity Assay. The target population is critically ill patients with septic shock and endotoxemia (as measured by the EAA™). 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.

Spectral's EUPHRATES trial is the world's first theranostics trial conducted in the area of sepsis. Theranostics, a combination diagnostic and therapeutic, is a novel way of approaching patient care for sepsis. The power of theranostics is the ability to direct a treatment to patients who are both most at risk and most likely to respond to the targeted therapy. Incorrect patient selection is often considered the cause for the failure of many previous clinical trials in sepsis. In Spectral's EUPHRATES trial, the EAA™ will be used to determine the level of endotoxin in the bloodstream of a patient with septic shock. If EAA™ is elevated (≥ 0.6 EAA™ units), the patient will be eligible for randomization to Toraymyxin plus standard of care, or standard of care alone.

At present, there are few therapeutic treatment options available for 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 80,000 patients worldwide and, when guided by Spectral's EAA™ diagnostic, has the potential to address this large unmet medical need, which is valued at more than $1 billion annually in the U.S.

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 risk of developing sepsis, Spectral's EUPHRATES trial is the world's first theranostics trial in the area of sepsis.

Toraymyxin has been approved for therapeutic use in 18 countries, and has been used safely and effectively in more than 80,000 patients to date. In March, 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin, and in November, 2010, signed an exclusive distribution agreement for this product in Canada. More than 250,000 patients are diagnosed with severe sepsis and septic shock in North America each year, representing a greater than $1 billion market opportunity for Spectral. Spectral is listed on the Toronto Stock Exchange under the symbol SDI.

For further information please visit www.spectraldx.com

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 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 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.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

 

SOURCE Spectral Diagnostics Inc.

For further information:

Anthony Businskas
Executive Vice President and CFO
416-626-3233 ext. 2200
  Adam Peeler
Investor Relations
TMX Equicom
416-815-0700 ext. 225
apeeler@equicomgroup.com

 

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