Spectral announces new clinical data is being presented at international sepsis forum
TORONTO, Nov. 9, 2012 /CNW/ - Spectral Diagnostics Inc., (TSX: SDI) (OTCQX: DIAGF), a Phase III company developing the first theranostic treatment for patients with septic shock, today announced that new clinical data from a recently completed pilot study is being presented in an abstract presentation at Sepsis 2012, a prominent summit on sepsis being held November 7 to 9, 2012 at the Pasteur Institute in Paris, France. The data show increased endotoxin levels are associated with clinical deterioration in moderate severity, emergency department sepsis patients.
Increased levels of endotoxin activity are associated with escalating mortality in intensive care unit patients. The removal of endotoxin through polymyxin B hemoperfusion has been shown to decrease organ dysfunction and reduce mortality in septic shock patients. The study's objective was to determine the ability of endotoxin measurement - and its change over 24 hours in sepsis patients with normal blood pressure - to predict clinical deterioration.
"The data from this pilot study indicate that increased endotoxin levels can supplement clinical decision-making to help clinicians identify high-risk sepsis patients," said Dr. Paul Walker, President and CEO of Spectral. "The study also illustrates the growing acceptance of the value of Spectral's Endotoxin Activity Assay in assessing patients with sepsis who are at risk of developing more severe sepsis."
The pilot study, set in a single-center urban, academic medical center, used Spectral's FDA-cleared Endotoxin Activity Assay (EAATM) to measure patients' endotoxin levels at enrollment and again at 24 hours. The patients were followed for the development of increased organ failure within 72 hours of admission or in-hospital mortality. Fifty seven patients were enrolled over a 12-month period.
Sponsored by the International Sepsis Forum, Sepsis 2012 is an annual symposium at which world experts address the diagnosis, epidemiology, science and clinical treatment of sepsis. The event is attended by international thought leaders from the fields of critical care, infectious diseases, internal medicine and surgery. Participants collectively have extensive expertise in the clinical care of patients with sepsis, the science and laboratory investigation of sepsis and the host response to sepsis, and in the design, conduct and interpretation of clinical trials conducted to investigate the treatment of sepsis.
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of severe sepsis with 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 second 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 100,000 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, and on the OTQ QX under the symbol DIAGF. 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 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.
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