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
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
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:
Executive Vice President and CFO
416-626-3233 ext. 2200
416-815-0700 ext. 225