TORONTO, Sept. 28, 2011 /CNW/ - Spectral Diagnostics Inc., (TSX: SDI), a Phase III company developing the first theranostic treatment for
patients with septic shock, today announced the publication of a study
utilizing Spectral's Endotoxin Activity Assay (EAA™ ) to identify
children at high risk of complications from open heart surgery.
The study, which is published in the online version of the American Journal of Respiratory and Critical Care Medicine (AJRCCM), showed that intestinal injury, endotoxaemia and activation of
endotoxin signaling pathways are prevalent in children with congenital
heart disease. In addition, the study, authored by Dr. Nazima Pathan
and her group of investigators from Imperial College of London and
several other prominent institutes in the United Kingdom, concluded
that endotoxin activity correlates with a number of outcome variables
in this population, and may be used to guide the use of gut-protective
"The AJRCCM is the highest-impact journal in the field of critical
care," said Dr. Paul Walker, CEO of Spectral Diagnostics. "This study
demonstrates the important role endotoxin can play in many different
disease states. The better understanding of the mechanisms for
translocation of endotoxin discovered in this manuscript lends support
to our EUPHRATES trial design in sepsis. We are especially pleased that
the EAA is being tested by sophisticated research groups like Dr.
Pathan's to help identify other potential populations for future
research on targeting endotoxemia to improve patient outcomes."
About 35,000 infants (1 out of every 125 children) are born in the
United States each year with some form of congenital heart defect. Many
of these children go on to require open heart surgery.
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 Japan and Europe,
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
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:
| Anthony Businskas |
Executive Vice President and CFO
416-626-3233 ext. 2200
| Adam Peeler |
416-815-0700 ext. 225