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