FDA allows Spectral to double the number of trial sites for the
Company's personalized medicine approach to treating septic shock
To date, the EUPHRATES trial is tracking a similar composite mortality
rate as the EUPHAS Randomized Controlled Trial
TORONTO, June 20, 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 the U.S. Food and Drug
Administration (FDA) approved the Company's request to add up to an
additional 30 clinical trial sites to its Phase III EUPHRATES trial.
The Company's EUPHRATES trial is currently the most innovative Phase
III trial in the area of septic shock.
EUPHRATES is a randomized, double-blind controlled, 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's primary endpoint is 28-day
Spectral now has the capability to expand to a total of 60 clinical
sites in North America and internationally. There are currently 22
operational sites. Management anticipates that there will be 40 sites
enrolling by the end of this year and the rest, as necessary, in 2013.
Management believes that adding more sites will accelerate the rate of
patient enrollment, which should help the Company meet its timelines to
receive final data from the trial.
There have been 141 patients who have met the clinical entry criteria,
and 54 patients have been randomized into the trial after meeting the
biomarker criteria of a high endotoxin level. The EUPHRATES trial's
enrollment rate continues to exceed, on a per-site basis, enrollment
rates of previous sepsis trials.
The data and safety monitoring board (DSMB) has indicated that there
have been no safety concerns with the trial through five scheduled
"This is good news for Spectral, its shareholders, and potentially for
patients with septic shock," said Dr. Paul Walker, CEO of Spectral
Diagnostics. "Our eligibility criteria allow us to enroll patients with
septic shock who are most likely to benefit from our personalized
medicine approach for treatment. We are committed to the pursuit of a
life saving product in this group of critically ill patients where the
treatments that currently exist only target infection and provide
supportive therapy for organ failure."
Spectral's focused approach to patient selection, using a high endotoxin
level as entry criteria, has resulted in a composite mortality rate to
date of approximately 40%, compared to a predicted composite mortality
of 27.5%. A challenge faced by recent, unsuccessful sepsis trials has
been the low rate of placebo mortality, which may make demonstration of
The EUPHRATES trial to date has a similar composite mortality rate as
the EUPHAS trial. The EUPHAS composite mortality rate, as published in
the Journal of the American Medical Association in 2009, was 42%. That trial concluded that 'polymyxin B hemoperfusion
added to conventional therapy significantly improved hemodynamics and
organ dysfunction and reduced 28-day mortality in a targeted population
with severe sepsis and/or septic shock from intra-abdominal
Spectral's interim analysis strategy is currently under review by the
FDA and is expected to be finalized in the third quarter.
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead
theranostics product for the treatmentof 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 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, and on the OTQ QX under
the symbol DIAGF. For more information please visit www.spectraldx.com
SOURCE Spectral Diagnostics Inc.
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