Enrolment in the EUPHRATES trial is continuing with no safety issues
TORONTO, Feb. 4, 2013 /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 the first interim
analysis has been conducted on the initial 76 randomized patients in
its EUPHRATES trial.
The Data Safety and Monitoring Board (DSMB), consisting of experts in
the fields of critical care medicine, infectious disease, nephrology,
biostatistics and regulatory affairs, reviewed the totality of the data
set for evidence of safety concerns, such as adverse events and/or
adverse device effects, related to the use of the Toraymyxin cartridge.
The results from the first interim safety analysis by the DSMB state
that there are no safety issues to date concerning the application of
the Toraymyxin cartridge to patients in the EUPHRATES trial. In
addition, the results state that the EUPHRATES clinical protocol
appears to be defining the correct target patient population for this
"We are making consistent progress with our pivotal Phase III trial,"
said Dr. Paul Walker, Chief Executive Officer of Spectral Diagnostics.
"We remain committed to our protocol which randomizes only patients in
septic shock who are endotoxemic, as they are at greatest risk for a
poor outcome and therefore most likely to benefit from our theranostic
There have been 191 patients who have met clinical entry criteria so
far. As predicted, approximately 50% of these patients have an elevated
level of endotoxin, which is associated with a high rate of mortality
in septic shock patients.
The combined 28-day mortality rate remains stable at 35% for patients
randomized either to the standard of care with SHAM hemoperfusion
event, or to the Toraymyxin cartridge plus standard of care. This was
also commented on by the DSMB as a positive sign and provides further
evidence that the correct patient population is being studied. For
those patients with low levels of endotoxin who were not randomized to
the trial, the 28-day mortality rate is approximately 25% to date.
The DSMB encourages the continued enrolment of patients into the
Spectral continues to initiate new sites to the EUPHRATES trial in
Canada and the United States. The Company anticipates that it will
have 45-50 sites enrolling patients by the end of June, 2013.
Spectral remains on track to achieve the trial's next milestone, which
will be a second planned interim analysis after 184 randomized patients
have been followed for 28 days. At the second analysis, the DSMB will
advise Spectral on the trial's safety, efficacy or futility, with
stopping rules in place for efficacy and futility. A sample size
recalculation will be done if necessary. Management expects to
disclose information from the second interim analysis in the first half
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead
theranostics product for the treatment of 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.
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
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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
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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
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SOURCE: Spectral Diagnostics Inc.
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