- Approval includes two interim analyses -
TORONTO, Sept. 26, 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 the U.S. Food and Drug
Administration has approved an amended protocol for Spectral's
EUPHRATES trial, which will now have two planned interim analyses
instead of one.
Spectral requested the amendment, including the strategy for two interim
analyses, primarily because the composite mortality rate (combined
mortality rate for the treated and the placebo groups) for the
EUPHRATES trial continues to track at a higher-than-predicted rate
(approximately 35% compared to a predicted rate of 27.5%), resulting in
a higher-than-anticipated event rate in the trial. The higher composite
mortality rate suggests that patients who are most at risk and most
likely to benefit from treatment are being randomized into the trial. A
higher event rate gives greater statistical power to the trial.
"This is a very positive development for Spectral and, potentially, for
patients with septic shock," said Dr. Paul Walker, President and CEO of
Spectral. "With an established, steady patient enrolment rate, we are
looking forward to the results of both interim analyses, which we
expect will provide valuable information to guide the remaining portion
of the trial."
The first interim analysis will occur when 76 randomized patients have
been followed for 28 days, at which point the DSMB will evaluate and
report on the trial's ongoing safety. Management anticipates that,
based on the current rate of enrolment, it will disclose the results of
that analysis before the end of the first quarter of 2013. To date, 68
patients have been randomized into the trial after meeting both the
clinical criteria and the biomarker criteria of a high endotoxin level.
The second interim analysis will occur after 184 randomized patients
have been followed for 28 days. At the second analysis, the DSMB will
advise Spectral on the trial's safety and efficacy. Stopping rules for
efficacy and futility are included in the second interim analysis. A
sample size recalculation will be done if necessary. Management
anticipates it will disclose information from the second interim
analysis in early 2014.
The trial is currently targeted to enroll 306 evaluable patients at up
to 60 North American sites. Contingent on maintaining current enrolment
rates and timely site start ups, the trial should be fully enrolled by
the end of 2014.
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. Spectral's EAA™
is the only FDA-cleared diagnostic for the risk of developing sepsis.
The target population for EUPHRATES is critically ill patients with
septic shock and endotoxemia (as measured by the EAA™). The trial's
primary endpoint is 28-day mortality.
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.
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
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
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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