Spectral Announces Enrollment Milestone for its EUPHRATES Trial
05 Dezembro 2012 - 1:00PM
OTC Markets
TORONTO, Dec. 5, 2012 - Spectral
Diagnostics Inc. (TSX: SDI) (OTCQX: DIAGF), a Phase III company
developing the first theranostic treatment for patients with septic
shock, today announced that 76 patients have been randomized into
its EUPHRATES trial and have been followed for 28 day mortality
assessment in accordance with the trial's protocol.
A meeting of the trial's Data and Safety Monitoring Board
(DSMB) has been scheduled for the end of January, 2013. The DSMB
will evaluate the interim data to determine if there are any safety
concerns and if they are satisfied with the study conduct. Spectral
anticipates that it will disclose the details of this interim
analysis by the end of February, 2013.
"We achieved this enrollment milestone for our first planned
interim analysis due to the commitment of our site investigators
and the trial's steady patient enrollment rate," said Dr. Paul
Walker, President and CEO of Spectral Diagnostics. "We are looking
forward to the results of this analysis on the trial's conduct and
safety. Our second planned interim analysis will provide valuable
information to guide the completion of this Phase III trial."
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, efficacy or
futility, with stopping rules in place for efficacy and futility. A
sample size recalculation will be done if necessary. Management
remains on track to disclose information from the second interim
analysis in the first quarter of 2014.
Spectral's EUPHRATES trial continues to track at a
higher-than-predicted composite mortality rate, which is the
combined mortality rate for the treated and the placebo groups
(approximately 35% compared to a predicted rate of 27.5%). 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. Spectral continues to initiate sites in
Canada and the United States into the EUPHRATES trial in order to
meet recruitment targets. 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 visit www.spectraldx.com
Forward-looking statement
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
currently expected.
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
Investor Relations
416-815-0700 ext. 225
apeeler@tmxequicom.com
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