Spectral Reaches Enrollment Milestone for its Phase III Euphrates Trial
27 September 2013 - 12:33AM
OTC Markets
- Results of the Second Interim Analysis on Track for Q1, 2014
-
Spectral Diagnostics Inc. (TSX:SDI)
(OTCQX:DIAGF)
("Spectral" or the "Company"), a Phase III company developing the
first
theranostic treatment for patients with severe sepsis and septic
shock, today
announced that the 184 patients required for the planned, second
interim
analysis have been randomized into its EUPHRATES trial. After the
randomized
patients have been followed for 28 days, all data will be
accumulated and
analyzed.
The Data Safety Monitoring Board (DSMB) will
then review the
data and report to the Sponsor, which is expected to occur in early
2014. The
DSMB will review the overall progress of the trial and advise
Spectral on the
trial's safety, futility and efficacy, with stopping rules in place
for
efficacy. If necessary, a sample size recalculation will then be
performed.
The current composite 28-day mortality rate of
33 percent for
randomized patients in the trial continues to suggest that the
trial is
enrolling patients who are at greatest risk for a poor medical
outcome and,
therefore, would most likely benefit from the Company's theranostic
treatment.
"We are looking forward to the outcome of the
second interim
analyses, which we anticipate will allow Spectral to plan for the
successful
completion of the EUPHRATES trial," said Dr. Paul
Walker, President and CEO of Spectral. "All indications
suggest that we
are enrolling the appropriate patients for this trial."
"The dedication of our clinical sites and staff
has allowed us
to reach the 184 randomized patients almost one quarter ahead of
this year's
prediction," said Ms. Debra Foster,
Spectral's Vice
President of Clinical Development. "The trial is currently
enrolling patients at
44 sites, operating in 49 hospitals in North
America, at a consistent and robust rate."
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA
approval for
its lead theranostic product for the treatment of 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
theranostic
trial in the area of sepsis.
Toraymyxin has been approved for therapeutic use in
Japan and Europe, and
has been used safely and effectively on 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 one million patients in the
United States are diagnosed with sepsis each year.
Approximately one
third of these patients progress to severe sepsis and septic shock,
representing
a significant unmet medical need, and a potential market size
approaching $2 billion.
Spectral is listed on the Toronto Stock Exchange
under the
symbol SDI, and on the OTCQX 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, the ability to manufacture products and supply the
market, 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
TMX Equicom
416-815-0700 ext.
225
apeeler@tmxequicom.com
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