- Results of the Second Interim Analysis on Track for Q1, 2014
-
TORONTO, Sept. 26, 2013 /CNW/ - 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.