TORONTO, Jan. 28, 2014 /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 Data Safety Monitoring Board (DSMB) has
evaluated the safety, efficacy and futility of its EUPHRATES trial
based on actual data for 184 randomized patients followed for 28 days.
The DSMB has recommended that the trial continue, but has asked that
further analysis be performed before recalculation of the trial's
sample size is finalized.
"The Company will await the specifics of the DSMB report, expected soon,
before determining next steps in its clinical and commercial pathway,"
said Dr. Paul Walker, President and CEO of Spectral Diagnostics.
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 in excess of $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.
