TORONTO, March 11, 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 septic shock today announced
an update on its ongoing EUPHRATES trial.
On January 27, 2014, the Data Safety Monitoring Board ("DSMB") met to
review the results of the second interim analysis after 184 patients
had been randomized and followed for 28 days in accordance with the
Statistical Analysis Plan agreed to with the FDA. On that date, the
DSMB reported that stopping rules for safety, efficacy and futility
were not met and that the trial should continue. The DSMB did not,
however, provide the planned sample size recalculation at that time.
The DSMB requested that additional analysis be performed by the
Contract Research Organization on the original 184 patients prior to
the recalculation. This analysis is ongoing and is expected to take
several more weeks to complete. In the meantime, the enrollment in
EUPHRATES continues with currently 256 patients randomized.
Spectral has scheduled the next quarterly DSMB meeting for early April
2014, at which time it expects to receive the recommendations of the
DSMB based on its review of the requested detailed analysis, as well as
data from additional patients enrolled since the 184 patient cut off
for the second interim analysis.
A sample size recalculation is expected to be performed and reported to
the Sponsor, as well as any other recommendations. The EUPHRATES trial
was designed to show a benefit in mortality between the treated group
and the control group of between 10% to 15% at a power of eighty
percent. The original sample size of 360 enrolled patients would be
required to show a 15% benefit in mortality, while demonstrating a 10%
difference could require up to approximately 700 patients.
The Company expects to announce its clinical pathway forward after
receiving and evaluating the DSMB recommendations.
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead
theranostics product (Toraymyxin) 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 OTC 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, 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.
SOURCE Spectral Diagnostics Inc.
