TORONTO, June 3, 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 that the U.S. Food and Drug
Administration (FDA) has approved the amended protocol for its
EUPHRATES trial, reflecting the recommendations of the Data Safety
Monitoring Board (DSMB) of April 9, 2014. The DSMB recommended an
additional exclusion criterion be added to the clinical protocol and
that the sample size should be increased to 650 patients.
The DSMB recommended that patients with a Multiple Organ Dysfunction
Score (MODS) score of ≤ 9 no longer be eligible for randomization in
the trial. The MODS score is a recognized scoring system used to
evaluate the degree of organ dysfunction which exists in patients with
sepsis. This recommendation is consistent with data from previous PMX
trials, which demonstrated that the PMX column is most effective in
reducing mortality rates of sicker patients.
"These are very important and positive recommendations for our trial,"
said Dr. Paul Walker, President and CEO of Spectral. "We believe these
refinements in our patient population significantly increase our
chances for a positive outcome. The depth of information from our
second interim analysis, as was originally planned, has enabled our
trial to focus on those patients most likely to benefit from our
"Our trial has been using the new exclusion criterion since its
recommendation on April 9, 2014," stated Debra Foster, Vice President
of Clinical Development for Spectral. "Our committed trial sites have
incorporated this new exclusion criterion and we are targeting
enrolment rates consistent with the timelines we have predicted for the
completion of the trial by the end of the first half of 2016. To date,
600 patients have met all clinical inclusion criteria and 283 patients
with high endotoxin levels have been randomized into the trial."
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
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.
For further information:
Spectral Diagnostics Inc.
Dr. Paul Walker
President and CEO
416-626-3233 ext. 2100
416-815-0700 ext. 225