Spectral announces new clinical data is being presented at international sepsis forum
09 Novembro 2012 - 2:44PM
OTC Markets
Spectral announces new
clinical data is being presented at international sepsis
forum
TORONTO, Nov. 9, 2012 - Spectral Diagnostics Inc., (TSX: SDI)
(OTCQX: DIAGF), a Phase III company developing the first
theranostic treatment for patients with septic shock, today
announced that new clinical data from a recently completed pilot
study is being presented in an abstract presentation at Sepsis
2012, a prominent summit on sepsis being held November 7 to 9, 2012
at the Pasteur Institute in Paris, France. The data show increased
endotoxin levels are associated with clinical deterioration in
moderate severity, emergency department sepsis
patients.
Increased levels of endotoxin activity are associated with
escalating mortality in intensive care unit patients. The removal
of endotoxin through polymyxin B hemoperfusion has been shown to
decrease organ dysfunction and reduce mortality in septic shock
patients. The study's objective was to determine the ability of
endotoxin measurement - and its change over 24 hours in sepsis
patients with normal blood pressure - to predict clinical
deterioration.
"The data from this pilot study indicate that increased
endotoxin levels can supplement clinical decision-making to help
clinicians identify high-risk sepsis patients," said Dr. Paul
Walker, President and CEO of Spectral. "The study also illustrates
the growing acceptance of the value of Spectral's Endotoxin
Activity Assay in assessing patients with sepsis who are at risk of
developing more severe sepsis."
The pilot study, set in a single-center urban, academic
medical center, used Spectral's FDA-cleared Endotoxin Activity
Assay (EAATM) to measure patients' endotoxin levels at enrollment
and again at 24 hours. The patients were followed for the
development of increased organ failure within 72 hours of admission
or in-hospital mortality. Fifty seven patients were enrolled over a
12-month period.
Sponsored by the International Sepsis Forum, Sepsis 2012 is an
annual symposium at which world experts address the diagnosis,
epidemiology, science and clinical treatment of sepsis. The event
is attended by international thought leaders from the fields of
critical care, infectious diseases, internal medicine and surgery.
Participants collectively have extensive expertise in the clinical
care of patients with sepsis, the science and laboratory
investigation of sepsis and the host response to sepsis, and in the
design, conduct and interpretation of clinical trials conducted to
investigate the treatment of sepsis.
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for
its lead theranostics product for the treatment of severe sepsis
with 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 second
theranostics trial in the area of sepsis.
Toraymyxin has been approved for therapeutic use in Japan and
Europe, and has been used safely and effectively in 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 250,000 patients
are diagnosed with severe sepsis and septic shock in North America
each year, representing a greater than $1 billion market
opportunity for Spectral. Spectral is listed on the Toronto Stock
Exchange under the symbol SDI, and on the OTQ 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 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.
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