TORONTO, June 18 /CNW/ - Spectral Diagnostics Inc. (TSX:SDI), a company
developing products for the treatment of sepsis, today announced that findings
demonstrating the Toraymyxin(TM) cartridge, a blood purification device that
absorbs endotoxin from the bloodstream, when added to conventional therapy,
significantly improved hemodynamics and organ dysfunction and reduced 28-day
mortality in patients with severe sepsis and septic shock. The article
entitled "Early Use of Polymyxin B Hemoperfusion in Abdominal Septic Shock:
The EUPHAS Randomized Controlled Trial," was published in the Journal of the
American Medical Association (JAMA). Spectral has exclusive rights to
Toraymyxin(TM) in the United States and plans to initiate a trial in the U.S.
in the latter half of 2009.
"The degree of reduction in mortality demonstrated by Toraymyxin(TM) in
the EUPHAS trial is an unprecedented result for sepsis therapies and indicates
that this product has the potential to fulfill an unmet need for the
approximately 100,000 patients that develop severe sepsis or septic shock in
the U.S. each year," said Dr. Paul Walker, President and CEO of Spectral
Diagnostics. "Our Endotoxin Activity Assay (EAA(TM)) has the ability to
identify patients who could benefit from this therapy and monitor its effect.
Together, this diagnostic and therapeutic have the potential to provide a more
effective treatment for patients with severe sepsis and septic shock caused by
The objective of this study was to determine whether Toraymyxin(TM), when
added to conventional medical therapy, improves clinical outcomes and
mortality compared with conventional therapy alone, in a targeted patient
population with severe sepsis and/or septic shock associated with
- 28 day mortality was 32% (11/34 patients) in the Toraymyxin(TM) group
and 53% (16/30 patients) in the conventional therapy group.
- Mean Arterial Pressure (MAP) increased (76 to 84 mm Hg;
P = 0.001) in the Toraymyxin(TM) group but not in the
conventional therapy group (MAP, 74 to 77 mm Hg; P =
- Vasopressor requirement decreased (inotropic score, 29.9 to 6.8; P
(less than) 0.001) at 72 hours in the Toraymyxin(TM) group but not in
the conventional therapy group (inotropic score, 28.6 to 22.4; P
- Sequential Organ Failure Assessment scores improved in the Toraymyxin
(TM) group but not in the conventional therapy group (change in SOFA,
-3.4 vs -0.1; P (less than) 0.001).
The abstract and full text of the article is available online at
www.jama.ama-assn.org and appears in JAMA. 2009; Vol. 301 No. 23, 2445-2452.
About Spectral Diagnostics
Spectral is a leader in the battle against sepsis. Spectral's lead
product is its Endotoxin Activity Assay (EAA(TM)), the only FDA cleared assay
for the measurement of endotoxin. With the growing awareness for the role of
endotoxemia in sepsis and the increasing number of therapies being developed
for this indication, Spectral is well-positioned to drive the adoption of the
EAA(TM), which can be used to identify patients, enable therapeutics and
monitor treatment. In March 2009, Spectral obtained the exclusive development
and commercial rights in the U.S. for Toraymyxin(TM), a therapeutic for the
treatment of sepsis that removes endotoxin from the bloodstream. Spectral will
seek FDA approval for Toraymyxin(TM) and intends to commercialize the product
together with EAA(TM). Spectral is listed on TSX under the symbol SDI.
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.
For further information:
For further information: Dr. Paul Walker, President & CEO, (416)
626-3233 ex. 2100; Casey Gurfinkel, Investor Relations, (416) 815-0700 ext.