Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:
EDT), a late stage theranostic company advancing
therapeutic options for sepsis and septic shock, as well as
commercializing a new proprietary platform targeting the renal
replacement therapy market through its wholly-owned subsidiary
Dialco Medical Inc. (Dialco), today announced that the United
States Federal Food and Drug Agency (“FDA”) has approved a protocol
amendment to its Tigris trial allowing for the use of sequential
organ failure assessment (“SOFA”) scoring as inclusion criteria
into the study. Additionally, the Company announced five
additional clinical sites to begin enrollment, including Louisiana
State University, Cleveland Clinic, University of Arkansas,
University of Michigan and Colorado Springs bringing the total
number of participating sites to fifteen.
Dr. John Kellum, Chief Medical Officer of
Spectral, commented, “We are very pleased with the FDA approval of
our Tigris protocol amendment to allow the use of SOFA, which is an
alternative scoring system used to quantify severity of illness.
Adding SOFA as an alternative to capture cardiovascular dysfunction
when it is already being treated by vasopressor drugs removes a
critical barrier to enrollment using MODS and harmonizes the study
protocol with current sepsis guidelines and practice patterns
across most hospitals. We are very excited to implement SOFA into
the study as we believe it should have a significantly positive
impact on enrollment. We estimate enrollment will increase by 25%
to 50% using SOFA.”
“The ability to include patients based on SOFA
scores removes a major barrier to enrollment in Tigris,” said Dr.
Ali Al-Khafaji, Professor of Critical Care Medicine at the
University of Pittsburgh School of Medicine. “While our site has
enrolled patients based on MODS, the ability to now enroll patients
based on SOFA should have a material impact on our enrollment
rates. I would expect this enrollment impact to be universal across
other Tigris sites, and should greatly reduce the time needed to
complete the trial.”
Despite a challenging clinical environment due
to COVID-19, Spectral has had success in adding new trial sites
into the Tigris trial. At present, there are 15 sites committed to
the trial. Dr. Kellum continued, “Although all sites are very much
engaged in the trial, they are challenged by balancing the demands
of COVID and their ability to focus on clinical trial enrollment
activities. That being said, all of our Tigris sites have been
specifically targeted for our study based on numerous
characteristics, including expertise in sepsis, blood purification
devices and conducting clinical trials. We are pleased to announce
the additions of Louisiana State University, Cleveland Clinic, and
University of Arkansas, all of which are renowned institutions in
the field of sepsis. Furthermore, University of Michigan and
Colorado Springs are now open to enrollment.”
“We are very excited to join the Tigris trial,”
said Dr. Kyle Gunnerson, Associate Professor, Emergency Medicine at
the University of Michigan Medical School. “Sepsis remains a major
unmet patient need, and we view PMX as a potentially consequential
therapy to address this unmet need. As a clinical site partner, we
view the Tigris trial as a well designed study positioned for a
positive outcome. With the flu and winter seasons around the
corner, and as COVID recedes, we are expecting an increase in
sepsis cases, and believe we can be an active enrolling site.”
Chris Seto, CEO of Spectral, commented, “As we
head into 2022, the Tigris trial is well positioned to accelerate
enrollment and finalize the trial as expeditiously as possible.
While it’s important for the overall clinical environment to
continue to normalize, we now have the full complement of sites
engaged. Furthermore, we are encouraged by the current mortality
results, which exceed expectations.”
MODS vs. SOFA Summary
Both MODS and SOFA are measures of organ
dysfunction. They report on the same six organ systems with
complementary variables with the exception of the assessment of
cardiovascular dysfunction. The MODS score utilises a formula that
includes blood pressure, heart rate and central venous pressure,
while the SOFA score targets blood pressure and degree of
vasopressor requirements. With the ability to utilize both scoring
systems, the breadth of opportunities for enrolment increases as
not all patients with sepsis have central venous pressures
measured. In those cases, the SOFA method may be used.
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA
approval for its unique product for the treatment of patients with
septic shock, Toraymyxin™ (“PMX”). PMX is a
therapeutic hemoperfusion device that removes endotoxin, which can
cause sepsis, from the bloodstream and is guided by the Company’s
Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic
for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and
Europe, and has been used safely and effectively on more than
300,000 patients to date. In March 2009, Spectral obtained the
exclusive development and commercial rights in the U.S. for PMX,
and in November 2010, signed an exclusive distribution agreement
for this product in Canada. Approximately 330,000 patients are
diagnosed with severe sepsis and septic shock in North America each
year.
Spectral, through its wholly owned subsidiary,
Dialco Medical Inc., is also commercializing a new set of
proprietary platforms addressing renal replacement therapy
(RRT) across the dialysis spectrum. SAMI is
targeting the acute RRT market, while DIMI is targeting the chronic
RRT market. Dialco is currently pursuing regulatory approval for
U.S. in-home use of DIMI, which is based on the same RRT platform
as SAMI, but will be intended for home hemodialysis use. DIMI
recently received its FDA 510k clearance for use in hospital and
clinical settings, and obtained its Health Canada license for use
within Canadian hospitals, clinics and in home.
Spectral is listed on the Toronto Stock Exchange
under the symbol EDT. 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.
For further information, please contact:
Chris Seto |
Ali Mahdavi |
David Waldman/Natalya Rudman |
CEO |
Capital Markets & Investor
Relations |
US Investor Relations |
Spectral Medical Inc. |
Spinnaker Capital Markets
Inc. |
Crescendo Communications,
LLC |
416-626-3233 ext. 2004 |
416-962-3300 |
212-671-1020 |
cseto@spectraldx.com |
am@spinnakercmi.com |
edt@crescendo-ir.com |
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