Spectral Medical Reports Progress on Tigris Clinical Trial
11 Februar 2022 - 2:00PM
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 provided a clinical trial update on Tigris, a follow on study
designed to build on knowledge gained from the earlier EUPHRATES
trial, evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a
randomized controlled trial of adults treated for endotoxemia and
septic shock. The Tigris trial end point is a reduction in the
28-day mortality in subjects with septic shock using the PMX
hemoperfusion cartridge versus standard of care.
Key Tigris Trial Updates:
- Patient mortality data continues to exceed expectations
- 30 patients randomized to-date (out of the 150 total patients
to be enrolled in the Tigris trial)
- Of the three patients enrolled over the past month, two were
enrolled as a result of the recent FDA approved protocol amendment
allowing for the use of sequential organ failure assessment (SOFA)
scoring as inclusion criteria into the study
- Investigator meeting scheduled for February 17, 2022, expected
to be well attended by existing and new trial sites
Chris Seto, CEO of Spectral, commented, “We are
highly encouraged by both the patient mortality data thus far, as
well as the recent rate of patient screening, enrollment, and
randomization activity. We attribute the increased enrollment to a
number of factors, including the implementation of our United
States Federal Food and Drug Agency (FDA) approved SOFA amendment
and new sites coming online. Notably, we recently opened enrollment
at UC Health Memorial Hospital in Colorado Springs, one of the
highest enrolling sites in the Euphrates trial, which has already
enrolled two patients in the past month alone. We look forward to
our upcoming investigator meeting later this month, which we expect
will be well attended and will feature Professor Claudio Ronco, MD,
and Dr. Paul Walker as keynote speakers.”
“It’s gratifying to see the commitment from our
participating Tigris sites,” said Dr. John Kellum, Chief Medical
Officer of Spectral. “COVID-19 has again disrupted research
activities across the U.S., but the passion for sepsis care and
research shown by our sites is quite remarkable. We have still
managed to enroll patients even with COVID cases occupying most of
the ICU beds. Now that COVID cases are falling, we expect a
meaningful increase in enrollment in the coming weeks. Equally
important, early efficacy signals continue to exceed targets.”
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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