Spectral Medical Announces Publication of Tigris Trial Methods Paper and Simulation of Results
14 November 2023 - 2:00PM
Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:
EDT), a late-stage theranostic company advancing
therapeutic options for sepsis and septic shock, today announced
the publication of its Tigris trial methods paper in Critical Care,
which discusses the use of Bayesian methods in clinical trial
design. Simulation studies incorporating historical data from a
179-patient subgroup of Spectral’s EUPHRATES trial combined with
data from the ongoing Tigris trial demonstrated an increase in
power across a range of observed hypothetical results.
Dr. John Kellum, Chief Medical Officer of
Spectral Medical, commented, “We are pleased to see the publication
of this paper, in a major scientific journal. The analysis clearly
indicates that our trial strategy is highly likely to succeed and
not only will this support our FDA approval for PMX, but will also
have a major impact on how trials in the ICU are conducted in the
future. The simulations involving over 2,000 potential trial
results show that using the planned 75% weight on the prior
EUPHRATES data, an observed absolute risk reduction for mortality
of 7% in Tigris is at approximately the 95% probability threshold
for declaring PMX effective. Current results from Tigris are far in
excess of this threshold.”
Chris Seto, Chief Executive Officer of Spectral
commented, “We are also pleased to see all of our study site
investigators participating as authors on the study as we continue
to work aggressively to complete the enrollment of our Tigris
Trial. We are proud to be a part of this effort to help patients
suffering from endotoxic septic shock and hope to bring a new
standard of care to the market.”
The Tigris Trial methods paper “Bayesian
methods: a potential path forward for sepsis trials” can be
accessed at: https://doi.org/10.1186/s13054-023-04717-x
About Critical Care
Critical Care is a high-quality, peer-reviewed,
international clinical medical journal. Critical
Care aims to improve the care of critically ill patients by
acquiring, discussing, distributing, and promoting evidence-based
information relevant to intensivists. Critical Care aims
to provide a comprehensive overview of the intensive care
field.
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
340,000 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. In July 2022, the U.S. FDA granted
Breakthrough Device Designation for PMX for the treatment of
endotoxic septic shock. Approximately 330,000 patients are
diagnosed with septic shock in North America each year.
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 company’s ability to raise capital and
the availability of funds and resources to pursue R&D projects,
the recruitment of additional clinical trial sites, the rate of
patient enrollment, the successful and timely completion of
clinical studies, the success of Baxter’s commercialization
efforts, 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:
Ali Mahdavi |
David Waldman/Natalya Rudman |
Blair McInnis |
Capital Markets & Investor
Relations |
US Investor Relations |
CFO |
Spinnaker Capital Markets
Inc. |
Crescendo Communications,
LLC |
Spectral Medical Inc. |
416-962-3300 |
212-671-1020 |
416-626-3233 |
am@spinnakercmi.com |
edt@crescendo-ir.com |
bmcinnis@spectraldx.com |
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