Spectral Medical Announces the Opening of Three Additional Tigris Clinical Trial Sites
July 05 2023 - 7:00AM
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 opening of three new clinical trials sites, the University of
Alabama at Birmingham (UAB), Rutgers, The State University of New
Jersey (RU), and a major medical center in Wisconsin, bringing the
total number of active clinical trial sites to eighteen for the
Company’s Tigris trial, a Phase 3 follow-on study evaluating the
use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled
trial of adults treated for endotoxemia and septic shock.
- On track to have 25 active trial sites open by the end of
September 2023, with 18 current sites and 2 more expected in
July.
- 65 patients enrolled to date and continuing to close in on the
interim target of 90 patients, an important milestone as the
Company’s strategic commercial partner, Baxter, will have the
opportunity to view the data as well as provide a second milestone
payment to Spectral.
- The enrollment rate experienced over the past twelve weeks
maintains the target timeline of 90 patients enrolled around the
end of 2023.
- Crude 28-day mortality results, thus far, continue to exceed
efficacy targets.
Dr. John Kellum, Chief Medical Officer of
Spectral, commented, “We are pleased to add three additional
excellent clinical trial sites for Tigris, which is expected to
accelerate patient enrollment and enable us to more rapidly reach
our 150 total patient target. A strong pace of enrollment now is
important as July and August are traditionally slower months for
clinical trials. We continue to advance our Tigris trial and remain
encouraged by the outlook with preliminary mortality data that
continually exceeds our expectations. With no approved or cleared
treatment on the market to date, we believe, if Tigris is
successful, we can swiftly move towards FDA submission and address
a significant unmet medical need with a market currently estimated
at $2 billion in the United States alone.”
While the Company continues to witness initial
benefits of its business initiatives, Management believes that the
Company will realize the full impact of these initiatives over
time. Management looks forward to reporting Tigris progress as
material developments unfold.
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
endotoxemic 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 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:
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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