Spectral Medical Provides Early February Tigris Trial Update
05 Februar 2024 - 1:30PM
Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:
EDT), a late-stage theranostic company advancing
therapeutic options for sepsis and septic shock, today provided an
update on 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.
Enrollment:
- Robust enrollment activity continues
throughout 2024:
- 88 patients enrolled to-date
- Six patients
enrolled in the month of January, which is the highest monthly
enrollment experienced since the start of the Tigris study
- One patient enrolled in February to
date
- Closing in on
the interim enrollment target of 90 patients (“Interim
Enrollment”); at Interim Enrollment, Baxter has the option to make
the second milestone payment to Spectral to maintain its PMX
exclusive distribution rights.
Trial Sites:
- Continue to make progress opening an
additional six new, high quality clinical sites.
- University of
Texas Health Sciences Center at Houston finalized and executed the
Tigris clinical trial agreement; the Company anticipates another
Texas-based site to execute its clinical trial agreement in the
coming days
- Expect
significant site onboarding activity in Q1/24, with final training
scheduled at four sites in February so far
“With the robust enrollment activity experienced
to start 2024, we are rapidly approaching our interim enrollment
milestone of 90 patients, which is expected to play as a major
catalyst for the Company,” said Chris Seto, Chief Executive Officer
of Spectral Medical. “Additionally, with 62 patients to go, we are
entering the final push to fully enroll and finish the Tigris
trial.”
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.
The Tigris Trial is a confirmatory study of PMX
in addition to standard care vs standard care alone and is designed
as a 2:1 randomized trial of 150 patients using Bayesian
statistics. Endotoxic septic shock is a malignant form of sepsis
https://www.youtube.com/watch?v=6RANrHHi9L8.
The trial methods are detailed in
“Bayesian methods: a potential path forward for sepsis
trials”.
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 |
Chris Seto |
Capital Markets & Investor
Relations |
US Investor Relations |
CEO |
Spinnaker Capital Markets
Inc. |
Crescendo Communications,
LLC |
Spectral Medical Inc. |
416-962-3300 |
212-671-1020 |
|
am@spinnakercmi.com |
edt@crescendo-ir.com |
cseto@spectraldx.com |
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