Spectral Medical Provides April Tigris Trial Update
May 06 2024 - 7:30AM
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
continuing throughout 2024:
- 105 patients enrolled at end of
April 2024
- Record monthly
enrollment with seven patients enrolled in April
- 24 patients
enrolled in 2024 so far – represents the most robust enrollment
rates since the start of the Tigris study
- With 45 patients
to full enrollment, the Company is entering the final push to fully
enroll and finish the Tigris trial
- To support
sustained enrollment, Spectral hosted an in-person Investigator
Meeting March 12th & 13th in conjunction with the 29th
International Conference on Advances in Critical Care Nephrology in
San Diego
- In-person
meeting well attended with multiple stakeholders present,
including: principal investigators and clinical research
coordinators from existing and new trial sites; CRO, Beaufort; and
representatives from the Company’s strategic partner Baxter
Trial Sites:
- Continued progress opening
additional high quality clinical sites
- Recently
onboarded the University of Virginia
- Two pending
sites in the pipeline finalizing contracting and training
- Spectral
clinical team focused on trial site management activities to ensure
that Tigris sites have the support and resources to enroll patients
as efficiently as possible
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 |
|
Chris Seto |
Capital Markets & Investor Relations |
|
CEO |
Spinnaker Capital Markets Inc. |
|
Spectral Medical Inc. |
416-962-3300 |
|
|
am@spinnakercmi.com |
|
cseto@spectraldx.com |
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