Spectral Medical Announces Tigris Clinical Trial Update
25 Juli 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
that it has enrolled a total of 69 patients 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.
- Rutgers, The State University of New Jersey (RU) enrolled its
first patient within three weeks of opening for enrollment in the
Tigris Trial.
- University of Alabama at Birmingham (UAB) enrolled its second
patient in less than a month since opening for enrollment in the
Tigris Trial.
- 69 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.
- Based on the enrollment rate experienced over the past three
months, the Company remains on pace to achieve its target timeline
of 90 patients enrolled around the end of 2023.
- On track to achieve 25 active trial sites open by the end of
September 2023; 18 sites are currently active with four more
expected by the end of August.
- Crude 28-day mortality results, thus far, continue to exceed
efficacy targets.
Dr. John Kellum, Chief Medical Officer of
Spectral, commented, “We are pleased with the enrollment momentum
these past few months, with four new enrollments in July alone,
which is particularly noteworthy as we typically experience slower
enrollment in the summer months. Since we communicated our business
initiatives to increase enrollment just this past April, we have
already enrolled 16 new patients in the Tigris Trial, of which,
nearly half have come from new sites opened for enrollment in
2023. We continue to make progress opening additional
sites, which should positively impact the pace of enrollment.
Overall, we are rapidly advancing our Tigris trial and remain
highly encouraged by the outlook, given the fact preliminary
mortality data continues to exceed our expectations.”
While the Company continues to witness the
benefits of its enrollment initiatives, Management believes that
the Company will realize increasing benefit from these and other
initiatives over time. Management looks forward to reporting
additional Tigris progress and milestones 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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