Spectral Medical Provides Tigris Trial Update
07 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
that it has enrolled a total of 76 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.
- Emory Healthcare newest trial site
addition (Tigris site #20) enrolling out of two hospitals.
- University of California San
Francisco (UCSF) and University of Alabama at Birmingham (UAB)
continue to be strong Tigris enrollers, with the enrollment of
patients 75 and 76 at the end of October.
- 76 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 (NYSE:BAX), will have the opportunity to view the data as
well as provide a second milestone payment to Spectral.
- Crude 28-day mortality results, thus
far, continue to exceed efficacy targets.
Dr. John Kellum, Chief Medical Officer of
Spectral, commented, “After a somewhat sluggish September, we are
pleased with October’s robust screening activity which resulted in
two new enrollments at the end of October. 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.”
“We are taking measured, yet rapid action to
maintain and even increase momentum in patient enrollment with a
view to enrolling our interim count of 90 patients, which is
expected to play as a major catalyst for the Company,” said Chris
Seto, Chief Executive Officer of Spectral Medical. “Based on the
pace of patient enrollment in the past number of months, and our
activities around site additions, we are optimistic on the prospect
of reaching the 90 patient interim milestone around the end of
2023.”
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 |
Capital Markets & Investor
Relations |
US Investor Relations |
Spinnaker Capital Markets
Inc. |
Crescendo Communications,
LLC |
416-962-3300 |
212-671-1020 |
am@spinnakercmi.com |
edt@crescendo-ir.com |
|
Blair McInnis |
|
CFO |
|
Spectral Medical Inc. |
|
416-626-3233 |
|
bmcinnis@spectraldx.com |
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