Spectral Medical Provides Update on Favorable Tigris Clinical Trial Enrollment
30 Mai 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 provided an enrollment update on Tigris, the Company’s
follow-on study designed to build on knowledge gained from the
earlier EUPHRATES trial, which evaluated the use of Polymyxin B
Hemoperfusion (“PMX”) in a randomized controlled trial of adults
treated for endotoxemia and septic shock. The Tigris trial end
point is a reduction in the 28-day mortality in subjects with
septic shock using the PMX hemoperfusion cartridge versus standard
of care.
During the first quarter, the Company
implemented a number of business initiatives, as outlined in
Spectral’s investor update call on April 6, 2023, that are targeted
to enhance and accelerate Tigris enrollment. Management is pleased
to report positive progress on the following initiatives:
- Enrolled eight patients in the past
seven weeks since the Company’s investor update call.
- Witnessing early indications of
Tigris Investigator Meeting acting as a catalyst for enrollment,
with three patients enrolled in the subsequent week.
- 61 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.
- 28 patients were enrolled in the
last 12 months, up from 19 patients enrolled in the same period
ending May 31, 2022. Enrollment rate increased to 0.19
patients per site, per month from the previous 0.18, due to strong
enrollment in April and May. Enrollment rate for sites enrolling at
least one patient in the last 12 months has increased to 0.29.
Management is targeting an enrollment rate of 0.25 patients per
site per month for all sites.
- On track to have 25 active trial
sites open by the end of September 2023, with three new sites
anticipated to be open for enrollment in June.
- New CRO transition progressing on
schedule, with full transition expected to be complete by the end
of June.
- Crude mortality results of those
enrolled in the Tigris study, thus far, continue to exceed
expectations.
While the Company is witnessing 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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