- Recruitment activity returning to normalized levels with 12 trial sites actively screening patients
- 15 sites on track to open for enrollment by the end of Q3 2021
TORONTO, July 28, 2021 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing diagnostic and therapeutic options for septic shock as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly owned subsidiary Dialco Medical Inc. (“Dialco”), today provided a clinical trial update on Tigris, a follow on study designed to build on knowledge gained from the earlier EUPHRATES trial, evaluating 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.
Key Tigris Trial Updates:
- Recruitment levels returning to normalized levels as COVID-19 ICU cases fall
- 12 trial sites actively screening patients and open for enrollment, including the newest Tigris site – the University of Michigan
- Additional sites in process to commence enrollment with all 15 trial sites anticipated to be screening patients by the end of third quarter 2021
- 19 patients have been randomized to-date, six of which were in the last two months (out of the 150 total patients to be enrolled in the Tigris trial)
Dr. John Kellum, Chief Medical Officer of Spectral, commented, “I am pleased to report that the TIGRIS trial is getting back on track and patient enrolment is well underway. As previously reported, we experienced a delay in Tigris patient enrollment and onboarding of new trial sites due to the pandemic as many trial site ICUs refocused their efforts and resources on addressing the pandemic. In anticipation of COVID-19 receding and diminished strain on trial site ICUs, we conducted an investigator meeting in June 2021, which was well attended by the principal investigators, study site staff, and the Company’s clinical team. In turn, this allowed us to immediately ramp up our Tigris trial initiatives. Our sites have aggressively increased activities around the Tigris trial, including heightened patient screening, enrollment, and randomization. We are also onboarding additional clinical trial sites, including the University of Michigan, which is now actively screening patients. We are now in the process of onboarding the remaining clinical trial sites, which is on track for completion during the third quarter of 2021. Current, active clinical trial sites are screening an average of four-five patients on a weekly basis, and we expect this number to increase as additional sites open.”
Chris Seto, CEO of Spectral, further noted, “With a total of nineteen patients now randomized within the Tigris trial, we are pleased with the acceleration of trial activities and remain optimistic about the trial outcome. Moreover, the increase in number of sites should have a positive impact with access to a potentially much larger population of eligible patients. We remain highly encouraged by the outlook for the Tigris trial based on the outcome of the earlier EUPHRATES trial. The unmet need for new therapies for patients in septic shock remains a global challenge. In the United States alone, there are over 1.7 million new cases of sepsis each year with an estimated 250,000 annual deaths. We remain committed to bringing a focused, personalized approach to the treatment of septic shock to the market to reduce the burden on patients and health care funding.”
Spectral is a Phase III 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 has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 300,000 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. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (“RRT”) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
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.
Spectral Medical Inc.
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David Waldman/ Natalya Rudman
Crescendo Communications, LLC