Tigris trial enrollment at 60 patients.
TORONTO, Ontario – May 24, 2023 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today reported hosting an investigator meeting in Charlotte, North Carolina on May 17 – 18, 2023. The in-person meeting was attended by principal investigators (“PI”) and clinical research coordinators (“CRC”) from all existing and new trial sites, as well as the Company’s new CRO, Beaufort. The meeting is expected to help bolster ongoing enrollment activities related to the Tigris trial, the Company’s ongoing 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.
- Approximately 70 in-person attendees.
- Tigris trial sites represented: 15 existing sites and six new or pending sites with site initiation visits conducted at the meeting for multiple sites.
- Beaufort, Spectral’s new CRO: four representatives, including the project lead and head of quality assurance.
- Baxter, Spectral’s strategic commercial partner: four representatives, including clinical and marketing teams.
- The Balancing Act, a premier morning show airing on Lifetime, conducting interviews and filming discussions.
“We are pleased with the overwhelming success of our investigator meeting held last week,” commented Chris Seto, Chief Executive Officer of Spectral Medical. “During the meeting, participants shared past challenges, as well as best practices and solutions to overcome recruitment hurdles. Many attendees noted that all ICU trials are having trouble with recruitment. However, we now have significant recruitment efforts underway and are taking steps to accelerate enrollment, including the addition of multiple new sites, and a new CRO that many of these trial sites have worked with in the past. Given this progress, the investigator meeting was an important step, providing us the opportunity to reaffirm our unwavering commitment to the trial and advancing PMX to FDA submission and ultimate approval. Participants showed strong support, as well as shared in our eagerness to bring PMX to market.”
Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “Tigris is targeting a very important unmet need in the medical field, as endotoxemic septic shock is the most malignant form of sepsis. We have actively undertaken specific initiatives to assist in the acceleration of recruitment and enrollment. These efforts appear to be paying off as two patients were just randomized into the trial on May 22 and May 23, bringing the total enrolment to 60 patients. We continue to close in on our interim enrollment target of 90 patients. Interim enrollment would be a significant milestone as Baxter will have the opportunity to view the data as well as submit a milestone payment to Spectral. We were encouraged by the outlook of the trial and felt a high level of support and enthusiasm from participants at the investigator meeting. We look forward to reaching and reporting additional milestones in the near-term.”
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 TSX 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.
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Spectral Medical Inc.