Reaches 16 total clinical trial sites for Tigris and expects two more opening around the end of Q1
TORONTO, Ontario – March 9, 2023 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced the opening of two clinical trials sites, the Medical University of South Carolina (MUSC) and the University of California San Francisco (UCSF), bringing the total number of active clinical trial sites to 16 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.
Matthieu Legrand, MD, PhD, Professor and Director of Clinical Research for the Department of Anesthesia at UCSF, commented, “There is a resounding need for more effective therapies to treat endotoxemia and septic shock. We are quite excited about participating in a trial that uses a personalized medicine approach.”
Blaithin A. McMahon MD. Ph.D., Associate Professor of Medicine at MUSC, stated, “We’re already hard at work to identify patients for Tigris. There is an incredible need for sepsis research, because sepsis destroys the lives of many of our patients and we are quite excited to be on the team.”
Dr. John Kellum, Chief Medical Officer of Spectral, commented, “We are pleased to add two additional excellent clinical trial sites for Tigris, which is expected to accelerate patient enrollment and enable us to more rapidly reach our 150 total patient target. We also expect to have two more sites onboarded and actively enrolling around the end of the first quarter of 2023. We continue to advance our Tigris trial and remain encouraged by the outlook with preliminary mortality data that continually exceeds our expectations. With no approved or cleared treatment on the market to date, we believe, if Tigris is successful, we can swiftly move towards FDA submission and address a significant unmet medical need with a market currently estimated at $2 billion in the United States alone.”
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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