Trial Sites To me, this news release says there will be active 18 sites by the end of 1st Qtr 2023.. The question is whether we can expect at least 1 patent per site per month or more.. Hopefully that interim numbers may not take till next year..
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.”