| SPECTRAL MEDICAL ANNOUNCES U.S. FDA APPROVAL OF TIGRIS TRIAL PROTOCOL AMENDMENT TO EXPAND INCLUSION CRITERIA
Amendment aligns eligibility for Tigris with current clinical practice in septic shock Potential to improve Tigris enrollment rates by 25% to 50% and reduce time to trial completion Five additional clinical sites now participating with 15 total sites fully on board TORONTO, Canada – November 29, 2021 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and 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 announced that the United States Federal Food and Drug Agency (“FDA”) has approved a protocol amendment to its Tigris trial allowing for the use of sequential organ failure assessment (“SOFA”) scoring as inclusion criteria into the study. Additionally, the Company announced five additional clinical sites to begin enrollment, including Louisiana State University, Cleveland Clinic, University of Arkansas, University of Michigan and Colorado Springs bringing the total number of participating sites to fifteen.
Dr. John Kellum, Chief Medical Officer of Spectral, commented, “We are very pleased with the FDA approval of our Tigris protocol amendment to allow the use of SOFA, which is an alternative scoring system used to quantify severity of illness. Adding SOFA as an alternative to capture cardiovascular dysfunction when it is already being treated by vasopressor drugs removes a critical barrier to enrollment using MODS and harmonizes the study protocol with current sepsis guidelines and practice patterns across most hospitals. We are very excited to implement SOFA into the study as we believe it should have a significantly positive impact on enrollment. We estimate enrollment will increase by 25% to 50% using SOFA.”
“The ability to include patients based on SOFA scores removes a major barrier to enrollment in Tigris,” said Dr. Ali Al-Khafaji, Professor of Critical Care Medicine at the University of Pittsburgh School of Medicine. “While our site has enrolled patients based on MODS, the ability to now enroll patients based on SOFA should have a material impact on our enrollment rates. I would expect this enrollment impact to be universal across other Tigris sites, and should greatly reduce the time needed to complete the trial.”
Despite a challenging clinical environment due to COVID-19, Spectral has had success in adding new trial sites into the Tigris trial. At present, there are 15 sites committed to the trial. Dr. Kellum continued, “Although all sites are very much engaged in the trial, they are challenged by balancing the demands of COVID and their ability to focus on clinical trial enrollment activities. That being said, all of our Tigris sites have been specifically targeted for our study based on numerous characteristics, including expertise in sepsis, blood purification devices and conducting clinical trials. We are pleased to announce the additions of Louisiana State University, Cleveland Clinic, and University of Arkansas, all of which are renowned institutions in the field of sepsis. Furthermore, University of Michigan and Colorado Springs are now open to enrollment.”
“We are very excited to join the Tigris trial,” said Dr. Kyle Gunnerson, Associate Professor, Emergency Medicine at the University of Michigan Medical School. “Sepsis remains a major unmet patient need, and we view PMX as a potentially consequential therapy to address this unmet need. As a clinical site partner, we view the Tigris trial as a well designed study positioned for a positive outcome. With the flu and winter seasons around the corner, and as COVID recedes, we are expecting an increase in sepsis cases, and believe we can be an active enrolling site.”
Chris Seto, CEO of Spectral, commented, “As we head into 2022, the Tigris trial is well positioned to accelerate enrollment and finalize the trial as expeditiously as possible. While it’s important for the overall clinical environment to continue to normalize, we now have the full complement of sites engaged. Furthermore, we are encouraged by the current mortality results, which exceed expectations.”
MODS vs. SOFA Summary Both MODS and SOFA are measures of organ dysfunction. They report on the same six organ systems with complementary variables with the exception of the assessment of cardiovascular dysfunction. The MODS score utilises a formula that includes blood pressure, heart rate and central venous pressure, while the SOFA score targets blood pressure and degree of vasopressor requirements. With the ability to utilize both scoring systems, the breadth of opportunities for enrolment increases as not all patients with sepsis have central venous pressures measured. In those cases, the SOFA method may be used.
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 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. 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.
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