As the pandemic continues to challenge the market, Argus will discuss their forecast for 2022 on Tuesday, December 14th at 2 pm Eastern Time.
The amendment aligns Tigris' qualifications with current clinical practice in septic shock
Potential to increase Tigris enrollment rate by 25% to 50% and shorten trial completion time
Five additional clinical sites are now involved, and a total of 15 sites are fully involved
Toronto, November 29, 2021 (Global News Agency) - Spectral Medical Inc. ("Spectral" or "Company") (TSX: EDT), a post-treatment diagnostic company dedicated to the advancement of sepsis And septic shock treatment options, and the commercialization of a new proprietary platform for the renal replacement therapy market through its wholly-owned subsidiary Dialco Medical Inc. (Dialco), today announced the U.S. Federal Food and Drug Administration ("FDA") A protocol amendment to its Tigris trial has been approved to allow the use of sequential organ failure assessment ("SOFA") scores as the study's inclusion criteria. In addition, the company announced that it has begun recruiting five other clinical sites, including Louisiana State University, Cleveland Clinic, University of Arkansas, University of Michigan, and University of Colorado Springs, bringing the total number of participating sites to fifteen.
Spectral Chief Medical Officer Dr. John Kellum commented: “We are very pleased that the FDA has approved our Tigris protocol amendment to allow the use of SOFA, which is an alternative scoring system used to quantify the severity of the disease. When cardiovascular dysfunction has been added by blood vessels Adding SOFA as an alternative to capture cardiovascular dysfunction during drug treatment, eliminates the key barriers to the use of MODS for enrollment, and aligns the research protocol with the current sepsis guidelines and practice models of most hospitals. We are very happy to incorporate SOFA Implemented into the research because we believe it should have a significant positive impact on enrollment. We estimate that the enrollment rate using SOFA will increase by 25% to 50%."
Dr. Ali Al-Khafaji, Professor of Critical Care Medicine at the University of Pittsburgh School of Medicine, said: “The ability to include patients based on the SOFA score removes the main barrier to participating in Tigris.” “Although our website has recruited patients based on MODS, we are now recruiting patients based on SOFA. The ability to have should have a significant impact on our recruitment rate. I hope that this kind of registration impact is common in other Tigris sites and should greatly reduce the time required to complete the trial."
Although the clinical environment is full of challenges due to COVID-19, Spectral has successfully added a new test site to the Tigris trial. Currently, 15 sites are dedicated to trials. Dr. Kellum continued: “Although all sites are very involved in trials, they face the challenge of balancing COVID needs and the ability to focus on clinical trial registration activities. Having said that, all of our Tigris sites are specifically targeted at us based on many characteristics Research on sepsis, blood purification equipment, and expertise in conducting clinical trials. We are pleased to announce the addition of Louisiana State University, Cleveland Clinic, and the University of Arkansas, all of which are well-known institutions in the field of sepsis. In addition, the University of Michigan And Colorado Springs University are now open for admissions."
"We are very happy to join the Tigris Trial," said Dr. Kyle Gunnarsen, associate professor of emergency medicine at the University of Michigan School of Medicine. "Sepsis is still the main unmet need of patients, and we see PMX as a potential follow-up therapy to address this unmet need. As a clinical site partner, we view the Tigris trial as a well-designed study designed to achieve positive results. The result. As the flu and winter are approaching, as the COVID subsides, we anticipate an increase in sepsis cases and believe that we can become an active registry."
Spectral CEO Chris Seto commented: "As we enter 2022, the Tigris trial is in a good position to speed up registration and complete the trial as soon as possible. Although it is important that the overall clinical environment continues to normalize, we now have a complete site. In addition, , We are encouraged by the current mortality results that have exceeded expectations."
Both MODS and SOFA are indicators to measure organ dysfunction. They reported on the same six organ systems, with complementary variables in addition to the assessment of cardiovascular dysfunction. The MODS score uses formulas including blood pressure, heart rate, and central venous pressure, while the SOFA score targets blood pressure and vasopressor requirements. The availability of these two scoring systems increases the breadth of registration opportunities because not all patients with sepsis have their central venous pressure measured. In these cases, the SOFA method can be used.
Spectral is a phase 3 company that is seeking US FDA approval for its unique product Toraymyxin™ ("PMX") for the treatment of patients with septic shock. PMX is a therapeutic hemoperfusion device that removes endotoxins that can cause sepsis from the blood. It is guided by the company's Endotoxin Activity Assay (EAA™), which is the only FDA-approved method for diagnosing the risk of sepsis.
PMX is approved for treatment in Japan and Europe, and has been used safely and effectively in more than 300,000 patients so far. In March 2009, Spectral obtained the exclusive development and commercial rights of PMX in the United States, and signed an exclusive distribution agreement for the product in Canada in November 2010. In North America, approximately 330,000 patients are diagnosed with severe sepsis and septic shock each year.
Spectral also commercializes a new proprietary platform through its wholly-owned subsidiary Dialco Medical Inc. to address the entire dialysis field of renal replacement therapy (RRT). SAMI targets the acute RRT market, while DIMI targets the chronic RRT market. Dialco is currently seeking regulatory approval for the use of DIMI in American households. It is based on the same RRT platform as SAMI, but will be used for household hemodialysis. DIMI has recently obtained FDA 510k approval for use in hospitals and clinical settings, and has received approval for use in Canadian hospitals, clinics, and homes from Health Canada.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Information in this press release that is not current or historical facts may constitute forward-looking information within the meaning of securities laws. The information implicit in this information, especially assumptions about Spectral's future prospects and expected events or results, is based on the beliefs of Spectral's senior management and currently available information. Although these assumptions were deemed reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers should note that actual results will be affected by many risks and uncertainties, including the availability of funds and resources for R&D projects, the success and timely completion of clinical research, and Spectral's ability to take advantage of business opportunities in the biomedical field. The necessary approvals granted by industry and regulatory agencies, as well as overall economic, market, and business conditions, may differ materially from current expectations.
TSX has not reviewed the adequacy or accuracy of this statement and does not assume any responsibility.
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