- Spectral Medical (EDT) provides an update on the Tigris clinical trial
- The Tigris trial is a follow-up study, the endpoint is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus the standard of care
- Preliminary mortality outcome data to data continues to exceed expectations
- Spectral Medical (EDT) is a theranostic company advancing the treatment of patients with sepsis and septic shock
- Spectral Medical (EDT) is up today, trading at C$0.47 as of 1:23 pm ET
Spectral Medical (EDT) has provided an update on the Tigris clinical trial.
The Tigris trial is a follow-up on 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 endpoint is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.
Recruitment for the clinical trial vamped up at the end of September with 44 patients enrolling, bringing the total to 150 patients. The company has added 3 more clinical trial sites this month for a total of 17 sites. The company expects 20 total clinical trial sites by Q1 of 2023. Preliminary mortality outcome data to data continues to exceed expectations.
Chris Seto, CEO of Spectral Medical, remarked on the news.
“We anticipate having a total of 20 clinical trial sites onboard by the first quarter of 2023, which would significantly increase our recruiting efforts and provide the potential to enroll patients more rapidly. With data continually exceeding our expectations and no approved or cleared treatment on the market to date, we believe if Tigris is successful, we can swiftly move towards FDA submission and bring hope to the approximately 120,000 patients each year that suffer from endotoxemic septic shock and face an estimated mortality rate in excess of 50 per cent.”
Dr. John Kellum, Chief Medical Officer of Spectral Medical, added:
“Preliminary data received to date has surpassed our expectations and reinforces our prior EUPHRATES trial data, supporting our expressed confidence in the efficacy of PMX in this patient population. We remain encouraged by the progress of the Tigris trial to date and remain focused on our goal of bringing PMX to market.”
Toraymyxin, or 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, 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.
Spectral Medical (EDT) is a theranostic company advancing the treatment of patients with sepsis and septic shock. The company is seeking to commercialize a new platform targeting the renal replacement therapy market through its subsidiary company Dialco Medical.
Spectral Medical (EDT) is up today, trading at C$0.47 as of 1:23 pm ET.
