- Spectral Medical Inc. (EDT) provides Tigris Clinical trial update
- The Tigris trial endpoint is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care
- There are additional sites in the process of commencing enrollment with all 15 trial sites anticipated to be screening patients by the end of the third quarter of 2021
- Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™
- Spectral Medical Inc.(EDT) is flat on the day, trading at C$0.36 at 12:54 pm ET
Spectral Medical (EDT) has provided an update on the Tigris clinical trial of adults treated for endotoxemia and septic shock.
The Tigris trial is a follow-on study designed to build on knowledge gained from the earlier EUPHRATES trial, evaluating the use of Polymyxin B Hemoperfusion (PMX) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
Recruitment levels are returning to normalized as COVID-19 ICU cases fall. Twelve trial sites are actively screened patients, including the newest Tigris site – the University of Michigan.
There are additional sites in the process of commencing enrollment with all 15 trial sites anticipated to be screening patients by the end of third quarter 2021 and 19 patients have been randomized to date, six of which were in the last two months (out of the 150 total patients to be enrolled in the Tigris trial).
Dr. John Kellum, Chief Medical Officer of Spectral, commented,
“Our sites have aggressively increased activities around the Tigris trial, including heightened patient screening, enrollment, and randomization. We are also onboarding additional clinical trial sites, including the University of Michigan, which is now actively screening patients.”
“We are now in the process of onboarding the remaining clinical trial sites, which is on track for completion during the third quarter of 2021. Current, active clinical trial sites are screening an average of four-five patients on a weekly basis, and we expect this number to increase as additional sites open,” added Dr. Kellum.
Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™.
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 has been approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 300,000 patients to date.
Spectral Medical Inc.(EDT) is flat on the day, trading at C$0.36 at 12:54 pm ET.
