Spectral Medical Provides April Tigris Trial Update
Spectral Medical Inc.
Mon, May 6, 2024, 4:30 AM PDT3 min read
• 105 patients enrolled
• April represents a record breaking month for patient enrollment
TORONTO, May 06, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on 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.
Enrollment:
- Robust enrollment activity continuing throughout 2024:
- 105 patients enrolled at end of April 2024
- Record monthly enrollment with seven patients enrolled in April
- 24 patients enrolled in 2024 so far – represents the most robust enrollment rates since the start of the Tigris study
- With 45 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial
- To support sustained enrollment, Spectral hosted an in-person Investigator Meeting March 12th & 13th in conjunction with the 29th International Conference on Advances in Critical Care Nephrology in San Diego
- In-person meeting well attended with multiple stakeholders present, including: principal investigators and clinical research coordinators from existing and new trial sites; CRO, Beaufort; and representatives from the Company’s strategic partner Baxter
Trial Sites:
- Continued progress opening additional high quality clinical sites
- Recently onboarded the University of Virginia
- Two pending sites in the pipeline finalizing contracting and training
- Spectral clinical team focused on trial site management activities to ensure that Tigris sites have the support and resources to enroll patients as efficiently as possible
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