Spectral Medical has broadened its Phase III Tigris clinical trial by incorporating three new sites to evaluate the Polymyxin B Hemoperfusion (PMX) device. This device is designed to eliminate sepsis-inducing endotoxins from the bloodstream, potentially offering a new approach to treating septic shock and endotoxemia.
The newly added sites include the State University of New Jersey (RU), the University of Alabama at Birmingham (UAB), Rutgers, and a major medical center in Wisconsin, bringing the total number of active trial sites to 18. The randomized controlled study focuses on adult patients suffering from septic shock and endotoxemia.
The trial has recruited 65 patients and is progressing toward an interim target of 90 subjects, with an overall goal of enrolling 150 patients. Spectral anticipates adding two more sites by the end of the month and aims for a total of 25 sites by the end of September.
Strategic Partnership and Data Assessment
Baxter, Spectral's strategic commercial partner, will assess the data generated from the Tigris trial. Positive results could trigger a second milestone payment to Spectral, underscoring the commercial interest in the PMX device.
Management Commentary
Dr. John Kellum, Spectral's chief medical officer, expressed optimism about the trial's progress: "We are pleased to add three additional excellent clinical trial sites for Tigris, which is expected to accelerate patient enrolment and enable us to more rapidly reach our 150 total patient target."
He also noted the importance of maintaining a strong enrollment pace, particularly during traditionally slower months for clinical trials. Dr. Kellum added, "We continue to advance our Tigris trial and remain encouraged by the outlook with preliminary mortality data that continually exceeds our expectations."
Regulatory Status and Prior Approvals
The PMX device has already secured approval for therapeutic use in both Europe and Japan. In July of the previous year, the US FDA granted PMX breakthrough device designation for the treatment of endotoxemic septic shock, highlighting the unmet need and potential benefit of this therapy.
