Spectral Medical has launched three new sites for its Phase III Tigris clinical trial designed to assess the use of a Polymyxin B Hemoperfusion (PMX) device.
Guided by the company’s Endotoxin Activity Assay, PMX is a therapeutic hemoperfusion device that helps remove sepsis-causing endotoxin from the bloodstream.
With the launch of the State University of New Jersey (RU), the University of Alabama at Birmingham (UAB), Rutgers and a major medical centre in Wisconsin, the total number of active sites for the trial now reach 18.
The Phase III follow-on randomised controlled study will evaluate PMX in adults to treat septic shock and endotoxemia.
The company plans to add two more sites by the end of this month and a total of 25 sites by the end of September this year.
So far, the trial recruited 65 patients and continues to conclude with an interim target of 90 subjects.
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By GlobalDataThe company’s strategic commercial partner Baxter will assess the data and deliver a second milestone payment to Spectral.
Spectral chief medical officer Dr John Kellum said: “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.
“A strong pace of enrolment now is important as July and August are traditionally slower months for clinical trials. We continue to advance our Tigris trial and remain encouraged by the outlook with preliminary mortality data that continually exceeds our expectations.”
PMX already secured approval for therapeutic use in Europe and Japan.
In July last year, PMX received breakthrough device designation from the US FDA to treat endotoxemic septic shock.
