Spectral Medical Inc. - CMO, Dr. John Kellum
CMO, Dr. John Kellum
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  • Spectral Medical (EDT) provided a clinical trial update on Tigris, evaluating the use of Polymyxin B Hemoperfusion (PMX) in a randomized controlled trial of adults treated for endotoxemia and septic shock
  • First patient enrolled at the University of Michigan trial site
  • 40 patients randomized to date out of the 150 total patients to be enrolled in the Tigris trial
  • Recruitment steadily rising with 14 trial sites actively screening patients and open for enrollment
  • Spectral Medical Inc. (EDT) is up 9.28 per cent, trading at C$0.53 per share at 10:40 am ET

Spectral Medical (EDT) updated its clinical trial of Tigris.

The clinical trial evaluated the use of Polymyxin B Hemoperfusion (PMX) on adults treated for endotoxemia and septic shock.

This is a follow-on study designed to build on knowledge gained from the earlier EUPHRATES trial, with an end point being a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.

Key Tigris trial updates:

  • First patient enrolled at the University of Michigan (U of M) trial site
  • 40 patients randomized to date out of the 150 total patients to be enrolled in the Tigris trial
  • Recruitment steadily rising with 14 trial sites actively screening patients and open for enrollment

Spectral CEO Chris Seto explained that the company is making significant progress with its Tigris confirmatory trial and is very encouraged by the data seen so far.

“PMX targets a large unmet medical need that is currently estimated at $1.6 billion in the U.S. alone. With no approved or cleared treatments on the market, we believe, if Tigris is successful, we can swiftly move towards FDA submission, which follows our recent Breakthrough Device designation granted by the FDA. With continued progression of the Tigris trial, our Breakthrough Device designation, as well as our executed commercial partnership with Baxter, we remain laser focused on our goal of bringing PMX to market. Most importantly, we believe PMX will provide new hope for the approximately 120,000 patients each year that suffer from endotoxemic septic shock and face an estimated 50% mortality rate.”

Spectral’s Chief Medical Officer Dr. John Kellum added that the trial site at the University of Michigan has randomized its first patient.

“The clinical staff at U of M witnessed immediate improvement in the patient’s status following administration of PMX and the patient was able to transfer out of the intensive care unit (ICU) sooner than expected. We believe this positive patient outcome, and the fact that data thus far is exceeding expectations, reinforces our prior EUPHRATES trial data and our overall confidence in the efficacy of PMX in this patient population.”

A Professor and Emergency Medicine Director at the Emergency Critical Care Center within the University of Michigan, Kyle Gunnerson, MD, FCCM, further noted that the patient saw rapid improvement and recovery following administration of PMX and was transferred out of the ICU sooner than anticipated.

Spectral is a Phase 3 company seeking U.S. FDA approval for Toraymyxin, a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream.

Spectral Medical Inc. (EDT) is up 9.28 per cent, trading at C$0.53 per share at 10:40 am ET.

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