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Medical Device Daily Staff Writer

Last year, the Global Sepsis Alliance said that sepsis is a medical emergency beyond national borders and likely a major cause of death worldwide, claiming tens of millions of lives every year. The most life-threatening forms of sepsis – severe sepsis and septic shock – have a combined mortality rate of 30-35%. To make matters worse, there is little public understanding of the condition. A 2010 survey commenced by the Sepsis Alliance revealed that 66% of Americans had never heard of the word "sepsis." Of the remaining third familiar with the word, 35% of the group did not know what sepsis was.

One company is taking a more personalized approach in treating patients with the condition. Spectral Diagnostics (Toronto, Ontario) has developed a "theranostics" application - comprised of a diagnostic and a therapeutic hemoperfusion device to treat the condition which affects 750,000 patients and resulting in more than 250,000 deaths annually.

The firm, which was formed in 1991 and went public in 1992, has developed the Endotoxin Activity Assay (EAA) – the only FDA-cleared, CE-marked rapid diagnostic for endotoxemia – and has combined this with Toray's (Tokyo) Toraymyxin – a direct hemoperfusion adsorption column which is highly effective in removing endotoxin from the bloodstream.

Spectral President/CEO Paul Walker, MD said the journey to developing the device was challenging at times because some pharma companies just didn't turn out to be the right fit.

"Our major interest was not just the concept of a diagnostic, but in fact linking very specific diagnostics to a very specific therapy," Walker told Medical Device Daily. "So we worked with a number of the large pharma companies that had interest in anti-endotoxcin therapy. We found two things, one was that their drugs weren't terribly effective in blocking or neutralizing endotoxins, and secondly they didn't really want to link with a diagnostic because it might limit the size of their market."

He said ultimately, the firm settled on Toraymyxin, which has been marketed by Toray Industries in Europe and Japan since 2002 and 1994 respectively, and has been used safely on more than 80,000 patients. Spectral holds the exclusive rights for Toraymyxin in the U.S.

Walker said that both were a perfect fit for one another. He said that the EEA was tailored specifically to the patient's needs.

"We personalized this assay for each person because everyone reacts a little bit different to endotoxcin," he said. "We actually use a single one-point max calibrator for every patient, so that each patient acts as their own control. Then we get essentially a value, which is independent of everything else and reflects the endotoxin activity in that patient."

He added, "the nice part of this is that it's a whole blood assay and the results can be run in 30 minutes. That makes it highly useful as a diagnostic you would use to initiate therapy."

In 2009, interim results of a Phase II study were published in Journal of the American Medical Association demonstrating that Toraymyxin, when added to conventional therapy, significantly reduced 28-day mortality in patients with severe sepsis and septic shock, compared to patients only receiving conventional therapy. Due to these positive results, that trial was terminated early and a Phase III pivotal multicenter study has been launched in the U.S. and Canada.

A successful outcome of the EUPHRATES trial will serve as the pathway for a PMA submission in the U.S. of Toraymyxin and has the potential to change the way sepsis is treated for a significant patient population.

"It is being run in a most unusual way for sepsis trials in that were are utilizing the diagnostic as an entry criteria and we're doing it as a blinded device trial," he said. "So it's a very specific diagnostic and we're running a top tier trial."

Walker said that in general the company would be looking at an interim analysis of the trial data in 2013 and that would give the greatest guidance into how long the trial would take.

As for predictions on approval, the company would have a clearer picture once the trials were complete. Walker told MDD that if this were to garner approval it would add an interesting dynamic to sepsis treatment.

"This concept of treating all sepsis patients the same has clearly not been successful," Walker said. "What we're suggesting is that you really need to personalize it and make sure the metabolite that you're trying to go after is actually present."

Published  March 26, 2012

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