(Adds CEO comments)
By Natalie Grover
Oct 3 Spectral Medical Inc said its
experimental treatment for sepsis - a common, oft-deadly
complication of infection - failed a late-stage study, stymieing
the company's plans to bring to market the first FDA-approved
device for the condition.
Sepsis occurs when the immune system goes into overdrive to
fight infection or bacterial toxins, triggering a cascade of
physiological changes that can lead to multiple organ failure
Toronto-based Spectral Medical holds North American rights
to a system developed by Japan's Toray Industries Inc,
designed to restore blood pressure and correct organ dysfunction
by using an antibiotic to detoxify the blood.
Once the patient's blood has been extracted, it is passed
through two columns to remove a type of toxin, called an
endotoxin, which is believed to be a major trigger for sepsis.
The trial did not meet the main goal of absolute reduction
in mortality rate at 28 days but did demonstrate beneficial
treatment effects, Spectral said on Monday.
"We proved beyond doubt that endotoxin is bad and taking it
out is good," and Spectral will discuss with the U.S. Food and
Drug Administration the next steps, Chief Executive Paul Walker
A smaller-than-expected decrease in endotoxin adversely
affected the rate of mortality reduction, he said.
If we can show "more columns take out more endotoxin, then I
think we can get approved."
There are no specific FDA-approved medicines for the
treatment of sepsis, and there have been several high-profile
The leading cause of hospitalizations in the United States,
it can result from a simple cut, routine surgery or infections
associated with chronic disease.
Infants, the elderly and those with weakened immune systems
are most at risk.
In extreme cases, a dramatic drop in blood pressure can lead
to life-threatening septic shock, the category of patients
Spectral is targeting.
Toray has been selling the product, the Toraymyxin system,
in its home market since 1994 and through distributors in Europe
since 2002. The system is also approved for use in Canada.
Still, data supporting use of the device is intensely
debated, with trials conducted outside of Japan and Italy
failing to prove its efficacy.
Walker expects Spectral will now need to conduct an
observational study to show that four columns, for example, will
take out enough endotoxin to make a significant difference in
If all goes well, this could mean the device could win U.S.
approval by early 2018, he said.
(Reporting by Natalie Grover in Bengaluru; Editing by Martina