UPDATE 2-Spectral Medical's sepsis treatment fails late-stage study
(Adds CEO comments)
By Natalie Grover
Oct 3 (Reuters) - 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 and death.
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 told Reuters.
A smaller-than-expected decrease in endotoxin adversely affected the rate of mortality reduction, he said. Continued...