Spectral Medical`s sepsis treatment fails late-stage study

By Reuters Staff

(Reuters) - Spectral Medical Inc said its experimental treatment for sepsis failed a late-stage study, stymieing the company's plans to bring to market the first FDA-approved device for the condition.

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 a column to remove 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.

The data demonstrates a clear correlation between the amount of endotoxin removal and reduction in mortality, and Spectral will discuss with the U.S. Food and Drug Administration the next steps toward potential approval, it added.

There are no specific FDA-approved medicines for the treatment of sepsis, and there have been several high-profile clinical failures.

The leading cause of hospitalizations in the United States, it can result from a simple cut, routine surgery or infections associated with chronic disease.

Sepsis costs the U.S. healthcare system about $24 billion yearly, according to Sepsis Alliance, a San Diego-based patient advocacy organization.

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.