Gene-altered drug cuts deaths from shock by 40%, study says

February 14, 1991|By New York Times News Service

A new genetically engineered drug significantly cuts the death rate from septic shock, a quick and overwhelming infection of the bloodstream that kills tens of thousands of people each year.

Septic shock is an especially great threat for hospital patients and wounded soldiers.

The new treatment involves a human monoclonal antibody that homes in with a sharpshooter's precision on the bacterial toxin responsible for death from the infection.

In a study appearing today in the New England Journal of Medicine, researchers from 24 medical centers around the country report that the drug reduces fatalities from septic shock by about 40 percent.

Most surprisingly, the researchers said, the monoclonal antibodies rescued many patients in whom the infection had progressed so far that their organs had failed and their blood pressure had plummeted, a late-stage condition that until now was fatal in a great majority of cases.

"The study looks really promising," said Dr. Robert L. Quackenbush, chief of the bacteriology and mycology branch at the National Institute of Allergies and Infectious Diseases in Bethesda.

"You can't minimize the importance of this approach. It's going to save lives."

The new drug, produced by Centocor, a biotechnology company based in Malvern, Pa., is being reviewed by the Food and Drug Administration, and researchers said that today's report makes approval for the septic shock treatment highly likely.

The agency has already granted permission to use the drug in the treatment of septic shock among soldiers in the Persian Gulf.

Bacterial infections from battle wounds are a major cause of wartime fatalities.

Researchers said the new treatment could signal the start of a long-awaited revolution in monoclonal therapy.

The technique, which uses genetically engineered cells, has long been touted as holding the potential to cure cancer, AIDS and other disorders, but thus far it has yielded very few treatments.

When the septic shock drug is approved, "it will be the first human monoclonal antibody put into therapy," said Dr. Charles J. Fisher of Case Western Reserve University School of Medicine and University Hospitals in Cleveland, an author of the new report.

The rate of septic infections has risen threefold in the last 10 years, mostly as a result of more aggressive treatment for cancer, burns, trauma and other disorders.

Many patients survive chemotherapy or surgery, only to die of massive bacterial infections.

The federal Centers for Disease Control says 400,000 to 500,000 patients in the United States get septic infections each year.

Of every 1,000 admitted to hospitals, said Dr. Fisher, about 13 get bloodstream infections. And 20 percent to 60 percent of the patients will die of the bloodstream infection. People may also develop septic infections outside the hospital, for example, from a urinary tract infection.

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