Study Led By UT Southwestern Finds Promising New Treatment For Meningococcemia

November 13, 1997

DALLAS -- November 15, 1997 -- Giving patients extra doses of a protein that occurs naturally in the body may effectively treat meningococcemia, a frequently fatal childhood disease, researchers at UT Southwestern Medical Center at Dallas report.

In the Nov. 15 issue of The Lancet, Dr. Brett Giroir, assistant professor of pediatrics, and his colleagues report on using a recombinant form of bactericidal permeability-increasing protein (BPI) to treat children with severe meningococcemia, an infectious disease that strikes otherwise healthy children swiftly and without warning. Twenty percent to 50 percent of children with meningococcemia die, usually within 24 hours of the first symptoms. Those who survive the disease often develop gangrene (resulting in amputations), brain injury, developmental delays and emotional problems.

The bacteria involved is the same gram-negative bacteria that causes meningitis. But instead of infecting the fluid around the brain and spinal cord, it infects the bloodstream, triggering an explosive inflammatory response throughout the body that can damage organs and cause shock.

Penicillin and other antibiotics sometimes are effective in treating the disease, particularly in its early stages, but they often fail.

"Many children have a bad outcome no matter how early the disease is caught," said Giroir, the Thomas Fariss Marsh Jr. Professor in Pediatrics.

The protein used in the study is found in white blood cells. It acts early in an infection to kill gram-negative bacteria and neutralize their toxins, but there is not enough of it in the body to overcome the widespread infection caused by meningococcemia. The MENINGOCOCCEMIA TREATMENT -- XOMA Corp. of Berkeley, Calif., is developing bactericidal permeability-increasing protein-based products and testing them for a variety of uses in adults.

The trial led by UT Southwestern was the first to study the drug Neuprex in children. Twenty-six meningococcemia patients between the ages of 1 and 18 were enrolled in the study at six medical centers. Only one patient died.

"This compares with an expected mortality rate of 30 percent," Giroir said. "We are very encouraged with these preliminary results."

While meningococcemia is rare, outbreaks have become more frequent in recent years. Texas has one of the highest rates of meningococcemia in the United States -- 1.2 cases per 100,000 residents. The disease is most prevalent in North Central and Northeast Texas. It usually occurs in mid-winter and early spring.

Fifteen of the children involved in the study were patients at Children's Medical Center of Dallas. Other institutions participating in the study were Cook Children's Medical Center in Fort Worth; St. Joseph's Comprehensive Research Institute in Tampa, Fla.; University Community Hospital in Tampa; Legacy Emanuel Hospital in Portland, Ore.; Oregon Health Sciences University School of Medicine; and Children's Hospital of San Diego.

A Phase III study of Neuprex is under way at more than 20 institutions in the United States, Great Britain and Canada. The trial could lead to Food and Drug Administration approval of the drug.

UT Southwestern also is starting a clinical trial of Neuprex in cystic fibrosis patients who have bacteria in their lungs that is resistant to antibiotics.

"I anticipate that BPI will have many uses -- from treating general infections to treating complications of trauma," Giroir said.

Giroir is one of several researchers at UT Southwestern who will be receiving funding for their work from the 1997 Crystal Charity Ball of Dallas.
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UT Southwestern Medical Center

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