Results Of Phase 2 Hemorrhage Drug Reported

December 02, 1997

Hershey, Pa. -- Researchers say a new drug has tested well for patients who have suffered a severe blood loss (hemorrhage) due to trauma. The drug is Neuprex (rBPI21) and is made by the XOMA Corporation of Berkeley, Calif.

The trial showed a positive overall benefit on patient morbidity compared to a placebo. Specifically, Neuprex(TM) was effective in reducing the incidence of pulmonary complications.

J. Stanley Smith, M.D., professor of surgery at Penn State's College of Medicine, and chief of trauma services at Penn State Geisinger, The Milton S. Hershey Medical Center, discussed the results earlier this month at the Sixth Vienna Shock Forum, in Vienna, Austria.

"If patients survive the original trauma and then surgery, they often face a significant risk of other complications, such as pneumonia or acute respiratory distress syndrome. This drug shows great promise," says Smith.

This trial, conducted at several sites including Hershey Medical Center, was a 401-patient randomized, placebo-controlled, double-blind Phase II study to test Neuprex(TM) to determine its ability to prevent serious infections in patients who received at least two units of blood to replace that lost through trauma. The goal was to reduce the number of patients experiencing serious secondary complications such as infections or organ dysfunctions.

A major finding of the study was that Neuprex(TM) prevented pulmonary complications. In addition, pneumonia was by far the biggest problem for patients, but patients treated with Neuprex(TM) suffered pneumonia less frequently than those receiving a placebo. The drug also showed benefit in preventing various organ dysfunctions.

"Mortality in the study was low, only 5.5 percent. Therefore, the major benefit of Neuprex(TM) was a reduction of serious complications," says Smith.

It is estimated that at least 250,000 people a year suffer trauma. These traumas are often caused by car accidents, gunshot wounds and other kind of accidents. Trauma is the leading cause of death for Americans between the ages of 1 and 45.

XOMA corporation is now starting a Phase III trial. This will involve 1,650 patients from 40 trauma centers across the United States. Officials estimate it will take about two years to complete this phase. Based on his previous experience, Hershey Medical Center should be an important center for this new trial, adds Smith.

**lp**

Contacts: Leilyn Perri
(717) 531-8604 (o)
leilyn.perri@hmc.psu.edu


M. Steven Bortner
(717) 531-8607 (o)
(717) 838-5910 (h)

Penn State

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