MedImmune Inc. plans to conduct an additional Phase III test of RespiGam to support completed and ongoing trials of the drug for prevention of respiratory syncytial virus (RSV) disease in high-risk children, the Gaithersburg, Md., company said Friday. The new trial will evaluate RespiGam for prevention of RSV in children born prematurely or who have bronchopulmonary dysplasia. The trial, to start next month, will be a randomized, double-blind, placebo-controlled study involving 360 patients. The company expects to finish the trial next summer, at the same time as an ongoing Phase III study, which was begun in 1992 for prevention of RSV disease in infants with congenital heart disease. The new study is called the PREVENT trial. The ongoing study is the Cardiac trial. David Mott, MedImmune's vice president, business development, told BioWorld the new study is being conducted to reinforce existing studies, not because the company felt it necessary. The more data, the better, he said. "We have not been required in any way to do an additional study, and we continue to believe if the ongoing Cardiac trial is successful, that would be adequate to support [approval of the drug] for high- risk children," Mott said. About 265 patients of an expected 335 have been enrolled in the Cardiac trial. Completed studies include one, called the Groothuis trial, involving 249 patients and an open-label trial in 68 infants. An FDA committee failed to recommend the polyclonal antibody last December because concerns it had about the Groothuis trial's methodology, among others. MedImmune stock (NASDAQ:MEDI) closed at $5 per share Friday, up 25 cents. _ Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.