MedImmune Inc. plans to conduct an additional Phase III test ofRespiGam to support completed and ongoing trials of the drug forprevention of respiratory syncytial virus (RSV) disease in high-riskchildren, the Gaithersburg, Md., company said Friday.The new trial will evaluate RespiGam for prevention of RSV inchildren born prematurely or who have bronchopulmonarydysplasia. The trial, to start next month, will be a randomized,double-blind, placebo-controlled study involving 360 patients. Thecompany expects to finish the trial next summer, at the same time asan ongoing Phase III study, which was begun in 1992 forprevention of RSV disease in infants with congenital heart disease.The new study is called the PREVENT trial. The ongoing study isthe Cardiac trial.David Mott, MedImmune's vice president, business development,told BioWorld the new study is being conducted to reinforceexisting studies, not because the company felt it necessary. Themore 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 theCardiac trial. Completed studies include one, called the Groothuistrial, involving 249 patients and an open-label trial in 68 infants. AnFDA committee failed to recommend the polyclonal antibody lastDecember because concerns it had about the Groothuis trial'smethodology, among others.MedImmune stock (NASDAQ:MEDI) closed at $5 per shareFriday, up 25 cents. _ Jim Shrine
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