CEPHALON/CHIRON MYOTROPHIN/RILUTEK COMBO STUDY WOULD TAKE UP TO FOUR YEARS, CHIRON TELLS CMTE.; SPONSORS PREDICT FAILURE OF JAPANESE PHASE III STUDY
Executive Summary
A proposed 1,350-patient Phase IV combination study of Myotrophin and Rilutek for treatment of amyotrophic lateral sclerosis would take three to four years to complete, Chiron VP-Clinical Affairs Bruce Scharschmidt, MD, told FDA's Peripheral & Central Nervous System Drugs Advisory Committee May 8.