ARTICLE | Product Development
Antisoma rolls 1 die
June 11, 2001 7:00 AM UTC
Faced with FDA demands for more robust results and an unexpectedly high survival rate in all patients in the SMART Phase III trial of its pemtumomab antibody in ovarian cancer, Antisoma plc has chosen to continue its single trial strategy rather than launch a second pivotal study for approval.
ASM (London, U.K.) has decided to expand the SMART study, increasing enrollment by about 30%, which will push back pemtumomab's development time line by at least 12-18 months...