FDAnews
www.fdanews.com/articles/81197-neopharm-updates-data-in-precise-trial

NEOPHARM UPDATES DATA IN PRECISE TRIAL

September 27, 2005

NeoPharm has announced that its pivotal Phase III PRECISE trial for its lead drug product candidate cintredekin besudotox has randomized its 250th patient.

The company also announced updated Phase I/II survival data, originally presented in May at the World Federation of Neuro-Oncology in Edinburgh, Scotland, which included results from three clinical studies in which peritumoral Convection Enhanced Delivery (CED) of cintredekin besudotox following tumor resection was evaluated.

The updated overall survival data for the 45 patients with confirmed recurrent glioblastoma multiforme in the three studies who received peritumoral infusion of cintredekin besudotox continue to have a median of 44 weeks after a single treatment. Ten patients are still being monitored for survival; the length of follow-up for these 10 patients ranges from 48 to 215 weeks, with a median of 98 weeks.