Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke

This will be a randomized, double-blind, placebo-controlled, multicenter, multi-national,
parallel-arm, pivotal study comparing a placebo group to a DP-b99 group treated with
intravenous 1.0 mg/kg/d for 4 consecutive days, in acute ischemic stroke patients with an
entry National Institutes of Health Stroke Scale (NIHSS) score of 10-16 and a clinical
syndrome that includes at least 1 of the following: language dysfunction, visual field
defect or Extinction and Inattention (formerly Neglect) (as reflected by at least 1 point on
any of the corresponding items of the NIHSS: 9, 3 or 11). An interim analysis for futility
will be performed after Day 90 (or last available observation) primary endpoint data have
been collected on 50% of subjects planned to be enrolled. Enrollment will be stratified on a
one to one basis into two time-to-treatment tiers: 0- 4.5 hours, and >4.5 - 9 hours after
stroke onset. Clinical trial material (CTM) will be administered within 9 hours after the
onset of acute ischemic stroke symptoms. Subjects will be randomized at a ratio of 1:1 to
receive either DP-b99 or placebo. A data and safety monitoring board (DSMB) will assess the
accumulating safety data periodically and will oversee the interim futility analysis.