ThromboGenics enrolls MITI IV Ph II trial

Leuven, Belgium-based ThromboGenics NV, a biotechnology company focused on vascular diseases, eye diseases and cancer, has completed patient enrolment for its Phase II Microplasmin in Treatment of Ischemic stroke - IntraVenous study. The primary purpose of this is to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to acute stroke patients between four and 12 hours after the onset of the stroke.

MITI IV is a Phase II, multicenter, double-blinded, placebo-controlled, ascending-dose clinical trial evaluating the safety of the intravenous administration of microplasmin in 40 patients with acute ischemic stroke. The trial is investigating three dose regimens of microplasmin (2g/kg, 3g/kg and 4mg/kg total dose) and placebo. The trial is also designed to provide preliminary efficacy data using radiographic assessments and plasma surrogate biomarkers. Clinical outcomes are assessed at seven and 30 days post-treatment, and at each of these visits neurological assessments are performed.