The MITI IV is a Phase II, multicentre, 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 (2, 3, and 4mg/kg total dose) and placebo.
The trial also provides preliminary efficacy data using radiographic assessments and plasma surrogate biomarkers. Clinical outcomes are assessed at seven days and 30 days post-treatment, and at each of these visits neurological assessments are performed.
Steve Pakola, chief medical officer of ThromboGenics, said: “We look forward to the results, which should be available by the middle of this year. Once we have reviewed the data from this study, we will decide on our future development plans with microplasmin for the treatment of acute stroke.”