ThromboGenics Announces Promising Results of MITI IV Phase II Trial in the Treatment of Acute Stroke with Mi...( LEUVEN Belgium September 29 /- .....),Health

LEUVEN, Belgium, September 29 /PRNewswire-FirstCall/ --

- Results Presented at World Stroke Congress in Vienna

ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on novel therapies for eye disease, vascular disease and cancer, announces positive results from its MITI IV Phase II trial to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to acute stroke patients. The trial showed that microplasmin was generally well tolerated and also provided some interesting preliminary efficacy data. The overall results of the study were presented by Dr. Vincent Thijs on September 27 at a Late-Breaking Clinical Trial session at the World Stroke Congress.

The MITI IV (Microplasmin In Treatment of Ischemic stroke - IntraVenous) trial was a Phase II, multicentre, randomized, double-blinded, placebo-controlled, ascending-dose clinical trial evaluating the safety and preliminary efficacy of the intravenous administration of microplasmin in 40 patients, 4 to 12 hours after onset of acute ischemic stroke. The trial investigated three dose regimens of microplasmin (2, 3, and 4 mg/kg total dose) compared to placebo. Clinical outcomes were assessed at seven days and 30 days post-treatment, and at each of these visits neurological assessments were performed.

The study found that microplasmin was generally well tolerated with no evidence of increased bleeding risk; there were no systemic bleeding events reported and there was no evidence of increased rate of bleeding in general, in those patients that had been treated with microplasmin compared to those treated with placebo.

In addition, the study provided some interesting preliminary efficacy results. Approximately 25% of patients treated with microplasmin had reperfusion (restoration of blood flow) within eight hours of being treated, this compares with 10% of placebo-treated patients. Moreover, of the patients who had more severe va
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