Microplasmin in Stroke
In late September, the Company announced promising 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 overall results of the study were presented by Dr. Vincent Thijs on September 27 at the World Stroke Congress in Vienna.
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 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 vascular blockages, 33% of patients
treated with microplasmin achieved reperfusion compared with 14% of
placebo-treated patients. Due to the small number of patients in this
study, neither of these endpoints were statistically significant. However,
the study also s
|SOURCE ThromboGenics NV|
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