RxTrials Institute Drug Pipeline Alert

ThromboGenics’ microplasmin helped restore blood flow within eight hours in one-fourth of acute ischemic stroke patients who received the drug intravenously compared with 10 percent of those on placebo, a Phase II clinical study suggests.

The data came from a trial of 40 patients, and the trial’s small size prevents the results from being statistically significant, the Belgian company says. The study did show that microplasmin-treated patients had a statistically significant improvement in the damage to the blood-brain barrier compared with placebo-treated patients.

The study was a multi-site, randomized, double-blind, placebo-controlled, ascending-dose trial in which patients were enrolled four 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 with placebo. Patients received clinical and neurological assessments seven days and 30 days after treatment.