Home > Newsletters > RxTrials Institute Drug Pipeline Alert > ThromboGenics’ Microplasmin May Restore Circulation
RxTrials Institute Drug Pipeline Alert
Oct. 1, 2008 | Vol. 6 No. 40
ThromboGenics’ Microplasmin May Restore Circulation
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.
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