The results of the MisTIE phase 2 clinical trial have been published in The Lancet Neurology journal. While the results underline the reduction of brain hematoma, they also stressed the risk of rebleeding. Of note, this study was not designed to establish the clinical efficacy of rt-PA (alteplase) for the treatment of patients with intracerebral hemorrhage
This study is clearly positive regarding the feasibility of injecting a thrombolytic drug in a brain-seated hematoma of a patient with intracerebral hemorrhage. At the same time it also raises the question of the safety of this therapeutic option (minimal invasive surgery plus multiple injections of rt-PA), as the overall clinical benefit may be blunted when asymptomatic hemorrhages occur in some treated patients.
This study clearly supports the development of a new generation of thrombolytic agents that can ensure the safe evacuation of the brain hematoma. The formulated O2L-001is developed by Op2Lysis to address this medical need.