Prof. Denis Vivien, could you introduce yourself in a few words ?
DV. I am Professor of cellular biology at the University of Caen (France). I lead the Department of Innovation in Diagnosis and Therapeutics at the hospital of Caen and I am the Head of a research unit at Inserm that focuses on stroke. I built up my own team from 2005 and we are now more than 80 people, researchers and physicians, all dedicated to research and development in the field of stroke and multiple sclerosis, from discovery of new concepts and mechanisms, to biological/chemical entities and clinical validation.
What is your most important research contribution in the field of stroke ?
DV. The team has been historically focusing on the mechanism of action of an enzymatic protein, tissue plasminogen activator (tPA), in the working brain and more particularly during stroke. We have been developing original molecules to optimize stroke treatment. Several patents have now emerged from our research activities, one of them is licensed to Op2Lysis to develop a promising therapeutic strategy for the hemorrhagic stroke condition. We had also set up preclinical and clinical trials on the basis of our discoveries and for the benefit of stroke patients.
What is the main advantage oh the technology that is developed by Op2Lysis ?
DV. The O2L-001 technology, which Op2Lysis develops, results from more than 15 years of fundamental research. We have cautiously studied the mechanisms that contribute to the side effects of tPA in the stroke-affected brain, particularly neurotoxicity. From this research, we have generated O2L-001, a therapeutic solution that is optimized for brain application and for treatment of patients with an intracerebral hemorrhage.
What is you added-value to Op2Lysis ?
DV. Through the research activity in my lab and the international network that I have built over these two last decades, I have an extensive and integrative knowledge of stroke, from theory to clinical trials. I give advices to Op2Lysis in order to propose the best therapeutic innovation for ICH, which is the most severe form of stroke.
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.