The International Stroke Conference is one of the most important conventions in the area of stroke, with yearly meetings in the United States of America. The session this year, which was held in February, was of particular interest to Op2Lysis, as many trials in the hemorrhagic stroke area were presented.
The MISTIE Phase 3 clinical trial was indeed among the most awaited trial results this year. This study relied on the same minimally invasive surgery technology combined with the administration of a thrombolytic agent that we intend to use for O2L-001 administration. Alteplase was tested, administered every 8 hours for up-to 3 days to liquefy and thus remove the intracerebral hematoma in hemorrhagic stroke patients. The trial benefited from two consecutive presentations by Prof. Daniel Hanley and Prof. Issam Awad in the Main Event Session on February 7th.
The study did not succeed in demonstrating a statistically significant superiority in the primary endpoint. The study was designed to show a 13% increase in the number of patients with either no or mild disability 365 days after the stroke event versus control group, but a smaller difference was observed. However, the MISTIE trial showed a very robust correlation between the amount of blood remaining at the end of the procedure and the clinical benefit and lower risk of disability in patients. This is the clinical proof of concept that a more effective reduction of the hematoma volume with this technology can improve the outcome of hemorrhagic stroke patients. Moreover, a favorable observation in death rate and a demonstration of the safety of the procedure were pointed out by the neurosurgeons. Very positive feedbacks were relayed in the medical press, which underlines the very encouraging results that were applauded by the attending medical community.
Altogether, the MISTIE 3 trial results suggest best chance of success for the Op2Lysis technology, as it is tailored to provide better/faster reduction of hematoma volume, reduced risk of re-bleeding and reduced risk of neurotoxicity. These 3 attributes should contribute together to the clinical success of O2L-001. To address the yet uncovered medical need for hemorrhagic stroke patients, our plan is to enter clinical stage of development in the next 2 years.
Reference : Hanley D, et al. Lancet online