With the support of Enterprise Europe Network, Op2lysis has
been selected by EU-Japan to be part of the Biotech Cluster SME mission.
This selection will provide Op2lysis with the opportunity to attend BioJapan Expo 2019, next October. This mission will allow the company to meet with Japanese companies.
This mission comes at the right time for Op2lysis, as it
will allow us to extend a network of contacts and to favour a partnership with
a Japanese company in order to integrate Japan at the early stage of our
Hemorrhagic stroke accounts for about 30% of all strokes in
Japanese patients. Japan is the world’s second-largest market for hemorrhagic
With the support of the Enterprise Europe Network France, we are very proud of having been selected among many candidates for this mission. With this great opportunity, we hope to produce the best possible benefit for our development.
The second half of May was the opportunity for two important conventions in the area of hemorrhagic stroke :
The 7th WICH (Woldwide Intracranial Hemorrhage) conference, specifically dedicated to hemorrhagic strokes, on May 19th-21st in Granada, Spain ;
And the ESOC (European Stroke Organization Conference), on May 22nd-24th in Milano, Italy
Although dedicated to a broader scope, ESOC offered many presentations and sessions on hemorrhagic stroke, reinforcing the increasing activity and hope in this area as it appeared at the last International Stroke Conference in February.
Of particular interest for Op2Lysis was a presentation by Wendy Ziai on the analysis of mortality in the MISTIE (Minimally Invasive Thrombolysis in Intracerebral Hemmorhage Evacuation) trial. The primary results of this study, which were presented on last February, showed a lower rate of mortality in the minimally invasive surgery plus thrombolytic group of patients versus control group, more specifically over the first 30 days that followed symptom onset.
The more detailed analysis presented at ESOC indicated that deaths were mainly from neurological cause (60%) and consecutive to withdrawal of life support. The reduction in intracebral hematoma volume, which was the objective of the treatment tested in MISTIE, influenced favorably the maintenance of life support. These results further strengthen the rationale for the product developed by Op2Lysis for the treatment of patients with an intracerebral hematoma following an hemorrhagic stroke.
The modified Rankin Score (mRS) is used by health professionals to measure the degree of disability following a stroke in a patient. This disability scale includes 6 levels of score ranging from level 0 for patients with no symptoms to level 5 for patients with major disabilities and total loss of autonomy. A separate category, Level 6, is usually added by the medical profession for patients who do not survive their stroke.
The mRS scale, deemed reliable and easy to use, is
recognised by the health authorities for the registration of a medicinal
product on the market but also recognized by health insurances, since this
scale also allows them to determine the cost of managing a patient based on
level of disability.
It is therefore used as the primary clinical criterion in most
clinical trials for the registration of new stroke treatments. Standardized
interviews to obtain a mRS score are recommended every 3 months (90 days) after
discharge from the hospital.
The clinical development program of O2L-001 will therefore also call on the mRS score. Our ambition is to reduce the number of patients with severe disabilities and severe socio-economic dependence.
Op2Lysis will be in Granada during the World
Intracranial hemorrhage Conference (WICH) from 19 to 21 May 2019.
This conference, focusing on the management of intracranial hemorrhage and head injuries, allows many neurologists and neurosurgeons to exchange and work in close collaboration, as well as other professionals of related specialties such as, intensive care and basic sciences (research), joining in a multidisciplinary approach to intracranial bleeding.
During a side event of this conference, Op2Lysis will take the opportunity to meet, once again, academic experts and hemorrhagic stroke scientists. A specific meeting will provide an opportunity to exchange and obtain recommendations on:
• the technology developed by the company. • design of pre-clinical and clinical studies over the next four years
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.
Op2Lysis will attend
again the International Stroke Conference, which will take place on from
February, 6th to February, 8th.
The International Stroke
Conference is one of the most important meetings dedicated to the science and
treatment of cerebrovascular diseases and stroke. Many topics will be adressed,
including clinical trials ; emergency care ; acute neuroimaging ; endovascular treatment;
and post-stroke rehabilitation.
The hemorragic stroke area will be of paticular
interest at ISC 2019, as the results of the MISTIE III study (with alteplase in
a minimally invasive surgery procedure) and those of the iDEF study (with deferoxaline)
will be presented.
This will also be an opportunity for Op2Lysis to meet
with key international experts in the hemorrhagic stroke area
Through this mini-series of articles, we want to present you our whole team and skills of each.
Marie-Julie, can you introduce yourself briefly ?
I am in charge of Op2Lysis translational studies and regulatory affairs. Chemist with a Master 2 in pharmaceutical and biomedical engineering, I pursued my education with a PhD and I graduated from Université catholique de Louvain (Brussels, Belgium) in April 2018. During my PhD, I worked on the development of an innovative mucolytic agent for Cystic Fibrosis. I was fully in charge of conception and execution of pre-clinical studies as well as of data interpretation. During my training, I also benefited from a US research experience. I worked in pharmaceutical development in a biotech company based in Cambridge, MA.
Why did you choose to join the Op2Lysis team?
I was very pleased to join Op2Lysis. The project is in all respects consistent with my education and my wish to be part of an innovative project responding to a major medical need. Moreover, the company values are in line with my vision of the professional environment in which I want to evolve.
What is the strength of the technology developed by Op2Lysis?
The strength of Op2Lysis is based on the multidisciplinary skills of each fellow. Our wide knowledge of hemorrhagic stroke, of our product as well as of innovative solutions for precise medical needs are the foundation of our project.
What is your personal contribution to Op2lysis?
I am in charge of the pre-clinical development of our product as well as of the regulatory activities related to its future registration.
My professional experiences helped me develop skills in project management and in pre-clinical studies. The diversity of fields I have dealt with allows me to quickly integrate and become invested in the aspects of the project entrusted to me.
Op2Lysis was at Biofit 2018 on December 4-5, in Lille. Op2Lysis was invited
to present the company’s project at the start-up slams session. This was also
the opportunity to meet and discuss with many patners, investors and preclinical
or clinical research organisations. Technical and financial aspect of our development
project could be shared.
Biofit is an international business convention organized
every year in France and specifically dedicated to technology transfer, academic-industry
collaborations and early stage innovations in the life sciences. The goal is to
increase the flow of patent trades and to foster the emergence of innovative
products, processes and services in the field of life sciences.
Biofit helps the biotechnology community to share newscientific knowledge, to promote innovation and to detect and seize new marketopportunities, by connecting many international players in the field of humanand animal health.