Who are we? Meet Solène Palmieri, Pharmacist – Episode #9

Through this mini-series of articles, we want to present you our whole team and skills of each.

  • Hello Solène, could you please introduce yourself?

I am both pharmacist and toxicologist. I studied pharmacy at the University of Bordeaux and specialised in the toxicology field at the University of Paris Descartes. I worked as a Study Director at Charles River Laboratories (Evreux facility, Normandy), where I oversaw regulatory toxicology studies for pre-clinical development. I joined Op2lysis in September 2020 as a Regulatory Affairs Manager. My main mission is to develop and coordinate the regulatory strategy for our project, in collaboration with the other team members and external experts.

  • Why did you choose to join the Op2Lysis team?

There was three main motivations to join Op2Lysis:

The project: I had a high interest and motivation for Op2lysis project, I am glad to be part of an innovative project and to be able to contribute to its development.

The position: through my missions I can improve both my scientific and regulatory knowledges while I develop other professional skills.

Workplace: I was attracted by the environment a start up provides with various missions and activities. By integrating a small company, I am fully involved in the decision of the company, I can support my ideas and proposition during team meetings, which make me feel useful and an active player of the project. 

  • What is the strength of the technology developed by Op2Lysis?

To my point of view the main strenghts of the technology are

  1. The innovativeness of the therapeutic solution in a pathology with deleterious impact, severe disabilities
  2. A strong scientific knowledges and proofs of concept
  3. the easiness to use (simple and reproductible route of administration)
  4. The indication that is still an unmet medical need.
  • What is your personal contribution to Op2lysis?

Thanks to my education I have strong basis on regulatory non-clinical drug development and good scientific knowledges. In my previous position as I worked in a controlled and rigorous regulatory environment, I acquired professional skills relevant for the development of our project (project management, communication, reporting, problem solving)

Op2Lysis receives a seal of Excellence from the European Commission

Op2Lysis receives the seal of Excellence for the development the first medical treatment dedicated to patients with intracerebral hemorrhage (EIC Accelerator – SME Phase II).

Op2Lysis project was scored as a high quality proposal in this highly competitive evaluation process. #SMEinstrument #SealOfExcellence

More Information about SME instrument: https://ec.europa.eu/programmes/horizon2020/en/h2020-section/eic-accelerator-pilot

Op2Lysis has been selected by EU-Japan for the 2019 Biotech cluster SME mission

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 clinical development.

Hemorrhagic stroke accounts for about 30% of all strokes in Japanese patients. Japan is the world’s second-largest market for hemorrhagic stroke.

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.

For more information : Click here

Last Updates on Hemorrhagic Strokes at WICH and ESOC – Focus on new MISTIE data

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.

What is the mRS and why is it important for Op2Lysis?

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.

World Intracranial Hemorrhage Conference

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

To access the WICH program click here

The MISTIE Phase 3 Study at The International Stroke Conference 2019 offers a Clinical Proof of Concept to the technology developed by Op2Lysis.

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

Op2Lysis at the l’International Stroke Conference 2019

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

To access ISC program, please click below