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Paris, June 14, 2018 – Acticor Biotech, a clinical stage biotechnology company involved in the acute phase of thrombotic diseases, including stroke and pulmonary embolism, as part of the development of its first drug candidate ACT017 who has just successfully completed a phase 1 study in the healthy volunteer, confided to Simbec-Orion carrying out his first in patient study, in acute ischemic stroke.
This phase 2 study, which will include a first group of 100 patients in 8 European countries, must be used to confirm the patient’s safety of use while trying to provide evidence of vascular and neurological efficacy.
This randomized study will be conducted in expert centers that can accommodate this type of patient 24 hours a day, 7 days a week, giving them the best standard of care, namely intravenous thrombolysis and thrombectomy.
It is precisely this standard of care that will be used as a comparison with ACT017, which will be injected as a 6-hour infusion in addition to the standard of care.
The study will start in the autumn and the submission of the protocol to the competent authorities of the countries concerned will be made starting in June.
Dr. Gilles Avenard, CEO of Acticor Biotech commented on this decision: “This study is key for us because it initiates all the clinical development of our drug candidate in a severe and frequent indication in dire need of new treatments. It was essential that it be conducted with the best experts and European centers we trust. We selected Simbec-Orion following a very wide consultation based on their international experience in this indication. Our goal is to confirm the interest of inhibition of platelet glycoprotein GPVI in patients in acute ischemic phase. ”
Fabrice Chartier, Group Chief Operating Officer of Simbec-Orion, commented: “We are very honored to have been chosen by Acticor Biotech for this essential study. We are very confident in the professionalism of the R & D team of this company and also in the value of this very innovative project. This is an important challenge too, as such studies are highly qualified and require constant attention. It is in the spirit of Simbec-Orion to seek to meet such challenges and be a partner of choice for innovation companies. ”
Simbec-Orion Group is an international, full service, niche CRO which specializes in working with biotech and small to mid-cap pharmaceutical companies. Providing a full service package to manage Phase I to regulatory Phase IV studies including central laboratory and IMP Management. Simbec-Orion has an international reach to successfully manage studies in the USA and in Europe and to facilitate access to patients with innovative recruitment strategies.
About ACT017, the Therapeutic Candidate
Acticor is developing ACT017, a humanized Antibody Fragment (Fab). The therapeutic candidate is directed against a novel target of major interest, platelet glycoprotein VI (GPVI), and inhibits its action. Evidence of antithrombotic efficacy of ACT017 and safety of inhibition of GPVI have been established both ex vivo and in vivo. The target is involved in the growth of the thrombus, but not in physiological haemostasis. This limits the bleeding risk associated with its inhibition.
About Acticor Biotech
Acticor Biotech is a clinical stage biotechnology company, spin-off of INSERM, dedicated to developing an innovative treatment in the therapy of acute thrombotic diseases, including ischemic stroke and pulmonary embolism. Acticor Biotech is built upon the expertise and the results of researches conducted by, the founders: Dr. Martine Jandrot-Perrus at INSERM Paris and Pr. Philippe Billiald at Paris-Sud University.
For more information, go to: https://acticor-biotech.com/
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