The first-in-human study with ACT017 will be conducted at QPS facilities in Groningen, the Netherlands.
Paris, February 23rd, 2017 – Acticor Biotech, a biotechnology company focused on the treatment of acute ischemic stroke, today announced that it selected its CRO (Contract Research Organization) to manage its clinical study phase I.
The first-in-human study with ACT017 will be conducted at QPS facilities in Groningen, the Netherlands. QPS is a GLP/GCP-compliant contract research organization supporting discovery, preclinical and clinical drug development.
The submission is planned for September 2017 and the first cohort of volunteers is planned for October 2017. The clinical study will enrol 48 subjects in 6 escalating dose level cohorts, with each cohort consisting of 8 subjects: 6 on active and 2 on placebo at the following planned doses: 100, 250, 500, 750, 1,000 and 2,000 mg.
The goal is to assess safety and tolerance as well as parameters of haemostasis and coagulation and to determine pharmacokinetic and pharmacodynamics parameters.
About Ischemic stroke
Stroke is now the second cause of death in industrialized countries (6 million deaths worldwide), the second cause of dementia after Alzheimer’s disease and the leading cause of acquired disability in adults. In Europe and in the US, the annual incidence of stroke is estimated at more than 1,500,000 cases. This devastating disease is responsible for health and economic needs that current treatments do not address. In fact, less than 15% of patients can be treated with thrombolysis and/or thrombectomy. Therefore, it is urgent to promote new therapeutic, innovative, safe and effective strategies for the treatment of acute ischemic stroke. New antiplatelet drug represents a unique opportunity to increase the efficacy of acute stroke therapies with reduced adverse events.
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 bio-pharmaceutical company, spin-off of Inserm (U1148 – Bichat Hospital, Paris, France) founded late 2013, dedicated to developing an innovative treatment in the therapy of acute ischemic stroke, a Fab directed against platelet glycoprotein GPVI. Acticor Biotech is built upon the expertise of and the results of researches conducted by, the founders: Dr. Martine Jandrot-Perrus at INSERM Paris and Professor Philippe Billiald at Paris-Sud University.
For more information, go to: https://acticor-biotech.com/
About QPS Holdings, LLC
Founded in 1995, QPS is a GLP/GCP-compliant contract research organization (CRO) and life sciences products supplier supporting discovery, preclinical, and clinical drug development, providing quality services to pharmaceutical and biotechnology clients worldwide. QPS linearly integrated core competencies include: neuropharmacology, DMPK, liver research, toxicology, bioanalysis, translational medicine, and clinical research program management. QPS regional laboratories and testing facilities are located at company headquarters in Newark, DE; Springfield, MO; Fargo, ND; Research Triangle Park, NC; Hollywood, FL; South Miami, FL, USA; Groningen, The Netherlands; Graz, Austria; Hyderabad, India; Barcelona, Spain; and Taipei, Taiwan.
For more information, visit: http://www.qps.com
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