21.03.2014 07:00:00
|
THERADIAG Selected as a Partner of the ABIRISK Project, the First Consortium of Pharmaceutical and Academic Experts Dedicated to the Monitoring of Biotherapies
Regulatory News:
Theradiag (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specializing in theranostics and in vitro diagnostics, is proud to announce that it has been selected by the European pharmaceutical and academic consortium ABIRISK (Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the RISK) to participate in the evaluation of immunogenicity risks linked to existing biotherapies. Theradiag will provide Lisa-Tracker theranostics kits for 3 years as part of the project.
Theradiag conducted successfully over 5 000 analyses and validation tests in order to meet the sensitivity and accuracy requirements of the consortium.
”We are proud to have been selected by the ABIRISK consortium. Being a partner of ABIRISK is a clear validation by pharmaceutical and scientific experts of our products and expertise. Lisa-Tracker is one of the best-performing products currently on the market for the monitoring of biotherapies in auto-immune and inflammatory diseases” comments Michel Finance, CEO of Theradiag.
”ABIRISK is a unique initiative in Europe, whose goal is to evaluate the immunogenicity of existing biopharmaceutical products. To do so, the consortium needs accurate and sensitive tests to monitor the development of anti-drug antibodies throughout the treatment. Greater harmonization of the monitoring of treatments, and thereby standardization and characterization of anti-drug antibodies, is one of the main objectives of ABIRISK” added Marc Pallardy, academic coordinator of ABIRISK, INSERM and Université Paris-Sud.
ABIRISK is a joint project of the European pharmaceutical industry, universities and research institutes, which aims at monitoring the development of anti-drug antibodies (ADAs) and neutralizing antibodies (Nab) and their effect on patients treated with biotherapies. ABIRISK marks the recognition by the pharmaceutical industry and the actors of the European healthcare system of the risks generated by the immunogenicity of monoclonal antibodies and recombinant proteins.
A clinical study will be conducted as part of the project on several large cohorts of European rheumatoid arthritis and Crohn’s Disease patients. The dosage of ADAs will be done exclusively through the use of Lisa-Tracker kits. These prospective cohorts will recruit patients who have not been treated with biotherapies.
About ABIRISK
The European project ABIRISK is the
collaboration between the European Federation of Pharmaceutical
Industries, the Innovative Medicine Initiative (IMI), and the European
Union. It counts 39 partners : large members of the pharmaceutical
industry (Pfizer, GSK, Sanofi-Aventis, Merck, UCB, Ipsen, Novartis, Novo
Nordisk, Bayer), academic labs and reserach institutes (INSERM, CNRS,
CEA, University College London, Karolinska Institute, Leiden University)
universities and university hospitals. The ABIRISK project’s goal is to
provide an integrated approach to anti-drug immunization, bringing
together, in an extensive and coordinated manner, a large network of
clinicians from various specialties with broad experience in the care of
patients treated with various type of biopharmaceutical products and
developing anti-drug antibodies, biologists familiar with the immune
monitoring of patients, scientists specialized in the mechanisms of
immunogenicity, methodologists and biostatisticians. It will ensure
direct transfer of the experimental findings into biopharmaceutical
products development and patient management. The project will cost €34.9
million and last 60 months. More information at www.abirisk.eu
About Theradiag
Capitalizing on its expertise in the
distribution, development and manufacturing of in vitro diagnostic
tests, Theradiag innovates and develops theranostics tests (combining
treatment and diagnosis) that measure the efficiency of biotherapies in
the treatment of autoimmune diseases, cancer and AIDS. Theradiag is thus
participating in the development of "customized treatment”, which favors
the individualization of treatments, the evaluation of their efficacy
and the prevention of drug resistance. Theradiag market the Lisa-Tracker
range (CE marked), which is a comprehensive multiparameter theranostic
solution for patients with autoimmune diseases treated with
biotherapies. With its subsidiary Prestizia, Theradiag is also
developing new diagnostics biomarkers thanks to its microRNA platform,
in order to diagnose and monitor HIV/AIDS and rectal cancer. The Company
is based in Marne-la-Vallée, near Paris, and in Montpellier, and has
over 60 employees.
For more information about Theradiag, please visit our website: www.theradiag.com
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu Biomedical Diagnosticsmehr Nachrichten
Keine Nachrichten verfügbar. |