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Process transfer of DCVax-l to Europe and initiation of a phase III clinical trial in UK and Germany

      DCVax-L is an autologous immunotherapy applicable for treatment of a wide range of cancers. It consists of Dendritic Cells (DC's) loaded with tumor lysate generated from patient's own tumor tissue. DC's are manufactured in an eight-day process by using a leukapheresis product as starting material. After finishing promising Phase I/II studies in the US, Northwest Biotherapeutics Inc. is now under way with a 312-patient double blind, randomized Phase III study in both the US and Europe. Most small US biotech companies do not undertake their clinical trials in Europe as well as the US – especially for a complex product such as an autologous cell therapy. In order to bring this Phase III trial to Europe, and reach more patients, Northwest Biotherapeutics and its manufacturer, Cognate Bioservices Inc., have started in 2011 a process transfer of the entire GMP manufacturing process to Germany (to Fraunhofer IZI). After a 15 month tech transfer, a DCVax-L specific manufacturing authorization according to §13 German Drug Act was granted to Fraunhofer IZI. This period of time was necessary to create all documents, to establish the methods and train the Fraunhofer personnel both in Germany and in the US, to set-up the supply chain, to qualify the suppliers and to perform a process validation as well as a validation of the analytical methods. In parallel, it was necessary to qualify the tumor procurement centers in order to comply with 2006/17/EC requirements, and to qualify the apheresis units for ensuring compliance with 2002/98/EC. After creating an Investigational Medicinal Product Dossier (IMPD) clinical trial applications were filed to MHRA (UK) and Paul-Ehrlich-Institut (Germany). After successful approval in both countries, the clinical trial launched in Europe (in the UK) in the late spring 2013 and is currently being expanded by including further clinical trial centers.
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