Northwest Biotherapeutics receives authorisation for new cancer therapy in accordance with §4b German Medical Act
Since 2011 the Fraunhofer Institute for Cell Therapy and Immunology (IZI) has supported the North American company Northwest Biotherapeutics (NWBT) in the clinical trials on an innovative, autologous method within cell therapy intended to treat brain tumours (glioblastoma multiforme).
In Europe also, the so-called DCVax-L method has been evaluated since June 2013 as part of a phase III clinical study; this multi-centric study was initially launched in the United States. Cooperating closely with Fraunhofer IZI and Pharmalex GmbH, the company reached a further milestone in the clinical application of DCVax-L on 6 March 2014. Based on a two-year, extremely intense regulatory process the Paul-Ehrlich- Institute (PEI) granted NWBT the authorisation to apply the method to patients outside of the ongoing clinical study within the framework of the regulations defined under §4b German Medical Act (»hospital exemption according to the Directive (EU) no. 1394/2007«). NWBT and Fraunhofer IZI are hence the first institutions to successfully apply for this form of authorisation for a new product from the class of somatic cell therapy agents. The specific agents for the patients in the clinical study and for provision under authorisation according to §4b German Medical Act will be manufactured at Fraunhofer IZI.
Further information and contact details for physicians and patients can be found in the detailed press release by Northwest Biotherapeutics: