March 12, 2014 -- 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:
http://nwbio.com/nw-bio-announces-two-german-approvals-hospital-exemption-forearly- access-program-with-dcvax-l-and-eligibility-of-dcvax-l-for-reimbursement/
The Fraunhofer Institute for Cell Therapy and Immunology IZI investigates and develops specific problem solutions at the interfaces of medicine, life sciences and engineering. The Institute practices contract research for biotechnological, pharmaceutical and medical-technological companies, hospitals, diagnostic laboratories and research facilities. Within the Business Units of Agents, Cell Therapy, Diagnostic and Biobanking, the Institute develops, optimizes and validates methods, materials and products. The Institute's core competencies are located in the field of Regenerative Medicine, in particular in the indication areas of oncology, ischemia and autoimmune, inflammatory and infectious diseases. The Institute is clinically oriented and conducts quality checks and the GMP-compliant manufacture of investigational medicinal products. Moreover, the Institute provides support in obtaining manufacturing authorizations and approvals.
Research of practical utility lies at the heart of all activities pursued by the Fraunhofer-Gesellschaft. At present, the Fraunhofer-Gesellschaft maintains 67 institutes and independent research units in Germany. More than 23,000 staff work with an annual research budget of €2.0 billion. Of this sum, more than €1.7 billion is generated through contract research. More than 70 percent of the Fraunhofer-Gesellschaft’s contract research revenue is derived from contracts with industry and from publicly financed research projects. Affiliated international research centers and representative offices provide contact with the regions of greatest importance to present and future scientific progress and economic development.
Further contacts
Dr. Gerno Schmiedeknecht l Phone +49 341 35536-9705 l gerno.schmiedeknecht@izi.fraunhofer.de | Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany l www.izi.fraunhofer.de
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