Set-up of NanoActivators(TM) initially in five leading centers in Germany Start of center initiation in the post-marketing study forthcoming Berlin, Germany, April 08, 2013 - MagForce AG (Frankfurt, XETRA: MF6), a leading medical technology company in the field of nanomedicine in oncology, announced today that it has received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to start the post-marketing clinical study in recurrent glioblastoma. The approval of the ethics committee was previously granted end of December 2012 and the Company will now proceed to install the required NanoActivators(TM) in the treatment centers and preparing for the clinical study initiation. The trial is an open-label, randomized, controlled study to determine the efficacy and safety of NanoTherm monotherapy alone and in combination with radiotherapy versus radiotherapy alone in up to 280 glioblastoma patients. It will be conducted in about 15 centers in Germany and will be initially started in five leading centers, including the University Hospitals Berlin, Duesseldorf, Giessen, Cologne and Muenster. Together with a steering committee of leading experts in neurooncology, MagForce has designed a study protocol to support and supplement the results of a previous study, which led to the approval of the NanoTherm Therapy … Continue reading
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