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Provider: Edison Investment Research
Provider: Edison Investment Research

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MagForce AG Receives BfArM Approval To Start Post-Marketing Study In Glioblastoma With NanoTherm Therapy

Monday, 8 Apr 2013 04:56am EDT 

MagForce AG announced 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 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 centers, including the University Hospitals Berlin, Duesseldorf, Giessen, Cologne and Muenster. Together with a steering committee of 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 and medical devices in brain cancer. In addition, the application procedure of the NanoTherm particles into the tumor should be optimized. This study is also designed to comply with the current guidelines for the development of medicinal products. 

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