MagForce AG / MagForce AG Receives BfArM Approval to Start the Post-Marketing Study in Glioblastoma with NanoTherm® Therapy.
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* Set-up of NanoActivators™ initially in five leading centers in Germany
* Start of center initiation in the post-marketing study forthcoming
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™ 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 and its 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.
"We are excited about the BfArM approval that now triggers the start of our post-marketing clinical study, which we have carefully prepared over the last few months in collaboration with leading neurosurgeons, neurooncologists, and radiotherapists. With this trial we intend to provide validation of the available results with our NanoTherm® Therapy involving leading medical experts in the field of neurooncology, the key opinion leaders in the application of this technology", Prof Dr Hoda Tawfik, COO and co- CEO of MagForce, commented.
"Glioblastoma is an aggressive brain tumor with annually about 120,000 new cases worldwide. Although therapeutic improvements were achieved in the recent years, there is still a high medical need for effective treatment options to help patients suffering from this dismal disease. The previous study of MagForce's NanoTherm® Therapy showed promising results. I am pleased to contribute to this new trial, which is designed to validate the previous results in a larger patient population with direct comparison to established treatment. This will allow us to draw meaningful conclusions about the potential of this new approach to treat these desperate patients", added Prof Dr Walter Stummer, Director of the Department of Neurosurgery and Neurooncology, University Hospital Muenster, Germany, President of the NOA (Neuroonkologische Arbeitsgemeinschaft) and Coordinating Principal Investigator (LKP) of the study.
About NanoTherm® Therapy
The NanoTherm® Therapy is a new approach for the local treatment of solid tumors. The principle of the method is the direct introduction of superparamagnetic nanoparticles into a tumor and their subsequent heating in an alternating magnetic field. The nanoparticles are extremely small (approximately 15 nanometers in diameter) and contain an iron oxide core with an aminosilane coating. The particles are activated by a magnetic field that changes its polarity 100,000 times per second, and heat is produced. Depending on the duration of treatment and the achieved intratumoral temperatures, the tumor cells are either directly destroyed (thermal ablation) or sensitized for concomitant chemotherapy or radiotherapy (hyperthermia). With this new therapeutic approach, it is possible to combat the tumor from the inside out, thereby sparing surrounding healthy tissue. The nanoparticles remain in place at the treatment area, allowing for repeat treatments and the integration of multimodal therapy concepts. NanoTherm® Therapy has regulatory approval in 27 European countries.