Federal Institute

The approval of the Ethics Committee was granted end of December 2012, so that the company can now proceed with the installation of the necessary NanoActivatoren in the treatment centres and the preparations for the start of the clinical trial. The randomized, controlled, open-label study investigated the efficacy and safety of NanoTherm as Mono therapy alone and in combination with radiotherapy compared with radiotherapy alone in up to 280 patients with glioblastoma. It is planned to carry out the study at 15 sites in Germany. She should start at five leading German centres at the University hospitals of Berlin, Dusseldorf, Giessen, Cologne and Munster. MagForce has developed an inspection plan together with an advisory from leading opinion formers of the neuro-oncology, to substantiate the results of the previous study that therapy and their corresponding medical devices for the treatment of brain tumors has led to approval of NanoTherm, and complement. In addition, the process of bringing the NanoTherm particles into the tumor to be optimized. The study is also equivalent to the current guidelines for the development of medical products.

We are very pleased in the BfArM-approval which gave the go-ahead for the start of our post marketing trial. We have carefully prepared this study over the past few months along with leading neurosurgeons, neuro-oncologists and Radiotherapists.