MagForce AG (Frankfurt, Xetra: MF6), a leading medical technology company in the area of nanotechnology which focuses on oncology, today announced the enrollment of the first patient in the MF 1001 clinical study. MF 1001 is an open-label, randomized, controlled clinical trial assessing the efficacy and safety of NanoTherm® therapy as monotherapy and in combination with radiotherapy compared to radiotherapy alone in glioblastoma patients at first relapse.
During NanoTherm® therapy, superparamagnetized iron oxide nanoparticles are injected into the tumor and then heated in the alternating magnetic field of the NanoActivator® in order to kill the tumor cells.
Prof Dr Walter Stummer, Director of the Department of Neurosurgery of the University Hospital Muenster and Chair of the Muenster Brain Tumor Centre, who leads the MF 1001 study, stated: "I am delighted that we are the first centre to actively recruit for the MF 1001 study and that patient recruitment has now begun for this very important neurosurgical study. Now that recruitment has begun, we hope that the study can proceed quickly. It will enable us to gain more experience in the use of this special thermo therapy in the treatment of glioblastoma patients at first relapse and to demonstrate the value of this technology for patients. Our centre will also provide NanoActivator® treatment for patients who have received NanoTherm® injections into the tumor in nearby hospitals. We will work hard to generate additional efficacy data from this randomized study."
Prof Dr Hoda Tawfik, Chief Medical Officer/Chief Operating Officer for Therapy Development, MagForce AG: "Input at a very early stage from important neurooncological and neurosurgical opinion leaders was a determining factor in the design of this new glioblastoma study. Now that the enrollment of patients in this study has begun, we are an important step closer to our goals and to introducing NanoTherm® therapy to expert medical specialists. It is our goal to take NanoTherm® therapy to the next level and confirm previous clinical results."
The new MF 1001 glioblastoma study is designed to validate the results generated with NanoTherm® therapy to date by means of a direct comparison with established radiotherapy in a large patient population. This will allow the Company to draw substantiated conclusions about the potential of this new treatment option for glioblastoma patients. To date, three study centers have been equipped with a NanoActivator® where the complete treatment will take place and three further centers have been initiated without a NanoActivator® where the injection of the nanoparticles into glioblastoma tumors will be performed while the treatment in the NanoActivator® will be conducted in the nearest centre with a NanoActivator®. During the coming months, further study centers will be initiated with and without a NanoActivator®.
About MagForce AG
MagForce AG is a leading medical device company in the field of nanomedicine in oncology, listed in the entry standard (MF6). The Company's proprietary NanoTherm® therapy, enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles. NanoTherm®, NanoPlan®, and NanoActivator® are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. For more information, please visit magforce.com.