A new study to validate NanoTherm® therapy and build confidence within the specialist medical community

In a systematic effort to successfully establish MagForce’s technology, we are conducting a new glioblastoma study to provide additional validation of NanoTherm® therapy. Involving key medical opinion leaders in the field of oncology in applying the technology is crucial to achieving this. In collaboration with leading neurosurgeons, neurooncologists, and radiotherapists, MagForce has designed a study protocol which is intended to support and supplement the results of the study that led to the approval of NanoTherm® therapy as a medical device, and also conforms with the current guidelines regarding therapeutic agents. The study also prepares the ground for the start of the FDA approval process in the US. The study is headed up by Prof. Dr. Walter Stummer, Director of the Clinic for Neurosurgery and Neurooncology at the University Hospital Münster. In addition to the glioblastoma study, other studies, for example for prostate cancer, are planned.

Key Parameters of the New Study in Germany

The new study is an open-label, randomized, controlled study in ten to fifteen centers in Germany and possibly additional centers in other European countries. The main goal is to show the efficacy in patients with recurrent gliobastoma of using NanoTherm® therapy alone and/or in combination with radiation therapy in comparison to radiation on its own. The primary endpoint is defined as the survival rate of patients twelve months after the start of the study. A secondary objective is the evaluation of additional efficacy parameters, such as the overall survival rate, progression-free survival, tumor response as well as safety parameters and quality of life. The preparations for this study were completed in 2013. At present, NanoActivator® devices are installed in Berlin, Münster, Kiel, Cologne and Frankfurt, study centers without own device exist in Düsseldorf and Giessen. Installation of a further device is currently planned for Göttingen.

Patient enrolment has started in the first quarter of 2014.

The new glioblastoma study (MF 1001) is registered with the German Clinical Trials Register. Please click here for more detailed information regarding the study.

Glioblastoma multiforme (GBM)

is the most common and most aggressive malignant type of brain tumor in adults. Recent publications estimate that there are at least 10 ,000 new cases of GBM diagnosed annually that require treatment in the US, and it is expected that this number will grow constantly with increasing age and demographic changes. Standard therapy consists of surgical resection to the extent that is safely feasible, followed by adjuvant radiotherapy/chemotherapy. The prognosis for glioblastoma is extremely poor (medium survival is 1.2 years from the time of diagnosis) since recurrence is very likely (>90%) after primary standard treatment. There is no standard and effective treatment schedule for recurrent glioblastoma patients.