The German Federal Institute for Drugs and Medical Devices (BfArM) has granted approval to MagForce to commence a post-marketing clinical study in recurrent glioblastoma patients using its NanoTherm Therapy device.
The device directly introduces small superparamagnetic nanoparticles containing an iron oxide core with an aminosilane coating into the brain tumor.
The particles are then activated by a magnetic field that changes its polarity 100,000 times per second, for the production of heat.
Depending on the duration of treatment and the achieved intratumoral temperatures, the tumor cells are either directly destroyed (thermal ablation) or sensitised for concomitant chemotherapy or radiotherapy (hyperthermia), according to the German-based medical technology company.
The controlled, open-label and randomised study is designed to determine the efficacy and safety of NanoTherm monotherapy alone and in combination with radiotherapy versus radiotherapy alone in up to 280 glioblastoma patients.
The study, which will be conducted in about 15 German-based centres, will initially start in the university hospitals Berlin, Duesseldorf, Giessen, Cologne and Muenster.
The study is also designed to comply with the current guidelines for the development of medicinal products.
University Hospital Muenster neurosurgery and neurooncology department director and study coordinating principal investigator Dr Walter Stummer said there is still a high medical need for effective treatment options to help patients suffering from the aggressive brain tumor disease.
"The previous study of MagForce‘s NanoTherm Therapy showed promising results," Stummer said.
"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."