The controlled, open-label and randomized study will enroll 280 patients to determine the safety and efficacy of the company’s NanoTherm Therapy device alone and in combination with radiotherapy versus radiotherapy alone in treating glioblastoma patients.
MagForce said the study will initially be started in the University Hospitals Berlin, Duesseldorf, Giessen, Cologne and Muenster among the 15 German-based centers.
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 added.
"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."
The device directly introduces small superparamagnetic nanoparticles, containing an iron oxide core with an aminosilane coating, that produces heat by activating the magnetic field for the treatment of brain tumor.
