Ctni-12. Oscillating Magnetic Fields to Treat Glioblastoma and Diffuse Midline Glioma-a Powerful Technology With Studies From the Petri Dish to Clinical Trials

We treated end-stage recurrent glioblastoma (GBM) and diffuse midline glioma (DMG) patients with oscillating magnetic fields with a wearable noninvasive Oncomagnetic device (OMD). OMD selectively kills and prevents proliferation of cancer cells through a mechanism completely different from Optune. Powerful pre-clinical evidence indicates it inhibits mitochondrial respiratory complexes, disrupts electron transport, enhances immune susceptibility, and selectively elevates cytotoxic reactive oxygen species (ROS) in cancer cells. In Vitro studies demonstrated increased ROS to toxic levels in GBM and DMG cells, inducing caspase 3 mediated apoptosis. Normal human astrocytes and neurons were not affected, because of lower baseline levels of ROS and better antioxidant defenses. Animal PDX studies using a 7T MRI demonstrated complete resolution of tumors. We studied the preliminary safety and efficacy of the OMD in adult end-stage recurrent GBM and DMG patients under an FDA expanded access program. Eleven end-stage patients were rested with the OMD, 9 with end-stage GBM and two with DMG. All failed standard therapy and had co-morbidities and recurrences, including LMD in five. Two-hour OMT was given 1 – 4 times daily, initially for 3 days in the clinic and subsequently at home. Tumor imaging periodically assessed treatment response. All patients tolerated OMT well with no serious adverse events. Contrast-enhanced tumor volumes showed ~19 – ~91% reduction in 7 patients during treatment. Using RANO criteria, ten patients had Stable Disease, one had a Complete Response, and one showed a Complete Response that lasted for 11 months after a second recurrence during OMT. The median survival was 13.6 months, excluding two patients who died from unrelated causes. OMD monotherapy involving a novel mechanism of action holds considerable promise as a safe and effective noninvasive treatment for GBM and DMG and may obviate the need for high dose radiation. An international clinical trial in Germany is now in progress.