Brainsway® Ltd. is pleased to announce that it has received the final results of a clinical trial performed by Advanced Technologies Innovation Distribution SRL (“ATID”) in Italy to explore the efficacy of Deep TMS in the opening of the blood-brain barrier (“BBB”) in patients with brain tumors. The study was conducted in the framework of collaboration between Ben-Gurion University (Principal Investigator – Dr. Alon Friedman) and the University of Rome (Principal Investigator – Dr. Maurizio Inghilleri).
A total of 19 patients with glioblastoma multiforme (“GBM”) tumors were recruited for the study. All of these patients had undergone surgery more than a year before the trial. The data from 3 patients were excluded due to technical problems, while in 4 other subjects the limited size of post-resection tumor prevented analysis. In addition four subjects with no tumors were also recruited to serve as a control group. The final results indicated that high-intensity Deep TMS treatment protocols induced a temporary but significant degree of BBB opening in 10 of the remaining 12 patients (83%), following the REAL stimulation in comparison to SHAM stimulation, in an area within and around the tumor zone. This clinical trial confirms and extends the findings of a previous animal study conducted at Ben-Gurion University.
BBB opening was observed in patients immediately following the stimulation protocol (which included magnetic field intensities higher than those used in other Deep TMS clinical trials), and was quantified using magnetic resonance imaging and special protocols for BBB permeability measurement developed at the Zlotowski Center for Neuroscience at Ben Gurion University. The changes in BBB permeability were measured in each patient by comparing the effects of Deep (REAL) TMS stimulation to SHAM stimulation. In the control group, no significant changes in the BBB permeability were observed in the brain following the REAL stimulation in comparison to SHAM stimulation. No adverse events following the stimulation were observed in any of the subjects in the study.
It should be noted that the opening of the BBB is temporary. It is believed that timing this transient opening to coincide with drug delivery could focus and enhance drug delivery, thereby increasing the effectiveness of existing drugs. The researchers hope that this new method will prove effective in enhancing delivery of chemotherapy drugs to brain tumors, and perhaps even in the treatment of other central nervous system diseases. Furthermore, the prospect of timed opening of the BBB opens possibilities for the development of new and/or hitherto impractical drugs.
Dr. Friedman commented, “The final results, which support the interim results of the study, attest to a novel non-invasive technique to safely and efficiently open the BBB. We, therefore, recommend that a a multi-center trial be initiated in patients with GBM and other brain tumors in which the efficacy and safety of this novel method for BBB opening in combination with drug delivery would be investigated.”
In parallel to this clinical effort, animal experiments are being carried out in BGU in order to further characterize the method and its potential mechanisms.