The first patient completed chemotherapy cycles in a clinical trial to investigate the safety and efficacy of focused ultrasound for disrupting the blood brain barrier (BBB) in patients with glioblastoma (GBM).
HAIFA, ISRAEL and SEOUL, KOREA January 30, 2019 – Insightec®, a global medical technology innovator of incisionless surgery, and Yonsei University announced today that the first patient worldwide completed chemotherapy cycles in a clinical trial to investigate the safety and efficacy of focused ultrasound for disrupting the blood brain barrier (BBB) in patients with glioblastoma (GBM). This first patient successfully completed all six sessions of their planned complete adjuvant temozolomide (TMZ) with BBB disruption treatment. There were no complications or side effects following disruption of the BBB with focused ultrasound.
Glioblastoma is the most common primary malignant brain tumor in adults1. The blood brain barrier not only protects the brain from toxins, it also prevents the effective delivery of therapeutic agents to treat brain tumors, such as GBM, which is why disrupting the BBB is key for introducing treatment options.
“This is the world’s first complete treatment using low frequency focused ultrasound to temporarily increase the permeability of the BBB in a glioblastoma patient during adjuvant TMZ and allow the passage of a therapeutic agent,” commented Jin Woo Chang, MD, PhD, Professor in the Department of Neurosurgery, Director of the Brain Research Institute at Yonsei University College of Medicine and the trial’s principal investigator. “Clinical research such as this is critical to evaluating the potential of new technologies.”
The investigational Exablate Neuro device from Insightec delivers low frequency focused ultrasound without surgical incisions to temporarily disrupt the BBB. In the clinical trials, following surgical resection and radiotherapy plus concomitant TMZ, focused ultrasound is delivered during the first treatment of each of the six maintenance cycles of TMZ.
“This trial is a strong example of the brightest researchers exploring new frontiers in neuroscience,” said Maurice R. Ferré MD, Insightec’s CEO and Chairman of the Board. “Insightec’s focused ultrasound technology has the potential to break down the barriers to treatments in the brain such as glioblastoma with the ultimate goal of improving patient lives.”
Insightecis a global healthcare technology innovator transforming patient lives through incisionless brain surgery using MR-guided focused ultrasound. The company’s award-winning Exablate Neuro™ is used by neurosurgeons to perform the Neuravive™ treatment to deliver immediate and durable tremor relief for essential tremor patients. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, Florida, with offices in Dallas, Tokyo and Shanghai.
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