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NaviFUS Launches Neuronavigation-guided Clinical Trial to Open the Blood-Brain-Barrier for Combination FUS-Bevacizumab Therapy in rGBM Patients

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September 11, 2020

NaviFUS Corporation, a subsidiary of Taiwan-based focused ultrasound (FUS) manufacturer Genovate Biotech has announced the start of its clinical trial (NCT04446416) for the combination of FUS plus bevacizumab therapy.

NaviFUS Corporation notes researchers at Linkou Chang Gung Memorial Hospital are investigating the use of Neuronavigation-guided FUS to repeatedly and temporarily open the blood-brain barrier (BBB) and enhance bevacizumab’s efficacy in patients with recurrent glioblastoma (rGBM). To date, the first patient has been enrolled and is undergoing treatment.

Led by neurosurgeon Dr. Kuo-Chen Wei at Linkou Chang Gung Memorial Hospital, the clinical trial will evaluate the safety and preliminary efficacy of repeated FUS-induced BBB opening with bevacizumab using the company’s NaviFUS System. NaviFUS System utilizes neuronavigation and prior patient CT/MR images to guide the FUS energy. Additionally, the system includes a real-time acoustic emissions monitoring function that can personalize a safe and optimal level of FUS energy treatment for each patient.

The study plans to enroll six rGBM patients who will undergo biweekly bevacizumab treatment. Per the clinical trial protocol, patients will receive FUS treatment with every bevacizumab dose up to the 34th week or until further disease progression. The first patient enrolled in August, and preliminary monitoring from the initial bevacizumab with FUS treatments have shown the patient’s condition is stable with no adverse events.

“The goal of the study is to investigate the possibility of delivering a large molecular weight drug to the brain in higher concentrations using FUS technology,” said NaviFUS Chief Executive Officer Arthur Lung, Ph.D. “To our knowledge, this is the first time large molecular bevacizumab delivered into the brain in significant quantities. Should we observe positive results from the study, we expect it will be a good model for further extension to other biologicals, antibodies, antibody-drug conjugates, and cell therapies. This trial is an important step in meeting the goal of our company, which uses an innovative and safe way to help treat the central nervous system (CNS) diseases in the future.”

This clinical trial is also funded in part by the Focused Ultrasound Foundation. “This trial uses an innovative device to open the blood-brain barrier repetitively,” says Foundation Chairman Neal F. Kassell, MD. “It is an important step in the path to developing novel approaches for delivering a variety of therapeutic agents to the brain. This trial can facilitate the treatment of primary and metastatic brain tumors as well as neurodegenerative diseases for which there are few other treatments, including Parkinson’s, Alzheimer’s, and ALS.”

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