NaviFUS completes innovative pilot study investigating FUS and re-radiotherapy combination treatment for recurrent glioblastoma tumors
NaviFUS Corporation is excited to announce that it recently received approval by the United States Food and Drug Administration (FDA) for an investigational device exemption (IDE) clinical trial using its NaviFUS® System focused ultrasound (FUS) device. The pilot-early feasibility study will be conducted at University of Virginia and will evaluate the combined effect of using the NaviFUS System® to open the blood-brain-barrier (BBB) and bevacizumab (Avastin®) drug treatment in rGBM patients.
The IDE trial in the US will be conducted alongside its corresponding pivotal trial in Taiwan, which was approved by the Taiwan FDA earlier at the end of January. Since the two trials also utilize a similar trial design, this strategic timeline provides the added benefit that clinical data from the pivotal trial can serve as a reference and facilitate future regulatory submissions for potential pivotal studies in the US. NaviFUS plans to accelerate the breakthrough of its FUS device into the global brain tumor therapeutics market and offer accessibility to a patient population that urgently needs effective treatments.
Besides its progress in its FUS clinical trials for rGBM, the NaviFUS® System has also made great strides in its clinical development for FUS epilepsy treatment. In Taiwan, its clinical trial using FUS neuromodulation to treat drug-resistant epilepsy has yielded promising data. The preliminary efficacy and safety results were published at the International Epilepsy Congress in Dublin, Ireland, in October last year. Noticeable improvement in the frequency of post-treatment epileptic seizures was observed within 2 to 6 months.
To advance the clinical development of FUS treatments for epilepsy, NaviFUS is planning multiple clinical trials across various prestigious institutions this year. In addition to another trial in June last year sponsored by a joint venture created by NaviFUS Corporation and Genovate Biotech at The Alfred Hospital in Melbourne, Australia, other trials are expected to launch this year in Taiwan (Taipei Veterans General Hospital) and the United States (Stanford University, University of Virginia Hospital, and Brigham Women’s Hospital). By investigating different treatment designs at three sites around the world, optimal treatments for clinical commercial use can be designed more quickly, while simultaneously promoting international collaboration.
CEO Arthur Lung states, NaviFUS is on track in following its plans for product development and clinical applications; recently, it has achieved critical business milestones like acquiring a tech-business license earlier in January, preparing for the launch of its next round of equity raising, and expanding its clinical study portfolio to many prestigious sites around the world. By continuing its long-term cooperation with global business partners and making good progress in its clinical projects, NaviFUS is optimistic that its hard work from previous years will come to fruition this year.
View source version on： 浩宇治復發性腦瘤試驗 獲美國IDE臨床許可