NaviFUS Corp’s Focused Ultrasound System in Plans for Phase III recurrent Glioblastoma Multiforme Pivotal Trial

NaviFUS Corp’s Focused Ultrasound System in Plans for Phase III recurrent Glioblastoma Multiforme Pivotal Trial

NaviFUS System for BBB Opening Pivotal Study of FUS Avastin for rGBM

The NaviFUS® System, the Neuronavigation-guided focused ultrasound system developed by NaviFUS Corp., has completed a Phase II clinical trial in Taiwan for recurrent glioblastoma multiforme. Primary efficacy assessment data has shown promising results, and subsequently, the company plans to initiate a Phase III trial in Taiwan and a clinical trial in the United States. Additionally, it is exploring opportunities for international collaboration and patent sublicensing.

The NaviFUS® System combines their focused ultrasound technology platform with recurrent glioblastoma multiforme standard care drug Avastin. By directing focused ultrasound energy to the central nervous system tissues deep within the brain while also using microbubbles, the interaction can temporarily open the blood-brain barrier, allowing the device to enhance the delivery of the drug.

In the Phase II study, the primary efficacy endpoint observed was the 6-month progression-free survival (PFS-6), and the results showed a superior 6-month PFS rate compared to historical 6-month PFS for Avastin-only standard treatment. This suggested that the combination of NaviFUS® System and Avastin enhances the effectiveness of drug penetration through the blood-brain barrier.  

According to data from the World Health Organization and the American Brain Tumor Registry, there were approximately 308,000 new brain cancer cases globally in 2020. In 2022, the United States alone had around 93,000 new brain cancer cases, with a total estimated 450,000 brain cancer patients in the Americas. Among these newly diagnosed patients, approximately 30% have primary malignant tumors, and their prognoses are often not optimistic.

Patients with glioma tumors have a median survival period of around 8 months. In North America and Europe, the incidence of glioma tumors ranges from 2 to 5 cases per 100,000 people, accounting for over 50% of primary malignant brain tumors. As a result, it is estimated that there are approximately 250,000 new glioma cases worldwide each year and around 200,000 deaths attributed to gliomas.

NaviFUS points out that in 2021, the market size for Avastin was approximately $3 billion. If focused solely on sales of Avastin for the treatment of glioblastoma multiforme, global sales in 2020 reached $550 million, with a compound annual growth rate of 4.7%. It is projected that the global market size will reach $870 million by 2030.

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