A groundbreaking sonodynamic therapy (SDT) approach has demonstrated remarkable safety and efficacy in treating glioblastoma patients, offering new hope in an area with limited therapeutic options.
Early clinical findings revealed that three patients with newly diagnosed glioblastomas, who were not candidates for gross total tumor resection, responded positively to a single dose of SDT. The treatment successfully induced cancer cell death while preserving healthy brain tissue, with no adverse events reported.
Innovative Treatment Mechanism
The novel therapy, developed by Alpheus Medical, combines low-intensity diffuse ultrasound (LIDU) with oral 5-ALA administration. This non-invasive approach uniquely targets cancer cells throughout the brain without requiring imaging or sedation, addressing a significant challenge in neuro-oncology by reaching the peripheral invasive zone and beyond.
"Sonodynamic therapy's ability to selectively induce immediate tumor cell death while sparing healthy brain tissue is unprecedented," stated Walter Stummer, professor and director of the Department of Neurosurgery at the University Hospital Münster, Germany. "These factors suggest that SDT could be a significant breakthrough in glioblastoma treatment."
Promising Clinical Trial Results
In an open-label, multicenter phase 1/2 trial (NCT05362409) focusing on recurrent high-grade gliomas, SDT demonstrated remarkable efficacy. The study enrolled 12 patients who received escalating treatment durations of 60, 90, and 120 minutes per monthly session.
Key findings presented at the 2024 Society of Neuro-Oncology Annual Meeting revealed:
- Median overall survival of 15.7 months, significantly exceeding the historical benchmark of 6-8 months for recurrent glioblastoma
- Improved median progression-free survival of 5.5 months, compared to the standard 1.8 months
- Robust safety profile with no treatment-related deaths, serious adverse events, or significant toxicities
Patient Selection and Trial Design
The trial carefully structured patient eligibility across multiple cohorts. Initial participants included patients with various high-grade gliomas showing recurrence after radiotherapy. Later trial phases specifically focused on glioblastoma patients experiencing their first recurrence.
Based on these encouraging results, a randomized control trial evaluating SDT for newly diagnosed glioblastoma patients is scheduled to commence later this year, potentially marking a significant advancement in brain cancer treatment options.
