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Alpheus Medical has announced exciting results from their Phase 1/2 sonodynamic therapy (SDT) trial in recurrent or refractory high-grade glioma. The results were also presented at the SNO conference by Dr. Michael Schulder.
The trial combined low-intensity diffuse ultrasound with oral 5-aminolevulinic acid (5-ALA) in 12 patients across three cohorts, with escalating treatment durations. The treatments were delivered monthly for a minimum of four sessions, and a treatment duration of 120 minutes was established after dose escalation.
Results showed significantly extended median overall survival (OS) to 15.7 months and progression-free survival (PFS) to 5.5 months, compared to historical data of approximately 6-8 months and 1.8 months, respectively. This is particularly impressive given that two patients were enrolled after multiple recurrences and seven patients had multifocal or multicentric disease.
Alpheus plans to start a randomized, controlled trial at multiple centers across the U.S. in 2025. We did a webinar with Alpheus in early 2023, and we hope to host another updated one soon!