US-based private, clinical-stage oncology company Alpheus Medical, Inc. announced on Sunday positive results from its Phase one/two clinical trial in patients with recurrent or refractory high-grade gliomas.

The data was presented by Michael Schulder, MD, at the 2024 Society of Neuro-Oncology (SNO) Annual Meeting.

Alpheus Medical says that its proprietary therapy demonstrated a strong safety profile and extended median overall survival (OS) and progression-free survival (PFS) compared to historical data. Key findings from the study include - median overall survival (OS): 15.7 months compared to historical around six to eight months; median progression-free survival (PFS): 5.5 months compared to 1.8 month; and no treatment-related deaths, serious adverse events (SAEs), or duration-limited toxicities (DuLTs) were reported.

The Phase 1/2 trial (NCT05362409) is an open-label, multicentre, duration-escalation study evaluating the safety, optimal dose, and efficacy of Alpheus Medical's proprietary SDT platform. Twelve patients were enrolled across three cohorts, with treatment durations escalating to 60, 90, and 120 minutes per monthly session.

The company plans to initiate a randomised, controlled trial at multiple centres across the US in 2025.