Alpheus Medical Reports Positive Phase 1/2 Trial Results for Recurrent High-Grade Gliomas Treatment

Alpheus Medical, Inc., a private clinical-stage oncology company, has announced promising results from its Phase 1/2 clinical trial focused on patients with recurrent or refractory high-grade gliomas. This announcement, made on November 24, 2024, highlights the potential of their novel sonodynamic therapy (SDT) platform, which has shown to significantly extend median overall survival (OS) and progression-free survival (PFS) compared to historical data.

The preliminary findings were shared by Dr. Michael Schulder at the 2024 Society of Neuro-Oncology (SNO) Annual Meeting. David Reardon, MD, Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and member of Alpheus Medical's Scientific Advisory Board, highlighted the aggressive nature of glioblastomas, emphasizing the limited and often ineffective current treatment options due to the disease's diffuse spread across the blood-brain barrier. He expressed optimism about the potential of Alpheus’s SDT therapy, which offers a new approach for patients in desperate need of effective treatments.

Alpheus Medical's SDT therapy is non-invasive and can be administered in an outpatient setting. It combines low-intensity diffuse ultrasound (LIDU™) with oral 5-aminolevulinic acid (5-ALA) to target and destroy cancer cells across the entire hemisphere without requiring imaging or sedation. The key outcomes from the study include:

- Median overall survival (OS) of 15.7 months compared to the historical average of 6-8 months.
- Median progression-free survival (PFS) of 5.5 months versus the historical 1.8 months.
- No treatment-related deaths, serious adverse events (SAEs), or duration-limited toxicities (DuLTs).

Dr. Schulder, one of the trial's primary investigators and Director of the Brain Tumor Center at Northwell Health, noted the ease of use of the SDT therapy as a considerable improvement over existing treatments, which are often uncomfortable and toxic. This therapy's strong safety profile and early efficacy indications are promising signs for expanding patient access.

The Phase 1/2 trial, registered under NCT05362409, is an open-label, multicenter study evaluating the safety, optimal dose, and efficacy of Alpheus Medical's SDT platform. The trial included twelve patients divided into three cohorts, with treatment durations increasing to 60, 90, and 120 minutes per monthly session. The company is planning to start a randomized, controlled trial across multiple centers in the U.S. in 2025.

Alpheus Medical is focused on innovating cancer treatment through its proprietary SDT platform, which combines Low-Intensity Diffuse Ultrasound with an oral sensitizing agent, 5-aminolevulinic acid. Their technology is designed to selectively target and destroy cancer cells in the brain while preserving healthy tissue, offering a non-invasive alternative to traditional treatments.