On November 24, 2024 Alpheus Medical, Inc., a private, clinical-stage oncology company pioneering sonodynamic therapy (SDT) for the treatment of solid body cancers, reported positive results from their Phase 1/2 clinical trial in patients with recurrent or refractory high-grade gliomas (Press release, Alpheus Medical, NOV 24, 2024, View Source [SID1234648593]). The company’s proprietary therapy demonstrated a strong safety profile and extended median overall survival (OS) and progression-free survival (PFS) compared to historical data. The data were presented by Michael Schulder, MD, at the 2024 Society of Neuro-Oncology (SNO) Annual Meeting.
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"Glioblastomas are the most common and aggressive primary brain cancer, presenting a devasting diagnosis for patients and their familes," said David Reardon, MD, Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, and member of the Alpheus Medical Scientific Advisory Board. "Current treatment options are limited and often ineffective due to the diffuse spread of the disease across the blood-brain barrier and often across the entire hemisphere, making it universally fatal with a rapid timeline. The early clinical results of Alpheus’s therapy are promising, offering hope for this new approach. I look forward to further exploring the potential benefits of their SDT therapy for this patient population who is in critical need of an effective solution."
Alpheus Medical’s non-invasive SDT treatment, which can be delivered in an outpatient setting, combines low-intensity diffuse ultrasound (LIDU) with oral 5-aminolevulinic acid (5-ALA) to target and kill cancer cells across the entire hemisphere without the need for imaging or sedation. Key findings from the study include:
Median overall survival (OS): 15.7 months vs. historical ~6-8 months
Median progression-free survival (PFS): 5.5 months vs. historical 1.8 month
Safety: No treatment-related deaths, serious adverse events (SAEs), or duration-limited toxicities (DuLTs) reported
"In addition to the strong safety data and early indications of efficacy, Alpheus’ non-invasive SDT therapy stands out for its ease of use – a significant improvement over the uncomfortable and often toxic treatments currently available for this rapidly fatal condition," stated Dr. Schulder, Director of the Brain Tumor Center at Northwell Health, and one of the trial’s primary investigators. "We look forward to expanding the ability for patients to receive this promising therapy."
The Phase 1/2 trial (NCT05362409) is an open-label, multicenter, 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 randomized, controlled trial at multiple centers across the U.S. in 2025.