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

• The results from their first-in-human study demonstrated that median overall survival was doubled and progression-free survival improved 3-fold
• The Company's novel sonodynamic therapy platform selectively targets and destroys cancer cells in the brain while preserving healthy tissue 

CHANHASSEN, Minn., Nov. 24, 2024 /PRNewswire/ -- Alpheus Medical, Inc., a private, clinical-stage oncology company pioneering sonodynamic therapy (SDT) for the treatment of solid body cancers, today announced positive results from their Phase 1/2 clinical trial in patients with recurrent or refractory high-grade gliomas. 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.

"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.

About Alpheus Medical, Inc.

Alpheus Medical is a private, clinical-stage oncology company revolutionizing the treatment of solid body cancers with its pioneering sonodynamic therapy (SDT) platform that combines Low-Intensity Diffuse Ultrasound (LIDU^™) with the sensitizing agent, oral 5-aminolevulinic acid (5-ALA). The company's proprietary, non-invasive technology is designed to selectively target and destroy cancer cells in the brain while preserving healthy tissue. Learn more at www.alpheusmedical.com.

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SOURCE Alpheus Medical