#United States #Alpheus Medical #Sonodynamic Therapy #Gliomas #Chanhassen

Alpheus Medical's Promising Phase 1/2 Trial Results

Alpheus Medical, Inc., a clinical-stage oncology company based in Chanhassen, Minnesota, is making waves in the biotechnology sector with the announcement of favorable results from its Phase 1/2 clinical trial targeting recurrent high-grade gliomas. The trial evaluated a novel treatment that employs sonodynamic therapy (SDT), which integrates low-intensity diffuse ultrasound (LIDU™) and oral 5-aminolevulinic acid (5-ALA) to selectively eliminate cancerous cells while protecting adjacent healthy tissues.

Clinical Background

High-grade gliomas are known to be among the most aggressive forms of brain cancer. These tumors often come with a grim prognosis, with existing treatments struggling against the disease's invasive nature and its ability to evade traditional therapies. The trial's outcomes were heralded as a breakthrough, potentially offering hope to patients facing limited treatment options in the current medical landscape.

Key Findings from the Trial

Presented at the 2024 Society of Neuro-Oncology Annual Meeting by Dr. Michael Schulder, notable findings include:
1. Median Overall Survival (OS): The results indicate a median OS of 15.7 months, significantly improved from the historical 6-8 months for comparable cases.
2. Median Progression-Free Survival (PFS): The therapy achieved a median PFS of 5.5 months, a considerable rise when contrasted with the historical average of 1.8 months.
3. Safety Profile: Importantly, no treatment-related deaths or serious adverse events were recorded, underscoring the safety of SDT.

Dr. David Reardon, Clinical Director at Dana-Farber Cancer Institute and a member of Alpheus Medical's advisory board, noted the urgent need for effective treatments for glioblastomas, stating: "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."

Advantages of SDT

Unlike conventional treatments, the non-invasive nature of SDT allows the therapy to be administered in an outpatient setting. This ease of application, combined with a solid safety record, provides an optimistic outlook compared to more intrusive and often toxic alternatives.

Dr. Schulder highlighted the procedure's benefits, stating: "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."

Future Directions

The Phase 1/2 trial, identified by the clinical trial number NCT05362409, was an open-label, multicenter study evaluating different doses and treatment durations. A total of twelve patients participated across three cohorts, with treatment sessions escalating to 60, 90, and 120 minutes monthly.

Looking ahead, Alpheus Medical plans to initiate a randomized, controlled trial across multiple U.S. centers in 2025 to further validate the findings and expand access to this innovative therapy.

About Alpheus Medical, Inc.

Alpheus Medical is on the forefront of cancer treatment, dedicated to revolutionizing therapies for solid cancers through its pioneering SDT platform. The company focuses on delivering safe and effective solutions that not only address the cancer but also preserve the quality of life for patients. For more information, visit Alpheus Medical's website.

As new developments unfold, the medical community remains hopeful that groundbreaking therapies like those tested by Alpheus Medical can significantly impact treatment outcomes for high-grade glioma patients, who are in dire need of effective alternatives.