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.

Media Contact

Carla Benigni

carla@sprigconsulting.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/alpheus-medical-announces-positive-phase-12-trial-results-for-the-treatment-of-recurrent-high-grade-gliomas-302314785.html

SOURCE Alpheus Medical

First published on Mon, Nov 25, 2024

Enjoyed what you read? Great news – there’s a lot more to explore!

Dive into our content repository of the latest tech news, a diverse range of articles spanning introductory guides, product reviews, trends and more, along with engaging interviews, up-to-date AI blogs and hilarious tech memes!

Also explore our collection of branded insights via informative white papers, enlightening case studies, in-depth reports, educational videos and exciting events and webinars from leading global brands.

Head to the TechDogs homepage to Know Your World of technology today!

Disclaimer - Reference to any specific product, software or entity does not constitute an endorsement or recommendation by TechDogs nor should any data or content published be relied upon. The views expressed by TechDogs' members and guests are their own and their appearance on our site does not imply an endorsement of them or any entity they represent. Views and opinions expressed by TechDogs' Authors are those of the Authors and do not necessarily reflect the view of TechDogs or any of its officials. While we aim to provide valuable and helpful information, some content on TechDogs' site may not have been thoroughly reviewed for every detail or aspect. We encourage users to verify any information independently where necessary.

Tags:

Alpheus Medical Sonodynamic Therapy SDT Gliomas Brain Cancer Oncology Clinical Trial Phase 1/2 Survival Rate

Join The Discussion

Healthcare Technology

Alpheus Medical Announces Positive Phase 1/2 Trial Results For The Treatment Of Recurrent High-Grade Gliomas

Join Our Newsletter