Alpheus Medical Unveils Encouraging Results from Phase 1/2 Clinical Trial in the Battle Against 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, showcasing the potential of this innovative therapy.
- The Company’s novel sonodynamic therapy platform selectively targets and obliterates cancer cells in the brain while ensuring the protection of healthy tissue.
CHANHASSEN, Minn., Nov. 24, 2024 /PRNewswire/ — Alpheus Medical, Inc., a cutting-edge, private clinical-stage oncology firm, today announced optimistic outcomes from their Phase 1/2 clinical trial, focusing on patients battling recurrent or refractory high-grade gliomas. This trial highlighted the company’s proprietary sonodynamic therapy (SDT) as not only safe but also significantly increasing median overall survival (OS) and progression-free survival (PFS) relative to historical benchmarks. These compelling findings were presented by Michael Schulder, MD, at the prestigious 2024 Society of Neuro-Oncology (SNO) Annual Meeting.
“Glioblastomas stand as the most prevalent and aggressive form of primary brain cancer, presenting a devastating diagnosis for patients and their families,” stated David Reardon, MD, Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and a member of the Alpheus Medical Scientific Advisory Board. “Current treatment options are constrained and frequently futile due to the cancer’s diffuse infiltration across the blood-brain barrier and often throughout the entire hemisphere, leading to a dire prognosis with swift progression. The early clinical outcomes from Alpheus’s therapy are very encouraging, providing a glimmer of hope for a new therapeutic approach. I eagerly anticipate further investigation into the promise of their SDT therapy for this vulnerable population in desperate need of effective interventions.”
Alpheus Medical’s non-invasive SDT treatment, which can be conveniently administered in an outpatient setting, merges low-intensity diffuse ultrasound (LIDU™) with oral 5-aminolevulinic acid (5-ALA) to precisely target and eradicate cancer cells across the entire hemisphere, eliminating the necessity for imaging or sedation. Key findings from the study encapsulate the following:
- Median overall survival (OS): 15.7 months vs. historical ~6-8 months, highlighting a significant advancement in patient outcomes.
- Median progression-free survival (PFS): 5.5 months vs. historical 1.8 months, indicating substantial improvement.
- Safety: No treatment-related deaths, serious adverse events (SAEs), or duration-limited toxicities (DuLTs) reported, reinforcing the therapy’s safety profile.
“Beyond the robust safety data and early signs of efficacy, Alpheus’ non-invasive SDT therapy is remarkable for its simplicity of administration – a considerable upgrade over the uncomfortable and often toxic therapies available for this aggressively fatal condition,” commented Dr. Schulder, Director of the Brain Tumor Center at Northwell Health, and one of the trial’s primary investigators. “We are keen to broaden patient access to this promising therapy.”
The Phase 1/2 trial (NCT05362409) is an open-label, multicenter, duration-escalation study designed to evaluate the safety, optimal dose, and efficacy of Alpheus Medical’s proprietary SDT platform. Twelve patients were enrolled across three cohorts, with treatment durations gradually escalating to 60, 90, and 120 minutes for each monthly session.
The company is optimistic and plans to initiate a randomized, controlled trial at multiple centers across the U.S. in 2025, to further validate its promising findings.
About Alpheus Medical, Inc.
Alpheus Medical is a private, clinical-stage oncology company poised to revolutionize the management of solid body cancers through its pioneering sonodynamic therapy (SDT) platform. This innovative therapy combines Low-Intensity Diffuse Ultrasound (LIDU™) with the sensitizing agent, oral 5-aminolevulinic acid (5-ALA). Their non-invasive technology is meticulously designed to selectively target and annihilate cancer cells in the brain, while safeguarding healthy tissue. For additional information, visit www.alpheusmedical.com.
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SOURCE Alpheus Medical
What are the key findings from Alpheus Medical’s Phase 1/2 clinical trial for treating recurrent high-grade gliomas as discussed by Dr. Michael Schulder?
**Interview with Dr. Michael Schulder, Director of the Brain Tumor Center at Northwell Health**
**Interviewer:** Thank you for joining us today, Dr. Schulder, to discuss the recent results from Alpheus Medical’s Phase 1/2 clinical trial. Could you summarize the key findings of this study?
**Dr. Schulder:** Absolutely, I’m glad to be here. The trial focused on patients with recurrent high-grade gliomas, and the results were quite promising. We observed a median overall survival of 15.7 months, which is a substantial improvement compared to the historical average of roughly 6-8 months. Additionally, the median progression-free survival increased to 5.5 months from about 1.8 months historically. Importantly, there were no treatment-related deaths or serious adverse events reported, underscoring the therapy’s safety profile.
**Interviewer:** That’s impressive. Can you explain a bit about the therapy itself? How does this low-intensity diffuse ultrasound and 5-ALA combination work to target cancer cells effectively?
**Dr. Schulder:** The therapy combines low-intensity diffuse ultrasound (LIDU™) with oral 5-aminolevulinic acid (5-ALA). This combination allows us to target and destroy cancer cells across the entire hemisphere of the brain, while sparing healthy tissue. One of the game-changing aspects of this therapy is that it doesn’t require imaging or sedation, making it much easier for patients to access and undergo treatment compared to traditional methods, which can be uncomfortable and quite toxic.
**Interviewer:** It sounds like this could be a significant advancement in treating a notoriously aggressive form of brain cancer. What are your hopes for the future of this therapy?
**Dr. Schulder:** I’m very optimistic about the potential for this non-invasive approach. It not only enhances patient comfort but shows early signs of efficacy that could change the landscape of treatment options for gliomas. We are eager to broaden patient access to this therapy and look forward to further investigations that could solidify its role in clinical practice.
**Interviewer:** Thank you, Dr. Schulder, for sharing these insights. It sounds like a significant step forward in neuro-oncology.
**Dr. Schulder:** Thank you for having me. It’s an exciting time in the field, and we hope to continue making strides in improving patient outcomes.
