- 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
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SOURCE Alpheus Medical
