CHANHASSEN, Minn. — Alpheus Medical, Inc., a private, clinical-stage biotechnology company, today announced the initiation of its Phase 2b randomized controlled trial in newly diagnosed glioblastoma (nGBM) with 10 patients enrolled to date and additional clinical sites continuing to come online.
Glioblastoma is a highly infiltrative brain tumor in which cancer cells extend beyond the visible tumor margins and spread throughout the brain hemisphere, limiting the effectiveness of surgery and localized therapies.
To address this challenge, the Alpheus study is evaluating an investigational therapy based on Porphyrin Metabolite Activation (PoMA), an approach previously described in the literature as Sonodynamic Therapy (SDT). This drug-centered approach leverages a molecule that preferentially accumulates in tumor cells, followed by activation using low-intensity ultrasound to enable localized pharmacologic effects. The treatment is designed to act within tumor cells throughout the affected hemisphere.
“Glioblastoma patients have few effective treatment options and poor long-term outcomes, highlighting the urgent need for innovation,” said David Reardon, MD, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, and Principal Investigator of the study. “Alpheus’ approach is designed to address the diffuse nature of the disease by enabling treatment across the affected hemisphere. We look forward to generating data to understand its potential role in patient care.”
“The Phase 2b trial marks an important step forward in bringing our new therapeutic approach to patients with glioblastoma,” said Vijay Agarwal, MD, FAANS, FCNS, Chief Executive Officer of Alpheus Medical. “We believe our drug-centered approach has the potential to address the diffuse nature of the disease in ways that localized treatment cannot. With strong early enrollment, we are focused on generating the randomized clinical data to advance this therapy.”
About the Therapy and Trial
Alpheus Medical is developing a novel therapeutic approach based on Porphyrin Metabolite Activation (PoMA), a drug-centered strategy that leverages a molecule that preferentially accumulates in tumor cells, followed by activation using low-intensity, diffuse ultrasound designed to enable treatment across the affected hemisphere, achieving localized pharmacologic effects. Previously described in clinical literature as SDT, this non-invasive approach is intended to activate the molecule directly within tumor cells while minimizing systemic exposure.
The company’s Phase 2b study (NCT07225621) is a multi-center, randomized trial expected to enroll more than 100 newly diagnosed high-grade glioma patients at up to 15 U.S and European sites. Eligible patients have undergone resection and standard radiochemotherapy. The study compares standard of care alone to standard of care plus investigational therapy. The primary endpoint is progression-free survival (PFS) with key secondary endpoints including overall survival (OS), safety, and tolerability.
For patients and caregivers seeking more information about the study and enrolling sites, visit www.BrainCancerTrial.com.
About Alpheus Medical, Inc.
Alpheus Medical is a private, clinical-stage biotechnology company developing a novel therapeutic approach based on Porphyrin Metabolite Activation (PoMA). This drug-centered strategy leverages a molecule that preferentially accumulates in tumor cells, followed by activation using low-intensity ultrasound to enable localized pharmacologic effect. This non-invasive approach is designed to activate the molecule directly within tumor cells while minimizing systemic therapy exposure, potentially addressing the diffuse nature of the disease. Built on a growing foundation of evidence, the company’s lead program focuses on glioblastoma and is currently under clinical investigation. Learn more at www.alpheusmedical.com.
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