On October 8, 2026 Alpheus Medical, Inc., a private, clinical-stage biotechnology company, reported the initiation of a new clinical trial evaluating its investigational Porphyrin Metabolite Activation (PoMA) therapy in patients with butterfly glioblastoma (GBM), a particularly aggressive form of brain cancer that extends across the corpus callosum. In the Alpheus Butterfly trial (NCT07862647), patients with newly diagnosed butterfly GBM will receive PoMA therapy, which combines 5-aminolevulinic acid (5-ALA) with bilateral low-intensity defocused ultrasound. Patients must enroll before beginning standard chemoradiation therapy.
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"Patients with butterfly glioblastoma are among the most challenging patients we treat because of the tumor’s bilateral nature. Historically, many clinical trials have excluded this group, leaving patients with few options," said David Reardon, MD, Chief of the Division of Neuro-Oncology and Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute. "This tumor’s diffuse distribution requires us to think differently about treatment. Alpheus’ strategy is designed to address disease across both hemispheres while maintaining tumor selectivity, representing a potentially important new and targeted approach in this patient population."
Butterfly glioblastoma carries a median survival of three to six months in published research, and the tumor’s spread across the midline makes surgical resection difficult or impossible. Because the disease involves both hemispheres, these patients are frequently ineligible for glioblastoma trials that exclude bilateral or multifocal disease.
Alpheus’ investigational PoMA therapy combines a tumor-localizing drug with proprietary low-intensity defocused ultrasound. Following oral administration of 5-ALA, protoporphyrin IX (PpIX) preferentially accumulates in tumor cells and is subsequently activated using externally delivered ultrasound. The therapy is delivered while the patient is awake in an outpatient setting and is designed to be repeatable.
In the multi-center Butterfly study, PoMA therapy is administered alongside standard of care. The Dent Neurologic Institute in Buffalo, New York is currently enrolling patients with additional U.S. clinical centers expected in the coming months.
The company raised additional financing to support the Butterfly GBM study and continued development of PoMA therapy.
"Butterfly glioblastoma is a devastating diagnosis for patients who have very limited treatment options," said Vijay Agarwal, MD, Chief Executive Officer of Alpheus Medical. "We designed this study specifically around the characteristics of the disease and the ability of PoMA therapy to treat both hemispheres non-invasively. We want patients and physicians caring for them to know that this study is available, but they need to reach us early in their treatment journey."
About the Butterfly GBM Clinical Trial
The study (NCT07862647) will evaluate the safety and clinical activity of Alpheus Medical’s investigational PoMA therapy in patients with newly diagnosed butterfly glioblastoma. Patients must enroll before beginning chemoradiation treatment.
Patients, caregivers and clinicians seeking information about eligibility and participating clinical centers should visit www.BrainCancerTrial.com.
(Press release, Alpheus Medical, OCT 8, 2026, View Source [SID1234673290])