Alpheus Medical has begun the multi-centre Butterfly study to assess its investigational Porphyrin Metabolite Activation (PoMA) therapy in patients with butterfly glioblastoma (GBM).
The study aims to evaluate the safety and clinical activity of the experimental regimen in individuals with newly diagnosed disease.
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Butterfly GBM is described as an aggressive form of brain cancer that spreads across the corpus callosum into both cerebral hemispheres.
Under the study protocol, participants will receive the PoMA therapy together with standard medical care. Eligible candidates must enrol before starting standard chemoradiation treatment.
The non-invasive procedure is administered on an outpatient basis while the patient remains awake, and it is designed for repeated use.
The therapeutic approach combines oral 5-aminolevulinic acid (5-ALA) with bilateral, externally administered low-intensity defocused ultrasound.
Following ingestion of 5-ALA, protoporphyrin IX (PpIX) gathers preferentially within malignant cells, where it is subsequently triggered by the targeted ultrasound waves.
Alpheus Medical CEO Vijay Agarwal said: “Butterfly GBM is a devastating diagnosis for patients who have very limited treatment options.
“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.”
Patient recruitment is currently taking place at the Dent Neurologic Institute in Buffalo, New York, with further clinical trial sites across the US anticipated to join the programme in the coming months.
Alpheus Medical secured additional backing to support the Butterfly study and fund the ongoing development of PoMA therapy.
The private, clinical-stage biotechnology company develops tumour-selective oncology treatments targeting 5-ALA-derived PpIX, with its lead candidate currently under investigation in a randomised Phase IIb trial in newly diagnosed GBM.
