Background – Glioblastoma and CV-01
The diffuse nature of Glioblastomas, often across the hemisphere, makes it an extremely challenging disease to treat.
There are very few effective options, leading to poor patient outcomes
Even with a complete resection, we know that only part of the tumor has been removed.
This is a disease that requires more than just a focal therapy.
During the procedure, the patient is awake and can go home the same day.
Alpheus Medical’s device, which is called CV-01, is applied to the entire diseased hemisphere, targeting tumor cells you can see and those you can’t.
How is it Done?
Step I – The patient drinks a drug, 5-ALA, that is already FDA approved for use in brain tumor surgery
Step II – The drug accumulates inside brain cancer cells but not in healthy cells
When the ultrasound hits the drug molecules, they release a form of oxygen (called an oxygen radical) in the cancerous cells, causing cell death.
Current Situation Recurrent Glioblastoma Patients
Orphan drug designation and fast track designation was granted to CV-01 as a treatment strategy for patients with recurrent Glioblastoma and other malignant gliomas, according to a press release from Alpheus Medical.
The trial will evaluate the safety, optimal application, and efficacy of the platform.
The study has an estimated enrollment of 33 patients for the phase 1 portion.
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