Glioblastoma, GBM – A New & Novel Option for Patients

Background – Glioblastoma and CV-01

Glioblastoma is a diffuse, infiltrative disease with tumor cells invading far beyond the borders of the visible tumor.

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. 

Alpheus Medical is developing a technology to address this problem by targeting tumor cells beyond the borders of the tumor via a non-invasive procedure.

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.

Recently, the US Food and Drug Administration, the FDA, granted Orphan Drug Designation and Fast Track Designation to CV-01 for the treatment of recurrent Glioblastoma.

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

Step III – Once the tumor cells are loaded with drug molecules, ultrasound is non-invasively delivered to the brain by CV-01

When the ultrasound hits the drug molecules, they release a form of oxygen (called an oxygen radical) in the cancerous cells, causing cell death.

Finally, the immune system eliminates the broken-down cancer cells from the body.

The strategy can be used in an outpatient setting without the need for imaging.

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.

Patients are being enrolled in a phase 1 trial (NCT05362409) evaluating 5-ALA plus CV-01 delivery of ultrasound in a population with recurrent high-grade gliomas.

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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Glioblastoma, GBM - A New & Novel Option for Patients
Glioblastoma, GBM – A New & Novel Option for Patients

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