Duke University Gets “Green Light” From FDA to Fast-Track Trial Reviews for GBM Treatment

In the midst of Brain Tumor Awareness Month, hope may be on the horizon for those living with glioblastoma multiforme (GBM), a type of malignant (cancerous) brain tumor.

An early-phase clinical trial being performed at Duke University has been focusing on a cutting-edge treatment for GBM. Following two 60 Minutes segments that aired last year, the trial has received plenty of attention for using a genetically re-engineered poliovirus known as PVS-RIPO to effectively treat the condition. After the initial airing, Duke continued experimenting with PVS-RIPO, adding more patients to the trial with some very encouraging results in the face of an extremely deadly enemy.

As a result, the Food and Drug Administration (FDA) recently gave Duke Breakthrough Therapy Designation status. In short, this means that the FDA will fast-track the review of this potential new therapy. (Though, this does not guarantee the therapy’s approval.) With designation in hand, Duke is now looking to move to the next phases of the trial as soon as possible.

How does PVS-RIPO therapy work?

Simply put, human cancers form a shield around themselves that make them undetectable to the immune system. By infecting the tumor with the virus, the shield is removed, allowing the immune system to effectively destroy the tumor.

In addition, the virus itself may play a part in killing the tumor cells because of the way it has been re-engineered. A key genetic sequence was removed and replaced with a harmless portion of cold virus. As a result, the poliovirus cannot reproduce in normal cells. It can, however, reproduce in cancer cells, poisoning the cells with toxins in the process.

What is glioblastoma multiforme?

As previously mentioned, GBM is a primary malignant brain tumor. It is the most common and deadliest of these types of brain tumors. In fact, GBM accounts for approximately 30 percent of all primary brain tumors in adults and about nine percent of brain tumors in children.

GBM is classified as a Grade IV (most serious) astrocytoma and originates in star-shaped cells known as astrocytes that support the nerve cells in the brain. It normally occurs in the cerebral hemispheres, but may also be found in other areas of the brain, brainstem and spinal cord. This cancer grows rapidly because of the rate in which the cells reproduce and can quickly spread to other parts of the body, including the lungs, bones and lymph nodes.

How is glioblastoma multiforme traditionally treated?

While treatments may vary depending on the size and location of the tumor, surgery is the standard treatment. However, it should be noted that this technique is not always successful, even in combination with radiation therapy, brachytherapy (inserting radioactive material in or near the tumor) or chemotherapy. Due to the nature of the disease, the tumor is likely to return despite months of aggressive treatment.

Hopefully, with the PVS-RIPO therapy, the horizon will change for these patients.


At IGEA Brain & Spine, our specialists have years of experience in treating GBM and other debilitating brain conditions. Utilizing the latest advancements in the field, our neurosurgeons are able to effectively diagnose and treat patients while maintaining a superior quality of care.

For more information on GBM or to schedule an appointment with one of our brain tumor specialists, contact IGEA Brain & Spine today.

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