'Pied Piper' Device That Lures Tumors From The Brain Awarded Breakthrough Status By FDA

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Brain tumors are notoriously difficult to treat, often growing quickly and spreading through the brain. But what if we could trick the cancerous cells to proliferate in a new direction, essentially luring them out of the brain and outside the skull? Well, researchers are attempting to do just that, and their work has been awarded “breakthrough status” by the Food and Drug Administration (FDA).

Called the Tumor Monorail, the device has been described as a “pied piper”, thanks to its ability to trick and lure cells away from a tumor, just as the Pied Piper lured rats, and then children, away from the town of Hamelin in the well-known fairy tale.

The Tumor Monorail is essentially a long, thin tube with a small reservoir at one end. The reservoir sits on top of the skull, just under the scalp, and tricks tumor cells into migrating up the tube and out of the brain where they can be removed by a surgeon. It does this by mimicking the brain’s white matter, where the tumor would normally grow. The cancerous cells spread up the tube, thinking they are growing further into the brain and expanding the tumor. Gotcha.

So far, the Tumor Monorail has only been tested successfully in rats. The researchers now need to work on testing its safety and efficacy in humans. That’s why its new breakthrough status is so important. Developing new treatments and proving they are fit for clinical use is a long, arduous process, but the FDA breakthrough initiative helps to fast-track the development and review of new treatments for serious or life-threatening illnesses.

Glioblastoma – an aggressive type of brain tumor with a poor survival rate – is one of these conditions. Innovative new ways to tackle it, like the Tumor Monorail, could have a hugely positive impact, so speeding up its development is key. Still, it’s important to note that the new allocation doesn’t mean the device has been approved for clinical use by the FDA. The researchers behind it will have to prove it's both safe and effective in people first.

“The tumor monorail device is a true game-changer in how we think about treating brain tumors,” said Barun Brahma, a neurosurgeon at Children’s Healthcare of Atlanta, in a statement. “There are many tumors that are considered inoperable due to the location of the tumor or the frailty of the patient. This device affords clinicians the ability to surgically treat these tumors with a minimal approach.”

 

Back in 2014, the researchers successfully managed to get their device to work in rats. The rats’ brain tumors shrank by more than 90 percent and spread more slowly. Since then, the researchers have tweaked the device, and repeatedly shown its effectiveness in rats.

“This was the first demonstration that you can engineer migration inside the body and move a tumor from point A to point B by design,” explained Ravi Bellamkonda, the Vinik Dean of the of Duke University’s Pratt School of Engineering at Duke University, who began the research while at Georgia Tech. “It was also the first demonstration of bringing the tumor to your drug rather than your drug going into the brain and killing valuable cells.”

Five years on and the device has breakthrough status. “The most exciting part about this designation is that it gives us the opportunity to look at the FDA as a partner rather than a reviewer,” said project leader Nassir Mokarram. “With direct access to the FDA reviewers, we can get more efficient, faster feedback on our experimental ideas to make sure we’re addressing all of their concerns from the very start.”

 

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