Breakthrough Status Achieved for IFF-Backed Tumor Monorail Device

A biomedical tool that tricks aggressive brain tumors into moving into an external container instead of throughout the brain has been designated a “breakthrough device” by the U.S. Food and Drug Administration.

The device, known as the Tumor Monorail or Pied Piper, is funded by Ian’s Friends Foundation, an Atlanta nonprofit focused on curing pediatric brain tumors, along with The Marcus Foundation and the National Institute of Health’s EUREKA program. Georgia Tech and Emory University researchers made headlines in 2014 with their initial exploratory study of the Tumor Monorail.

Phil Yagoda, founder and president of IFF, explained that the breakthrough status is reserved for research that has the potential to dramatically alter cancer research.

“What that means is that the FDA will almost act as your partner. They’ll assign people to the monorail device and try to get it through as fast as possible,” Yagoda said.

Dr. Barunashish Brahma from Children’s Healthcare of Atlanta and professor Ravi Bellamkonda of Duke University are the researchers behind the technique, which implants a small device in the brain, mimicking the characteristics of white matter.

In doing so, the device attracts tumors that may be in otherwise inoperable locations to a more easily accessed area, where they can be more readily dealt with.

“There are a lot of areas where it is too risky to operate, so this device uses the tumor’s natural ability to move against itself,” Brahma said.

Yagoda, along with his wife Cheryl, founded IFF in 2006 when their son Ian was diagnosed with an inoperable brain tumor. He said that the monorail device is exactly the kind of novel research that IFF looks for when funding projects.

“We’re looking for things that have the potential to be game changers, even if that means that chances of success are a little lower,” Yagoda said. “A lot of other places aren’t willing to go for it if it’s risky. In my opinion, the only thing that will make a difference is what’s not already being done.”

Brahma explained that IFF had played a key role, providing the initial seed money for the research as well as being a cheerleader for the innovative device. Since then, the project has been awarded $1.3 million from the EUREKA grants, and $7 million dollars from the Marcus Foundation.

The device is the first of its kind, demonstrating guided movement of a brain tumor toward a designated point, and can fundamentally reduce complexity of operations and increase survival rates.

“The implantation of it [the device] is one of the simpler types of neurosurgical operations. We create a small incision and it’s a very small device that goes into the brain,” Brahma said. “We expect that the patient would be outpatient or one-day overnight stay.”

Brahma added that breakthrough status and the FDA’s hands-on interaction with the research significantly speeds up the process.

“We have a conversation with them every two weeks, and they have some things they want us to demonstrate — that it’s safe and meets their standards,” he said. “Because they’re a partner in this process, it really helps us to expedite.”

The breakthrough designation is a huge step forward for the device, which Brahma said is aiming to move on to the first trials in human patients by the end of 2020. He added that while cancer survival rates are reasonably high, they have been stagnating in the 21st century.

“I think that the thing about cancer research is that it hasn’t really changed on the whole for the last 20 years,” he said. “Our goal is to try to offer something to children and families where you can hopefully get better results long term.”

Yagoda quoted another influential Atlantan in discussing IFF’s goals.

“Billi Marcus of The Marcus Foundation said it best, ‘Children and cancer should never be in the same sentence.’”