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The Nativis Voyager, the company’s first device. It uses electromagnetic fields to mimic the effects of drugs. (Nativis Photo)

Nativis, a Seattle-based company developing a device that uses low-frequency radio energy waves to treat cancer and other diseases, announced Tuesday that its Voyager device is being considered for fast-track approval by the U.S. Food and Drug Administration.

The device has been assigned a humanitarian use device (HUD) designation for the treatment of medulloblastoma, a rare and deadly childhood brain cancer. That means Nativis, which has raised more than $60 million to develop the treatment, now has the chance to commercialize the Voyager without going through the normal clinical trial process.

The company must first convince the FDA that there is a good reason to expect its device will work to some degree in treating medulloblastoma patients, a much lower scientific bar than a randomized clinical trial.

Nativis CEO Chris Rivera. (Nativis Photo)

Nativis CEO Chris Rivera said the step is good news for medulloblastoma patients. The disease primarily affects children under 19 and is often fatal. Children who survive the disease and its treatment often have ongoing health problems.

“They’re very rare, it’s very difficult to get drugs past the blood brain barrier to have impact, they’re typically inoperable… and they’re terminal,” Rivera said about the cancer.

Rivera said the company’s technology gets around those limitations. First, it records the electronic frequency profile of a molecule, in this case a chemotherapy called Taxol. Then the Voyager device “plays back” the signal at a patients’ tumor. In theory, the signal impacts the cancer cells the same way molecules of Taxol would.

“We’re learning more about [the technology] and we’re learning more about how we can hopefully slow the progression of this disease, if not eventually stop it,” Rivera said. The company is also targeting a terminal adult brain cancer, glioblastoma. It is currently conducting clinical trials of the Voyager in glioblastoma patients.

Rivera said the HUD designation will help the company bring the treatment to patients more quickly. He also said that the disease is so rare — just a few hundred children are diagnosed with it each year — it is difficult to conduct a randomized trial, making the HUD path the most obvious to bring it to the market.

But Nativis’ technology and the data it has shared have drawn skepticism from some in the scientific community.

Derek Lowe — a longtime researcher and author of the In The Pipeline blog — has been an outspoken critic of the company’s technology.

“My concerns are mostly scientific, and scientific at a pretty basic level,” Lowe told GeekWire. “Everything I know about physics and chemistry tells me that this mechanism they’re proposing cannot work.”

He said others in the scientific community feel the same way and that he received emails and comments from many other scientists after writing several posts about the company’s work. He received a letter from Nativis in 2010 that threatened potential legal action based on his blog posts, and comments that readers left there. Lowe said nothing came of that letter and he continued to criticize the company’s work.

“You cannot mimic a drug with radio waves. You cannot. If you could show that you could do that, you would win a Nobel Prize. They would build statues to you,” he said. Lowe is also a director of chemical biology and therapeutics at Novartis Institutes for BioMedical Research, but said he does not speak for his employer.

The kind of technology Nativis claims to have created would indeed be revolutionary, but the company has released very little data that demonstrates the technology’s effectiveness. Although the company has been working on the technology since 2002, its website only points to five published studies. Four of those studies were conducted in a lab, not in human patients.

The fifth study is the only data released from the glioblastoma clinical trial so far, an abstract from the American Society of Clinical Oncology annual meeting that reported partial data. It said that, of the eleven patients studied, two saw a “partial result” in the first few months and two were “progression free” after six months. The trial seems to have successfully proved the Voyager is safe to use, but it leaves open many questions about the device’s effectiveness.

The data from that trial has not yet been fully published. Rivera said the company has completed the second phase of the trial and is preparing the data from both phases for publication in a scientific journal.

Nativis also lists Fred Hutchinson Cancer Research Center as a research collaborator on its website. When contacted by GeekWire, a Fred Hutch spokesperson said the organization doesn’t currently work with Nativis. Rivera said the connection was through Dr. Jerry Radich, a Fred Hutch researcher who is also on the company’s board of scientific advisers. Fred Hutch is not participating in the company’s glioblastoma trial, although two Seattle hospitals are:  Virginia Mason Medical Center and Swedish Medical Center.

Nativis says its technology works by recording the electromagnetic signal unique to a drug and replaying the signal into a tumor, theoretically imparting the same effect as the drug. (Nativis image)

Lowe said the lack of evidence behind Nativis’ work leaves him, and others in the scientific community, unconvinced.

“If they want to claim that they’ve got this incredible technology, there’s a lot of experiments to do and they’re also the sorts of experiments that other people could reproduce,” he said. “The old saying is: Extraordinary claims demand extraordinary evidence. These are some extraordinary claims, and the evidence they’ve provided is nowhere near that level.”

Targeting rare, deadly brain cancers like medulloblastoma and glioblastoma also raised Lowe’s eyebrows. If the company is successful, it would bring treatments to hundreds of people fighting terminal cancer every year. But targeting those cancers also lowers the bar that it must meet to get its product onto the market, and thus into the hands of paying customers.

“When you show up offering hope to really desperate patient populations, there’s a lot of pressure on the FDA to do something,” Lowe said, “even if it doesn’t work.”

Rivera said he could not predict how much treatment with the Voyager would cost. He said the device would also be used in clinical trials, which would provide the treatment free of charge.

Rivera said the company is “comfortable and confident” that it is doing things “the right way,” adding that the focus on terminal brain cancers was spurred by the company’s scientific advisers with expertise in neurooncology.

“That’s how new drugs and new devices are created,” he said. “Someone has to be willing to take the time and the energy and the research and hopefully bring something to the market that can help patients that otherwise might not have something for them.”

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