Radio Waves Show Promise in Treating Hepatocellular Carcinoma

A targeted therapy using non-thermal radio waves improved overall survival in hepatocellular carcinoma (HCC) patients and had no side effects, a new study found.

For the study, published online in 4Open, Wake Forest School of Medicine researchers utilized TheraBionic P1, which is a hand-held device that emits radio frequencies via a spoon-shaped antenna that is placed on the patient’s tongue and delivers low levels of radiofrequency electromagnetic fields throughout their body.

The TheraBionic device, which received Breakthrough Devices Designation from the Food and Drug Administration in 2019, is currently under evaluation and is not yet in commercial use.

One of the inventors of the device, Boris Pasche, MD, PhD, director of Wake Forest Baptist’s Comprehensive Cancer Center in Winston-Salem, NC, told Managed Healthcare Executive® that he does not know when the device will be officially approved by the FDA.

Still, the new study results are promising in the treatment of HCC, the most common type of liver cancer.

“HCC accounts for nearly 90 percent of all liver cancers, and current survival rates are between 6 and 20 months,” Pasche said in a news release. “Currently, there are limited treatment options for patients with this advanced liver cancer.”

The study included 18 patients with advanced HCC and researchers analyzed previously published data on 41 patients from a phase 2 study and historical controls from earlier clinical trials.

“Our findings show an improvement in overall survival of more than 30 percent in patients with well-preserved liver function and also in those with more severe disease,” Pasche said.

Researchers also tracked side effects, and no patients stopped TheraBionic P1 treatment because of adverse reactions. “We’re encouraged by these initial findings,” Pasche said. “Our study shows a benefit in overall survival, and the treatment isn’t associated with any significant side effects.”

TheraBionic P1, invented by Pasche and Alexandre Barbault of TheraBionic GmbH in Ettlingen, Germany, works by delivering cancer-specific, amplitude-modulated radiofrequency electromagnetic fields programmed specifically for HCC.

The frequencies used are specific to the patient’s type of cancer as identified through tumor biopsies or blood work, Pasche said. Pasche and Barbault have discovered radio frequencies for 15 different types of cancer.

The study does have several limitations, Pasche noted, particularly the small sample size and “selection bias inherent in the use of historical control data.”

Two additional clinical trials testing TheraBionic P1 are underway. One is a single-center study to assess the safety and effectiveness of the TheraBionic device in combination with regorafenib (brand name Stivarga and others), a chemotherapy drug, as a second-line treatment.

Another multicenter, double-blind, randomized study comparing TheraBionic with placebo will assess the safety and effectiveness of the device as a third-line therapy in the treatment of advanced HCC. “We expect to see a longer overall survival and better quality of life in patients that receive TheraBionic vs patients who receive placebo,” Pasche said.

Pasche holds stock in TheraBionic Inc. and TheraBionic GmbH, and is chairman of the board and CEO of TheraBionic Inc. and co-CEO of TheraBionic GmbH.