Radio waves show promise in the treatment of hepatocellular carcinoma

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Targeted therapy using non-thermal radio waves improved overall survival in patients with hepatocellular carcinoma (HCC) and had no side effects, according to a new study.

Targeted therapy using non-thermal radio waves improved overall survival in patients with hepatocellular carcinoma (HCC) and had no side effects, according to a new study.

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

The TheraBionic device, which received the Breakthrough Device 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, said Managed Health Care Leader® that he doesn’t know when the device will be officially approved by the FDA.

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

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

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

“Our results 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 monitored side effects, and no patient stopped treatment with TheraBionic P1 due to side effects. “We are encouraged by these early findings,” Pasche said. “Our study shows an advantage in terms of overall survival and the treatment is not 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 type of cancer the patient has identified by tumor biopsies or blood tests, Pasche said. Pasche and Barbault discovered radio frequencies for 15 different types of cancer.

The study has several limitations, Pasche noted, in particular the small sample size and the “selection bias inherent in using historical control data.”

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

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

Pasche owns shares in TheraBionic Inc. and TheraBionic GmbH, and is Chairman of the Board and CEO of TheraBionic Inc. and co-CEO of TheraBionic GmbH.

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