Indian device for Cancer fight gets USFDA’s ‘breakthrough’ tag

Introduction

The US Food and Drug Administration (FDA)'s Centre for Devices and Radiological Health has designated a medical invention by a Bengaluru-based scientist as a “breakthrough device” in the treatment of liver, pancreatic and breast cancers. Cytotron, developed by Rajah Vijay Kumar, aids in tissue engineering of cancer cells, altering how specific proteins are regulated to stop these cells from multiplying and spreading.

“We are pleased to inform you that your device and proposed indication for use meet the criteria and have been granted designation as a breakthrough device,” states a communique from the FDA wing to Shreis Scalene Sciences, the company that had taken the device to the US.

Cytotron is intended to cause degeneration of uncontrolled growth of tissues. “It is indicated for treating protein-linked, abnormally regenerating disorders such as neoplastic disease, and allowing extended progression free survival, with pain relief, palliation, improved quality and dignity of life,” says the letter.

Kumar had developed Cytotron at the Centre for Advanced Research and Development, which is headquartered in Bhopal, after nearly 30 years of research into cellular pathways and interactions with specifically modulated fast radio bursts.

“It is a great feeling that after so many years of hard work, against all odds, an institution like the USFDA is designating our work as a breakthrough in the treatment of three types of cancers,” Kumar said.

New technologies in the battle against cancer have generally been hard to come by. It's even rarer for an Indian device to get breakthrough status in the US. The Centre for Devices and Radiological Health is responsible for pre-market approval of all medical devices in the US, ensuring they are safe for use and effective.

“The devices will all be made in India, given that there are hardly any imported components. And our American partner will take the device to the US. Cytotron is already an approved medical device and is in use in the UAE, Mexico, Malaysia and Hong Kong, among others,” Kumar said.

How it works

Generically known as rotational field quantum magnetic resonance, Cytotron uses fast radio bursts (FRB), high energy and powerful short radio bursts in which both electric and magnetic components of the electromagnetic signals are “circularly”polarised.

FRBs are produced when a radio signal travels through a powerful instantaneous magnetic field on its path to the target. “FRBs can be used to communicate with the cellular command and control, to up or down regulate a specific protein or gene,” Kumar said in a statement.

He added: “In cancer cells, Cytotron does two things: First, it alters the protein pathways of a pro-apoptosis protein called p53 via p21 inducing programmed cell death in the cancer cells. Second, exposure to Cytotron stops metastasis by inhibiting the epithelial mesenchymal transition cells, responsible for spread of cancer; 90% cancer patients die due to metastasis.

Source

Times of India, 12 November 2019