The U.S. FDA's breakthrough devices program continues to rack up new designations, this latest one for Shréis Scalene Sciences LLC's Cytotron device. The noninvasive whole-body system, which is intended to break down or interrupt the growth of malignant tumors, is already CE marked and available in the European Union.

Employing a platform technology called quantum magnetic resonance therapy (QMRT), the Cytotron induces programmed cell death, or apostosis, by noninvasively reactivating the body's own tumor suppression mechanisms to stop uncontrolled growth of abnormally growing cells. It does so by delivering precise doses of radio- or sub-radiofrequency, nonionizing, nonthermal electromagnetic waves to the affected tissues. This prompts the body to produce new tumor suppressing genes nucleo-proteins that kindle apostosis and the tumor's demise.

The company's designation request to the FDA said that the Cytotron "is intended to be used to cause degeneration of uncontrolled growth of tissues. It is indicated for the treatment of protein-linked, abnormally regenerating disorders such as neoplastic disease, by selectively targeting and enabling tissue apoptosis, allowing extended progression-free survival, with pain relief, palliation, improved quality and dignity of life." Gaithersburg, Md.-based Shréis is initially targeting the device for treatment of solid tumors of the breast, liver and pancreas.

Trial will target three cancer types

Shréis intends to launch U.S. clinical trials in the indications granted under the breakthrough designation "at the earliest" possible time, Meena Augustus, cofounder, CEO and chief scientific officer, told BioWorld MedTech. She said the company will work with FDA staff on the data development plan, which will include all three cancer types.

"We plan to complete the clinical trial within a year, depending on the number of patients the FDA recommends for inclusion," Augustus said. "The duration of the trail could be significantly shortened, leading to market approval by the FDA, by having multiple devices in multiple trial centers, based on partnerships established for conducting the clinical trials."

Historically, Shréis has positioned the Cytotron as a therapy for advanced cancer patients, "to add quality of life and dignity in end-of-life situations, in addition to efficacy, pain relief and palliation," Augustus said. In the U.S., the trials will include patients earlier in the disease lifecycle to impact their experience as cancer survivors.

"The clinical trial with this noninvasive, tissue engineering platform technology called quantum magnetic resonance therapy . . . could eventually help to establish the Cytotron as an integral adjunct to existing standards of care in the cancer armamentarium," said Rajah Vijay Kumar, inventor of the device and Shréis' partner at Scalene Cybernetics Ltd. and the Scalene Center for Advanced Research & Development (S-CARD) in Bengaluru, India.

Shréis conducted a survey of existing standards of care and available technologies in the cancer space and found no other noninvasive, whole-body devices capable of targeting both primary and metastatic lesions, including all solid tumors, simultaneously – regardless of cancer type, location, genetic etiology or the specific targets, according to Augustus. "This was the justification for the submission to the FDA for breakthrough designation, and a very detailed justification was presented to the FDA on how the Cytotron platform technology is very different and unique in its mechanism of action," she said.

Second breakthrough request in the works

While pushing ahead on U.S. studies for the current proposed indications, the company is also preparing to submit a request for FDA breakthrough designation in other indications such as adult and pediatric brain tumors, lung cancer and other life-limiting diseases. "Since the QMRT platform technology is the same for all solid tumors, we simultaneously plan other clinical trials with clinical collaborators within the [Maryland] region or elsewhere in the U.S.," Augustus said, adding that Shréis plans to pursue these in an "accelerated time frame."

In addition to solid tumors, the platform technology is indicated for noninvasive tissue regeneration and rehabilitation in musculoskeletal disorders such as osteoarthritis, to regrow cartilage, spinal dysplasia and sports injuries.

Privately held Shréis Scalene Sciences is one of three med-tech companies under the Shreis Scalene Group umbrella. A sister company, Shréis Cardiotech LLC, has a CE-marked noninvasive cardiovascular diagnostic tool called Haemoseis 256. It is currently approved by the FDA for use in research.

The Cytotron technology won CE mark approval in the EU in 2012 for the patented whole-body nine-axes system in use today for noninvasive tissue regeneration in osteoarthritis patients and tissue degeneration in cancers. The CE mark was supported by an "all comer compassionate trail" in Bangalore, India that included solid tumors in patients who had failed all other available treatment options. Scalene Cybernetics and S-CARD oversaw that trial.

Shréis markets the device in Europe, as well as Canada and Caribbean territories and other countries that have memoranda of understanding with the CE body or are CE-compliant. The company's marketing strategy is focused on three large regions: North and South America, Europe and the Middle East and Asia.

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