IsoRay Announces Study Accepted for Publication in the International Journal of Radiation Oncology, Biology, Physics entitled “Re-irradiation using Permanent Interstitial Brachytherapy (PIB): A Potentially Durable Technique for Salvaging Recurrent Pelvic Malignancies”

Sep 26, 2017

Study Demonstrates Ability to Control Local Disease Over Reasonably Long Period of Time, A Major Step in Preserving Quality of Life

RICHLAND, Wash.Sept. 26, 2017 /PRNewswire/ — IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for the treatment of prostate, brain, lung, head and neck and gynecological cancers, today announced the acceptance for publication of a study entitled “Re-irradiation using Permanent Interstitial Brachytherapy (PIB): A Potentially Durable Technique for Salvaging Recurrent Pelvic Malignancies” in the highly respected International Journal of Radiation Oncology, Biology, Physics (the “Red Journal”).

The accepted manuscript of the study was published on the Red Journal’s website on August 27, 2017. The study was led by Jonathan Feddock, M.D., Department of Radiation Medicine, Markey Cancer Center, University of Kentucky, Lexington, KY.

The study was conducted to evaluate whether re-irradiation using permanent interstitial brachytherapy (“PIB”) provides curative potential to recurrent pelvic malignancies even in the setting of prior radiation. Pelvic-only recurrent disease is challenging to manage, with surgical removal of pelvic organs too often the only option. This radical surgery carries with it a high rate of complications and a large impact on a patient’s quality of life. PIB is an often forgotten, yet extremely useful local radiation technique that can deliver targeted curative radiation doses, while limiting the dose to uninvolved adjacent tissues. Cesium-131 is the isotope of choice for PIB in gynecologic/pelvic cancers due to its lower mean energy and lower toxicity profile compared to other isotopes.

In the study forty-two patients were treated with 52 Cesium-131 implants. Median follow-up was 16.3 months. The study found that women treated with PIB for small volume recurrences avoided radical surgery and in most cases, toxicity was acceptable from the re-irradiation. PIB also controlled local disease over a reasonably long period of time, which contributed to preserving quality of life. Importantly, even when PIB failed, the treatment was able to provide the patients with a treatment option that provided improved quality of life until time of recurrence – time that was free of a colostomy or other significant morbidities.

Dr. Jonathan Feddock commented, “Recurrent pelvic malignancies are difficult cancers to treat and permanent interstitial brachytherapy using Cesium-131 has the inherent ability to deliver curative radiation doses while limiting the dose to uninvolved adjacent tissues. In addition, and perhaps most importantly, the ability to avoid radical surgery and control local disease is a major step forward for the quality of life of these recurrent cancer patients.”

“The durable positive outcomes achieved in Dr. Feddock’s study adds to the growing evidence of Cesium-131’s efficacy in treating multiple types of cancers,” said Bill Cavanagh, Chief Scientific Officer of IsoRay, Inc. “Cesium-131’s low toxicity profile and minimized impact on patients’ quality of life supports its promise to be effective for many in need.”

About IsoRay, Inc.

IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 by visiting Join us on Facebook/IsoRay. Follow us on Twitter@IsoRay.

Safe Harbor Statement

Statements in this news release about IsoRay, Inc.’s future expectations, including the advantages of our products and their delivery systems, whether Cesium-131 therapy will demonstrate disease control in other  recurrent pelvic malignancies or cancers or will prove to be a safe approach compared to other treatment options, the perception by the patient of quality of life outcomes, , and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released that support the conclusions of this and other past studies, whether ongoing patient quality of life results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases in conjunction with other treatments, successful completion of future research and development activities, whether we, our distributors, and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell, and use our products in its various forms, continued compliance with ISO standards, the success of our sales and marketing efforts, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay, Inc.’s reports filed with the Securities and Exchange Commission. Unless required to do so by law, IsoRay, Inc. undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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