IsoRay, Inc. Announces the Launch of a Pilot Study Using Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Resectable High Risk Recurrent Head and Neck Cancer by Case Comprehensive Cancer Center

Dec 21, 2016

RICHLAND, Wash.Dec. 21, 2016 /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 launch of a pilot study investigating the role of Cesium-131 in the management of recurrent head and neck cancer at the Case Comprehensive Cancer Center, Case Western Reserve UniversityCleveland, Ohio.  The study has been approved by University Hospitals of Cleveland Institutional Review Board (IRB).

The Case Comprehensive Cancer Center is a National Cancer Institute (NCI) designated Cancer Center and is also part of the National Comprehensive Cancer Network (NCCN).  NCI-designated Cancer Centers are a group of 68 cancer research institutions in the United States supported by the National Cancer Institute and Case Comprehensive is among the 41 designated Comprehensive Cancer Centers. The principal investigator for the study is Chad Zender M.D., an associate professor of otolaryngology at the Case Western Reserve University School of Medicine.  Among his co-investigators are other head and neck surgeons, radiation oncologists, medical oncologists and statisticians.

This study will evaluate the impact of Cesium-131 therapy on disease control in recurrent head and neck cancers as well as the safety of the approach. The study is expected to begin enrolling 42 patients with recurrent cancers of the head and neck in early 2017.  Upon completion of enrollment, the study is expected to last 24 months. According to the American Cancer Society, there are 61,760 head and neck cancer cases expected to be diagnosed in the U.S. in 2016.

These cancers pose a particularly troublesome challenge due to the presence of vital anatomy in the head and neck.  If the cancer recurs – which it does 30% – 40% of the time – potentially useful radiation therapy may not be possible due to the previous exposure of the patient’s head and neck anatomy to radiation. Brachytherapy with Cesium-131 delivers a compact, highly conformal dose of radiation and is used to treat a variety of human cancers.

“This important study of Cesium-131’s effectiveness on recurrent head and neck cancers perfectly lines up with IsoRay’s mission to identify challenging problems in radiation oncology and work with innovative clinicians to provide possible solutions,” said Thomas LaVoy, Chairman and CEO of IsoRay.  “Case Comprehensive Cancer Center is among the leaders in cancer research and we’re proud to be working with such a prestigious institution, Dr. Zender and an accomplished slate of investigators.”

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 www.isoray.com. Join us on Facebook/IsoRay. Follow us on Twitter @IsoRay.

Safe Harbor Statement—

Statements in this news release about IsoRay’s future expectations, including: the advantages of our products and their delivery systems, whether the study will ultimately be completed, whether Cs-131 therapy will demonstrate disease control in recurrent head and neck cancers or prove to be a safe approach compared to other treatment options, 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 and ultimate corporate actions 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 and support the conclusions of past studies, whether ongoing patient 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, 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 as audited by BSI, 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’s reports filed with the SEC. Unless required to do so by law, the Company 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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