IsoRay, Inc. Announces the Launch of a Phase II, Multicenter Clinical Trial with Cesium-131 Adjuvant Radiation for Retroperitoneal Sarcoma Delivery System (CARDS Trial) by University of Louisville, Division of Surgical Oncology

Nov 9, 2017

Potential New Application for Cesium-131 for Unmet Medical Need

RICHLAND, Wash., Nov. 09, 2017 (GLOBE NEWSWIRE) — IsoRay, Inc. (NYSE: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 Phase II, Multicenter Clinical Trial with Cesium-131 Adjuvant Radiation for Retroperitoneal Sarcoma Delivery System (CARDS Trial) by the University of Louisville, Division of Surgical Oncology, Louisville, KY.

The Division of Surgical Oncology at the University of Louisville has a long-standing commitment to excellence in research, education, and patient care. As one of the largest Divisions of Surgical Oncology in the U.S., and one of the top training programs as well, the faculty members have broad clinical and research interests. The principal investigator for the study is Charles R. Scoggins, M.D., a professor of Surgical Oncology. Among his co-investigators are other surgical oncologists as well as Robert C.G. Martin II MD, PhD, Prejesh Philips MD, and Michael Egger MD, MS.

The primary objective of the study is to compare the efficacy of Cesium-131 mesh placement on overall and recurrence free survival of patients who underwent resection for retroperitoneal sarcoma to historical series where resection is the sole treatment. The study is expected to begin enrolling 12 patients with retroperitoneal sarcoma who will have the Cesium-131 implant placed in the abdominal cavity at the time the sarcoma is surgically removed.  The Cesium-131 implant delivers a high dose of radiation very close to where tumor cells may be left behind after a surgery intended to remove all of these cells has been completed. Due to the very compact and targeted nature of the dose, other critical structures in the retroperitoneum are not expected to be exposed to these high levels of radiation, reducing the possibility of radiation injury to uninvolved anatomy.

According to the American Cancer Society, approximately 15%, or 2,000, of all sarcomas diagnosed in the United States annually will occur in the retroperitoneum, an anatomical space in the abdominal cavity. There is an unmet medical need for these patients who have an average 5-year survival of less than 50% primarily due to the location of the tumor, which often grows to large mass (many have lesions greater than 20 cm) before causing symptoms that prompt diagnosis. In addition, the location of the tumor and the size of the mass does not usually lend to efficient surgery or the use of external beam radiation. As a result, retroperitoneal sarcoma recurs in nearly two-thirds of patients and also often metastasizes to the lung and the liver.

“Growing recognition of Cesium-131’s unique ability to deliver a highly targeted dose of intense radiation treatment while limiting the radiation exposure to surrounding tissue is opening up a number of potential new applications for its use, especially where there are unmet medical needs such as retroperitoneal sarcoma,” said Thomas LaVoy, Chairman and CEO of IsoRay. “IsoRay continues to support the work of innovative clinicians to provide possible solutions for challenging problems in radiation oncology and we look forward to working with Drs. Scoggins and Martin and their team on this important study.”

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 Cesium product and their targeted delivery systems, whether the study will ultimately be completed and if so will be successful, whether Cesium-131 therapy will demonstrate tumor cell control in retroperitoneal sarcoma, 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 the success or perceived success of the study, physician acceptance, training and use of our mesh placement 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 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 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, 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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