SOURCE: IsoRay Inc.

IsoRay Inc.

January 20, 2015 08:15 ET

UPMC Study Reports IsoRay's Cesium-131 Prostate Treatment Provides Strong Cancer Control With Lower Side Effects, Providing Men Improved Quality of Life

Cesium-131 Seed Brachytherapy Offers Extremely High Efficacy Compared to Other Isotopes or Treatment Modalities Used in Treating Prostate Cancer, With the Advantage of Rapid Return to Pre-Treatment Urinary Function, and at Lower Cost

RICHLAND, WA--(Marketwired - Jan 20, 2015) - IsoRay Inc. (NYSE MKT: ISR), a medical technology company and innovator in brachytherapy and medical isotope applications, today announced that researchers at the University of Pittsburgh School of Medicine (UPMC) released peer-reviewed study results on Cesium-131 prostate cancer treatment, published in the December issue of Clinical Oncology. The study title is "Five Year Prostate-specific Antigen (PSA) Outcomes after Caesium Prostate Brachytherapy."

http://www.isoray.com/assets/Benoit_PSA_Outcomes_Clin_Oncol_25_December%202014.pdf

Dr. Benoit at UPMC noted, "Our program began using Cesium-131 in 2006 in hopes of decreasing the duration of the bothersome lower urinary tract symptoms that accompany prostate brachytherapy. Our hope was that cancer control with Cesium-131 would be equivalent to the cancer control we achieved with Iodine-125 and Palladium-103. However, our intermediate term results demonstrate that in addition to decreasing morbidity, oncologic outcomes with Cesium-131 are actually exceeding those of Iodine-125 and Palladium-103."

Standard treatment options for localized prostate cancer include radical prostatectomy, external beam radiotherapy, and prostate brachytherapy. Radical prostatectomy is an invasive procedure with the highest risk of urinary incontinence and erectile dysfunction of all treatments for localized prostate cancer. External beam radiation has a lower risk of these complications, but requires eight weeks of daily therapy.

Prostate brachytherapy is a third treatment option for localized prostate cancer. Prostate brachytherapy has a significantly lower risk of urinary incontinence and erectile dysfunction when compared to radical prostatectomy, but very similar cure rates. Prostate brachytherapy is an outpatient procedure with a much faster return to full activity than radical prostatectomy. Men who undergo prostate brachytherapy for treatment of their prostate cancer also avoid the long course of treatment required when one undergoes external beam radiation.

A drawback of prostate brachytherapy, however, has been the bothersome urinary and bowel symptoms that can accompany the procedure. Previous studies have demonstrated that by using the isotope Cesium-131, the duration of these symptoms is dramatically decreased when compared to men who undergo prostate brachytherapy with the other available isotopes.

Dwight Babcock, IsoRay Chairman and CEO, commented, "We now have a peer reviewed study that confirms the reports from other centers that this decreased duration of urinary and bowel morbidity does not come at a price of poorer oncologic outcomes. Benoit, et al. have demonstrated that prostate brachytherapy with Cesium-131 provides at least equivalent if not improved cancer control when compared to prostate brachytherapy with other isotopes as well as to radical prostatectomy and external beam radiotherapy. We hope these findings will spur product adoption and ultimately contribute to IsoRay's growth."

Dr. Benoit reported, "Our results demonstrate that at least in the intermediate term, 5 years following treatment, Cesium-131 is outperforming Iodine-125 and Palladium-103 in terms of cancer control."

Mr. Babcock commented, "Convincing data continue to accrue in the United States from multiple centers describing the outstanding performance of Cesium-131 brachytherapy in cancer treatment throughout the body. We feel that this data will spur interest from physicians inside and outside the U.S. who feel strongly about offering highly effective, low impact cancer treatment to their patients. We are excited to now have a third peer reviewed study published in a leading journal demonstrating the success of Cesium-131 in treating a variety of cancers. As more centers try Cesium-131 and find similar results as other centers, we should be considered a standard of care alternative in treating cancer."

IsoRay is the exclusive manufacturer of Cesium-131. The pioneering brachytherapy therapy is one of the most significant advances in internal radiation therapy in 20 years. Cesium-131 allows for the precise treatment of many different cancers because of its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation).

In addition to its CMS codes, Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form for the treatment of brain cancer, prostate cancer, lung cancer, ocular melanoma cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body. The treatment can be deployed using several delivery methods including single seed applicators, implantable strands and seed sutured mesh. IsoRay also sells several new implantable devices, including the GliaSite® radiation therapy system. 

About IsoRay

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 GliaSite® and 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 IsoRay will be able to continue to expand its base beyond prostate cancer, whether sales of our products will continue at historic levels or increase, whether the use of our products will increase or continue, whether awareness of our products in the medical community will continue or increase, whether future studies of treatment of various cancers using our products will have favorable results, 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 beyond prostate, 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.

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