At Median 5.5 Years Post-Treatment, Return to Baseline is Sustained
RICHLAND, Wash., May 3, 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 “Long-term Quality of Life in Prostate Cancer Patients Treated with Cesium-131” in the highly respected International Journal of Radiation Oncology, Biology, Physics (the “Red Journal”). The study was published on the Red Journal’s website March 31, 2017 and will also be published in an upcoming issue of the Red Journal. The study was conducted by Sushil Beriwal, MD, Ryan P. Smith, MD, and Ronald M. Benoit, MD, from the departments of Radiation Oncology and Urology at the University of Pittsburgh Medical Center (UPMC), Pittsburgh, PA.
The aim of the study was the evaluation of long-term quality of life (QOL) as reported by men treated at UPMC with Cesium-131 prostate brachytherapy. The study measured the long-term Quality of Life using the Expanded Prostate Cancer Index Composite (EPIC) system, a very sensitive means by which to measure quality of life following treatment for prostate cancer. The study from UPMC focused specifically on urinary and bowel side effects. Results were measured at a median 5.5 years post-treatment, which is sufficient to detect “late” complications (which may occur years following radiation treatment).
The study’s authors concluded that at last follow-up (median of 5.5 years post-treatment), there were no clinically significant changes found in the EPIC scores from baseline, demonstrating insignificant long-term changes in urinary or bowel patient-reported quality of life with Cesium-131 prostate brachytherapy. The report concludes that patients treated with Cesium-131 are able to recover from prostate cancer treatment quickly and then maintain their baseline quality of life over the long term.
Dr. Ron Benoit, urologist and study author stated, “We have previously reported that Cesium-131 leads to quicker recovery of voiding function, with return to clinical baseline by 3 months and statistical baseline by 6 months post-treatment. Our current findings strengthen this body of literature by demonstrating that patients treated with the Cesium-131 isotope are able to maintain this baseline quality of life in the long term.”
Dr. Benoit added, “We continue to observe that Cesium-131’s short half-life and high energy provide both long term efficacy and a lower toxicity profile in prostate cancer patients.”
Bill Cavanagh, Chief Scientific Officer of IsoRay, Inc. commented, “We’re pleased that Cesium-131 continues to show high efficacy and a very favorable side effect profile over the long term as demonstrated in Drs. Beriwal’s and Benoit’s study. This study reinforces the position of Cesium 131 as an effective, patient friendly treatment for localized prostate cancer. This is especially important as multiple studies are emerging that strongly suggest that the inclusion of brachytherapy must be considered for the treatment of high-risk prostate cancer – the toughest localized prostate cancer to cure.”
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, Inc.’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 result in different conclusions in future years, the efficacy and effectiveness of treatment of high-risk prostate cancer whether with or without use in conjunction with other treatments, and the perception by the patient of quality of life outcomes 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 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 SEC Securities and Exchange Commission. Unless required to do so by law, the Company 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.