9 Year Study Demonstrates Durable Positive Outcomes and Statistically Identical Results of Cesium-131
RICHLAND, Wash., Sept. 25, 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 a poster presentation at the 2017 Annual American Society for Radiation Oncology (ASTRO) Conference, the premier radiation oncology society in the world, being held on September 24-27, 2017. The poster, entitled “Long-term PSA Outcomes in a Single Institution, Prospective Randomized Cesium-131 / Iodine-125 Permanent Prostate Brachytherapy Trial”, was presented by Dr. Brian Moran, Medical Director, Prostate Cancer Foundation of Chicago, Westmont, Illinois.
The trial’s objective was to evaluate biochemical outcomes of a randomized group of low to intermediate risk, localized prostate cancer patients treated with permanent iodine-125 (I-125) or cesium-131 (Cs-131) brachytherapy. Median follow-up was 95 months for the 140-patient group. At nine years, the biochemical relapse-free survival (BRFS) was statistically equivalent for both groups, 89% for the I-125 group and 86% for the Cs-131 group (p=0.45). BRFS refers to a sensitive means of detecting persistent prostate cancer by measuring and trending prostate specific antigen (PSA) levels in the blood over time.
“The results of this trial, the longest data set available to date, demonstrates that permanent, low dose rate brachytherapy with Cesium-131 provides excellent PSA-based outcomes for low to intermediate risk localized prostate cancer patients. There was no significant difference in BRFS between these two isotopes over the nine-year follow-up period,” said Dr. Moran.
Bill Cavanagh, Chief Scientific Officer of IsoRay commented, “This is the longest study conducted to-date for low risk prostate cancer patients treated with Cesium-131. The durable positive outcomes and statistically identical results support the consideration of Cesium-131 as a viable treatment choice for these patients. These results, combined with the results from the recently published University of Pittsburgh Medical Center study* that concluded that patients treated with Cesium-131 prostate brachytherapy are able to recover from prostate cancer treatment quickly and then maintain their baseline quality of life over the long term, suggest that brachytherapy with Cesium-131 should be considered by men with low risk prostate cancer.”
* Long-Term Quality of Life in Prostate Cancer Patients Treated With Cesium-131 Glaser, Scott M. et al., International Journal of Radiation Oncology • Biology • Physics, Volume 98, Issue 5, 1053 – 1058
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.flywheelstaging.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 large brain metastasis, 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.
