Study Demonstrates 100% Freedom from Local Progression Rate & 0% Rate of Radionecrosis
RICHLAND, Wash., June 20, 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 publication of a study entitled, “Clinical Outcomes of Large Brain Metastases Treated with Neurosurgical Resection and Intraoperative Cesium-131 Brachytherapy: Results of a Prospective Trial” in the highly respected International Journal of Radiation Oncology, Biology, Physics (the ‘Red Journal’).”
The study was published on the Red Journal’s website on June 12, 2017. The study was conducted by Gabriella A. Wernicke, M.D., M.Sc. and Theodore H. Schwartz M.D., of the Stich Radiation Oncology Center and Department of Neurosurgery, Brain and Spine Center, Weill Cornell Medical College/New York-Presbyterian Hospital, NYC, NY.
The study assessed the impact of permanent low-dose rate Cesium-131 brachytherapy on local control and radionecrosis (RN) in patients treated for large brain metastases. Forty-two patients with a total of 46 metastases >2.0 cm in preoperative diameter were accrued onto a prospective trial between 2010 and 2015. Patients underwent surgical resection with intra-operative placement of stranded Cesium-131 seeds as permanent volume implants in the resection cavity.
The study demonstrated a 100% freedom from local progression rate, meaning that the surgically removed brain metastases did not re-grow. In addition, there was a 0% rate of radionecrosis, a significant side effect of radiation therapy to the brain. Radiation necrosis is especially problematic when larger brain metastases (with diameters 2 cm or larger) are treated with radiation.
The study’s authors concluded that intraoperative Cesium-131 brachytherapy is a safe and effective adjuvant therapy for large brain metastases requiring neurosurgical intervention.
Bill Cavanagh, Chief Scientific Officer of IsoRay, Inc. commented, “Evidence of Cesium-131’s efficacy in treating brain cancer continues to increase as supported by this important study. The work of Drs. Wernicke and Schwartz is truly pioneering and provides hope that we can continue to improve the available treatment for those afflicted with brain metastases. Treatment of brain metastases is a large unmet need and we’re gratified that our Cesium-131 product has promise to be effective for the many in need.”
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 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 SECSecurities 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.