100% Local (Resection Cavity) Freedom From Progression With 19.3 Month Median Follow-Up
Richland, WA (August 5, 2014) – – IsoRay Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced the publication of the first major peer reviewed study showing superior results using IsoRay’s Cesium-131 seeds in the treatment of metastatic brain cancer.
IsoRay CEO Dwight Babcock commented, “We are extremely excited to have growing evidence that Cesium-131 isotope seeds continue to perform so well against aggressive cancers throughout the body and specifically now metastatic brain cancer. We believe our marketing efforts will be enhanced by teaming up with medical industry thought leaders as they seek better solutions and outcomes for their patients. As we continue to develop our product offerings internally with support from industry leaders, our message is clear and the medical community is becoming increasingly aware of the innovative alternative our Cesium-131 products offer to cancer patients.”
Dr. A. Gabriella Wernicke, Radiation Oncologist, and Dr. Theodore H. Schwartz, Neurosurgeon, with Weill Cornell, were two of the co-authors of the publication, which stated: “The use of post resection permanent Cesium-131 brachytherapy resulted in no local recurrences and no radiation necrosis.” The study followed 24 patients enrolled between 2010 and 2012, with a median 19.3 month follow-up period. Each patient had stranded Cesium-131 seeds implanted at the resection of a brain metastasis. During the follow-up period, study participants had 100% local (resection cavity) freedom from progression (FFP) and 93.8% one-year regional FFP. While patients with metastatic brain cancer experience significant hazards to survival (overall one-year survival rate in this study was 50%), the excellent local control of the surgically removed and Cesium-131 treated brain tumor – along with the lack of significant complications and the improved quality of life compared to other radiation therapy approaches – represents an important step forward in managing these difficult cases. To review the entire paper, please follow the link provided here: http://thejns.org/doi/abs/10.3171/2014.3.JNS131140.
Babcock said, “Commercialization requires published studies, like this one, that are peer reviewed, providing patients and family members with new insights into technological advances being made to treat these dreaded diseases. Leaders in the medical arena recognize and rely on the reported results in such publications, providing a means to stay abreast of these new and powerful weapons now available in the battle against cancer. As with this latest publication on metastatic brain cancers, I believe Cesium-131 is now a proven solution that can meet patient needs.”
IsoRay’s various products, including Cesium-131 seeds, sutured seeds, stranded mesh and the GliaSite® radiation therapy system, give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of a tumor removal or by placing seeds within the prostate. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy surrounding tissue compared to other alternative treatments. IsoRay’s cancer fighting products diminish the ability of the tumor to recur, resulting in important benefits for patients in longevity as well as quality of life.
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.
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 we will continue to receive support from industry leaders, 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.