IsoRay® Announces Results of Prospective Trial Presented at Society of Neuro-Oncology Conference
95% of Targeted Cancers Showed No Regrowth of Tumor at the Operative Site
RICHLAND, Wash., June 21, 2016 /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 David G. Brachman, MD, FACRO, Director of Radiation Oncology, Barrow Neurological Institute, and Clinical Professor of Radiation Oncology, University of Arizona College of Medicine-Phoenix, presented the findings of a prospective trial entitled: "Prospective trial of surgery and permanent intraoperative brachytherapy (S+BT) using a modular, biocompatible radiation implant for recurrent aggressive meningiomas," at the Society of Neuro-Oncology Conference on Meningioma, Toronto, Canada.
Highlights of the presentation included:
- The study treatment involved a new means of delivering Cesium-131 brachytherapy to the brain, with the seeds embedded in collagen tiles and applied directly to the brain tissue after the tumor was removed (the GammaTile approach, which is not commercially available).
- The trial included 16 patients and 20 tumors.
- The patients in this study had recurrences of tumor after prior surgery and external beam radiation treatment and were considered by their physicians to be at an increased risk for additional recurrence.
- 95% of the treated tumors had no radiographic evidence of regrowth of tumor at the operative site (local control). The incidence of radiation side effects to the brain – a problem in previous attempts to perform brain brachytherapy – occurred in only two of the 20 treatments.
Dr. Brachman stated, "These are aggressive meningiomas that have recurred in patients despite previous surgery and radiation. These tumors pose a serious challenge to physicians due to their presence in the brain and the failure of prior treatments. Use of the Cesium-131 tiles, which were able to be implanted very quickly at the time of surgery, and starting radiation therapy at the time of resection as opposed to weeks after resection when using external beam radiation were advantages of our novel approach. We are seeing 95% local control of the treated tumors in our study using surgery and Cesium implants. In addition, we observed a very low rate of radiation injury, which has been a major concern in the past, for patients who have undergone multiple treatments for their brain tumors."
Tom LaVoy, CEO of IsoRay, Inc., stated, "We are encouraged to see this preliminary response to these challenging cancers. We are pleased Dr. Brachman had the opportunity to present his findings at such a prestigious forum of his peers."
Dr. Brachman concluded, "While we look forward to a future where systemic therapies are available for aggressive meningioma, our team believes the GammaTile approach using Cesium-131 offers a promising treatment option for patients."
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 Cesium-131 by visiting www.isoray.com. Join us on Facebook/IsoRay. Follow us on Twitter @IsoRay.
About GammaTile
GammaTile, LLC is an Arizona-based privately held medical device company dedicated to advancing the treatment of intracranial tumors of all types.
Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: the advantages of our products and their delivery systems, whether the GammaTile approach will be successful in future treatments, whether any future studies of the GammaTile approach will produce similar results to those reported in the presentation, 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, 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. Unless required to do so by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE IsoRay, Inc.
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