RICHLAND, WA, United States, via ETELIGIS INC., 12/01/2014 – – IsoRay Inc. (NYSE MKT: ISR), a medical technology company and innovator in brachytherapy and medical isotope applications, today announced the striking results of a study of brain cancer patients treated with IsoRay’s Cesium-131 internal radiation (brachytherapy) cancer therapy. The findings of the study, conducted by researchers at Barrow Neurological Institute, were presented at the November 2014 annual meeting of the Society for Neuro-Oncology in Miami, Florida.
The Barrow study reported on 27 patients who had a variety of deadly brain cancers, including high grade gliomas, high grade meningiomas, and brain metastases. The patients had received an average of 2 and as many as 4 extensive earlier treatments that had failed, resulting in a recurrence of their cancers in the same locations where treatment had previously been applied.
IsoRay Chairman and CEO Dwight Babcock commented, “Cancers that recur in the brain pose major problems. They have shown a resistance to the standard therapies of surgery and conventional radiation. Given the confined volume of the interior of the skull, the impact of brain tumors is debilitating. Expanding cancerous masses compress brain matter and nerves originating in the brain – leading to significant and life-altering complications.”
Oncologists at the prestigious Barrow Neurological Institute employed a technique developed by GammaTile, LLC that provides an intensive dose of Cesium-131-based radiation in tandem with surgical removal of these malignant growths. Following surgical removal of the tumor tissue, Cesium-131 was delivered to the targeted brain tissue using a modular, pre-commercial biocompatible carrier system that provided custom-tailored implants for each patient.
Barrow neuro-oncologist Dr. Christopher Dardis presented the data to an audience of neuro-oncologists – specialists who manage the treatment of brain cancer patients. According to Dr. Dardis’ presentation, the patients who were treated with the new approach using Cesium-131 fared better than they had using earlier, conventional treatment. In fact, 26 of the 27 patients (96%) had not experienced a recurrence of the treated cancer within the treated bed during the follow-up period.
Barrow Neurological Institute is among the world’s foremost brain cancer research and treatment sites. The study team was led by radiation oncologist Dr. David Brachman and neurosurgeon Dr. Peter Nakaji, both internationally renowned and respected in the field of brain cancer treatment.
Dr. Brachman, who serves as Chief Technology Officer at GammaTile, LLC, said: “As a rule, we don’t necessarily think that the second or third line treatment would work better than the first-line treatment. But this seems to be the case here. Based on these outcomes, this new therapy successfully treated patients who failed conventional therapies and we believe that it could help many other patients.”
IsoRay CEO Dwight Babcock commented, "We are extremely excited to see that Cesium-131 isotope seeds continue to perform so well against aggressive cancers throughout the body, including a variety of brain cancers as shown in this study. This further confirms other peer–reviewed results showing Cesium-131 can have a very favorable impact on local control, especially for cancers that have shown a tendency to recur at the site of surgery. We remain committed to helping patients afflicted with these horrible cancers and enhancing their quality of life. The message is clear and the medical community is becoming increasingly aware of the innovative alternative our Cesium-131 products offer to cancer patients.”
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 http://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.
SOURCE: IsoRay, Inc.