IsoRay Reports Results of Prospective Trial: '95% of Targeted Cancers Showed No Regrowth of Tumor at the Operative Site'

IsoRay Inc. 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."