Preliminary Results Suggest Surgery Plus GammaTile™ Extends Median Time to Surgical Site Recurrence
RICHLAND, Wash., Nov. 29, 2016 /PRNewswire/ – IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in Cesium-131 seed brachytherapy and medical radioisotope applications for the treatment of prostate, brain, lung, head and neck and gynecological cancers, today announced a poster presentation at the 21st Annual Meeting of the Society for Neuro-Oncology that was held on November 17 – 20, 2016. The poster, entitled “Cs-131 Brachytherapy for Salvage of Recurrent High Grade Glioma,” was presented by Emad Youssef, MD, Radiation Oncologist, Barrow Neurological Institute, Phoenix, Arizona.
Highlights of the presentation included:
- High grade gliomas (a type of brain cancer that includes glioblastoma multiforme) are among the most difficult-to-treat cancers, with the majority of these cancers recurring despite aggressive multi-modality therapy. Once these cancers have recurred in the brain, life expectancy is 3 to 6 months on average.
- In this series, 18 patients who had recurrences of high grade glioma following standard-of-care therapy (typically surgery, external beam radiation therapy and chemotherapy) were treated with surgical removal of the recurrent tumor and placement of the GammaTile™ radiation therapy system.
- The GammaTile™ system uses Cesium-131 radiation sources embedded in a collagen carrier. Using GammaTile™, very high doses of radiation are precisely delivered to targeted tissue – in this case the surgical margin that likely contains remnants of cancer cells following surgical removal of the tumor.
- In these 18 patients, the tumor had re-grown at the surgical site following standard-of-care treatment at a median of four months. This short time to recurrence despite multi-modality therapy highlights the vexing nature of these cancers.
- Following surgery plus GammaTile™ treatment, three patients (16%) experienced a re-growth of the tumor at the surgical site at the median time of analysis of approximately six months. In order to determine the median time to surgical site recurrence, 50% of the patients would be required to experience recurrence. However only 16% of the patients have had a surgical site recurrence at the time of analysis, suggesting that the median time to recurrence is greater than six months.
Dr. Youssef commented, “Seeing an improvement, although not yet statistically significant, in the freedom from tumor re-growth was particularly surprising in this group of patients, since the treatments available when these cancers recur, such as GammaTile™, are generally not as effective as the front line treatments. With 10 of these patients still living, the median time to recurrence may be extended even more. In addition, the complications we observed after the surgery plus GammaTile™ treatment were minimal.”
“With only 16% of patients experiencing a surgical site recurrence at 6 month median follow-up, it’s clear that the GammaTile™ approach extends the time to recurrence when compared to standard-of-care treatment in this group of patients, although the final time frame currently remains undefined,” said Tom LaVoy, Chairman and CEO of IsoRay. “The advantages of using Cesium-131 brachytherapy products in the brain and other parts of the body are gaining momentum with the medical community, and are increasingly responsible for improving the lives of cancer patients.”
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’s future expectations, including: the advantages of our products and their delivery systems; whether interest in and use of our products will increase or continue; whether the advantages of using Cesium-131 brachytherapy products in the brain and other parts of the body are gaining momentum with the medical community; whether surgery plus GammaTile™ extends median time to surgical site recurrence, and the extent to which it extends median time to surgical site recurrence; whether future studies will report positive treatment 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, 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.