Results Point to Expanded Availability of Accelerated Partial Breast Irradiation With 80% Reduction in Hospital Visits for Radiation
RICHLAND, Wash.--(BUSINESS WIRE)-- IsoRay, Inc. (Amex: ISR) announced, today, it has completed an initial feasibility study, which demonstrates the ability to use its patented Cesium-131 (Cs-131) brachytherapy seeds (internal radiation therapy) in accelerated partial breast irradiation (APBI) for breast cancer treatment. APBI is one of the most exciting, emerging treatments available, today, for early stage, localized breast cancer.
Using an FDA-cleared third party device, IsoRay conducted a series of internal studies to evaluate the prospect of utilizing Cesium-131 internal radiation therapy in APBI treatment. The studies included Monte Carlo simulations, used to determine radiation dose delivery to the proper site, which is considered the most accurate method of simulating radiation treatment. In addition, image-based brachytherapy treatment planning and physical dose measurements obtained from a specially designed phantom simulating a human breast were utilized. The initial studies prove Cesium-131 internal radiation therapy to be a viable alternative to high dose rate radiation (HDR) successfully delivering the radiation dosage required for APBI.
APBI is an emerging, leading-edge radiation treatment that is used in tandem with breast-conserving surgery (lumpectomy) in order to obtain the highest possible rate of breast cancer control while offering minimal cosmetic impact from the outcome of breast cancer treatment. It delivers radiation treatment in the area of the breast directly around the lumpectomy site, which is where most cancers are likely to reoccur. This targeted approach reduces implications for healthy tissues and organs like the heart and lung that would otherwise be in the treatment field. Without APBI, women who have a lumpectomy undergo up to six weeks of radiation treatment for the entire affected breast following surgery. A substantial part of the body is exposed to radiation and the breast can be left deformed.
Right now, APBI is only available in a limited number of facilities, nationwide, because it requires high dose rate radiation. As a result, hospitals must have specifically designed, highly secure, shielded environments where treatment is delivered two times a day for five days. The ability to use IsoRay's Cesium-131 low dose rate internal radiation therapy would dramatically increase the availability of this leading-edge breast cancer treatment, nationwide, as these special facilities would not be required. Using IsoRay's pioneering internal radiation therapy, women would have a temporary device implanted at the time of the lumpectomy surgery eliminating multiple visits to the hospital for radiation treatment. Instead, patients would then be able to go home for four to five days until the Cesium-131 internal radiation therapy was completed and then return for device removal.
Radiation is one of the most important and potent weapons used in treating cancers. Brachytherapy is internal radiation therapy in which radioactive material (isotopes) is used to kill cancer cells. IsoRay's patented Cs-131 brachytherapy seeds represent the biggest advancement in internal radiation therapy in twenty years providing several advantages over other internal radiation therapies. Doctors can vigorously treat a variety of cancers limiting the damage to healthy surrounding tissues and organs compared to other radiation therapies.
IsoRay CEO Dwight Babcock says he is optimistic about IsoRay's future progress. "We believe this new application of Cesium-131 will have a significant impact on breast cancer and improve the quality of life for many women who are struggling with this devastating disease. It is extremely fitting that we are able to reveal this important development during Breast Cancer Awareness Month. I have high expectations for the treatment's availability in 2011," he said. Babcock went on to discuss IsoRay's implementation of its strategic plan. He explained that IsoRay is aggressively pursuing its plan to advance the adoption and usage of its revolutionary internal radiation therapy to treat cancers throughout the body.
With established CMS codes, Cesium-131 is FDA-cleared for use in the treatment of cancers throughout the body including breast cancer. More than 100 centers across the country are using Cesium-131 to treat brain, colon, head and neck, lung, ocular melanoma, and prostate cancers.
About IsoRay, Inc.
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the exclusive 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.
Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: the advantages of our Cesium-131 seed, whether IsoRay will be able to expand its base beyond prostate cancer, whether IsoRay's Cesium-131 seed will be used to treat additional cancers and malignant disease, whether Cesium-131 will be able to be used for APBI in human patients, whether the use of Cesium-131 to treat breast or other cancers using APBI or other methods will be successful in the initial and any future implants, whether a clinical trial for APBI will be completed, 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, the ability for users of the Cesium-131 implants to comply with regulations related to ongoing radiation emitting from the breast, 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 early clinical studies, whether initial implants of Cesium-131 to treat breast other cancers using APBI or other methods result in favorable patient outcomes, whether resources are available as needed to conduct a clinical trial for APBI and whether results of any such trial are favorable, patient results achieved when Cesium-131 is used for the treatment of cancers and malignant diseases beyond prostate cancer, successful completion of future research and development activities, and other risks detailed from time to time in IsoRay's reports filed with the SEC.
Sharon Schultz, 301-351-0109
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