
NEWS RELEASE for July 27, 2009
| Contact | Dwight Babcock, CEO 520 240 4840 dbabcock@isoray.com |
Richland, WA (July 28, 2009) — IsoRay, Inc. (Amex: ISR) announced today that on June 4, 2009, Dr. Karen Pitman of the Department of Otolaryngology and Communicative Sciences and Dr. Michael Baird of the Radiation Oncology Department of the University of Mississippi Medical Center performed the world’s first head and neck permanent seed Cesium-131 implant.
The implant was performed using Vicryl- embedded seeds in the tonsilar area in a patient who had locally failed IMRT external beam radiation and chemotherapy. Drs. Pitman and Baird chose Cesium 131 for this implant based on its high energy (30.4 kev) and short half-life (9.7 days). This combination allowed them to achieve a high dose of radiation to the recurrent disease, while limiting the dose to the previously heavily irradiated tissues of the neck. Cesium’s short half-life reduced the duration of side effects and the need for radiation protection.
Dr. Baird stated, “Although too early to determine the overall efficacy of treatment, the patient’s tolerance to the implant has been good. His acute reactions peaked at three weeks, and have resolved by six weeks. His clinical reaction in the implant volume corresponds well to the post implant dosimetry.”
Until now clinical experience with Cesium-131 has been focused on prostate cancer and ocular melanoma. However, Cesium-131 has been cleared by the FDA for use in the treatment of malignant disease (e.g., prostate, ocular melanoma, head and neck, lung, brain, breast, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity.
Dwight Babcock, IsoRay's CEO, stated “This is an important development in our strategy to significantly broaden our base beyond prostate cancer. Cesium-131 has unique characteristics for treating many additional cancers such as this new application that provided a minimally invasive treatment option for this patient.”
About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of the Proxcelan Cesium-131 brachytherapy seeds, used to treat prostate, ocular melanomas, and other cancers. Proxcelan seeds offer a significantly shorter half-life than the two other isotopes commonly used for brachytherapy, which results in a substantially faster delivery of therapeutic radiation, lower probability of cancer cell survival and reduction of the longevity of common brachytherapy side effects. (a) (b). IsoRay is based in Richland, Washington. More information is available about IsoRay at www.isoray.com.
(a) Armpilia CI, Dale RG, Coles IP, et al. The Determination of Radiobiologically Optimized Half-lives for Radionuclides Used in Permanent Brachytherapy Implants. Int. J. Radiation Oncology Biol. Phys. 2003; 55 (2): 378-385.
(b) Prestidge B.R., Bice W.S., Jurkovic I., et al. Cesium-131 Permanent Prostate Brachytherapy: An Initial Report. Int. J. Radiation Oncology Biol. Phys. 2005; 63 (1): 5336-5337.
Safe Harbor Statement Statements in this news release about IsoRay's future expectations, including: the advantages of our Proxcelan 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 the use of Cesium-131 to treat head and neck cancers will be successful in the initial and any future implants, 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 early clinical studies, whether initial implants of Cesium-131 to treat head and neck cancers result in favorable patient outcomes, 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.