IsoRay Begins Prostate Cancer Trial (BCR) (ISR) (RDY) (TGX)

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Medical isotope maker IsoRay Inc (ISR) has initiated a new combination therapy study using its Cesium-131 (an isotope) internal radiation therapy (“brachytherapy”) and external beam radiation. The study has been designed to evaluate the effectiveness of combining Cesium-131 brachytherapy with intensity modulated radiation therapy (“IMRT”) in treating intermediate and high risk prostate cancer.

Prostate cancer is the second most prevalent cancer (after skin cancer) among American men and the second-leading cause (after lung cancer) of cancer-related death. High level of PSA (a protein produced in the prostate) generally indicate the presence of this disease. More than 30,000 people succumb to prostate cancer annually in the U.S.

Based on the available study results, the dual therapy (brachytherapy and external beam radiation) has shown to offer major benefits to prostate cancer patients. Given the high success rate of the Cesium-131 monotherapy in early stage prostate cancer patients, physicians are enthusiastic about using it in combination with other therapies for intermediate and high risk cases.

The new study is expected to show that the combination of Cesium-131 brachytherapy and external beam radiation will improve treatment by reducing the dosage of these therapies, thereby offering improved outcome for high risk patients and potentially lowering side effects typically associated with conventional treatments. Moreover, the study will also assess PSA response and its return to normal levels.

Washington-based IsoRay develops and markets isotope-based medical products and devices for the treatment of cancer and other malignant diseases. It competes with Theragenics (TGX) and C.R. Bard (BCR) among others.

IsoRay’s product sales surged 17% year over year in third-quarter fiscal 2011, boosted by higher adoption of its internal radiation therapy across the U.S. This was the second-highest quarterly sales in the company’s history.

IsoRay is optimistic that expanded market traction of Cesium-131 coupled with ongoing clinical developments would spur growth moving forward. The company, during the third quarter, received the European CE mark approval for its stranded and mesh seed configurations of cesium-131 for cancer applications throughout the body (including head and neck, lung, brain, colon and prostate).

IsoRay is currently seeking FDA approval for a liquid form of Cesium-131 for use with its GliaSite radiation therapy system, the only approved balloon catheter in the U.S. used in the brachytherapy treatment of brain cancer. The company has recently won exclusive global licensing rights to Iotrex (a key component in the GliaSite system) from Dr. Reddy’s Laboratories (RDY).

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