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Richland Firm Introduces Promising Isotope for Cancer Treatment; Prostate Cancer Patient Receives New Seed Therapy By IsoRay Medical, Inc. In a Worldwide First for Cesium-131

Posted on: Tuesday, 26 October 2004, 14:00 CDT

A new isotope for low-dose (LDR) seed brachytherapy was implanted into a prostate cancer patient at the University of Washington Medical Center today, marking the first brachytherapy seed implant in the world utilizing the radioactive isotope Cesium-131. This new isotope represents the first major advancement in LDR seed brachytherapy in more than 18 years.

IsoRay Medical, Inc., the Richland, Washington-based company that developed the isotope, received Food & Drug Administration (FDA) approval to market its Cs131 Seed for the treatment of prostate cancer and other malignancies in March 2003. Medicare and Medicaid have established a specific reimbursement code for Cesium-131, and most insurance companies also cover low-dose (LDR) seed brachytherapy.

"We fully expect our Cs131 Seed to become a leading worldwide treatment therapy for prostate cancer and other malignancies," said IsoRay Medical Chairman and CEO, Roger Girard.

The first patient, Chuck Moore, 74, was diagnosed with prostate cancer in May 2004. He received the Cs131 Seeds in an outpatient procedure performed by Dr. Leroy Korb, assistant professor of Radiation Oncology at UW Medical Center.

The Cs131 Seed by IsoRay Medical combines the beneficial characteristics of short half-life and high energy, giving it significant clinical advantages over Iodine-125 and Palladium-103, the brachytherapy isotopes commonly used in LDR cancer treatment today. When placed inside or near a tumor, Cs131 Seeds deliver radiation directly to cancer cells while reducing or eliminating damage to surrounding tissue.

"We have every reason to believe it will cure the prostate cancer of Mr. Moore and that any side effects will be minimal," said Girard. He said IsoRay Medical intends to first market its seed for prostate cancer patients, although the treatment holds promise for other types of cancer, including breast, brain, liver, head and neck cancers, and other malignant disease.

In the coming weeks, additional prostate cancer patients will be treated with Cs131 Seeds by the following doctors: Dr. Brad Prestidge, Texas Cancer Center, San Antonio, TX.; Dr. David Beyer, Arizona Oncology Group, Scottsdale, AZ.; Dr. Brian Moran, Chicago Prostate Cancer Center, Chicago, Il.; Dr. Don Fuller, Radiation Medical Group, San Diego, CA.; and Dr. Gil Lederman, Cabrini Medical Center, New York City, NY.

The Cs131 Seed is not yet widely available to physicians and patients. Initial production is occurring at facilities contracted with Pacific Northwest National Laboratory and the Department of Energy in Richland, Washington. Production will increase in the third quarter of 2005, when IsoRay Medical opens a fully automated manufacturing facility in Richland. The company expects to employ 250 when the facility is running at full production.

"We've been working on this for a very long time," said IsoRay Medical Chief Chemist Lane Bray, who developed the patented process for separating and purifying Cesium-131.

"We're excited about this first patient and the opportunity to develop more isotopes for more cancer patients," said Bray, an internationally recognized expert in the field of separation chemistry of medical isotopes.

Low-dose brachytherapy (from the Greek prefix "brachy," meaning "short" or "close") is a convenient and cost-effective cancer treatment that employs the direct placement of radioactive seeds into or near the tumor. The seeds, about the size of an uncooked grain of rice, are injected into the prostate gland and benefit the patient by providing a high radiation dose to the cancer cells while minimizing the amount of radiation to the surrounding healthy tissue and body organs. Brachytherapy seeds containing the radioactive isotope Iodine-125 were first implanted into a cancer patient in 1967.

More information is available on the IsoRay Medical Web site: www.isoray.com.

Safe Harbor Statement

Statements in this news release about IsoRay Medical, Inc.'s future expectations, including: the advantages of our Cs131 seed and all other statements in this release, other than historical facts, are forward-looking statements. 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 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, and our ability to enforce our intellectual property rights, among other factors.

Source: Business Wire

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