The implant using Cesium-131 will be the first in the Northeast U.S., offering a new treatment option for patients in the region. More than 230,000 men will be diagnosed with prostate cancer in the United States this year.
The first procedure using the Cesium-131 isotope will be performed Tuesday (June 28) by Dr. LeRoy Korb, the first doctor to use the new isotope when it was introduced at the University of Washington Medical Center last October. Warren General Hospital is the first medical facility in the Northeast to offer the treatment.
Compared to the two other LDR seeds currently in use, Cesium-131 delivers a higher dose of radiation over a shorter period of time. The isotope received Food & Drug Administration (FDA) approval to market its Cesium-131 seed for the treatment of prostate cancer and other malignancies in March 2003.
"We believe Cesium-131 to be a very effective option for men choosing brachytherapy to treat their prostate cancer," said Dr. Korb. "In short, we expect it to kill the cancerous cells more rapidly, with a shorter duration of side-effects. Ideally, this will allow patients to return to a normal lifestyle as quickly as possible."
Warren resident Cole Marion will receive the seed implant Tuesday afternoon. The 50- years-old patient has been legally blind since the age of seven. He is permanently disabled, and is a "Mr. Mom" to his two sons who are 13 and 14 years old. He and his wife and sons live in Warren.
He said the Cesium-131 seed developed by IsoRay Medical offers a significantly shorter half-life, which results in a substantially faster delivery of the total radiation dose compared with the other types of seeds currently on the market.
The procedure involves the use of special needles to implant the seeds, which are smaller than a grain of rice. No incision or suturing is required and the patient usually returns to his normal daily activities within two to three days. Recently published clinical data shows that patient outcomes for seed brachytherapy compare very favorably to radical prostatectomy and external beam radiation.
The Cesium-131 seed by IsoRay Medical combines the beneficial characteristics of a short half-life with a high energy to penetrate the cancer cells while delivering significantly less total radiation to the patient, giving it significant clinical advantages over Iodine-125 and Palladium-103, the brachytherapy isotopes commonly used in LDR cancer treatment today.
"The new Cesium-131 seed has a significantly higher initial dose rate than iodine. This allows for the delivery of more radiation in a shorter period of time to maximize its effectiveness and minimize the duration of side effects," Dr. Korb said. "The treatment is over in one-sixth the time of iodine--with radiation leaving the body 500 days faster."
The Cesium-131 seed has a half-life of 9.7 days, compared to 60 days for Iodine-125 seeds and 17 days for Palladium-103. It delivers more than 90 percent of its total radiation dose in less than 33 days.
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. Brachytherapy seeds containing the radioactive isotope Iodine-125 were first implanted into a cancer patient in 1967.
Medicare and Medicaid have established a specific reimbursement code for Cesium-131, and most insurance companies also cover low-dose (LDR) seed brachytherapy.
Warren General Hospital in Warren, PA, is an 89-bed acute care facility. Nestled at the edge of the Allegheny National Forest, WGH is a full-service hospital, providing comprehensive quality care, close to home. WGH and its board certified medical staff provides leading edge technology in Cancer Care, Wound Care, Pain Management, and Diagnostic Imaging. Maternal-Child Health; General and Thoracic surgical services; comprehensive psychiatric and detox programs; Renal Care; therapeutic rehab including physical, speech, occupational and respiratory programs round out the full range of health care services provided by Warren General Hospital.
The Cesium-131 seed is not yet widely available to physicians and patients. Production will increase this year as IsoRay Medical expands its production at new facilities in the coming months.
"We fully expect our Cesium-131 seed to become a leading worldwide treatment therapy for prostate cancer and other malignancies," said IsoRay Medical Chairman and CEO, Roger Girard. He said that 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.
More information is available about IsoRay Medical at www.isoray.com.
Safe Harbor Statement
Statements in this news release about IsoRay Medical, Inc.'s future expectations, including: the advantages of our Cesium-131 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.