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Press Releases

New Cesium-131 radioactive isotope seed offers aggressive option for treatment of prostate cancer; FDA cleared for other malignant cancers

Booth # 1773 at ASTRO Annual Meeting, October 16-20

RICHLAND, Washington--Radioactive “seeds” have been used to cure thousands of cases of prostate cancer since first used some 40 years ago.

IsoRay Medical™, Inc., a subsidiary of IsoRay, Inc (Pink Sheets: ISRY), is producing a powerful new kind of radioactive, cancer-destroying isotope seed made from Cesium-131 that is implanted directly into tumors.

This breakthrough will be in the spotlight at the 47 th ASTRO Annual Meeting in Denver, October 16-20 (Booth # 1773). IsoRay Medical™ executives and physicians who have introduced this brachytherapy option, will be available at the booth for media briefings. Media materials will be available at the booth and in both media rooms.

An initial report on the use of Cesium-131 for low dose rate (LDR) prostate brachytherapy will be presented at ASTRO by Dr. Bradley Prestidge, MD, Medical Director at the

Texas Cancer Clinic. Dr. Prestidge will be available at the IsoRay booth on Monday, October 17 from 1 p.m. to 2 p.m. and on Tuesday, October 18 from 2:30 to 3:30 p.m.

Cesium-131 delivers its therapeutic radiation faster than other isotope seeds now being used and at reduced risk to patients when compared to surgery. Introduced in September, 2004, the clinical use of cesium-131 marks the biggest advancement in seed brachytherapy (the Greek prefix brachy means short or close) in 19 years.

The Food and Drug Administration (FDA) cleared Cesium-131 for marketing in March 2003. Its initial use has focused on prostate cancer, but it is approved for other malignant cancers, including head, neck, breast, brain, and liver cancers.

For more information on the Cesium-131 cancer treatment breakthrough, visit www.cesium131.com or www.isoray.com.

Patients at leading cancer treatment hospitals and clinics across the United States are now receiving Cesium-131. The centers for Medicare and Medicaid Services have established a specific reimbursement code for Cesium-131, and most insurance companies also cover the cost of the brachytherapy procedure.

Cesium-131 differs from other brachytherapy treatments in several ways:

  • Faster acting – It delivers 90% of the therapeutic radiation in just 33 days, compared to 58 days for Palladium-103 and 204 days for Iodine-125, resulting in a fast and aggressive radiation treatment plan to destroy the cancer cells before they have a chance to reproduce.

  • Reduces the chances of normal tissue damage – Cesium-131 has a 9.7 day half-life, compared to 60 days for Iodine-125 and 17 days for Palladium-103, that delivers significantly less total radiation to the patient. This reduces or eliminates any damage to healthy surrounding tissue from the effects of lingering radiation and significantly reduces the patient’s exposure to prolonged and unnecessary periods of radiation.

  • Better tumor penetration – The energy level of the isotope is 29 KeV which provides more than 30% greater penetration of the cancerous tissue than Palladium-103.

  • Efficient and effective capsule design – The seed is created by chemically attaching Cesium-131 to an inert material placed inside a 4.5 mm x 0.8 mm biocompatible titanium capsule. It provides a more predictable field of radiation that eliminates or reduces “hot/cold spots” and further reduces the potential for cancer cell survival and tumor recurrence.

Lane A. Bray, chief chemist of IsoRay Medical™, Inc. and brachytherapy treatment pioneer, Donald C. Lawrence, who founded IsoRay Medical™ in Richland, WA in 1998, developed the Cesium-131 seed. Mr. Lawrence first created cancer-destroying radioactive seeds in the early 1960s. He was a longtime proponent of using Cesium-131 instead of other radioactive medical isotopes, but scientific and economic considerations prevented its commercial development until now.

The treatment of prostate cancer is an obvious first application for IsoRay Medical’s Cesium-131 technology. Seed therapy is a proven and common treatment for this form of cancer, with 50,000 to 60,000 procedures conducted each year.

Also known as low-dose radiation (LDR), seed brachytherapy has a proven high cure rate in prostate cancer patients, particularly in early stages of the disease (T1 and T2 prostate cancer).

A seed brachytherapy procedure involves the use of special needles to implant the seeds, which are smaller than a grain of rice, using ultrasound guidance. The implant procedure is fast and convenient and the patient typically returns to normal daily activities within two to three days. Recently published clinical data shows that patient outcomes for seed brachytherapy surpasses those for radical prostatectomy and external beam radiation at far less cost while providing patients with a higher quality of life.

Among the advantages of LDR seed brachytherapy for prostate cancer are:

  • It is a cost-effective, minimally invasive and effective outpatient cancer treatment that usually takes less than an hour. Traditional external beam radiation treatment is given multiple times over many weeks and is costly and prostatectomy requires a 3-5 day hospital stay and months of rehabilitation.

  • The radioactive seeds are placed very close to the cancerous tissue thereby reducing damage to surrounding healthy tissue.

  • Most patients return to normal activities within one to two days, compared to as long as 12 weeks or more after prostatectomy (surgical removal of the prostate gland).

  • Typical side effects of seed brachytherapy are considered to be significantly less than prostatectomy.

About IsoRay

IsoRay, Inc. (Pink Sheets: ISRY) through its subsidiary, IsoRay Medical™, Inc., is the sole producer of the Cesium-131 brachytherapy seed, used to treat prostate and other cancers. The Cesium-131 seed offers a significantly shorter half-life than the two other isotopes commonly used for brachytherapy, which results in a substantially faster delivery of therapeutic radiation and lower probability of cancer cell survival. 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 seeds. Because of this shorter half-life, it delivers more than 90 percent of its total radiation dose in less than 33 days, reducing the incidence of common brachytherapy side effects. IsoRay is based in Richland, Washington. More information is available about IsoRay at www.isoray.com.


Safe Harbor Statement

Statements in this news release about IsoRay’s future expectations, including: the advantages of our Cesium 131seed, expansion into a new facility 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, 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, and our ability to enforce our intellectual property rights, and other risks detailed from time to time in IsoRay's reports filed with the SEC.


Media Contacts :

Roger Girard , President and CEO

IsoRay, Inc. 206.849.6507 (cell)

rgirard@isoray.com

 

Barry Bartlett, The Bartlett Group Public Relations

206.285.0673 ; 206.335.4694 (cell)

barry@bartlettgrouppr.com