Production of the FDA-approved medical isotope is expected to begin this month in a 4000 square-foot facility leased from Pacific EcoSolutions at 2025 Battelle Boulevard, according to Roger Girard, CEO and chairman of the board of directors. Management has indicated that the new production facility will give IsoRay Medical the capacity - assuming a significant increase in staffing and availability of a sufficient amount of Cesium-131 for manufacture - to manufacture up to 60.000 radioactive "seeds" per month, serving the needs of approximately 600 patients. This represents a factor of ten increase in production capacity over IsoRay's current capability.
"This new facility will enable us to more efficiently produce and ship Cesium-131 isotope to meet the growing demand from physicians and patients", stated Roger Girard. "In addition to boosting production, we will be able to accommodate custom preloading of seeds into cartridges and needles, a process we have subcontracted up to now."
IsoRay Medical received Food & Drug Administration approval to market its proprietary Cesium-131 seed for the treatment of prostate cancer and other malignancies in March 2003. In addition to prostate cancers, it is approved for the treatment of breast, liver, lung, pancreatic and other malignancies. Seed implant 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 tumour.
Until now, IsoRay's seed production has occurred exclusively at Pacific Northwest National Laboratory (PNNL) facilities. According to IsoRay Vice President-Operations David Swanberg, IsoRay Medical will continue to have a relationship with PNNL for ongoing process development activities and specialized analysis functions. IsoRay Medical's administrative offices will continue to be located at 350 Hills Street in Richland.
David Swanberg said in addition to completing the installation of specialized seed production and custom pre-loading equipment at the new facility, IsoRay has also obtained an amended radioactive material license from the Washington State Department of Health to produce and ship the Cesium-131 seeds from the new facility.
This facility will provide interim production capacity until a planned full-scale facility of even greater capacity can be completed. Sites in Idaho and Washington are currently under consideration for the full-scale production facility.
Roger Girard leads a management team of highly experienced technical, financial, quality, sales and marketing talent to assist him in the development of the company and its products. Initial development of the Cesium-131 seed began more than 40 years ago. Lane A. Bray, chief chemist of IsoRay Medical Inc. and cancer-treatment pioneer Donald C. Lawrence, who founded IsoRay Medical in Richland, Washington in 1998, developed the Cesium-131 seed. The late Dr. 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 development until now.
The first Cesium-131 implant was performed in October 2004 at the University of Washington Medical Center and since that time, leading cancer treatment hospitals and clinics across the United States have begun providing this new isotope to their prostate cancer patients. "The original vision of Lane Bray and Don Lawrence is now a reality. Cesium-131 is an aggressive and fast acting treatment option for prostate cancer patients", stated Roger Girard. "Additionally, the potential for treating cancers of other organs and tissues is exciting."
A 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 show that patient outcomes for seed brachytherapy are better than or equal to those for radical prostatectomy and external beam radiation, at far less cost and with a much higher quality of life.
IsoRay Inc., 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.