Healthcare Industry News: iodine
News Release - November 1, 2007
New Studies Unveiled at ASTRO's 49th Annual Meeting of Radiation Oncology Specialists Support the Effectiveness of IsoRay Medical's Proxcelan(TM) for the Treatment of Prostate Cancer
Proxcelan(TM) (Cesium-131) is the Newest Advancement in Permanent Brachytherapy Seed Implants for Prostate CancerLOS ANGELES--(HSMN NewsFeed)--Several newly released scientific findings focusing on various aspects of Proxcelan™ (Cesium-131) seeds’ effectiveness in the treatment of prostate cancer -- supporting and broadening the growing body of evidence on the newest medical isotope being used in permanent seed therapy.
The findings -- which include one in a new area of investigation, and four in continuing areas of investigation -- reinforce preceding published results about the success of Cesium-131. These studies add over 400 patients to the overall number of subjects being observed in Cesium-131 clinical studies.
The results by leading cancer researchers were presented at the 49th ASTRO Annual Meeting, held in Los Angeles, October 28-November 1, 2007. ASTRO is the largest radiation oncology organization of its kind, with over 9,000 members who include radiation oncologists, radiation oncology nurses, medical physicists, radiation therapists, dosimetrists, and biologists.
Proxcelan (www.proxcelan.com) is the brand name of the medical isotope Cesium-131 used in brachytherapy seed treatment, specifically for prostate cancer. It is a proprietary product of IsoRay Medical™ -- a wholly owned subsidiary of a public company, IsoRay, Inc. (“IsoRay”) (AMEX:ISR ), based in Richland, WA. Proxcelan is currently available in over 50 medical centers across the U.S.
“The findings presented at ASTRO further support and confirm earlier results regarding Proxcelan’s excellent dosimetric properties and applicability for prostate cancer,” said IsoRay Chairman and CEO Roger Girard. “From a patient’s standpoint, this underscores Proxcelan’s advantages -- targeting cancer cells while allowing the patient to resume normal activities quickly. Quality of life issues are increasingly important to patients as well as physicians dealing with follow-up care.”
A key finding of the latest study, entitled Is Cesium-131 or iodine-125 or Palladium-103 the “Ideal” Isotope for Prostate Boost Brachytherapy? - A Dosimetric Viewpoint, is that Cesium-131 seeds yielded “homogeneous” dose distributions within the prostate while providing desired dose coverage and acceptable normal tissue doses compared to iodine-125 or Palladium-103 seed implants. The lead researcher who conducted the 15-patient study is W. Choi; research institutions involved were the Montefiore Medical Center, the Albert Einstein College of Medicine, Bronx, New York, NY and The Haakon Ragde Foundation for Advanced Cancer Studies, Seattle, WA.
Expanded ongoing studies supporting the increasing positive results of Proxcelan presented at the annual meeting include:
Principal Researcher: B.J. Moran
Research Institution: Chicago Prostate Cancer Center, Westmont, IL
Highlights: Between November 2004 and April 2007, 171 consecutive patients underwent Cesium-131 brachytherapy by a single physician at a single out-patient center. Based on observed data, the resolution of urinary symptoms as measured by group IPSS scores may occur more rapidly with Cesium-131 than with iodine-125.
Principal Researcher: B. Prestidge
Principal Research Institutions: Texas Cancer Clinic, San Antonio, TX; and International Medical Physics Service, Helotes, TX
Highlights: Dosimetric guidelines for Cesium brachytherapy were developed from the results of this 100-patient trial. A total of seven institutions participated in this study from November 2004 to February 2007. The study concluded that Cesium-131 is a viable alternative to Palladium-103 or iodine-125 for prostate brachytherapy.
Principal Researcher: W. Bice
Research Institutions: International Medical Physics Service, Helotes, TX; and Texas Cancer Clinic, San Antonio, TX
Highlights: This 100-patient, multi-institutional study suggests that Cesium-131 is an acceptable alternative to Palladium-103 and iodine-125.
Principal Researcher: J.S. Musmacher
Research Institution: North Shore Medical Accelerator, Smithtown, NY
Highlights: This study quantified dosimetric outcomes using post-plan dosimetry data following Cesium-131 and Palladium-103 after therapeutic implantation. The study concluded that, given the greater average energy of Cesium-131 relative to Palladium-103, it may be possible to deliver a more homogenous implant with Cesium-131 than with Palladium-103.
The efficacy of Proxcelan demonstrated in these studies complemented the theme of this year’s annual ASTRO meeting, “Treating Cancer While Preserving Quality of Life.” Founded in 1958, ASTRO’s mission is to advance the practice of radiation oncology by promoting research and disseminating research results, promoting excellence in patient care, and representing radiation oncology in a rapidly evolving healthcare environment.
Proxcelan™ with Cesium-131 offers patients a number of unique advantages over other low-dose radiation medical isotopes. Increasingly, prostate cancer patients and their doctors who decide on seed brachytherapy choose Cesium-131 treatment because of its significant advantages over Palladium-103 and iodine-125, two other isotopes currently in use. These advantages include:
Higher Energy
Proxcelan with Cesium-131 has a higher average energy than any other commonly used prostate brachytherapy isotope on the market. Energy is a key factor in how uniformly the radiation dose can be delivered throughout the prostate. This is known as homogeneity. Early studies demonstrate ProxcelanTM with Cesium-131 implants are able to deliver the required dose while maintaining good homogeneity across the gland itself and potentially reducing unnecessary dose to critical structures such as the urethra and rectum. (1)
Shorter Half-Life
Cesium-131 has the shortest half-life of any prostate brachytherapy isotope at 9.7 days. Cesium-131 delivers 90% of the prescribed dose to the prostate in just 33 days compared to 58 days for Palladium-103 and 204 days for iodine-125. The short half-life of Cesium-131 reduces the duration of time during which the prostate receives the irritating effects of the radiation. Early studies demonstrate Cesium-131 is well tolerated with minimal to moderate urinary symptoms that resolve relatively rapidly, within approximately 4-8 weeks. (2)
Higher Biologically Effective Dose
Another benefit to the short half-life of ProxcelanTM with Cesium-131 is what is known as the "biological effective dose" or BED. BED is a way for health care providers to predict how an isotope will perform against slow versus fast growing tumors. Studies have shown Cesium-131 is able to deliver a higher BED across a wide range of tumor types than either iodine-125 or Palladium-103. Although prostate cancer is typically viewed as a slow growing cancer it can present with aggressive features. Cesium-131's higher BED may be particularly beneficial in such situations. (3)
For more information on the Proxcelan™ with Cesium-131 cancer treatment breakthrough, visit www.proxcelan.com.
Medicare / Medicaid
Medicare and Medicaid have established specific reimbursement codes for Proxcelan™ with Cesium-131, for loose seeds and for stranded seeds, and insurance companies typically also cover low-dose (LDR) seed brachytherapy.
FOOTNOTES:
(1) Prestidge B.R., Bice W.S., et al. Results of a multi-institutional trial using cesium-131 permanent prostate brachytherapy, poster presented at the 49th Annual ASTRO Meeting in Los Angeles CA.
(2) Prestidge B.R., Bice W.S., Jurkovic I., et al. Cesium-131 Permanent Prostate Brachytherapy: An Initial Report. Int. J. Radiation Oncology Biol. Phys. 2005: 63 (1) 5336-5337.
(3) Armpilia CI, Dale RG, Coles IP et al. The Determination of Radiobiologically Optimized Half-lives for Radionuclides Used in Permanent Brachytherapy Implants. Int. J. Radiation Oncology Biol. Phys. 2003; 55 (2): 378-385.
About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of the Proxcelan™ Cesium-131 brachytherapy seed, used to treat prostate and other cancers. The Proxcelan™ 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, lower probability of cancer cell survival and reduction of the longevity of common brachytherapy side effects (2)(3). 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 Proxcelan™ Cesium-131 seed, future demand for IsoRay’s Proxcelan™ Cesium-131 seed, and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. 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 IsoRay’s products, IsoRay’s ability to successfully manufacture, market and sell its products, IsoRay’s ability to manufacture its products in sufficient quantities to meet demand within required delivery time periods while meeting its quality control standards, IsoRay’s ability to enforce its intellectual property rights, whether additional studies support the conclusions of early clinical studies, and other risks detailed from time to time in IsoRay’s reports filed with the SEC.
Source: IsoRay
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
