RICHLAND, WA--(Marketwired - Oct 7, 2014) - IsoRay, Inc. (
In March 2014, a seven year old Peruvian girl was diagnosed with a potentially life-threatening brain cancer known as a glioblastoma multiforme (GBM). The 2.7 cm tumor was located very close to the brainstem, making surgical removal too risky to attempt.
She was seen in consultation by neurosurgeon Dr. Carlos Alvarez Peña, head of the Instituto del Cerebro y la Columna Vertebral (Brain and Spine Institute), Lima, Perú. Dr. Alvarez realized that the tumor was inoperable, but was aware of the emergence of IsoRay's Cesium-131 isotope and its applications in the treatment of brain cancers.
Because of the increasing pressure on the brain produced by the tumor, the young patient was experiencing significant weakness, trouble maintaining alertness and even walking. A drain was placed into the patient's brain to help alleviate a steadily worsening situation. External whole brain radiation therapy and chemotherapy resulted in no improvement to the patient's worsening condition.
After working with IsoRay's Richland, Washington, U.S. based team, a custom Cesium-131 implant was designed and manufactured for placement directly into the tumor in the patient's brain. Care was taken to devise an aggressive implant that could deliver a high dose of cancer-killing radiation to the cancer while sparing the very closely associated brain (thalamus) and brainstem structures.
In July 2014, Dr. Alvarez treated the patient (using a stereotactic localization approach) placing the Cesium-131 seed implant directly into the brain tumor.
The patient's recovery was remarkable as she was alert and eating the next day. She recovered from the implant without incident. A minor neurological symptom (gaze palsy) was noted but began resolving a few weeks following implant. After a couple of weeks she was again able to walk without assistance. As of September 2014, ten weeks after the implant, with over 99% of the radiation from the implant delivered, an MRI scan showed a 70% reduction in the mass of the tumor. This young girl has now returned to school without assistance or special accommodations and also returned to her normal activities.
Dr. Alvarez commented, "This patient is a very tender young girl who has had to deal with a tremendous problem which even now menaces her life: a multiform glioblastoma localized deep inside her brain in the left cerebral hemisphere. There is no conventional neurosurgical option for treatment of this kind of brain cancer.
"When I informed the patient's relatives about the possibility of using Stereotactic Interstitial Radiotherapy with a relatively new Cesium-131 seeds, they were conscious about the risks of such an approach. We knew she faced a very short life expectancy. The remarkable 70% reduction in the tumor and the other early results are far better than expected.
"We are working on a scientific paper in order to share with the scientific community this exciting new way of dealing with these life-threatening cancers."
IsoRay Chairman and CEO Dwight Babcock commented, "We can only hope we have positively impacted this child's life. IsoRay is committed to supporting many of these difficult and recurrent cancer cases giving growing evidence of Cesium-131 cancer killing ability. This new stereotactic approach of placing Cesium-131 seeds in aggressive tumors will offer more hope when inoperable cancers are discovered throughout the body. Our hope is that with time, a growing number of leading surgeons and radiation oncologists will see the significant results being achieved by major medical institutions currently utilizing Cesium -131 and adopt it for their patients."
IsoRay's Cesium-131 products utilize the uniqueness of the Cesium-131 isotope to attack cancers in the prostate and other body sites, such as brain cancer, head and neck cancer, lung cancer and gynecological cancers, while providing patients with a better quality of life than many competing treatments.
The Company is actively bringing new brachytherapy applications to market, providing new solutions to leading physicians throughout the world. The Company's continued investment in research and development focusing on Cesium-131's efficacy for treatment of various cancers located throughout the body is expected to have a direct impact on its overall growth with an expanding array of non-prostate cancer treatments. In addition, the recent reorganization and increase in the size and quality of IsoRay's sales organization in the US market has created the means to contact more facilities than ever before with the Company's new and novel treatment alternatives.
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of Cesium-131 brachytherapy seeds, which
is expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington
company and explore the many benefits and uses of GliaSite® and Cesium-131 by visitingwww.isoray.com. Join
us on Facebook/Isoray. Follow us on Twitter@Isoray.
Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: whether future studies and treatments of various cancers using our products will have favorable results, whether awareness of our products in the medical community will continue or increase, future demand for IsoRay's existing and planned products, whether regulatory approvals and licenses will be obtained or maintained in foreign countries, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether additional studies will be published with favorable outcomes from treatment with our products, whether IsoRay's sales and marketing and research and development efforts will contribute to growth, whether new products will be developed and if so whether they will be adopted by physicians, 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, changing levels of demand for IsoRay's current and proposed future products, IsoRay's ability to reduce or maintain expenses while increasing sales, whether additional studies are released and support the conclusions of past studies, patient results achieved with our products, successful completion of future research and development activities, our ability of our distributors and customers to receive and maintain all required regulatory approvals in the U.S. and internationally, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, IsoRay's ability to successfully manufacture, market and sell its products, whether institutions will receive all required state, federal and foreign regulatory approvals and licenses to use IsoRay's 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, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay's reports filed with the SEC.