RICHLAND, Wash., Dec. 21, 2016 /PRNewswire/ -- IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and
innovator in seed brachytherapy and medical radioisotope applications for the treatment of prostate, brain, lung, head and neck
and gynecological cancers, today announced the launch of a pilot study investigating the role of Cesium-131 in the management of
recurrent head and neck cancer at the Case Comprehensive Cancer Center, Case Western Reserve
University, Cleveland, Ohio. The study has been approved by University Hospitals of
Cleveland Institutional Review Board (IRB).
The Case Comprehensive Cancer Center is a National Cancer Institute (NCI) designated Cancer Center and is also part of the
National Comprehensive Cancer Network (NCCN). NCI-designated Cancer Centers are a group of 68 cancer research institutions
in the United States supported by the National Cancer Institute and Case Comprehensive is among
the 41 designated Comprehensive Cancer Centers. The principal investigator for the study is Chad Zender
M.D., an associate professor of otolaryngology at the Case Western Reserve University School
of Medicine. Among his co-investigators are other head and neck surgeons, radiation oncologists, medical oncologists and
statisticians.
This study will evaluate the impact of Cesium-131 therapy on disease control in recurrent head and neck cancers as well as the
safety of the approach. The study is expected to begin enrolling 42 patients with recurrent cancers of the head and neck in early
2017. Upon completion of enrollment, the study is expected to last 24 months. According to the American Cancer Society,
there are 61,760 head and neck cancer cases expected to be diagnosed in the U.S. in 2016.
These cancers pose a particularly troublesome challenge due to the presence of vital anatomy in the head and neck. If
the cancer recurs – which it does 30% - 40% of the time – potentially useful radiation therapy may not be possible due to the
previous exposure of the patient's head and neck anatomy to radiation. Brachytherapy with Cesium-131 delivers a compact, highly
conformal dose of radiation and is used to treat a variety of human cancers.
"This important study of Cesium-131's effectiveness on recurrent head and neck cancers perfectly lines up with IsoRay's
mission to identify challenging problems in radiation oncology and work with innovative clinicians to provide possible
solutions," said Thomas LaVoy, Chairman and CEO of IsoRay. "Case Comprehensive Cancer Center
is among the leaders in cancer research and we're proud to be working with such a prestigious institution, Dr. Zender and an
accomplished slate of investigators."
About IsoRay, Inc.
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are
expanding brachytherapy options throughout the body. Learn more about this innovative Richland,
Washington company and explore the many benefits and uses of Cesium-131 by visiting www.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: the advantages of our products and their
delivery systems, whether the study will ultimately be completed, whether Cs-131 therapy will demonstrate disease control in
recurrent head and neck cancers or prove to be a safe approach compared to other treatment options, 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 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, our ability to enforce our intellectual property rights, whether additional studies are released and support
the conclusions of past studies, whether ongoing patient results with our products are favorable and in line with the conclusions
of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers
and malignant diseases, successful completion of future research and development activities, whether we, our distributors and our
customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our
products in its various forms, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing
efforts, 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. Unless required to do so by law, the Company undertakes no obligation
to publicly update or revise any forward-looking statements, whether as a result of new information, future events or
otherwise.
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SOURCE IsoRay, Inc.