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.