RICHLAND, Wash., June 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 David G.
Brachman, MD, FACRO, Director of Radiation Oncology, Barrow
Neurological Institute, and Clinical Professor of Radiation
Oncology, University of Arizona College
of Medicine-Phoenix, presented the findings of a prospective trial
entitled: "Prospective trial of surgery and permanent
intraoperative brachytherapy (S+BT) using a modular, biocompatible
radiation implant for recurrent aggressive meningiomas," at the
Society of Neuro-Oncology Conference on Meningioma, Toronto, Canada.
Highlights of the presentation included:
- The study treatment involved a new means of delivering
Cesium-131 brachytherapy to the brain, with the seeds embedded in
collagen tiles and applied directly to the brain tissue after the
tumor was removed (the GammaTile approach, which is not
commercially available).
- The trial included 16 patients and 20 tumors.
- The patients in this study had recurrences of tumor after prior
surgery and external beam radiation treatment and were considered
by their physicians to be at an increased risk for additional
recurrence.
- 95% of the treated tumors had no radiographic evidence of
regrowth of tumor at the operative site (local control). The
incidence of radiation side effects to the brain – a problem in
previous attempts to perform brain brachytherapy – occurred in only
two of the 20 treatments.
Dr. Brachman stated, "These are aggressive meningiomas that have
recurred in patients despite previous surgery and radiation.
These tumors pose a serious challenge to physicians due to their
presence in the brain and the failure of prior treatments.
Use of the Cesium-131 tiles, which were able to be implanted
very quickly at the time of surgery, and starting radiation therapy
at the time of resection as opposed to weeks after resection when
using external beam radiation were advantages of our novel
approach. We are seeing 95% local control of the
treated tumors in our study using surgery and Cesium
implants. In addition, we observed a very low rate of
radiation injury, which has been a major concern in the past, for
patients who have undergone multiple treatments for their brain
tumors."
Tom LaVoy, CEO of IsoRay, Inc.,
stated, "We are encouraged to see this preliminary response to
these challenging cancers. We are pleased Dr. Brachman
had the opportunity to present his findings at such a prestigious
forum of his peers."
Dr. Brachman concluded, "While we look forward to a future where
systemic therapies are available for aggressive meningioma, our
team believes the GammaTile approach using Cesium-131 offers a
promising treatment option for patients."
About IsoRay
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.
About GammaTile
GammaTile, LLC is an Arizona-based privately held medical device
company dedicated to advancing the treatment of intracranial tumors
of all types.
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 GammaTile approach will be successful
in future treatments, whether any future studies of the GammaTile
approach will produce similar results to those reported in the
presentation, 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.