RICHLAND, Wash., Nov. 29, 2016 /PRNewswire/ -- IsoRay, Inc.
(NYSE MKT: ISR), a medical technology company and innovator in
Cesium-131 seed brachytherapy and medical radioisotope applications
for the treatment of prostate, brain, lung, head and neck and
gynecological cancers, today announced a poster presentation at the
21st Annual Meeting of the Society for Neuro-Oncology that was held
on November 17 - 20, 2016. The
poster, entitled "Cs-131 Brachytherapy for Salvage of Recurrent
High Grade Glioma," was presented by Emad
Youssef, MD, Radiation Oncologist, Barrow Neurological
Institute, Phoenix, Arizona.
Highlights of the presentation included:
- High grade gliomas (a type of brain cancer that includes
glioblastoma multiforme) are among the most difficult-to-treat
cancers, with the majority of these cancers recurring despite
aggressive multi-modality therapy. Once these cancers have recurred
in the brain, life expectancy is 3 to 6 months on average.
- In this series, 18 patients who had recurrences of high grade
glioma following standard-of-care therapy (typically surgery,
external beam radiation therapy and chemotherapy) were treated with
surgical removal of the recurrent tumor and placement of the
GammaTile™ radiation therapy system.
- The GammaTile™ system uses Cesium-131 radiation sources
embedded in a collagen carrier. Using GammaTile™, very high doses
of radiation are precisely delivered to targeted tissue – in this
case the surgical margin that likely contains remnants of cancer
cells following surgical removal of the tumor.
- In these 18 patients, the tumor had re-grown at the surgical
site following standard-of-care treatment at a median of four
months. This short time to recurrence despite multi-modality
therapy highlights the vexing nature of these cancers.
- Following surgery plus GammaTile™ treatment, three patients
(16%) experienced a re-growth of the tumor at the surgical site at
the median time of analysis of approximately six months. In order
to determine the median time to surgical site recurrence, 50% of
the patients would be required to experience recurrence. However
only 16% of the patients have had a surgical site recurrence at the
time of analysis, suggesting that the median time to recurrence is
greater than six months.
Dr. Youssef commented, "Seeing an improvement, although not yet
statistically significant, in the freedom from tumor re-growth was
particularly surprising in this group of patients, since the
treatments available when these cancers recur, such as GammaTile™,
are generally not as effective as the front line treatments. With
10 of these patients still living, the median time to recurrence
may be extended even more. In addition, the complications we
observed after the surgery plus GammaTile™ treatment were
minimal."
"With only 16% of patients experiencing a surgical site
recurrence at 6 month median follow-up, it's clear that the
GammaTile™ approach extends the time to recurrence when compared to
standard-of-care treatment in this group of patients, although the
final time frame currently remains undefined," said Tom LaVoy, Chairman and CEO of IsoRay. "The
advantages of using Cesium-131 brachytherapy products in the brain
and other parts of the body are gaining momentum with the medical
community, and are increasingly responsible for improving the lives
of cancer patients."
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 interest in and use of our products will
increase or continue; whether the advantages of using Cesium-131
brachytherapy products in the brain and other parts of the body are
gaining momentum with the medical community; whether surgery plus
GammaTile™ extends median time to surgical site recurrence, and the
extent to which it extends median time to surgical site recurrence;
whether future studies will report positive treatment results; 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.