marks initiation of international multicenter trial evaluating targeted
radiation therapy and bevacizumab for the treatment of the most common and aggressive
type of malignant brain tumor


research supporting novel therapy approach recently published in peer-reviewed journal,
Surgical Neurology International 


For the
first time in the U.S., the Xoft® Axxent®
Electronic Brachytherapy (eBx®) System®
was recently used to treat a patient with recurrent
glioblastoma (GBM). The procedure took place at Providence Saint John’s Health
Center in Santa Monica, CA, as part of an international multi-center trial led
by principal investigator and world-renowned neuro-oncologist, Santosh Kesari,
MD, PhD, Chair and Professor, Department of Translational Neurosciences at the Saint
John’s Cancer Institute, Santa Monica, CA.


“This is a
milestone achievement, not only for iCAD but also for patients with this
devastating disease,” said Stacey Stevens, President and incoming CEO of iCAD,
Inc. “It is our expectation that the GLIOX study and its forthcoming data will
add to the growing body of evidence that supports intraoperative radiation
therapy (IORT) with the Xoft System for the treatment of various types of
tumors, including recurrent GBM.”


The GLIOX[i] trial is designed
to compare Xoft IORT plus Avastin® (bevacizumab) to the
investigational arm of RTOG-1205 (EBRT plus bevacizumab). Researchers hope this
study will validate the intriguing initial results from a prospective two
center comparative study at the European Medical Center (EMC) in Moscow, Russia.
Compelling data from
this study were recently published in study and a
subsequent erratum in the
peer-reviewed journal, Surgical Neurology International.


“This is a
significant milestone, not just for our institute, but also for patients with
recurrent glioblastoma,” said the site’s principal investigator, Naveed Wagle,
MD, Associate Professor of Neurosciences at the Saint John’s Cancer Institute
in Santa Monica, CA. “The initiation of a clinical trial under normal
circumstances is no small feat, but the COVID pandemic presented additional
challenges that had to be overcome. It truly was an enormous achievement, and
we are excited that we can now offer it to patients.”



New Research
Supports Innovative Therapy Approach


Compelling data
supporting Xoft Brain IORT for the treatment of recurrent GBM were recently published
in study and a
subsequent erratum in the peer-reviewed journal, Surgical Neurology International. Under the
guidance of lead investigator, Alexey Krivoshapkin, MD, PhD, professor and head of the neurosurgery
department at the European Medical Center (EMC), the comparative study
evaluated 15 patients with recurrent GBM who were treated with maximal safe
resection and Xoft Brain IORT, and 15 patients with recurrent GBM treated with
maximal safe resection and other modalities (control group), between June 2016
and June 2019.


As of March 2021, patients treated with Xoft Brain IORT lived for
up to 54 months after treatment without recurrence, whereas patients in the
control group had a recurrence within 10 months and lived for up to 22.5 months
after treatment. Researchers also found there were fewer complications, such as
radionecrosis, in the IORT group. Radionecrosis refers to the breakdown of
normal body tissue near the original tumor site after radiation therapy. One
patient from the IORT group was still alive in fall 2021, whereas none of the
patients in the control group survived.


“We feel that these initial results are encouraging, as the data
indicates Xoft Brain IORT may be a viable additional treatment option for
patients with recurrent GBM,” added Stevens. “This compelling research offers
important insights that shows this technique could potentially play a more
prominent role in the treatment of brain tumors.”


Additionally, a subgroup analysis of patients with postoperative
tumors volumes of less than 2.5 cm showed more favorable outcomes for patients
in the IORT group. The researchers concluded that the results are encouraging
and that further clinical trials are warranted.


“The results indicate Xoft Brain IORT may provide clinical benefit
in overall survival and progression-free survival, in combination with maximal
safe re-resection of recurrent GBM, compared to re-resection and standard
adjuvant therapy,” said Dr.
Krivoshapkin. “These data are particularly promising, especially for patients
with smaller postoperative residual tumors, which underscores the importance of
administering radiation directly after removing the tumor, rather than waiting
weeks after surgery, as may be the case with other treatment options.”


The Xoft System is FDA-cleared, CE marked and licensed in a
growing number of countries for the treatment of cancer anywhere in the body. It
uses the world’s smallest X-ray source to deliver a precise, concentrated dose
of radiation directly to the tumor site, which targets cancer cells while
minimizing the risk of damage to healthy tissue in nearby areas of the body.
For the treatment of certain types of tumors, including brain cancers, IORT
with the Xoft System may allow appropriately selected patients to potentially
replace weeks of post-operative external beam radiation therapy (EBRT) with a
single fraction of radiation.


IORT allows
radiation oncologists and surgeons to work together to deliver a full course of
radiation treatment in one day, at the time of surgery, while the patient is
under anesthesia. Once the tumor has been surgically removed, the Xoft System’s
miniature X-ray source is temporarily inserted inside a flexible balloon-shaped
applicator, which has been placed inside the tumor cavity, and is used to
deliver a single dose of radiation directly to the tumor bed.


The Xoft System is also currently being studied in the treatment
of other types of brain tumors. In 2020, a patient with a brain metastasis from
an Ewing’s Sarcoma was the first patient to be treated in Spain with Xoft Brain
IORT at the Miguel Servet University Hospital in Zaragoza, Spain, where doctors
successfully removed the metastasis and treated the patient using Xoft IORT.
More than five patients with either brain metastases or recurrent GBM have been
treated in Spain with Xoft Brain IORT since then.


“We continue to be
inspired by the widespread interest in this innovative technique and the GLIOX
trial from renowned key opinion leaders and international centers,” added
Stevens. “Xoft Brain IORT represents just one of the exciting new and emerging
applications we are currently exploring with the multiplatform Xoft System,
which can rapidly be adopted into facilities, given it is highly mobile, does
not require facility investment in additional shielding, and is already cleared
for use by the FDA for treatment of cancer anywhere in the body.”


GBM is the most
common and aggressive type of malignant primary brain tumor, with a median
survival of 10-12 months.[ii],[iii]
Worldwide, 308,102 new cases of brain and nervous system tumors were diagnosed
in 2020.[iv]
In the U.S., the incidence of metastatic brain tumor diagnosis is approximately
200,000 people annually.[v]


( Identifier: NCT04681677)

Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De
Vleeschouwer S, editor. Glioblastoma [Internet]. Brisbane (AU): Codon
Publications; 2017 Sep 27. Chapter 8. Accessed via 

[iii] Pan E, Prados MD. Glioblastoma Multiforme
and Anaplastic Astrocytoma.
In: Kufe DW, Pollock RE, Weichselbaum RR, et
al., editors. Holland-Frei Cancer Medicine. 6th edition. Hamilton (ON): BC
Decker; 2003. Accessed via 

WHO, IARC, Globocan Cancer Incidence and Mortality Worldwide in 2020. Accessed