First Recurrent Glioblastoma Tumor is Treated with Xoft Brain IORT in the United States
Treatment 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
Intriguing
research supporting novel therapy approach recently published in peer-reviewed journal,
Surgical Neurology International
NASHUA,
N.H. – December 14, 2021 – iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer
detection and therapy solutions, today announced that the first patient with recurrent
glioblastoma (GBM) was treated with the Xoft® Axxent®
Electronic Brachytherapy (eBx®) System® at Providence Saint John’s Health Center in
Santa Monica, CA. This procedure was part of the international multi-center GLIOX trial [i] 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 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]
About iCAD, Inc.
Headquartered
in Nashua, NH, iCAD® is a global medical technology leader providing innovative
cancer detection and therapy solutions. For more information, visit www.icadmed.com and www.xoftinc.com.
Forward-Looking Statements
Certain
statements contained in this News Release constitute “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements about the future prospects for the Company’s
technology platforms and products. Such forward-looking statements involve a
number of known and unknown risks, uncertainties and other factors which may
cause the actual results, performance or achievements of the Company to be
materially different from any prior results, performance or achievements
expressed or implied by such forward-looking statements. Such factors include,
but are not limited, to the Company’s ability to achieve positive results from
this or any future studies, business and strategic objectives, the ability of
IORT to provide flexibility, mobility or other advantages, to be more
beneficial for patients than traditional therapy or to be accepted by patients
or clinicians, the impact of supply and manufacturing constraints or
difficulties, product market acceptance, possible technological obsolescence of
products, increased competition, litigation and/or government regulation,
changes in Medicare or other reimbursement policies, risks relating to our
existing and future debt obligations, competitive factors, the effects of a
decline in the economy or markets served by the Company; and other risks
detailed in the Company’s filings with the Securities and Exchange Commission.
The words “believe,” “demonstrate,” “intend,” “expect,” “estimate,” “will,”
“continue,” “anticipate,” “likely,” “seek,” and similar expressions identify
forward-looking statements. Readers are cautioned not to place undue reliance
on those forward-looking statements, which speak only as of the date the
statement was made. The Company is under no obligation to provide any updates
to any information contained in this release. For additional disclosure
regarding these and other risks faced by iCAD, please see the disclosure
contained in our public filings with the Securities and Exchange Commission,
available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.
Media Inquiries:
Jessica Burns, iCAD
+1-201-423-4492
Investor Relations:
Jeremy Feffer, LifeSci Advisors
+1 (212) 915-2568
###
[i]
https://clinicaltrials.gov/ct2/show/NCT04681677
(ClinicalTrials.gov Identifier: NCT04681677)
[ii]
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
https://www.ncbi.nlm.nih.gov/books/NBK470003.
[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 https://www.ncbi.nlm.nih.gov/books/NBK12526/.
[iv]
WHO, IARC, Globocan Cancer Incidence and Mortality Worldwide in 2020. Accessed
via https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
[v]https://www.abta.org/tumor_types/metastatic-brain-tumors/