New Data Supports iCAD’s Xoft Brain IORT as Feasible Treatment for Recurrent Glioblastoma
New, Encouraging Results
and Overall Patient Survival Numbers to be Presented at European Congress of
Neurosurgery
NASHUA, N.H. – October 19, 2020 – iCAD, Inc. (NASDAQ: ICAD), a global
medical technology leader providing innovative cancer detection and therapy
solutions, today announced that new, promising clinical results supporting the Xoft®
Axxent® Electronic Brachytherapy (eBx®) System® for the treatment of recurrent
glioblastoma (GBM), will be presented at the European Association of
Neurosurgical Societies (EANS) Virtual Congress, October 19- 21,
2020.
New Data from the ongoing prospective study, entitled “Four-year
experience of maximal safe resection with intraoperative balloon electronic
brachytherapy for recurrent glioblastoma,” (AS-EANS-2020-00135) will be
presented by Alexey Gaytan, MD, PhD, a neurosurgeon at the European Medical
Center (EMC) in Moscow, Russia. The latest results demonstrate significant
improvement in overall survival (OS) and local progression-free survival
(locPFS) in patients with recurrent GBM treated with Xoft Intraoperative
Radiotherapy (IORT) versus patients treated with external beam radiation
therapy (EBRT) and systemic therapy.
“The latest results are extremely encouraging, as they underscore
the potential of Xoft IORT for recurrent glioblastoma while illustrating the
impact our innovative technology may have on the treatment of the most aggressive
primary brain tumors,” said Michael Klein, Chairman and CEO of iCAD. “GBM has a
median survival of 10-12 months[i],[ii]
and almost 297,000 cases of brain and nervous system tumors are diagnosed
worldwide each year,[iii]
with inevitable recurrence; however, this data is promising and may offer hope
to patients and their families.”
The study, under the guidance of Lead
Investigator, Alexey Krivoshapkin, MD, PhD, a neurosurgeon at the EMC, involves
28 patients with recurrent GBM who were
treated between August 2016 and June 2019. All
patients underwent maximal safe resection. Researchers concluded that IORT of
recurrent GBM is feasible and provides encouraging local progression-free and
overall survival, with a manageable toxicity profile, and that further clinical
trials are warranted.
As of May 2020, 5 patients from the IORT group were still alive,
whereas none of the patients in the EBRT group survived. Our earlier release of
January survival data included 7 patients surviving as of mid-December 2019. The
survival of patients in the IORT group ranged from 16 – 59 months after the
initial GBM diagnosis. As previously disclosed, the EBRT group survival ranged
from 5.5 – 38.5 months after initial GBM diagnosis.
“We continue to be greatly encouraged by these clinical results
and the benefits this treatment offers to patients with GBM,” said Professor
Krivoshapkin. “There is no standard approach on how to treat patients with
recurrent GBM and the repeated use of EBRT in recurrent brain tumors is often
limited by a relatively high risk of radiation toxicity. Intraoperative balloon
electronic brachytherapy has the potential to deliver the required prescribed
single focal dose that is equivalent to multiple sessions of EBRT while
minimizing radiation dose to neighboring healthy tissue.”
iCAD recently assembled a panel of experts to expand research on
Xoft Brain IORT to multiple leading cancer centers worldwide. The Company is
also exploring other emerging applications for the Xoft System, including the
treatment of early-stage rectal tumors.
The Xoft System is a 50 kV radiation oncology treatment solution
that uses a miniaturized X-ray source to deliver a precise, concentrated dose
of radiation directly to the tumor site while minimizing risk of damage to
healthy tissue in nearby areas of the body. The isotope-free radiation requires
minimal shielding, enabling medical professionals to remain in the room during
treatment.
About iCAD, Inc.
Headquartered in Nashua, NH, iCAD is a
global medical technology leader providing innovative cancer detection and
therapy solutions.
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 a proprietary miniaturized x-ray source to
deliver a precise, concentrated dose of radiation directly to the tumor site,
while minimizing risk of damage to healthy tissue in nearby areas of the body.
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 future
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 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 https://www.icadmed.com and
on the SEC’s website at http://www.sec.gov.
Media Inquiries:
Amy Cook, iCAD
+1 (925) 200-2125
Investor
Relations:
Jeremy Feffer, LifeSci
Advisors
+1 (212) 915-2568
###
[i] 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.
[ii] 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/.
[iii] WHO,
IARC, Globocan Cancer Incidence and Mortality Worldwide in 2018. Accessed via
https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.