iCAD Announces Renowned Neuro-Oncologist Santosh Kesari, MD, PhD to Lead Post-Market Study for Treatment of Recurrent Glioblastoma (GBM) with FDA-cleared Xoft Brain IORT Technology to Support Clinical Adoption
International
Multi-Center Study to Commence January 2021
University
of Louisville’s Trial on IORT for Large Brain Lesion Treatments Accelerating
First
European Patient Treated for Brain Metastasis with Xoft IORT System
NASHUA, N.H. – December 29, 2020 – iCAD, Inc. (NASDAQ: ICAD), a global
medical technology leader providing innovative cancer detection and therapy
solutions, today announced the appointment of Santosh Kesari, MD, PhD, a world-renowned
neuro-oncologist, as Principal Investigator of its International multi-center clinical trial evaluating
the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® as the sole radiation
therapy to treat recurrent glioblastoma (GBM) following surgical excision of the
malignancy. The study is planned to commence in January 2021 at leading academic
institutions and community hospitals worldwide.
“GBM is one of the most aggressive cancers with very poor survival
and innovative approaches are needed,” said SantoshKesari, MD, PhD, Chair and Professor, Department of Translational Neurosciences
and Neurotherapeutics at the John Wayne Cancer Institute in Santa Monica,
California. “We are eager to open this international Phase II multi-center study
using Xoft IORT as a potential new approach to local control of this
devastating disease. In particular, if the results of this Phase II medical
device trial confirm previously reported results, this innovative technology
could rapidly be adopted since it is already cleared for use by the FDA for
treatment of cancer anywhere in the body.”
According to Xoft Co-founder, Thomas W. Rusch, PhD, “Xoft IORT
treatment applied to the brain is consistent with our long-term vision of being
able to treat cancer and other proliferative disease anywhere in the body with
electronic brachytherapy.”
In this prospective study, a single
patient group of 80-100 participants with recurrent GBM will be treated with
single fraction intra-operative radiation therapy (IORT) using the Xoft eBx
System at the time of neurosurgical resection. 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 the risk of damage to healthy tissue in nearby areas of the brain,
such as the optic system. The isotope-free radiation requires minimal
shielding, enabling medical professionals to remain in the room during
treatment.
The primary outcome measures will assess the overall survival (OS)
of patients treated with Xoft Brain IORT following the surgical excision of the
recurrent GBM. Treatment with Bevacizumab, a targeted anti-cancer drug, will be
initiated 28-42 days after the surgery. Serving as both comparison and a
historical control will be the prospective, randomized interventional arm of
the RTOG-1205 trial. The
secondary endpoints will assess the pattern of disease progression, potential
adverse events and quality of life. It is anticipated some preliminary data
will be submitted for presentation by the end of the 2021.
“This trial serves to compare Xoft IORT plus Bevacizumab (Avastin)
to External Beam Radiotherapy (EBRT) plus Bevacizumab to help confirm the
promising early Xoft IORT results that have been previously reported,” said
Robert Burnside, Vice President of Clinical Innovation at Xoft.
“We’re excited to start this very important clinical trial with
Dr. Kesari as Lead Investigator, an accomplished researcher and clinician who
ranks in the top 1% of neuro-oncologists and neurologists in the U.S.,[1]”
said Michael Klein, Chairman and CEO of iCAD. “Xoft Brain IORT has the
potential to extend lives and address a substantial unmet need in the treatment
of recurrent GBM. There is no highly effective approach to treat these patients
and the repeated use of EBRT is often limited by a relatively high risk of
radiation toxicity. Specifically, Xoft Brain
IORT may provide an approach that improves patient outcomes, as well
as their quality of life while reducing treatment complications as a result of shorter
treatment duration compared to EBRT. These multiple weeks of daily radiation
treatments may be particularly problematic during COVID-19 and its aftermath.
“We are actively working with multiple
international centers that have expressed interest in implementing this
multi-center clinical trial at their facility,” continued Klein. “Our GBM
Expert Panel consists of over a dozen key opinion leaders from many luminary
sites in both the US and Europe. Many of the neurosurgeons, radiation
oncologists and neuro-oncologists are leaders in their respective fields. As a
result of their substantial interest and impetus, and with the anticipated
confirmation of earlier clinical data, the key rationale for this new trial, we
envision realizing commercial sales of the Xoft Brain IORT System well before the
end of 2021.”
This international multi-center trial and its forthcoming data
will likely add to existing findings from other clinical results previously
shared with the medical community. In October 2020, promising research
supporting the Xoft System for the treatment of recurrent GBM was presented at
the European Association of Neurosurgical Societies (EANS) Virtual Congress. The study is under
the guidance of Lead Investigator, Alexey Krivoshapkin, MD, PhD, a neurosurgeon
at the European Medical Center (EMC) in Moscow, Russia, and results demonstrate
significant improvement in OS and local progression-free survival (locPFS) in
patients with recurrent GBM treated with Xoft IORT versus patients treated with
EBRT and systemic therapy.
“We are encouraged by the promising results we’ve seen using IORT
to deliver the required prescribed single focal dose that is equal to multiple
sessions of EBRT while minimizing radiation dose to neighboring healthy tissue
for the treatment of recurrent GBM,” said Professor Krivoshapkin. “While our
findings concluded feasibility, more clinical trials are warranted, and we
whole-heartedly applaud the collaborative efforts.”
The Xoft IORT System is also currently being studied in a clinical
trial for the treatment of large brain metastases in patients treated with
neurological resection led by Shiao You Woo, MD, FACR, Professor and Chairman
of the Department of Radiation Oncology and Brian Williams, MD, Assistant
Professor in the Department of Neurosurgery at the University of Louisville
School of Medicine.
“We’ve treated four patients in our trial
and our initial experience suggests IORT using the Xoft eBx system for
treatment of large, resected brain metastases is well tolerated without
unexpected early adverse treatment effects,” said Mehran Yusuf, MD, radiation
oncologist at the James Graham Brown Cancer Center at the University of
Louisville.
In addition, the first patient in Europe to be treated with Xoft
Brain IORT took place at the Miguel Servet University Hospital in Zaragosa,
where a patient was treated for a brain metastasis from Ewing’s Sarcoma.
According to Reyes Ibanez, MD, the radiation oncologist responsible
for the clinical implementation and use of the Xoft System at the
hospital, “We were able to successfully remove the metastasis and treat
the patient using Xoft IORT. We’re very familiar with the Xoft eBx System, as
our hospital has performed hundreds of treatments with the technology for
breast and gynecological applications. As such, we are confident we will treat
more metastasis in the future using IORT.”
About Brain Tumors
Worldwide, almost 297,000 cases of brain and nervous system tumors
are diagnosed per year.[2]
In the U.S., the incidence of metastatic brain tumor diagnosis is approximately
200,000 people annually.[3]
GBM is the most common and aggressive type of malignant primary brain tumor,
with a median survival of 10-12 months.[4]
[5]
Treatment for brain tumors typically involves surgical removal, followed by
radiation therapy or chemotherapy.
About Xoft IORT
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
miniaturized x-ray source to deliver a precise, concentrated dose of radiation
directly to the tumor site while minimizing the risk of damage to healthy
tissue in nearby areas of the body. IORT with the Xoft System 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 inserted inside a flexible balloon-shaped applicator,
which is then placed inside the tumor cavity, filled with saline, and used to
deliver a single dose of radiation directly to the tumor bed. For the treatment
of certain types of brain tumors, 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.
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:
Amy Cook, iCAD
+1 (925) 200-2125
Investor Relations:
Jeremy Feffer, LifeSci Advisors
+1 (212) 915-2568
###
[1] Castle
Connolly Medical Ltd.
[2] 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.
[3] https://www.abta.org/tumor_types/metastatic-brain-tumors/
[4] 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.
[5] 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/.