iCAD Presents Positive New Clinical Data for Xoft Brain IORT at American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program
Promising clinical research supports Xoft brain IORT as a viable
treatment option for glioblastoma multiforme that may extend patients’ lives
Overall survival benefit reached statistical significance in the IORT
group with tumors less than or equal to 2.5 cm3 (p<0.05)
NASHUA, N.H. – May 13, 2020 – iCAD,
Inc. (NASDAQ: ICAD), a global medical
technology leader providing innovative cancer detection and therapy solutions,
today announced positive new clinical data supporting the Xoft® Axxent®
Electronic Brachytherapy (eBx®) System® for the treatment of glioblastoma
multiforme (GBM) will be presented at the American Society of Clinical Oncology
(ASCO) 2020 Virtual Scientific Program, which will take place May 29-31, 2020.
“This represents a
significant milestone for the company, as it further validates Xoft intraoperative
radiation therapy (IORT) in certain types of brain tumors and demonstrates the
impact that this unique technology offers,” according to Michael Klein,
Chairman and CEO of iCAD. “GBM is the most common and aggressive type of
malignant primary brain tumor, with a median survival of 10-12 months.1,2
With almost 297,000 cases of brain and nervous system tumors diagnosed
worldwide per year,3 this exciting new application for the Xoft
System could substantially expand our addressable market, but more importantly,
it has the potential to extend patients’ lives.”
The study, titled “Intra-operative
radiation therapy as salvage treatment option for recurrent glioblastoma
multiforme,” (abstract #291893) was submitted to ASCO by Nidal Salim, MD,
radiation oncologist and head of the radiotherapy center at the European
Medical Center (EMC) in Moscow, one of the largest private medical clinics in
Russia and an international leader in comprehensive care and oncology. It involved 30 patients with recurrent GBM who were
treated between August 2016 and June 2019. All patients underwent maximal safe
resection; 15 patients were treated with IORT without adjunctive chemotherapy, while the other 15 were treated with
external beam radiation therapy (EBRT) and temozolomide. According to study
findings, as of December 2019, median overall survival (OS) was 27
months in the IORT group, versus 21 months in the EBRT group. The local
progression free survival (locPFS) range for the IORT group was between 3.5 to
39 months, versus 2 to 10 months in the EBRT group. As of December 2019, 8 patients from the IORT group were still alive,
whereas none of the patients in the EBRT group survived. Kaplan-Meier OS
curves in patients with post-operative contrast-enhancing volume (POCEV) of ≤ 2.5cm3
showed more favorable outcomes for patients in the IORT group (p < 0.05).
Researchers concluded that IORT of recurrent GBM is feasible and provides
encouraging local progression-free and overall survival, with a manageable
toxicity profile.
Positive preliminary clinical data from this study was
presented in September 2019 by Alexey Gaytan, MD, PhD, neurosurgeon at the EMC
at the European Association of Neurosurgical Societies (EANS) Congress in
Dublin, Ireland.
“After researching this modality for nearly four years,
we are greatly encouraged by these clinical results and the benefits this
treatment offers to patients. For the treatment of GBM, IORT with the Xoft
System is a promising treatment option that may offer better outcomes for
patients, with minimal side effects, compared to traditional radiation
therapy,” according to the study’s lead researcher, Alexey Krivoshapkin, MD,
PhD and neurosurgeon at the EMC. “This treatment option not only has the
potential to increase overall survival, it may also enhance patients’ quality
of life by allowing them to forego weeks of daily radiation fractions and
instead spend that time with their families and loved ones.”
Prof. Krivoshapkin will discuss these findings in a
European Society for Radiotherapy (ESTRO) Virtual Satellite Symposium hosted by
Xoft, titled “Intraoperative Radiation Therapy (IORT) for Brain Cancer:
Local Tumor Control in Patients with Recurrent Glioblastoma,” on Thursday,
May 14, at 8 am ET and Tuesday, May 19, at 12 pm ET. Registration is available
for these events via this
link: https://www.icadmed.com/educational-webinars.html.
This research adds to the
growing body of evidence that continues to support the Xoft System across
multiple cancer types, including early-stage breast cancer, gynecological
cancers, nonmelanoma skin cancers and recently, brain tumors. The Xoft System
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. Xoft brain 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 remains 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.
“This research is
particularly relevant as COVID-19 continues to be a major global health
concern, as it is in line with recent clinical guidelines issued by several national medical societies
that recommend an abbreviated course of radiation, when appropriate,4,5”
noted Klein. “IORT with the Xoft System
offers a transformative solution that may help
to alleviate the burden placed on many hospitals and healthcare facilities
during the COVID-19 de-escalation phase. The ability to treat patients with a
full course of radiation in just one day may not only free up space in
hospitals and allow clinicians to focus on other critical needs, it may reduce
immunocompromised patients’ time in hospitals and minimize their potential
exposure to the virus.”
This research builds upon
a retrospective analysis published last year in World Neurosurgery by
Prof. Krivoshapkin, et al., which examined the repeat resection and the various
methods of IORT for the treatment of malignant brain gliomas (MBGs), including
high-energy linear accelerators and modern, integrated brachytherapy solutions
using solid and balloon applicators.6 The conclusions of this review
identified IORT with balloon applicators to be particularly promising.
iCAD also recently
announced the first metastatic brain tumor was treated in the U.S. with IORT
using the Xoft System at the James Graham Brown Cancer Center at the University
of Louisville. The procedure marked the start of a clinical trial on IORT for
patients with large brain metastases treated with neurological resection with
the Xoft System, led by Shiao Yuo Woo, MD, FACR, radiation oncologist, James Graham
Brown Cancer Center at the University of Louisville.7
“Our technology is world-class, and we remain steadfast
in our mission to unlock its full potential as we explore the clinical
development of FDA-cleared, CE marked Xoft technology across an ever-expanding
array of various types of tumors,” Klein added.
References:
1.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.
2.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/.
3.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.
4.American Society for Radiation
Oncology (ASTRO) COVID-19 Recommendations to Radiation Oncology Practices.
(2020). Accessed via
https://www.astro.org/Daily-Practice/COVID-19-Recommendations-and-Information.
5.The American Society of Breast
Surgeons (ASBrS), the National Accreditation Program for Breast Centers
(NAPBC), the National Comprehensive Cancer Network (NCCN), the Commission on
Cancer (CoC) of the American College of Surgeons, and the American College of
Radiology® (ACR®) joint recommendations.
Recommendations for Prioritization, Treatment and Triage of Breast
Cancer Patients During the COVID-19 Pandemic. (2020). Accessed via https://www.facs.org/-/media/files/quality-programs/napbc/asbrs_napbc_coc_nccn_acr_bc_covid_consortium_recommendations.ashx.
6.Krivoshapkin A, et al. Repeat
Resection and Intraoperative Radiotherapy for Malignant Gliomas of the Brain: A
History and Review of Current Techniques. World Neurosurgery (2019) 132:
356-362. Accessed via https://doi.org/10.1016/j.wneu.2019.09.037.
7.University
of Louisville. Study of Intraoperative Radiotherapy for Patients With Large
Brain Metastases Treated With Neurosurgical Resection. Accessed via
https://clinicaltrials.gov/ct2/show/NCT04040400. ClinicalTrials.gov Identifier:
NCT04040400.
8.Conant, E et al. (2019). Improving
Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital
Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4). Accessed via https://pubs.rsna.org/doi/10.1148/ryai.2019180096.
About iCAD, Inc.
Headquartered
in Nashua, NH, iCAD is a global medical technology
leader providing innovative cancer detection and therapy solutions.
ProFound AI™ is a high-performing workflow solution for 2D and 3D
mammography, or digital breast tomosynthesis (DBT), featuring the latest in
deep-learning artificial intelligence. In 2018, ProFound AI for Digital Breast
Tomosynthesis (DBT) became the first artificial intelligence (AI) software for
DBT to be FDA-cleared; it was also CE marked and Health Canada licensed that same
year. It offers clinically proven time-savings benefits to radiologists,
including a reduction of reading time by 52.7 percent, thereby halving the
amount of time it takes radiologists to read 3D mammography datasets.
Additionally, ProFound AI for DBT improved radiologist sensitivity by 8 percent
and reduced unnecessary patient recall rates by 7.2 percent.8
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 potential
effectiveness of our product for the various suggested uses, our ability to
extend patients’ lives, improve patient survival, offer a transformative
solution, the impact of supply and manufacturing constraints or difficulties,
uncertainty of future sales levels, to defend itself in litigation
matters, protection of patents and other proprietary rights,
product market acceptance, possible technological obsolescence of products, increased
competition, 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.
Contacts:
Media inquiries:
Jessica Burns, iCAD
+1-201-423-4492
Investor inquiries:
Jonathan Wexler,
Scope Investor Relations, LLC
+1-203-247-8767