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., Dec. 29, 2020 (GLOBE NEWSWIRE) — 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 Santosh Kesari, 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.45 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.
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.
Amy Cook, iCAD
+1 (925) 200-2125
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.
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/.
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