Company sees positive momentum as research contributes to growing body of evidence supporting Xoft intraoperative radiotherapy (IORT) technology for brain cancer
NASHUA, N.H. – May 17, 2021 – iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced a virtual roundtable discussion will feature leading experts on brain cancer from around the globe sharing clinical updates on how intraoperative radiation therapy (IORT) with the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is emerging as a multidisciplinary approach for the treatment of brain tumors. The free webinar, titled “IORT: Cana New Multidisciplinary Approach Make a Difference in Treating Brain Tumors?” will take place Tuesday, May 25, 2021, from 12:00 to 1:00 pm EDT. To register for the event, visit this link.
The following world-renowned experts will be featured in the virtual roundtable event:
- Santosh Kesari, MD, PhD, Director of Neuro-oncology, Chair and Professor, Department of Translational Neurosciences at Saint John’s Cancer Institute in Santa Monica, CA and lead investigator of the GLIOX international multi-center clinical trial evaluating the Xoft System as the sole radiation therapy to treat recurrent glioblastoma (GBM) following surgical excision of the malignancy. Dr. Kesari is ranked among the top 1% of neuro-oncologists and neurologists in the nation.[i]
- Alexey Krivoshapkin, MD, PhD, Professor, Head of Neurosurgery branch of Neurology and Neurosurgery School, Neurosurgeon at the European Medical Center (EMC) in Moscow, Russia, and lead investigator of the first prospective study evaluating the Xoft System for the treatment of recurrent GBM.
- Michael Howard, PhD, DABMP, RSO, Director of Oncology Services and Chief of Medical Physics at the Sarah Cannon Cancer Institute at the Parkridge Medical Center in Chattanooga, TN, where an independent clinical trial is currently underway to evaluate Xoft Brain IORT for recurrent GBM.
- Kristin Schmiedehausen, MD, Senior Director of Clinical Development at Xoft (moderator)
“This comprehensive webinar includes an esteemed panel of experts discussing the promising potential of Brain IORT with the Xoft System, a groundbreaking procedure that has the potential to extend lives and address a critically important need in the treatment of metastatic brain tumors and recurrent GBM,” said Michael Klein, Chairman and CEO of iCAD. “Current treatment methods are often limited by a high risk of toxicity from radiation; however, Xoft Brain IORTis a multidisciplinary treatment that is gaining recognition as a feasible option for treating brain tumors. We are inspired by the widespread interest from worldwide key opinion leaders and international centers in Xoft Brain IORT and the GLIOX trial to evaluate this new approach to local control of recurrent GBM, and to add to the growing body of clinical data.”
“Time is of the essence as typical outcomes for patients with malignant brain tumors tend to be extremely poor, in particular in patients with GBM,” according to Dr. Schmiedehausen. “This international multi-center study (GLIOX) exploring the addition of Xoft Brain IORT as a potential new approach to improve overall survival as well as local control in patients with recurrent GBM is vital, as this innovative concept may offer a promising new option for those patients. As such, Xoft has received immense interest from the global clinical community with multiple commitments to engage in the trial – supporting the ultimate goal of rapid clinical adoption, particularly because Xoft eBx is already FDA-cleared to treat cancer anywhere in the body.”
The GLIOX trial is designed to compare Xoft IORT plus Bevacizumab (Avastin) to the control arm of RTOG-1205 (external beam radiation therapy (EBRT) plus Bevacizumab) to help confirm early Xoft IORT results previously reported.
As multiple studies progress and new, encouraging data are shared, the body of research supporting Xoft Brain IORT as a new multidisciplinary approach that may make a significant difference in treating brain tumors continues to grow. Recent results as of late October 2020 show that four out of 15 Xoft IORT patients were still alive from the prospective study at the European Medical Center (EMC) in Moscow under the guidance of Dr. Krivoshapkin, whereas none of the patients on the EBRT arm of the study survived. These data continue to demonstrate significant improvement in overall survival (OS) and local progression-free survival (locPFS) in patients with recurrent GBM treated with Xoft IORT, versus patients treated with EBRT and systemic therapy.
In addition, a clinical trialat the Sarah Cannon Cancer Institute, where Dr. Howard directs Oncology Services, is currently recruiting patients to assess the feasibility and safety of treatments with Xoft to deliver a single fraction of 20 Gy intraoperatively following maximal neurosurgical resection of recurrent GBM.
“New treatments for recurrent GBM are greatly needed, and local recurrence is often inevitable after the first round of radiation therapy due to resistance to radiation,” said Dr. Howard. “However, clinical results are beginning to reveal that Xoft Brain IORT shows significant promise for treating recurrent GBM, and we are eager to begin evaluating its feasibility and safety on patients here at the Sarah Cannon Cancer Institute.”
The Xoft System is also currently being studied in the treatment of other types of brain tumors. In early 2020, a study began evaluation of Xoft IORT 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. Results from the initial stage of the trial indicate the feasibility and safety of Xoft IORT, as initial experience suggests that Xoft IORT for treatment of large, resected brain metastases is well tolerated without significant adverse treatment effects.
Also in 2020, a patient with a brain metastasis from Ewing’s Sarcoma was the first patient to be treated in Europe with Xoft Brain IORT at the Miguel Servet University Hospital in Zaragosa, Spain, where doctors successfully removed the metastasis and treated the patient using Xoft IORT.
iCAD’s panel of experts who are collaborating to expand research on Xoft Brain IORT to multiple leading cancer centers worldwide continues to grow, as does its team of advisors. Most recently, Minesh P. Mehta, MD, FASTRO, Deputy Director and Chief of Radiation Oncology at the Miami Cancer Institute in Florida, has agreed to advise the company on the treatment of brain cancer. Dr. Mehta is internationally recognized for his significant contributions to oncology, and he provides national and international guidance in Brain Tumor Clinical Trials through his leadership of the Brain Tumor Committee of the Radiation Therapy Oncology Group (RTOG). He has authored approximately 100 book chapters and published more than 800 scientific papers and abstracts.
To investigate the potential benefit of Xoft IORT beyond recurrent GBM, iCAD is developing an observational patient registry to capture and analyze data from all patients with any type of brain tumor treated with IORT. The results of this registry will help identify patients who may benefit most from IORT and to help clinicians understand the place of IORT in an overall therapeutic regimen for brain tumors.
About Brain Tumors
Worldwide, 308,102 new cases of brain and nervous system tumors were diagnosed in 2020.[ii] In the U.S., the incidence of metastatic brain tumor diagnosis is approximately 200,000 people annually.[iii] GBM is the most common and aggressive type of malignant primary brain tumor, with a median survival of 10 to 12 months.[iv],[v] 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.
Jessica Burns, iCAD
Jeremy Feffer, LifeSci Advisors
+1 (212) 915-2568
[i] Castle Connolly Medical Ltd.
[ii] 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.
[iv] 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.
[v] 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/.