First Recurrent Glioblastoma Tumor is Treated with Xoft Brain IORT in the United States

Treatment marks initiation of international multicenter trial evaluating targeted radiation therapy and bevacizumab for the treatment of the most common and aggressive type of malignant brain tumor

Intriguing research supporting novel therapy approach recently published in peer-reviewed journal, Surgical Neurology International

NASHUA, N.H., Dec. 14, 2021 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that the first patient with recurrent glioblastoma (GBM) was treated with the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® at Providence Saint John’s Health Center in Santa Monica, CA. This procedure was part of the international multi-center GLIOX trialⁱ led by principal investigator and world-renowned neuro-oncologist, Santosh Kesari, MD, PhD, Chair and Professor, Department of Translational Neurosciences at the Saint John’s Cancer Institute, Santa Monica, CA.

“This is a milestone achievement, not only for iCAD but also for patients with this devastating disease,” said Stacey Stevens, President and incoming CEO of iCAD, Inc. “It is our expectation that the GLIOX study and its forthcoming data will add to the growing body of evidence that supports intraoperative radiation therapy (IORT) with the Xoft System for the treatment of various types of tumors, including recurrent GBM.”

The GLIOX trial is designed to compare Xoft IORT plus Avastin® (bevacizumab) to the investigational arm of RTOG-1205 (EBRT plus bevacizumab). Researchers hope this study will validate the intriguing initial results from a prospective two center comparative study at the European Medical Center (EMC) in Moscow, Russia. Compelling data from this study were recently published in study and a subsequent erratum in the peer-reviewed journal, Surgical Neurology International.

“This is a significant milestone, not just for our institute, but also for patients with recurrent glioblastoma,” said the site’s principal investigator, Naveed Wagle, MD, Associate Professor of Neurosciences at the Saint John’s Cancer Institute in Santa Monica, CA. “The initiation of a clinical trial under normal circumstances is no small feat, but the COVID pandemic presented additional challenges that had to be overcome. It truly was an enormous achievement, and we are excited that we can now offer it to patients.”

New Research Supports Innovative Therapy Approach

Compelling data supporting Xoft Brain IORT for the treatment of recurrent GBM were recently published in study and a subsequent erratum in the peer-reviewed journal, Surgical Neurology International. Under the guidance of lead investigator, Alexey Krivoshapkin, MD, PhD, professor and head of the neurosurgery department at the European Medical Center (EMC), the comparative study evaluated 15 patients with recurrent GBM who were treated with maximal safe resection and Xoft Brain IORT, and 15 patients with recurrent GBM treated with maximal safe resection and other modalities (control group), between June 2016 and June 2019.

As of March 2021, patients treated with Xoft Brain IORT lived for up to 54 months after treatment without recurrence, whereas patients in the control group had a recurrence within 10 months and lived for up to 22.5 months after treatment. Researchers also found there were fewer complications, such as radionecrosis, in the IORT group. Radionecrosis refers to the breakdown of normal body tissue near the original tumor site after radiation therapy. One patient from the IORT group was still alive in fall 2021, whereas none of the patients in the control group survived.

“We feel that these initial results are encouraging, as the data indicates Xoft Brain IORT may be a viable additional treatment option for patients with recurrent GBM,” added Stevens. “This compelling research offers important insights that shows this technique could potentially play a more prominent role in the treatment of brain tumors.”

Additionally, a subgroup analysis of patients with postoperative tumors volumes of less than 2.5 cm showed more favorable outcomes for patients in the IORT group. The researchers concluded that the results are encouraging and that further clinical trials are warranted.

“The results indicate Xoft Brain IORT may provide clinical benefit in overall survival and progression-free survival, in combination with maximal safe re-resection of recurrent GBM, compared to re-resection and standard adjuvant therapy,” said Dr. Krivoshapkin. “These data are particularly promising, especially for patients with smaller postoperative residual tumors, which underscores the importance of administering radiation directly after removing the tumor, rather than waiting weeks after surgery, as may be the case with other treatment options.”

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 the world’s smallest X-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site, which targets cancer cells while minimizing the risk of damage to healthy tissue in nearby areas of the body. For the treatment of certain types of tumors, including brain cancers, 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.

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 is under anesthesia. Once the tumor has been surgically removed, the Xoft System’s miniature X-ray source is temporarily inserted inside a flexible balloon-shaped applicator, which has been placed inside the tumor cavity, and is used to deliver a single dose of radiation directly to the tumor bed.

The Xoft System is also currently being studied in the treatment of other types of brain tumors. In 2020, a patient with a brain metastasis from an Ewing’s Sarcoma was the first patient to be treated in Spain with Xoft Brain IORT at the Miguel Servet University Hospital in Zaragoza, Spain, where doctors successfully removed the metastasis and treated the patient using Xoft IORT. More than five patients with either brain metastases or recurrent GBM have been treated in Spain with Xoft Brain IORT since then.

“We continue to be inspired by the widespread interest in this innovative technique and the GLIOX trial from renowned key opinion leaders and international centers,” added Stevens. “Xoft Brain IORT represents just one of the exciting new and emerging applications we are currently exploring with the multiplatform Xoft System, which can rapidly be adopted into facilities, given it is highly mobile, does not require facility investment in additional shielding, and is already cleared for use by the FDA for treatment of cancer anywhere in the body.”

GBM is the most common and aggressive type of malignant primary brain tumor, with a median survival of 10-12 months.^ii,iii Worldwide, 308,102 new cases of brain and nervous system tumors were diagnosed in 2020.^iv In the U.S., the incidence of metastatic brain tumor diagnosis is approximately 200,000 people annually.^v

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:
Jessica Burns, iCAD  
+1-201-423-4492
jburns@icadmed.com

Investor Relations:
Jeremy Feffer, LifeSci Advisors
+1 (212) 915-2568
jeremy@lifesciadvisors.com

ⁱ https://clinicaltrials.gov/ct2/show/NCT04681677 (ClinicalTrials.gov Identifier: NCT04681677)
ⁱⁱ 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.
ⁱⁱⁱ 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/.
^iv 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.
^vhttps://www.abta.org/tumor_types/metastatic-brain-tumors/