In the US, the first recurrent glioblastoma tumor is treated with Xoft Brain IORT

0

The treatment marks the start of an international, multi-center study evaluating targeted radiation therapy and bevacizumab for the treatment of the most common and aggressive type of malignant brain tumors

Fascinating research supporting a novel therapeutic approach recently published in the journal Surgical Neurology International

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

“This is a milestone, not only for iCAD, but for patients with this devastating disease,” said Stacey Stevens, President and future CEO of iCAD, Inc will be the growing body of evidence supporting intraoperative radiotherapy (IORT) with the Xoft system for the treatment of various types of tumors, including recurrent GBM.”

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

“This is a significant milestone, not only for our institute, but also for patients with recurrent glioblastoma,” said the site’s principal investigator, Naveed Wagle, MD, associate professor of neuroscience at Saint John’s Cancer Institute in Santa Monica, California. “Starting a clinical trial is no small feat under normal circumstances, but the COVID pandemic presented us with additional challenges to overcome. It really was a tremendous achievement and we are excited to now be able to offer it to patients.”

New research supports innovative therapeutic approach

Compelling data supporting Xoft Brain IORT for the treatment of recurrent GBM were recently published in to learn and a subsequent one erratum in the peer-reviewed journal, Surgical Neurology International. Led by principal investigator Alexey Krivoshapkin, MD, PhD, Professor and Head of the Department of Neurosurgery at the European Medical Center (EMC), the comparative study evaluated 15 patients with recurrent GBM treated with maximally safe resection and Xoft Brain IORT and 15 patients with recurrent GBM treated with maximum safe resection and other modalities (control group) between June 2016 and June 2019.

As of March 2021, patients treated with Xoft Brain IORT lived up to 54 months post-treatment without recurrence, while patients in the control group relapsed within 10 months and lived up to 22.5 months post-treatment. The researchers also found that 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 following radiation therapy. One patient from the IORT group was still alive in fall 2021, while none of the patients in the control group survived.

“We believe these early results are encouraging as the data suggest that Xoft Brain IORT could be a viable additional treatment option for patients with recurrent GBM,” added Stevens. “This compelling research provides important insights that show this technique could potentially play a more important role in the treatment of brain tumors.”

In addition, a subgroup analysis of patients with postoperative tumor volumes 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 suggest that Xoft Brain IORT may provide clinical benefit in terms of overall and progression-free survival compared to resection and standard adjuvant therapy combined with maximally safe resection of recurrent GBM,” said Dr. Krivoshapkin. “These data are particularly promising, particularly for patients with smaller postoperative residual tumors, underscoring the importance of radiation therapy immediately after tumor removal, rather than waiting weeks after surgery as may be the case with other treatment options.”

the Xoft system is FDA cleared, CE marked and approved in a growing number of countries to treat 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, targeting cancer cells while minimizing the risk of damaging healthy tissue in nearby areas of the body. For the treatment of certain types of tumors, including brain tumors, IORT with the Xoft System may allow appropriately selected patients to potentially replace weeks of postoperative external beam radiation therapy (EBRT) with a single radiation fraction.

IORT allows radiation oncologists and surgeons to work together to deliver a full 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 into a flexible balloon-shaped applicator that has been placed in the tumor cavity and used to deliver a single dose of radiation directly to the tumor bed.

The Xoft system is also being studied for the treatment of other types of brain tumors. In 2020, a patient with a brain metastasis from Ewing’s sarcoma became the first patient treated in Spain with Xoft Brain IORT at the Miguel Servet University Hospital in Zaragoza, Spain, where doctors successfully removed the metastases and treated the patient with Xoft IORT . Since then, more than five patients with brain metastases or recurrent GBM have been treated with Xoft Brain IORT in Spain.

“We continue to be inspired by the widespread interest in this innovative technique and the GLIOX study from renowned 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 cross-platform Xoft system, which can be rapidly rolled out in facilities because it is highly mobile, requires no investment in additional shielding and already is FDA approved to treat cancer anywhere in the body.”

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

About iCAD, Inc.
Headquartered in Nashua, New Hampshire, iCAD® is a leading global medical technology company providing innovative solutions for cancer detection and therapy. For more information visit www.icadmed.com and www.xoftinc.com.

Forward-Looking Statements
Certain statements in this press 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 that could cause the Company’s actual results, performance or achievements to differ materially from any prior results, performance or achievements expressed or implied by such forward-looking statements . looking statements. These factors include, but are not limited to, the Company’s ability to achieve positive results from this or future trials, business and strategic objectives, IORT’s ability to provide flexibility, mobility or other advantages to be more beneficial to patients than conventional therapy or acceptance by patients or physicians, the impact of supply and manufacturing limitations or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or governmental regulations, changes in Medicare or other reimbursement policies, risks associated therewith our existing and future debt obligations, competitive factors, the effects of a downturn in the economy or in the markets served by the company; and other risks set forth 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 these forward-looking statements, which speak only as of the date on which the statement is made. The company undertakes no obligation to provide updates to the information contained in this press release. For additional disclosures regarding these and other risks iCAD faces, please see the disclosures in our public filings with the Securities and Exchange Commission, which are available in 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
[email protected]

Investor Relations:
Jeremy Feffer, LifeSci consultant
+1 (212) 915-2568
[email protected]

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; 27 September 2017. Chapter 8. Accessed from 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 from https://www.ncbi.nlm.nih.gov/books/NBK12526/.
IV WHO, IARC, Globocan Cancer Incidence and Mortality Worldwide in 2020. Accessed from https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
vhttps://www.abta.org/tumor_types/metastatic-brain-tumors/

Share.

Comments are closed.