University Hospitals Cleveland Medical Center Pilot Study Shows Promise for High-Risk Recurrent Head and Neck Cancer Treatment with Cesium-131 and Surgical Resection

Mar 31, 2021

RICHLAND, WASHINGTON – March 31, 2021 – A recently published small prospective series of patients with recurrent head and neck (H&N) cancers treated with surgical resection and Isoray’s Cesium-131 brachytherapy found potential benefits that support further research into combination therapy with Cesium-131 brachytherapy and surgical resection.

The prospective series was conducted at the University Hospitals Cleveland Medical Center and involved 12 patients who were consented to an IRB-approved protocol that began accruing patients in 2016. The research team was led by Dr. Min Yao, Department of Radiation Oncology, and Dr. Chad Zender, Department of Otolaryngology Head and Neck Surgery, University Hospitals Cleveland Medical Center. Yao is also a professor in the radiology department of the Case Western Reserve School of Medicine, and Zender is an associate professor at the Case Western Reserve School of Dental Medicine and in the department of otolaryngology at the University of Cincinnati.

The primary findings of this study include the fact that re-treatment of recurrent head and neck cancers with surgical resection and Cesium-131 brachytherapy appears safe and feasible. This finding is especially important due to the potential complications that follow re-irradiation of recurrent head and neck cancer using external beam radiation therapy (EBRT).

Study authors noted that brachytherapy provides the possibility of optimal dose conformity with sharp dose fall-off that limits radiation dose to normal tissues, leading to fewer side effects compared to EBRT. They also noted that brachytherapy performed at the time of surgery is convenient for patients, who would otherwise require 4-6 weeks of wound healing followed by 6-7 weeks of daily treatment with EBRT.

In addition, this small series found an acceptable rate of cancer recurrence inside the field of the Cesium-131 implant area – one out of twelve. The recurrence of most patients in this series was distant to the area of the Cesium-131 implant. The overall survival in this small series of patients were similar to those treated with a prolonged course of EBRT.

Dr. Min Yao said, “While this was a small prospective study, the findings are in line with several retrospective and prospective studies that have reported the feasibility of brachytherapy in postoperative re-irradiation in recurrent head and neck cancers. Further research exploring the combination of immunotherapy and Cs-131 implant is warranted. We are proud to continue our legacy as innovators committed to researching promising therapies to bring opportunities to patients through medical advancements and the very best in care.”

Commenting on the study, Isoray CEO Lori Woods said, “Looking to the future and bringing together the promise of Cesium-131 with surgical resection and immunotherapy represents what could prove to be a central moment in the treatment of head and neck cancer. We continue to strive to bring new brachytherapy treatment opportunities to the forefront to benefit patients and the medical professionals who care for them. This is yet another example of the commitment we have made as leaders in the field of brachytherapy.”

With over 66,600 new cases diagnosed in the U.S. every year and over 14,000 deaths a year, cancers of the head and neck represent a significant source of mortality and cancer-related morbidity. Cancers of the head and neck recur frequently following initial treatment, which typically involves a regimen of surgical resection, radiation treatment, and chemotherapy.

The anatomy of the head and neck is complex. It includes structures related with speech and swallowing and also critical structures such as spinal cord and carotid artery.  As a result, re-treatment with external beam radiation treatment becomes problematic due to the limited amount of radiation that can be administered to the area without giving rise to serious complications.

Brachytherapy with Cesium-131 offers a source of potentially effective radiation therapy for recurrent head and neck cancers due to the highly compact dose delivered by Cesium-131 implants.  Cesium-131 is capable of delivering high doses of radiation to the cancerous target following surgical resection in such a way that keeps the important anatomic structures of the head and neck from receiving damaging radiation.

Isoray is a medical technology company and innovator in seed brachytherapy. The Company is the world’s only producer of Cesium-131 brachytherapy, commercially known as Cesium Blu, which is powering expanding internal radiation treatment options throughout the body for difficult to treat head and neck, lung, brain, gynecological, pelvic, and colorectal cancers as well as prostate cancer.

 

Contact
Media and Public Relations: Sharon Schultz (302) 539-3747
Investor Relations: Mark Levin (501) 255-1910

 

About Isoray
Isoray, Inc., through its subsidiary, Isoray Medical, Inc., is the sole producer of Cesium -131, commercially known as Cesium Blu, brachytherapy seeds, which are expanding brachytherapy treatment options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium Blu by visiting www.isoray.com. Join us on LinkedIn and Facebook and follow us on Twitter.

 

Safe Harbor Statement
Statements in this news release about Isoray’s future expectations, including whether the study discussed in this news release will be successful and have favorable outcomes, the advantages of Cesium-131 and its delivery systems coupled with immunotherapy, the perception by patients of quality of life outcomes compared to other treatment options, whether demand for and use of Cesium-131 will increase or continue as anticipated and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing Isoray, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as the impact of COVID-19 on our financial results, suppliers, employees and scheduling of procedures, whether ongoing patient results are favorable and in line with the conclusions of clinical studies and initial patient results, physician acceptance, training and use of our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, changes in laws and regulations applicable to our products, and other risks detailed from time to time in Isoray’s reports filed with the U.S. Securities Exchange Commission. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations:

Mark Levin

Global IR Group
(501) 255-1910

Media and Public Relations:

Sharon Schultz
Schultz Public Relations
(302) 539-3747
schultzpr@mchsi.com