FDA Clears IsoRay, Inc. (ISR)’s GliaSite(R) Treatment for Brain Cancer

IsoRay, Inc. (Amex:ISR – News) announced today that the FDA has cleared its GliaSite® radiation therapy system, a balloon catheter device used in the treatment of brain cancer. The clearance was the major step required to return the GliaSite® radiation therapy system to the marketplace. The system’s balloon catheter is a landmark technology that allows physicians to treat more brain cancer patients than ever before with internal radiation or brachytherapy.
The GliaSite® radiation system offers a number of advantages in brain cancer treatment. A specified high dose of a liquid radiation source is placed in the areas most likely to contain cancer after brain tumor removal. This form of radiation is less likely to damage healthy brain tissue than other alternatives. The ability for the tumor to recur is greatly diminished, impacting patient longevity and quality of life.

IsoRay has exclusive worldwide distribution rights for the GliaSite® radiation therapy system as well as exclusive worldwide licensing rights to Iotrex®, a liquid iodine radiation for use in brain cancer treatment. IsoRay undertook a number of steps ranging from improvement in product design, rigorous testing, and new manufacturing techniques including a new balloon manufacturing system before seeking FDA clearance for use. IsoRay’s improved GliaSite® delivery system was found to have exceeded all prior product specifications during the reporting and testing phase.

Brain cancer is one of the fastest growing cancers and recurrence often proves fatal. Over 575 people a day are diagnosed with brain cancer in the United States alone. No two brain tumors are alike and brain cancers can range from Glioblastomas to metastasized brain cancer. Brain cancer’s impact can be devastating with its effect on the vital center that controls a person’s thinking, emotions, and movement. These tumors are very difficult to treat. Completely removing a tumor presents complex challenges to minimize damage to the brain. Doctors must also deal with the intricacies of tumors that tend to spread to healthy parts of the brain. Typically, surgeons remove as much as they can of the tumor and then treat the areas surrounding where the tumor was removed with radiation therapy. Chemotherapy is sometimes used as well. Treatment is further complicated by the fact that most cancerous brain tumors recur shortly following removal, and the cancer tends to return near the site of the original tumor.

With the FDA clearance, IsoRay will now be able to move forward in seeking additional regulatory approval for its new liquid form of Cesium-131 internal radiation therapy for the treatment of brain cancer that would be delivered using the GliaSite® system replacing Iotrex. In its current form, IsoRay’s patented Cesium-131 internal radiation therapy is demonstrating its value. Cesium-131’s current five year data has the highest cancer free success rate for patients being treated for prostate cancer. It represents the biggest advancement in internal radiation therapy in twenty years providing several advantages over other internal radiation therapies. Doctors can vigorously treat a variety of cancers with reduced side effects and limited damage to healthy surrounding tissues and organs compared to other internal radiation therapies. Cesium-131 radiation therapy impacts longevity and cure rates, can be performed outside a hospital setting, and results in a patient’s faster return to normal activities.

IsoRay CEO Dwight Babcock says the FDA clearance represents another step forward in achieving the Company’s goals. “FDA clearance of the GliaSite® system represents a key development in opening the door to further advances that can expand treatment efficacy as we seek clearance for the use of liquid Cesium-131. We have already seen the importance of Cesium-131 internal radiation therapy seeds in effecting survivability and quality of life in the treatment of cancers throughout the body. As a company, we are excited to see expanding adoption in hospitals and medical practices nationwide and internationally. Just as importantly, however, we are cognizant of this crucial milestone for patients who are searching for treatment options and hope in their fight against brain cancer. ”

Prior to the Company’s acquisition of the GliaSite® technology, approximately 500 GliaSite cases were performed annually at some 40 hospitals worldwide. Babcock says physicians are enthusiastically awaiting GliaSite®’s availability. “With our sales launch expected in the fourth quarter, we know there is great interest and a growing number of inquiries from the marketplace. We are already hearing from doctors who are anxious to access this leading-edge technology to treat their patients and give them more choices,” he noted.

The GliaSite® system has established reimbursement for both in-patient and out-patient settings. In addition to its CMS codes, Cesium-131 is FDA-cleared in seed form for the treatment of prostate, lung, ocular melanoma, brain, colorectal, gynecologic, and head and neck cancer and other cancers throughout the body.

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