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Wake Forest First in World to Perform New Brain Tumor Treatment

Physicians at Wake Forest University Baptist Medical Center are the first in the world to treat a brain tumor patient with the newly FDA-approved GliaSite® Radiation Therapy System (RTS). The GliaSite RTS delivers site-specific, internal radiation to malignant brain tumors, treating the target area while minimizing exposure to healthy tissue.

Stephen B. Tatter, M.D., Ph.D., assistant professor of neurosurgery at Wake Forest University School of Medicine, performed the procedure on a 27 year-old patient with a glioblastoma multiforme. "GliaSite represents an important new treatment option for malignant brain tumors," said Tatter. "Until now, treatment for patients with recurrent brain tumors has been extremely limited. Radiation combined with surgery is the single most effective treatment, and the GliaSite RTS will enable these patients to receive additional radiation, while minimizing the risks associated with external beam radiation."

The device is a balloon catheter that is inserted into the cavity created by surgical removal of the malignant brain tumor and filled with liquid radiation. Over a course of three to seven days, GliaSite delivers radiation directly to the tissue surrounding the cavity, where tumors are most likely to recur.

The American Cancer Society estimates that 16,500 U.S. patients will be diagnosed this year with malignant primary brain tumors and nearly all will experience tumor regrowth after initial treatment. In addition, research suggests that approximately 170,000 patients will be diagnosed with metastatic tumors that originate elsewhere in the body and migrate to the brain.

Traditionally, patients are first treated with external beam radiation therapy, in which the radiation travels from outside the body to the tumor site, passing through healthy brain tissue. While this treatment is proven to delay tumor regrowth, a second course of external beam radiation is rarely an option due to the high risk of damage to healthy tissue.

"It''s a significant advancement to be able to offer an improved therapy that delivers radiation directly to the site of the cancer, while maintaining the quality of life for patients by completing the treatment in just one week," said Tatter. In addition, study results suggest that the survival rate of these patients is favorable in comparison to the next best secondary treatment, which is surgery plus chemotherapy wafers.

Safety and performance of the device were demonstrated in a National Cancer Institute (NCI)-sponsored, multi-centered study. Tatter was the principal investigator for the national study, which involved patients with recurrent brain tumors. All of the patients had undergone previous surgery and radiation therapy, and more than half had received chemotherapy. The median survival rate of the patients is currently 14 months, with patients still being followed, a substantial improvement over the results historically seen with other treatments.

Additionally, GliaSite has the potential to be used in combination with external beam radiation when treating newly diagnosed tumors, and there is substantial interest in using the device in combination with surgical removal of metastatic brain tumors.

The GliaSite RTS was developed by Proxima Therapeutics Inc., a Georgia-based developer and marketer of site-specific cancer treatments.

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