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Gliasite RTS Safe, Effective Treatment For Recurrent Brain Tumors

ALPHARETTA, GA -- August 7, 2003 -- Proxima Therapeutics, Inc., a developer of site-specific radiation therapy systems for brain and breast cancer, announced publication of data from a multi-center study of its GliaSite® Radiation Therapy System (RTS) in the August issue of the Journal of Neurosurgery.

Cleared by the U.S. Food and Drug Administration (FDA) on April 25, 2001, the GliaSite RTS internally administers radiation following surgery to remove the tumor at the site where recurrence is most likely. Results showed that the GliaSite RTS performs safely and delivers a therapeutic dose of radiation to tissue at highest risk for tumor recurrence. A full outline of the study and its results can be found at: http://www.proximatherapeutics.com/about/news/news_idx.htm, under the "Articles" section.

The study evaluated the safety and performance of the GliaSite RTS in patients with recurrent malignant brain tumors, following surgical removal of these tumors. The study was sponsored by the National Cancer Institute's Clinical Trials Evaluation Program (CTEP) and conducted at Wake Forest University (Winston-Salem, N.C.), Henry Ford Hospital (Detroit, Mich.), Johns Hopkins (Baltimore, Md.), Emory University (Atlanta, Ga.), Moffitt Cancer Center (Tampa, Fla.) and the University of Texas (San Antonio, Texas).

"Through the course of this study continuing through today in our practice, we are seeing very positive results with GliaSite. On average, survival rates have been upwards of one year. For these patients, being able to prolong life, even by a few months, is quite remarkable," said Stephen B. Tatter, M.D., Ph.D., neurosurgeon at Wake Forest University School of Medicine and lead investigator of the study. "Our experience with the GliaSite treatment shows that the quality of life maintained by these patients is also noteworthy as a full course of radiation with GliaSite can be completed in less than a week."

"The publication of this data in an esteemed, peer-reviewed journal further validates the results being achieved by neurosurgeons and radiation oncologists who have incorporated the GliaSite RTS into their brain cancer treatment practices," said Timothy Patrick, president and chief executive officer of Proxima Therapeutics. "We are encouraged to be able to offer GliaSite to appropriate patients as clinical adoption becomes more widespread. The GliaSite is now accessible to more patients than ever before."

GliaSite RTS is a patented device comprised of a balloon catheter that is inserted into the cavity created by the surgical removal of the malignant brain tumor. The device is then filled with Iotrex®, a proprietary liquid radiation source. Over the course of several days, GliaSite delivers radiation directly to the tissue surrounding the cavity, where tumors are most likely to recur, while reducing radiation exposure to healthy brain tissue.

GliaSite RTS is currently available in more than 100 brain tumor treatment centers throughout the country. Physicians and patients who would like more information about GliaSite RTS should visit www.GLIASITE.com, or call 866-PROXIMA.


SOURCE: Schwartz Communications

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