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Data on GliaSite Radiation Therapy System for Recurrent Brain Tumors Presented at Neurological Surgeons Meeting


Posted on: 10/21/2004

Data on GliaSite Radiation Therapy System for Recurrent Brain Tumors Presented at Neurological Surgeons Meeting

October 20, 2004 09:00 AM US Eastern Timezone

56th Annual Meeting of the Congress of Neurological Surgeons (CNS)

SAN FRANCISCO & ATLANTA--(BUSINESS WIRE)--Oct. 20, 2004--

Post-Market Study Shows Improved Patient Survival with GliaSite Versus Surgery Alone or Surgery Followed Solely by Chemotherapy Wafers
Proxima Therapeutics, Inc. today announced encouraging results of a post-market study on the GliaSite Radiation Therapy System for treatment of recurrent brain cancer. Details from this multi-center, retrospective study were discussed at the Annual Meeting of the Congress of Neurological Surgeons (CNS) taking place in San Francisco, October 16-21, in a presentation entitled, "GliaSite Radiotherapy System for Treatment of Recurrent Malignant Glioma: A Multi-Institutional Analysis" presented by Neurosurgeon Abhay Sanan, M.D. of the University of Arizona. In this study, patients with recurrent glioblastoma multiforme had a median survival of 36 weeks, in comparison to studies that find median survival of 20 weeks when this patient population is treated with surgery alone or a median survival of 28 weeks in this population treated with surgery and internal chemotherapy alone.

The standard treatment for malignant brain tumors has been surgery to remove the tumor followed by whole brain radiation therapy. This radiation, which is externally administered over the course of six weeks, destroys tumor tissue that cannot be eradicated with surgery and/or kills cancer cells that may remain after surgery. However, most malignant brain tumors recur within a short period of time and a second course of whole brain radiation therapy is rarely an option due to the high risk of damage to healthy brain tissue. GliaSite provides a localized form of internal radiation therapy, which is safe and proven for patients who have historically had very few options.

"GliaSite is especially important to patients with recurrent brain cancer--it allows them to receive additional radiation therapy, because external beam radiation is rarely an option due to the risk of further harm to healthy brain tissue," said Dr. Sanan, co-author of the study. "This study revealed encouraging results with the GliaSite balloon, which are consistent with previously reported data of the GliaSite system. For these patients, being able to prolong life, by several months, is quite remarkable."

In addition, the first data on GliaSite as the primary treatment for metastatic brain tumors will be provided at CNS in a presentation entitled, "Interim Results of a Phase II Study of Resection and GliaSite Brachytherapy for a Single Brain Metastasis," presented by Dr. Lisa Rogers of Henry Ford Hospital in Detroit.

GliaSite was cleared by the U.S. Food and Drug Administration (FDA) in 2001 for delivering radiation therapy directly to the site of a tumor, from within the tumor cavity. With the safety and performance of GliaSite proven in a multi-center clinical study involving patients with recurrent brain tumors, this post-market study looks specifically at GliaSite as an initial treatment, following the surgical removal of the tumor, for patients with metastatic tumors.

About GliaSite

During surgery to remove the tumor, the GliaSite balloon catheter is placed inside the space left by the removal of the malignant brain tumor. Once the patient has recovered from surgery (as soon as three days later), a solution containing Iotrex, a proprietary liquid radiation source specifically designed to treat patients with malignant tumors, is injected into the catheter and fills the balloon. Iotrex delivers radiation to the edges of the tumor cavity, targeting tissue where cancer may remain. The Iotrex remains in the balloon for approximately three to seven days, until the prescribed amount of radiation is delivered. The Iotrex mixture is then withdrawn and the GliaSite catheter is removed.

GliaSite is currently available in more than 150 centers throughout the country. Physicians and patients who would like more information about GliaSite should visit www.GLIASITE.com.

About Proxima Therapeutics, Inc.

Based in Alpharetta, Ga., Proxima Therapeutics, Inc. is a privately held medical device company established in 1995 to develop site-specific cancer treatment systems for malignant tumors. Marketed products include MammoSite RTS for breast cancer and GliaSite RTS for brain cancer. Additional information is available on the company's Web site at www.proximatherapeutics.com. Physicians and patients may call 1-866-PROXIMA (1-866-776-9462) for more information.

Contacts
Schwartz Communications
Wendy Williams/Liza Heapes
781-684-0770
proxima@schwartz-pr.com


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