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First Data on GliaSite Radiation Therapy System as Primary Treatment for Metastatic Brain Cancer Presented at Radiation Oncology Meeting


Posted on: 10/04/2004

First Data on GliaSite Radiation Therapy System as Primary Treatment for Metastatic Brain Cancer Presented at Radiation Oncology Meeting

Press Release Source: Proxima Therapeutics, Inc.
Monday October 4, 12:00 pm ET

Encouraging Interim Results of Post-Market Study of GliaSite for Brain Metastasis

ATLANTA--(BUSINESS WIRE)--Oct. 4, 2004-- Proxima Therapeutics, Inc. today announced encouraging results of a post-market study on the GliaSite Radiation Therapy System as a first-line treatment for single resected brain metastasis. Each year, more than 150,000 people are diagnosed with metastatic brain tumors--tumors that first exist in other parts of the body and then spread to the brain. Details from this multi-center study were presented at the Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) taking place in Atlanta, October 3-7, in a poster discussion 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.

As treatments for all forms of cancer improve, patients are living longer with their systemic cancer and the incidence of it spreading to the brain is increasing. Surgery and whole brain radiation are proven therapies for brain metastasis, but whole brain radiation therapy has potential to result in delayed neurotoxicities, such as memory loss. In an attempt to improve quality of life for these patients, this study omitted whole brain radiation therapy and used a local form of radiation, GliaSite. There is considerable nationwide interest in exploring localized radiation therapy as an alternative to whole brain radiation in the initial management of brain metastasis, thus allowing whole brain radiation to be reserved for further disease progression, if it occurs.

"In order to reduce the potential immediate and delayed complications of whole brain radiation, our study looked at localized radiation therapy following surgery as a primary treatment method for treating a single brain metastasis. We are pleased with the local control and survival results of the study that were achieved while being able to preserve quality of life and reserve the option of whole brain radiation for the future," said Dr. Lisa Rogers, co-author of the study. "As we continue to study GliaSite for internal and targeted radiation delivery, we gather greater insight on its application and outcomes for patients with specific forms of brain tumors."

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. The device is FDA cleared for treating newly diagnosed, metastatic and recurrent brain tumors. 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 brain tumors.

Additional data on GliaSite will also be provided at ASTRO in poster discussion #1002 entitled, "GliaSite Radiotherapy System for Treatment of Recurrent Malignant Glioma: A Multi-Institutional Analysis."

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.

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


-------------------------------------------------------------------------------- Source: Proxima Therapeutics, Inc.


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