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


ATLANTA -- Encouraging Interim Results of Post-Market Study of GliaSite for Brain Metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases  
1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to
 

Proxima Therapeutics, Inc. today announced encouraging results of a post-market study on the GliaSite Radiation Therapy System as a first-line treatment A first-line treatment or first-line therapy is a medical therapy recommended for the initial treatment of a disease, sign or symptom, usually on the basis of empirical evidence for its efficacy.  for single resected brain metastasis. Each year, more than 150,000 people are diagnosed with metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 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 resection /re·sec·tion/ (-sek´shun) excision.

root resection  apicoectomy.

transurethral resection of the prostate  (TURP), transurethral prostatic resection
 and GliaSite Brachytherapy for a Single Brain Metastasis," presented by Dr. Lisa Rogers Lisa Rogers (born 7 September 1971 in Cardiff) is a Welsh-born television presenter and sometime actress. Early life
While at school she took jobs in a chocolate factory and as a cleaner, and while studying drama at Loughborough University, she was a nanny and manager of
 of Henry Ford Hospital Henry Ford Hospital is a hospital located in Detroit, Michigan a few blocks from Wayne State University and the New Center area, near the Fisher Building and Cadillac Place. The hospital was founded in 1915 by Henry Ford as a philanthropic project.  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 Brain Tumor Definition

A brain tumor is an abnormal growth of tissue in the brain. Unlike other tumors, brain tumors spread by local extension and rarely metastasize (spread) outside the brain.
."

GliaSite was cleared by the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) 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 glioma /gli·o·ma/ (gli-o´mah) a tumor composed of neuroglia in any of its states of development; sometimes extended to include all intrinsic neoplasms of the brain and spinal cord, as astrocytomas, ependymomas, etc. : A Multi-Institutional Analysis."

About GliaSite

During surgery to remove the tumor, the GliaSite balloon catheter balloon catheter
n.
A catheter with an inflatable balloon at its tip, used especially to expand a partially obstructed blood vessel or bodily passage and to measure blood pressure in a blood vessel. Also called balloon-tip 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 malignant tumor
n.
A tumor that invades surrounding tissues, is usually capable of producing metastases, may recur after attempted removal, and is likely to cause death unless adequately treated.
, 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 (Request To Send) An RS-232 signal sent from the transmitting station to the receiving station requesting permission to transmit. Contrast with CTS.

1. (operating system) RTS - run-time system.
2.
 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.
COPYRIGHT 2004 Business Wire
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Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Oct 4, 2004
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