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GE Medical Systems Partners with the National Cancer Institute on Groundbreaking Molecular Imaging Drug Trial.


Business Editors/Health/Medical Writers

WAUKESHA, Wis.--(BUSINESS WIRE)--Nov. 24, 2003

GE Medical Radiopharmacy Equipment to Enable PET Imaging

for Earlier Cancer Treatment Assessment

GE Medical Systems, a unit of General Electric Company (NYSE NYSE

See: New York Stock Exchange
:GE), has signed a clinical trial agreement with the Cancer Imaging Program of the National Cancer Institute (NCI See Liberate. ) for multi-site clinical trials of 18F-Fluorothymidine (FLT FLT Fault
FLT Flight
FLT Flat
FLT Filter
FLT Fleet
FLT Fermat's Last Theorem
FLT Fairlight (software cracking group)
FLT Float/Floating
FLT Fairfield Language Technologies
FLT Fork Lift Truck
FLT First Lieutenant
) as an agent for positron emission tomography positron emission tomography: see PET scan.
positron emission tomography (PET)

Imaging technique used in diagnosis and biomedical research.
 (PET), applied to the management of patients with cancer.

FLT is a PET radiopharmaceutical radiopharmaceutical /ra·dio·phar·ma·ceu·ti·cal/ (-fahr?mah-soo´ti-k'l) a radioactive pharmaceutical, nuclide, or other chemical used for diagnostic or therapeutic purposes.  used to image DNA synthesis DNA synthesis commonly refers to:
  • DNA replication - DNA biosynthesis (in vivo DNA amplification)
  • Polymerase chain reaction - enzymatic DNA synthesis (in vitro DNA amplification)
  • Oligonucleotide synthesis - chemical synthesis of nucleic acids
, showing high contrast in the presence of cellular proliferation in tumors and other proliferating tissues. FLT has shown preliminary promise for the in-vivo imaging of cellular proliferation.

The monitoring of the anti-proliferative effects of chemotherapeutic agents This is a list of specific pharmacologic agents that are known to be of use in the treatment of cancer, otherwise known as chemotherapeutic agents. This list is organized by "type" of agent, though the subsections are not necessarily definitive and are subject to revision.  may be important in the management of patients with cancer. An imaging agent that can provide an early assessment of an agent's anti-proliferative activity may assure that patients receive effective therapy.

The NCI will sponsor clinical trials at Johns Hopkins Noun 1. Johns Hopkins - United States financier and philanthropist who left money to found the university and hospital that bear his name in Baltimore (1795-1873)
Hopkins

2.
 Medical Institutions, Virginia Commonwealth University Formed by a merger between the Richmond Professional Institute and the Medical College of Virginia in 1968, VCU has a medical school that is home to the nation's oldest organ transplant program.  Medical Center, Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world , the University of Washington and the National Institutes of Health Clinical Center. GE Medical will provide TRACERlab FX synthesis systems to produce FLT for the clinical work that will be conducted at these sites.

It is anticipated that FLT will be one of the first PET agents for which there will be a United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 Investigational New Drug (IND) proceeding for the NCI-sponsored multi-site trials. This will also be the first clinical trial of an imaging agent supported by the General Electric Company.

"Today, cancer therapies are often given empirically: a treatment is provided to five or 10 people, and it may work in one or two," said, Dr. James Thrall, Chief of Radiology, Massachusetts General Hospital. "We prefer to give patients therapy that is very likely to be effective.

"By using agents like FLT that can specifically image proliferation and other aspects of tumor biology, we can look at tumors before and soon after treatment to determine reliably whether a given therapy will be effective or not," Thrall said. "The idea is to personalize therapy by using PET imaging of the cancer to choose the right treatment and enable the patient to avoid inappropriate therapy."

GE Medical technology will play an essential role in enabling the multi-site trials. Each site will use TRACERlab FXN FXN Function
FXN FF-XIII.net (Final Fantasy gaming website)
FXN Fox News
FXN Fusion Cross N (gaming clan
 synthesis boxes in an identical setup with standard operating protocols, ensuring that FLT is synthesized in a reproducible manner across all clinical sites. This, in turn, enables data from all sites to be reliably compared.

"We are proud to collaborate with the National Cancer Institute on this program," said Joe Hogan, President & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , GE Medical Systems. "This study can help advance the state of the art in molecular imaging to support better clinical diagnosis, staging, therapy and follow-up for cancer care."

Besides the TRACERlab FXN synthesis equipment, four out of five of the clinical sites will use GE Medical PET/CT PET/CT Positron Emission Tomography and Computed Tomography  or PET systems in the patient trials. Under the terms of the agreement with the NCI, GE Medical Systems also will be responsible for developing the standard FLT synthesis software and procedures.

GE Medical Systems brings molecular imaging expertise with multi-modality, pre-clinical and clinical imaging offerings, providing a bridge between novel drug discovery and the clinical needs of today. With pre-clinical CT and Optical imaging systems, GE Medical helps pharmaceutical researchers accelerate the development of new therapeutics and diagnostics. With the most extensive portfolio of high-resolution, high-sensitivity clinical scanners in the industry, GE Medical Systems delivers comprehensive advanced imaging solutions today.

For tomorrow, GE Medical and an expanding network of pharmaceutical and academic collaborators are actively advancing molecular medicine. In its role, GE is developing advanced imaging capabilities that combine the latest developments in targeted diagnostic chemistry with advanced informatics to visualize novel molecular markers of disease, so that in the future clinicians will noninvasively diagnose life-threatening disease earlier, treat it more specifically, and monitor it more closely.

About the National Cancer Institute

The National Cancer Institute, one of the National Institutes of Health, leads a national effort to achieve a future when all cancers are controlled or eliminated, by stimulating and supporting research and its application. It provides vision and leadership to the cancer community as it strives to more fully integrate discovery activities through interdisciplinary collaboration, to accelerate the development of interventions and new technology through translational research, and to ensure the delivery of these interventions through clinical and public health programs.

About GE Medical Systems

GE Medical Systems is a $10 billion global leader in medical imaging, point-of-care systems, healthcare services, and information technology. Its offerings include networking and productivity tools, clinical information systems, patient monitoring systems, anesthesia and respiratory care, maternal-infant care systems, surgery and vascular imaging, conventional and digital X-ray, dental imaging, computed tomography Computed tomography (CT scan)
X rays are aimed at slices of the body (by rotating equipment) and results are assembled with a computer to give a three-dimensional picture of a structure.
, electron beam tomography Electron beam tomography is a specific form of computed axial tomography (CAT or CT) in which the X-Ray tube is not mechanically spun in order to rotate the source of X-Ray photons. , magnetic resonance magnetic resonance, in physics and chemistry, phenomenon produced by simultaneously applying a steady magnetic field and electromagnetic radiation (usually radio waves) to a sample of atoms and then adjusting the frequency of the radiation and the strength of the , ultrasound and bone mineral densitometry densitometry /den·si·tom·e·try/ (den?si-tom´i-tre) determination of variations in density by comparison with that of another material or with a certain standard. , positron emission tomography, nuclear medicine, and a comprehensive portfolio of clinical and business services. For more than 100 years, health care providers worldwide have relied on GE Medical Systems for high quality medical technology and productivity solutions. For more information, visit the GE Medical Systems Web site at www.gemedical.com.

This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such forward-looking statements involve a number of risks and uncertainties and investors are cautioned not to put any undue reliance on any forward-looking statement. The Company cannot guarantee that the Company will actually achieve the plans, intentions or expectations disclosed in any such forward-looking statements. The Company's actual results may differ materially from the Company's historical results of operations and those discussed in the forward-looking statements for various reasons, including, but not limited to, the Company's ability to carry out its business and financial plans, to fund development necessary for existing products and to pursue new product opportunities, the risk of whether products result from development activities, protection of its intellectual property portfolio, ability to establish and successfully complete clinical trials where required for product approval, the risk associated with obtaining the necessary regulatory approvals, shifts in the regulatory environment affecting sales of the Company's products such as third-party payor reimbursement issues, dependence on the Company's partners for development of certain projects, the ability to obtain foreign regulatory approvals for products and to establish marketing arrangements in countries where approval is obtained. Any forward-looking statements made by the Company do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments the Company may make. The Company does not assume, and specifically disclaims, any obligation to update any forward-looking statements, and these statements represent the Company's current outlook only as of the date given.

NOTE TO EDITORS: In "18F-Fluorothymidine" the 18 is superscript Any letter, digit or symbol that appears above the line. For example, 10 to the 9th power is written with the 9 in superscript (109). Contrast with subscript. . In "TRACERlab FXN" the N is subscript.
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Nov 24, 2003
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