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Siemens Collaborates on Study of an Imaging Biomarker That Has the Potential to Detect Proliferative Activity of Cancer Cells.


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.
 Grants Investigational New Drug Exemption (IND) Allowing for the Commencement of a Phase I Clinical Trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase I
 of Research Imaging Biomarker 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
, Which Could Help in Assessing and Personalizing Cancer Therapies

HOFFMAN ESTATES, Ill. -- Siemens Medical Solutions Siemens Medical Solutions (Siemens Med) is a supplier to the healthcare industry, and is headquartered in Erlangen, Germany. Its U.S. division, Siemens Medical Solutions USA, Inc., is a Delaware corporation, with headquarters in Malvern, Pennsylvania.  (www.usa.siemens.com/medical) announced that it has been granted an Investigational New Drug (IND) Exemption by the U.S. Food and Drug Administration (FDA) to conduct a Phase I clinical trial of [F-18] 3'-fluoro-3'-deoxythymidine (FLT), a molecular imaging biomarker that has shown promise in monitoring the proliferation of cancer cells, which could help physicians quickly determine the effectiveness of cancer therapies.

To broaden the scope of FLT research, Siemens will support the FLT Phase I clinical trial that will be conducted at Memorial Sloan-Kettering Cancer Center The Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City is a cancer treatment and research institution founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets, with other locations in New  located in New York City New York City: see New York, city.
New York City

City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S.
, with whom Siemens has signed a research collaboration agreement focused on the codevelopment of imaging biomarkers that will be used in PET imaging. Through these collaborative efforts, Siemens intends not only to make FLT more readily accessible to research and academic institutions for further study, but also to continue research into new more target specific imaging biomarkers for PET.

"This research further demonstrates Siemens' commitment to advancing molecular medicine by working with the world's leading medical institutions to develop targeted imaging agents that will pave the way for more personalized therapies," said Michael Reitermann, president, Molecular Imaging Division, Siemens Medical Solutions. "We look forward to working with our colleagues at Memorial Sloan-Kettering to enable leading-edge FLT research that we anticipate will bring us closer to realizing its potential in the earlier assessment of cancer therapies."

The significance of FLT is that it may be able to allow researchers and physicians to detect the rate of the proliferation of cancerous cells through a molecular imaging technique like PET*CT (positron emission tomography positron emission tomography: see PET scan.
positron emission tomography (PET)

Imaging technique used in diagnosis and biomedical research.
*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.
), by enabling visualization of key steps in the replication of DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
, which precedes cell division. By enabling the imaging of the biological processes within cancer cells, FLT could help physicians to personalize cancer therapies by more quickly assessing cancer therapies, avoiding ineffective therapies and determining the most appropriate treatment for an individual patient.

Molecular imaging biomarkers - imaging agents that characterize biological processes and diseases - enable the biological mechanisms of disease to be identified and understood. Once imaging biomarkers bind to the diseased cells or tissues, they cause them to "light up" when scanned using PET*CT, Single-Photon Emission Computed Tomography (SPECT SPECT single-photon emission computed tomography.

SPECT
abbr.
single photon emission computed tomography


SPECT,
n See single photon emission computer tomography.
) or SPECT*CT. Results may help physicians determine personalized therapies for patients by pinpointing the active pathways in the disease progression. Imaging biomarkers not only enable early diagnosis, but also allow the measurement of how well certain therapies, such as prescription drugs, chemotherapy and radiation therapy, are working by measuring the impact of treatments on the disease indicators. This may aid the development of new therapies, and enable clinicians to non-invasively assess therapeutic responses and quickly adjust therapeutic approaches to arrive at optimum outcomes.

Siemens Medical Solutions is the world's leading producer and distributor of PET imaging biomarkers and has the largest U.S. network of cyclotron-equipped radiopharmacies, reaching as many as 99 percent of hospitals and imaging centers in the United States.

About Siemens Medical Solutions

Siemens Medical Solutions of Siemens AG (NYSE NYSE

See: New York Stock Exchange
:SI) is one of the world's largest suppliers to the healthcare industry. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting, and support services, to help customers achieve tangible, sustainable, clinical and financial outcomes. Recent acquisitions in the area of in-vitro diagnostics - such as Diagnostic Products Corporation and Bayer Diagnostics - mark a significant milestone for Siemens as it becomes the first full service diagnostics company. Employing more than 41,000 people worldwide and operating in over 130 countries, Siemens Medical Solutions reported sales of 8.23 billion EUR EUR

In currencies, this is the abbreviation for the Euro.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
, orders of 9.33 billion EUR and group profit of 1.06 billion EUR for fiscal 2006 (Sept. 30). Further information can be found by visiting www.usa.siemens.com/medical-pressroom.
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Publication:Business Wire
Date:Jul 30, 2007
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