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Bayer starts Phase III study to evaluate efficacy and safety of Gadovist® in magnetic resonance mammography
Berlin, March 10, 2010 - Bayer has started an international clinical Phase III
study to develop its contrast agent Gadovist® (gadobutrol®) for use in magnetic
resonance imaging (MRI) of the breast. The trial will evaluate the efficacy and
safety of Gadovist in contrast-enhanced breast MRI (magnetic resonance
mammography, MRM). Gadovist is already approved for the most frequently used
contrast-enhanced MRI examinations including imaging of the central nervous
system, the liver, the kidney and for imaging of blood vessels in adults and
for the use in children aged 2 years and older.
"As a pioneer in contrast-media research, Bayer is continuously working to
provide physicians with high-quality contrast media for use in various
indications of contrast enhanced MRI," said Thomas Balzer, Head of Global
Clinical Development Diagnostic Imaging at Bayer Schering Pharma. "Due to its
high T1-shortening - an important characteristic in the field of radiology -
Gadovist offers a potentially excellent image quality in MRI and thus could be
very valuable in MRM."
About the Phase III Trial Design
The objective of this multi-center, open-label, non-randomized Phase III study
with corresponding blinded image evaluations is to determine the efficacy and
safety of a single intravenous injection of 0.1 mmol/kg body weight of
Gadobutrol 1.0 Molar (Gadovist®) in patients with newly diagnosed breast cancer
referred for contrast-enhanced breast MRI. The extent of malignant disease will
be determined and compared between various imaging approaches, including
unenhanced breast MRI, gadobutrol-enhanced MRI, and X-ray mammography. The
active enrollment phase III will cover one year with the estimated completion
date around beginning 2011.
About Breast Cancer
With about 1.3 million new cases every year, breast cancer is the most common
form of cancer among women today. Diagnostic imaging plays an important role in
the detection and management of this devastating disease. MRI is considered to
be the most sensitive method for detection of breast cancer and also the best
method to exclude additional cancer lesions. Therofore, it is used as an
adjunct to X-ray mammogprahy for e.g., screening in high-risk patients,
pre-operative tumor staging, monitoring response to neo-adjuvant chemotherapy,
and evaluation of breast implants. The MRI procedure consists of unenhanced and
contrast-enhanced MRI scans to differentiate into benign and malignant lesions
using morphological (shape and margin) and dynamic (contrast enhancement,
signal intensity time curves) criteria. The performance of MRI strongly depends
on the efficacy and safety of the applied contrast agent.
About Gadovist®
Gadovist® is a modern, highly efficient contrast agent, approved for the
contrast-enhanced MRI of various parts of the body, including the brain, the
spinal chord, the liver, the kidney and the blood-vessel system. With its 1.0
mol/L concentration of gadobutrol, a stable macrocyclic gadolinium compound,
Gadovist contains twice as much gadolinium per unit of volume as other
extracellular contrast media available on the market. Moreover, Gadovist has a
high T1-relaxivity in plasma. Due to its combination of high concentration and
high relaxivity, Gadovist exhibits the highest T1-shortening per ml of all
gadolinium contrast media. This results in potentially excellent image quality
and offers practical advantages in the case of smaller injection volumes.
Gadovist received market authorization for the first time in 1998 and is now
approved in over 50 countries.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Bayer Schering
Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to
discover, manufacture and market products that will improve human and animal
health worldwide. Find more information at www.bayerhealthcare.com.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
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