GE Healthcare Announces Preliminary Phase 3 Results for Flutemetamol
All studies meet primary endpoints; full results to be reported later this year
PRINCETON, N.J.--(BUSINESS WIRE)--Apr 11, 2012 - GE Healthcare today announced the preliminary results of two Phase 3 studies of its investigational PET amyloid imaging agent, [18F]flutemetamol, where both studies met their primary endpoints. One study, in terminally ill patients who agreed to undergo brain autopsy, showed strong concordance between flutemetamol PET images and Alzheimer's disease-associated beta amyloid brain pathology. The other study, in young healthy volunteers under age 40, had results concordant with the known lack of brain amyloid in this population. Full results of these studies will be presented in the coming months. [18F]Flutemetamol is a GE Healthcare PET imaging agent in development for the detection of beta amyloid.
“The ability to detect or exclude significant amyloid deposits in the brain, along with other diagnostic tests, may help physicians make a more accurate assessment of patients with suspected Alzheimer's disease and other cognitive disorders. The results from these studies are quite encouraging in demonstrating the potential of flutemetamol in that regard,” said Carl Sadowsky, MD, Clinical Professor of Neurology at Nova Southeastern University Ft. Lauderdale, FL. “We need an accurate diagnosis and better treatment, as accurate diagnosis has the potential to enable better patient management, and may also save cost.”
The accumulation of beta amyloid in the brain is believed to play a role leading up to the degeneration of neurons in Alzheimer's disease (AD) and is one of several pathological characteristics implicated in the development of AD. Currently, AD is confirmed by histopathological identification of core features, including beta amyloid plaques, in post-mortem brain samples.1 Targeted amyloid imaging agents are being studied to determine their ability to help physicians detect amyloid deposition in living humans.
“Flutemetamol may well prove to be a clinically valuable component of a broader diagnostic workup that neurologists use when assessing patients with cognitive impairments, who may have AD,” said Jonathan Allis, MI PET Segment Leader, GE Healthcare Medical Diagnostics. “These studies support our application for regulatory approval of [18F]flutemetamol, and we intend to file later this year.”
[18F]Flutemetamol is one component of a broad portfolio of diagnostic solutions that GE Healthcare is currently developing in the Alzheimer's field. GE Healthcare is taking a comprehensive approach to understanding AD through its ongoing research to uncover the causes, risks and physical effects of the disease. For example, the company is partnering with pharma to identify a biosignature, or a biological indicator, which may help physicians diagnose Alzheimer's disease prior to the onset of clinical symptoms.
GE Healthcare offers a broad portfolio of imaging resources, which support accurate visualization of the signs of neurodegenerative diseases via state-of-the-art scanners, including MRI, PET and CT which deliver clear visualization of the brain; an expanding portfolio of imaging agents are being developed to enhance visual evidence of disease and innovative software applications which can aid physicians in image interpretation and determination of disease management. More specifically, our portfolio today includes cyclotrons and chemistry systems to manufacture PET imaging agents; PET and MR scanners to scan patients; and image analysis software to interpret the results.
GE Healthcare has also been a key contributor to the Alzheimer's Disease Neuroimaging Initiative (ADNI) since its inception. GE Healthcare also plays a key role in PredictAD, an EU-funded research project to develop solutions to enable earlier diagnosis of AD, and Coalition Against Major Diseases (CAMD).
Additionally, the combination of our different business offerings positions us well to offer an integrated global diagnostics solution for the next generation of therapies. To that end, we are working with potential partners in the pharmaceutical industry to understand their strategic needs. and design solutions accordingly, which may support market entry via conduct of pivotal trials, provision of complex technologies, and (potentially) expedited time to market.
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1 Dementia: Hope Through Research. National Institute of Neurological Disorders and Stroke website. http://www.ninds.nih.gov/disorders/dementias/detail_dementia.htm. Accessed July 13, 2011.
Posted: April 2012