Feature | April 13, 2012

GE Healthcare Amyloid Plaque PET Agent Has Promising Phase 3 Results

All studies meet primary endpoints, full results to be reported later this year

April 13, 2012 — GE Healthcare announced the preliminary results of two Phase 3 studies of its investigational positron emission tomography (PET) amyloid imaging agent, F-18 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. 

“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 (AD) and other cognitive disorders. The results from these studies are quite encouraging in demonstrating the potential of flutemetamol in that regard,” said Carl Sadowsky, M.D., clinical professor of neurology at Nova Southeastern University, Ft. Lauderdale, Fla. “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 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. 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 (molecular imaging) PET segment leader, GE Healthcare Medical Diagnostics. “These studies support our application for regulatory approval of flutemetamol, and we intend to file later this year.”

Flutemetamol is a GE Healthcare PET imaging agent in development for the detection of beta amyloid, and is part of a portfolio of diagnostic solutions the company 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 AD prior to the onset of clinical symptoms.

Earlier this week, the U.S. Food and Drug Administration (FDA) approved the first diagnostic agent to image Alzheimer’s disease beta-amyloid neuritic plaques in the living brain. Eli Lilly and Company and Avid Radiopharmaceuticals Inc., a wholly owned subsidiary of Lilly, released florbetapir (Amyvid), a positron emission tomography (PET) radioactive tracer agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.

For more information: www.gehealthcare.com

Related Content

Sponsored Content | Videos | Nuclear Imaging | August 24, 2017
Prem Soman, M.D., director of nuclear cardiology at the Heart and Vascular Institute, University of Pittsburgh, and p
Study Demonstrates First Human Application of Novel PET Tracer for Prostate Cancer

Transaxial 11Csarcosine hybrid PET/CT showed a (triangulated) adenocarcinoma in the transition zone of the anterior right prostate gland on PET (A), CT (B), and a separately obtained T2?weighted MR sequence (C) with resulting PET/MRI registration (D). Image courtesy of M. Piert et al., University of Michigan, Ann Arbor, Mich.

News | Radiopharmaceuticals and Tracers | August 16, 2017
In the featured translational article in the August issue of The Journal of Nuclear Medicine, researchers at the...
Novel PET Tracer Detects Small Blood Clots

PET images (MIP 0-60 min) of three Cynomolgus monkeys. Strong signals are detected at the sites where inserted catheters had roughened surfaces. Almost no other background signal is visible. Only accumulation in the gallbladder becomes visible at the bottom of the image. Credit: Piramal Imaging GmbH, Berlin Germany.

News | PET Imaging | July 07, 2017
July 7, 2017 — Blood clots in veins a

While subject No. 1 (left) was judged as positive for both the neuronal injury and the amyloid load biomarker, both Alzheimer's disease biomarkers were negative in subject No. 2 (right). Image courtesy of Henryk Barthel et al., University Hospital Leipzig, Leipzig, Germany

News | PET Imaging | June 14, 2017
More people die of Alzheimer's disease than prostate and breast cancer combined. Identifying the disease before major...
News | Clinical Study | June 09, 2017
The milestone Imaging Dementia — Evidence for Amyloid Scanning (IDEAS) Study is working with government and academic...
Lantheus and GE Healthcare Sign Agreement for Worldwide Development, Commercialization of Flurpiridaz F-18
News | Radiopharmaceuticals and Tracers | May 22, 2017
May 22, 2017 — Lantheus Holdings Inc., parent company of Lantheus Medical Imaging Inc., and GE Healthcare announced t
low-dose lung CT scan

An example of a low-dose CT scan of the lungs, showing lung cancer. Image courtesy of Toshiba.

Feature | Lung Cancer | May 05, 2017 | Alison Grimes
The term mesothelioma was coined in 1909, just a few years after the introduction of medical X-ray imaging.
Australian Team Finds New Method for Producing PET Radiotracers in Higher Radiochemical Yields
News | Radiopharmaceuticals and Tracers | April 28, 2017
April 28, 2017 — Researchers at the Australian Nuclear Science and Technology Organisation (ANSTO) have led the devel
Sponsored Content | Videos | Nuclear Imaging | April 28, 2017
David Wolinsky, M.D., director of nuclear cardiology at Cleveland Clinic Florida and past-president of the American S
News | Prostate Cancer | April 24, 2017
April 24, 2017 — Cancer Targeted Technology recently announced it is focusing on small molecules that target pivotal
Overlay Init