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

PET/CT, primary and metastatic prostate cancer, Journal of Nuclear Medicine study, JNM

Ga-68-BBN PET/CT of a 64-year-old man newly diagnosed with prostate cancer by biopsy. Multiple bone metastasis lesions (arrows) were detected. Image courtesy of Jingjing Zhang, Peking Union Medical College, Beijing, China.

News | Prostate Cancer | February 02, 2017
In the featured article from the February 2017 issue of the Journal of Nuclear Medicine, researchers document the first...
News | PET Imaging | January 25, 2017
In work published this week in the Journal of Clinical Investigation (JCI), a team led by Jacob Hooker at Harvard...
Medrad Intego PET Infusion System, recall
News | Nuclear Imaging | January 12, 2017
January 12, 2017 — Bayer Healthcare has initiated a recall of all its Medrad Intego PET Infusion System Source Admini
News | Prostate Cancer | December 14, 2016
Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology firm focusing on small molecules that...
Numa, NumaStatus, radiation dose reporting software, RSNA 2016
News | Radiation Dose Management | December 08, 2016
Numa introduced a new software application at the 2016 Annual Meeting of the Radiological Society of North America (...
prostate cancer, PET imaging, Johns Hopkins, Daniel Thorek, 11B6 antibody

Uptake of 89Zr-11B6 in the prostate of a transgenic mouse with prostate cancer. Image courtesy of Daniel Thorek

News | Prostate Cancer | November 30, 2016
An international group of researchers report success in mice of a method of using positron emission tomography (PET)...
Alzheimer's disease, early diagnosis, PET scans, imaging compound, Fluselenamyl

Researchers at Washington University School of Medicine in St. Louis have developed a chemical compound that detects the Alzheimer’s protein amyloid beta better than current FDA-approved agents. The compound potentially may be used in brain scans to identify people in the earliest stages of Alzheimer’s disease. In the image, the compound has passed from the bloodstream of a living mouse into its brain, where it is detected by a positron emission tomography (PET) scan. Arrows indicate clumps of amyloid beta. Credit Ping Yan and Jin-Moo Lee.

News | Radiopharmaceuticals and Tracers | November 02, 2016
November 2, 2016 — By the time unambiguous signs of memory loss and cognitive decline appear in people with Alzheimer
Axumin, fluciclovine F-18, PET agent, Phase 3 study, recurrent prostate cancer detection, Blue Earth Diagnostics
News | Prostate Cancer | October 25, 2016
Blue Earth Diagnostics Ltd. announced the peer-reviewed publication of results from a Phase 3 clinical trial of Axumin...
Lantheus, flurpiridaz F-18, myocardial perfusion imaging, MPI, cardiac stress testing, ASNC 2016
News | Radiopharmaceuticals and Tracers | October 17, 2016
Lantheus Holdings Inc. announced in late September that sub-analysis data from the first Phase 3 study of flurpiridaz F...
GE Healthcare, Discovery MI PET/CT system, FDA clearance, RSNA 2016
Technology | PET-CT | October 05, 2016
GE Healthcare recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Discovery MI digital...
Overlay Init