According to GE Healthcare, the preliminary results of two Phase 3 studies of their investigational PET amyloid-imaging agent, [18F]flutemetamol, a GE Healthcare PET imaging agent developed to detect beta amyloid, both met their primary endpoints. Full results of both studies will be presented in the near future.
One of the studies involved terminally ill patients, who agreed to undergo brain autopsy, displaying strong association between flutemetamol PET images and beta amyloid brain pathology linked to Alzheimer’s disease (AD), whilst the other study was performed in young, healthy volunteers below the age of 40 years, and achieved similar results with the known lack of brain amyloid in this population.
Carl Sadowsky, MD, Clinical Professor of Neurology at Nova Southeastern University Ft. Lauderdale in FL said:
“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. We need an accurate diagnosis and better treatment, as accurate diagnosis has the potential to enable better patient management, and may also save cost.”
A beta amyloid accumulation within the brain is thought to affect the lead-up of neuron degeneration in AD. It is also one of the numerous pathological characteristics that play a role in developing AD, which, at present, is diagnosed by histopathological identification of core features, such as beta amyloid plaques in post-mortem brain samples. Researchers are studying particular amyloid imaging agents in order to establish whether they are able to assist physicians in detecting amyloid deposition in living humans.
Jonathan Allis, MI PET Segment Leader, GE Healthcare Medical Diagnostics commented:
“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. These studies support our application for regulatory approval of [18F]flutemetamol, and we intend to file later this year.”
Since its inception, GE Healthcare has been a major contributor to the Alzheimer’s Disease Neuroimaging Initiative (ADNI), and plays a key role in PredictAD, an EU-funded research project, designed to develop solutions for earlier diagnosis of AD, and Coalition Against Major Diseases (CAMD). In its aim to reveal the causes, risks and physical effects of AD, GE Healthcare applies a comprehensive approach to achieve their goal.
For instance, by partnering with pharma to identify a biosignature, or a biological indicator that could help physicians in diagnosing AD before the onset of clinical symptoms. [18F]Flutemetamol is just one component of a wide spectrum of diagnostic solutions in GE Healthcare’s development of AD.
The company has a wide range of imaging resources to accurately detect signs of neuroregenerative diseases by using high-tech MRI, PET and CT scanners, which deliver a clear visual of the brain.
GE Healthcare is currently expanding its portfolio of imaging agents by developing an enhanced visual evidence of disease and novel software applications that can assist physicians in interpreting images and determining diseases. GE Healthcare’s current portfolio includes cyclotrons and chemistry systems for the manufacture of PET imaging agents, PET and MR scanners for patients, as well as image analysis software to interpret results.
Based on the company’s broad range of resources, which have elevated the company’s position in the global market, GE Healthcare is able to provide an integrated global diagnostics solution for the next generation of therapies. By collaborating with potential partners in the pharmaceutical industry, GE Healthcare aims to gain further insight into the strategic needs of pharmaceuticals to develop appropriate design solutions, providing complex technologies and potentially assist in expedited time to market through their use in pivotal trials.
Written By Petra Rattue