Piramal Imaging to Present New Research in PET Imaging at Society of Nuclear Medicine and Molecular Imaging 2015 Annual Meeting

BOSTON, June 6, 2015 /PRNewswire/ -- Piramal Imaging today announced six abstracts examining the use of its diagnostic imaging agent florbetaben F18 (FBB) in positron emission tomography (PET) imaging to be presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2015 annual meeting in Baltimore. The abstracts present new analyses and provide more detailed information on quantification and distribution of beta-amyloid plaques in the brain, which may help researchers to better understand the contributions different plaque types and deposition patterns have on Alzheimer's disease (AD) and dementia. 

"Past studies have shown that PET imaging with FBB and subsequent histopathology analyses provide greater detail assessment of beta-amyloid plaques in the brain," said Andrew Stephens, chief medical officer, Piramal Imaging. "These new datasets build on this research, demonstrating PET with FBB may also contribute to an improved understanding of the role of beta-amyloid plaques in the brain including which factors in the brain influence and contribute to signal assessment."

Among the FBB abstracts accepted, there will be two analyses presented during a scientific session on amyloid imaging on Monday, June 8. The first analysis assesses the influence of cerebellar plaques on FBB standardized uptake value ratios (SUVR) when using cerebellar gray matter as the reference. The second presentation evaluates data on the ability of FBB PET scans to detect morphologically distinct beta-amyloid deposits.

"Continued research into the role and influence of beta-amyloid plaques is crucial for gaining a better understanding of Alzheimer's disease for the optimization of patient care and initiation of appropriate therapy in AD and dementia," added Stephens. "As an emerging global leader in the field of molecular imaging, Piramal is dedicated to supporting the research community to discover innovative diagnostic imaging solutions to reduce the burden of these conditions. These studies on beta-amyloid plaques build on the results from the florbetaben phase III trial, which showed that beta-amyloid imaging with florbetaben is accurate."

About Neuraceq™ (florbetaben F18 injection)

INDICATION
Neuraceq™ is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline.

A negative Neuraceq™ scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq™ scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition.

Neuraceq™ is an adjunct to other diagnostic evaluations.

Limitations of Use

• A positive Neuraceq™ scan does not establish the diagnosis of AD or any other cognitive disorder.
• Safety and effectiveness of Neuraceq™ have not been established for:
  • Predicting development of dementia or other neurologic conditions;
  • Monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION

Risk for Image Interpretation and Other Errors
Neuraceq™ can be used to estimate the density of beta-amyloid neuritic plaque deposition in the brain. Neuraceq™ is an adjunct to other diagnostic evaluations. Neuraceq™ images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of Neuraceq™ images. Following training, image reading errors (especially false positive) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.

Radiation Risk 
Administration of Neuraceq™, similar to other radiopharmaceuticals, contributes to a patient´s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Most Common Adverse Reactions
In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 978 Neuraceq™ administrations were injection/application site erythema (1.7%), injection site irritation (1.2%), and injection site pain (3.9%).

About Piramal Imaging SA
Piramal Imaging SA, a division of Piramal Enterprises, Ltd., was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. By developing novel PET tracers for molecular imaging, Piramal Imaging is focusing on a key field of modern medicine. Piramal Imaging strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life threatening diseases, leading to better therapeutic outcomes and improved quality of life. For more information please go to www.piramal.com/imaging.

SOURCE Piramal Imaging

Related Links

http://www.piramal.com/imaging