BOSTON, Nov. 1, 2017 /PRNewswire-iReach/ -- Piramal Imaging today announced new research on positron emission tomography (PET) imaging tracers to be presented at the 10th Clinical Trials on Alzheimer's Disease conference in Boston. Presentations on the approved diagnostic imaging agent florbetaben F18 cover new kinetic analyses and more detailed information on the clinical impact of amyloid-PET imaging. Clinical updates of tau PET-imaging tracer PI-2620 will be presented.
Scientific updates at the CTAD conference – November 1-4, 2017
Location: Boston Park Plaza, Boston, MA, US
Presenter: Oral presentation by Dr. Andrew Stephens, MD, PhD Piramal Imaging
Presenter: Oral presentation by Dr. Mathieu Ceccaldi, MD, PhD AP-HM - Hôpital de la Timone, Marseille
Presenter: Poster presentation by Dr. Andrew Stephens, MD, PhD Piramal Imaging
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
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 1090 Neuraceq™ administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).
About the tau research collaboration
PI-2620 was discovered in a research collaboration between Piramal Imaging and AC Immune, a Swiss-based clinical stage biopharmaceutical company focused on neurodegenerative diseases. Piramal Imaging obtained the exclusive, world-wide license for research, development and commercialization of all tau PET tracers generated within the discovery program. First-in-man clinical studies were performed at Molecular Neuroimaging LLC, a division of Invicro LLC, New Haven, Connecticut.
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. www.piramal.com/imaging
For More Information:
Investor Relations: Hitesh Dhaddha / Bhavna Sinyal | Piramal Enterprises Ltd.
Tel #: +91 22 3046 6444 / +91 22 3046 6570 | [email protected]
For Media Queries:
Nicole Fletcher | Marketing Communications | Piramal Imaging
Tel #: +1 857-202-1122 | [email protected]
Dimple Kapur/ Riddhi Goradia | Corporate Communications | Piramal Enterprises Ltd.
Tel#: +91 22 3351 4269/ 4083 | [email protected]/[email protected]
Media Contact: Nicole Fletcher, Piramal Imaging, +1 (857) 202-1122, [email protected]
News distributed by PR Newswire iReach: https://ireach.prnewswire.com
SOURCE Piramal Imaging
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Scientific updates at the CTAD conference – November 1-4, 2017
Location: Boston Park Plaza, Boston, MA, US
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- Clinical evaluation of 18F-PI-2620, a next generation TAU PET agent in subjects with Alzheimer's disease and progressive supranuclear palsy
Presenter: Oral presentation by Dr. Andrew Stephens, MD, PhD Piramal Imaging
- Value of 18F-florbetaben amyloid PET in the diagnostic work-up of most complex patients with dementia in France: a naturalistic study
Presenter: Oral presentation by Dr. Mathieu Ceccaldi, MD, PhD AP-HM - Hôpital de la Timone, Marseille
- Simplified Non-Invasive Tracer Kinetic Analysis for 18F-Florbetaben PET using a Dual Time-Window acquisition protocol
Presenter: Poster presentation by Dr. Andrew Stephens, MD, PhD Piramal Imaging
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.
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 1090 Neuraceq™ administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).
About the tau research collaboration
PI-2620 was discovered in a research collaboration between Piramal Imaging and AC Immune, a Swiss-based clinical stage biopharmaceutical company focused on neurodegenerative diseases. Piramal Imaging obtained the exclusive, world-wide license for research, development and commercialization of all tau PET tracers generated within the discovery program. First-in-man clinical studies were performed at Molecular Neuroimaging LLC, a division of Invicro LLC, New Haven, Connecticut.
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. www.piramal.com/imaging
For More Information:
Investor Relations: Hitesh Dhaddha / Bhavna Sinyal | Piramal Enterprises Ltd.
Tel #: +91 22 3046 6444 / +91 22 3046 6570 | [email protected]
For Media Queries:
Nicole Fletcher | Marketing Communications | Piramal Imaging
Tel #: +1 857-202-1122 | [email protected]
Dimple Kapur/ Riddhi Goradia | Corporate Communications | Piramal Enterprises Ltd.
Tel#: +91 22 3351 4269/ 4083 | [email protected]/[email protected]
Media Contact: Nicole Fletcher, Piramal Imaging, +1 (857) 202-1122, [email protected]
News distributed by PR Newswire iReach: https://ireach.prnewswire.com
SOURCE Piramal Imaging
