New Research with Piramal Imaging's Compounds Presented at Human Amyloid Imaging Annual Meeting

MIAMI, Jan. 17, 2018 /PRNewswire-iReach/ -- Piramal Imaging announced today that new research on its positron emission tomography (PET) imaging tracers will be presented at the 12th Human Amyloid Imaging (HAI) meeting in Miami. Presentations on the approved diagnostic imaging agent florbetaben F18 cover more detailed information on the clinical impact of amyloid-PET imaging and on non-invasive tracer kinetic analyses. Clinical updates of the investigational next generation tau PET-imaging tracer PI-2620 will be given, including data from academic research collaborations. Piramal Imaging continues to broaden its clinical experience of PI-2620 globally.

HAI 2018 Miami Beach Resort in Miami Beach, Florida, US. Selected datasets with Piramal Imaging compounds at the conference include the following presentations:

• Clinical evaluation of 18F-PI-2620, a next generation tau PET agent in subjects with Alzheimer's Disease and progressive supranuclear palsy.

Date: January 17, 2018 | 4:15-4:30pm

Presenter: Oral presentation by Dr. Andrew Stephens, MD, PhD Piramal Imaging

• Impact of the appropriate use criteria: effect of amyloid imaging on diagnosis and patient management in an unselected memory clinic cohort: the ABIDE project.

Date: January 17, 2018 | 11:00-11:15am

Presenter: Oral presentation by Arno de Wilde, VU University Medical Center, Amsterdam, Netherlands

• Simplified non-invasive tracer kinetic analysis for 18F Florbetaben PET using a dual time-window acquisition protocol.

Date: January 17, 2018

Presenter: Poster presentation P30 (Session 1, 2:00 - 3:30pm) by Dr. Susan de Santi, PhD Piramal Imaging

• Increased GM regions in association with SUVR are candidate to predict convergence to Preclinical AD.

Date: January 19, 2018

Presenter: Poster presentation P129 (Session 3A, 10:15 - 11:00am; Session 3B, 4:15 ? 5:00pm) by Dr. Gemma Monté-Rubio, Fundació ACE. Institut Català de Neurociències Aplicades., Barcelona, Spain

About Neuraceqtm (florbetaben F18 injection)

Indication

Neuraceqtm 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 Neuraceqtm 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 Neuraceqtm 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.

Neuraceqtm is an adjunct to other diagnostic evaluations.

Limitations of Use

• A positive Neuraceqtm scan does not establish the diagnosis of AD or any other cognitive disorder.
• Safety and effectiveness of Neuraceqtm 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

Neuraceqtm can be used to estimate the density of beta-amyloid neuritic plaque deposition in the brain. Neuraceqtm is an adjunct to other diagnostic evaluations. Neuraceqtm images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of Neuraceqtm 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 Neuraceqtm, 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 Neuraceqtm 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 / Devanshi Dhruva | Piramal Enterprises Ltd.

Tel #: +91 22 3046 6444 / +91 22 3046 6376 | [email protected]

For Media Queries:

Nicole Fletcher | Marketing Communications | Piramal Imaging

Tel #: +1 857-202-1122 | [email protected]

Dimple Kapur/ Priyanka Sharma| Corporate Communications | Piramal Enterprises Ltd.

Tel#: +91 22 3351 4269/ 4132 | [email protected]/[email protected]

Media Contact: Nicole Fletcher, Piramal Imaging, +1 (857) 202-1122, [email protected]

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SOURCE Piramal Imaging