PRESS RELEASE
Life Molecular Imaging announces presentation of new scientific data at the Alzheimer’s Association International Conference
Research Presented Provides Further Insights into Amyloid, Tau and Neuroinflammation Imaging Agents
Life Molecular Imaging announces presentation of new scientific data at the Alzheimer’s Association International Conference
Research Presented Provides Further Insights into Amyloid, Tau and Neuroinflammation Imaging Agents
BERLIN, Germany, 29 July 2022. – Life Molecular Imaging (LMI) announces today that new research results on its approved and investigational positron emission tomography (PET) neuroimaging tracers will be presented at the Alzheimer’s Imaging Consortium (AIC) meeting and the Alzheimer’s Association International Conference (AAIC) in San Diego (July 30 – August 4, 2022), the biggest and most influential international meeting dedicated to advancing dementia science.
The contributions cover twelve (12) presentations demonstrating the utility of its approved compound Neuraceq® (florbetaben F18 injection), thirteen (13) presentations supporting the potential of its investigational tau tracer 18F-PI-2620 and one (1) presentation highlighting first-in-human data from its investigational neuroinflammation imaging tracer 18F-DED.
LMI is also proud to be contributing with The Amyloid imaging to Prevent Alzheimer’s Disease (AMYPAD) initiative to the AAIC program. A virtual featured research session entitled “Progressing the clinical and technical value of amyloid PET in dementia – the AMYPAD experience” will be held on August 1st.
LMI in conjunction with Clario will host a reception and presentations of tau PET imaging, quantification and use in clinical trials featuring Dr. Victor Villemagne.
“We are impressed by the data that research groups around the world have collected over the last year” said Dr. Andrew Stephens, MD, PhD, CMO of Life Molecular Imaging. “PET Neuroimaging is broadly expanding, revealing new insights into pathophysiology and providing important biomarker data for diagnosing patients and in therapeutic clinical trials.”
Datasets involving LMI compounds presented at the AAIC conference include the following presentations:
Amyloid-PET Neuroimaging presentations involving Neuraceq® (florbetaben F18 injection):
July 30, 2022 (AIC)
July 31, 2022
August 1, 2022
AMYPAD virtual featured research session “Progressing the clinical and technical value of amyloid PET in dementia – the AMYPAD experience”
August 3, 2022
Tau-PET Neuroimaging presentations involving 18F-PI-2620:
July 30, 2022 (AIC)
August 1, 2022
August 2, 202
Neuroinflammation-PET Imaging involving 18F-DED
August 2, 2022
About Neuraceq® (florbetaben 18F)
Indication
Neuraceq® is a radioactive diagnostic agent 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 Us
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 positives) 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®, like 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 PI-2620
Tau deposits, in conjunction with beta-amyloid plaques, represent the other pathological hallmark of Alzheimer’s disease, with tau deposits further playing an important role in other neurodegenerative diseases. PI-2620 is binding to 3R/4R and 4R tau deposits and is a next generation 18F-labeled investigational PET tracer with favourable properties and imaging characteristics. It was discovered in a research collaboration between Life Molecular Imaging and AC Immune, a Swiss-based clinical stage biopharmaceutical company. Life Molecular Imaging has the exclusive, world-wide license for research, development and commercialization of tau PET tracers generated within the discovery program.
About 18F-DED
Neuroinflammation represents a key pathologic mechanism in many neurodegenerative diseases, including AD, movement disorders and multiple sclerosis. In the brain it can be mediated by activated astrocytes (astrogliosis), which show increased activity of the enzyme monoamine oxidase B (MAO-B). The PET tracer [18F]DED is a deuterated deprenyl derivative that was designed to preferentially bind to areas with increased MAO-B activity.
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group (a member of the Life Healthcare Group) offering an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization 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. Please visit https://life-mi.com.
About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years’ experience in the South African private healthcare sector, and currently operates 66 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, and wellness, occupational health, primary health and emergency medical services. The Group owns Alliance Medical Group, the leading independent provider of medical imaging services (MRI, CT and PET scans) within Europe, operating internationally across 10 countries. Life Molecular Imaging, a division of Alliance is an integrated pharmaceutical business that includes research and development laboratories, access to a network of cyclotrons and radio-pharmacies and imaging facilities, with Life Radiopharma being Alliance’s distributor of radiopharmaceuticals to diagnose many types of diseases. Visit https://www.lifehealthcare.co.za/
Alya Schalabi
Marketing Europe | Life Molecular Imaging
Tel#: +49 151 1456 9895
a.schalabi@life-mi.com
PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-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 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: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS:
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.
SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
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