PRESS RELEASE
Life Molecular Imaging announces presentation of new scientific data at the European Association of Nuclear Medicine annual meeting 2022
Research Presented Provides Further Insights into Neuro- and Cardiovascular Imaging Agents
Life Molecular Imaging announces presentation of new scientific data at the European Association of Nuclear Medicine annual meeting 2022
Research Presented Provides Further Insights into Neuro- and Cardiovascular Imaging Agents
Berlin, Germany, 14 Ocotber 2022.
Life Molecular Imaging (LMI) announces today that new research results on its approved and investigational positron emission tomography (PET) tracers will be presented at the 35th Annual Congress of the European Association of Nuclear Medicine on October 15-19, 2022 in Barcelona, Spain.
The contributions cover ten (10) presentations demonstrating the utility of its approved compound Neuraceq® (florbetaben F18 injection), two (2) presentations supporting the potential of its investigational tau tracer 18F-PI-2620, one (1) presentation highlighting new data from its investigational neuroinflammation imaging tracer 18F-DED and one (1) presentation with its investigational cardiovascular imaging tracer 18F-GP1 in patients with prosthetic valve thrombosis.
“We are very 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 Imaging is broadly expanding, discovering new insights into pathophysiology and providing critical biomarker data for diagnosing and monitoring patients. We are particularly excited to be contributing to the EANM program with The Amyloid imaging to Prevent Alzheimer’s Disease (AMYPAD) initiative.”
Selected datasets involving LMI compounds presented at the EANM conference include the following presentations:
Amyloid-PET Neuroimaging presentations involving Neuraceq® (florbetaben F18 injection):
Tau-PET Neuroimaging presentations involving 18F-PI-2620:
Neuroinflammation-PET Imaging involving 18F-DED
Cardiovascular PET Imaging with 18F-GP-1
Oncologic PET Imaging with 18F-RM2
About Neuraceq (florbetaben 18F)
Indication
Neuraceq® is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Neuraceq should be used in conjunction with a clinical evaluation.
A negative Neuraceq® scan indicates sparse to no plaques, which is not consistent with a diagnosis of AD. Neuraceq is for diagnostic use only.
Limitations of Use
Important Safety Information
Risk for Image Interpretation and Other Errors
Neuraceq images should only be interpreted by readers trained in the interpretation of PET images with florbetaben (18F). A negative scan indicates sparse or no density of cortical β-amyloid plaques. A positive scan indicates moderate to frequent density. Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.
Radiation Risk
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is about 5.8 mSv when the maximum recommended activity of 300 MBq of florbetaben (18F) is administered, these adverse reactions are expected to occur with a low probability.
Common Adverse Reactions
The overall safety profile of Neuraceq is based on data from 1,295 administrations of Neuraceq to 1,077 subjects and 12 subjects who received vehicle. Repeat dosing in yearly intervals showed that there was no difference in safety profile after first, second or third dosing. Common adverse reactions include injection site pain and injection/ application site erythema.
About [18F]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. [18F]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 [18F]-GP1
GP1 is a small molecule labeled with fluorine-18 designed for thrombus imaging. It binds with high affinity and selectivity to GPIIb/IIIa, the key receptor involved in thrombus formation. Clinical proof-of-concept study confirmed its potential for imaging thrombotic events in various diseases and settings.
About RM2
RM2 is a small peptide binding with high affinity to the GRP receptor, highly expressed in early and recurrent prostate cancer and other tumors. Its metal-chelate moiety allows for labeling with gallium-68 or with lutetium-177 for further exploration as theranostic agent.
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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