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 and Tau Imaging Agents

 

BERLIN, Germany, 14 July 2023 – 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 Amsterdam (July 15 – July 20, 2023), the biggest and most influential international meeting dedicated to advancing dementia science.

The contributions cover twenty-eight (28) presentations demonstrating the utility of its approved compound Neuraceq® (florbetaben F18 injection) and nine (9) presentations supporting the potential of its investigational tau tracer 18F-PI-2620.

LMI is also proud to be contributing with The Amyloid imaging to Prevent Alzheimer’s Disease (AMYPAD) initiative to the AAIC program. A featured research session entitled “Towards clinical implementation of Centiloid quantification: Lessons learned from the AMYPAD consortium” will be held on July 16th.

“We are impressed by the extraordinary wealth of 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 patient diagnosis. Furthermore, Amyloid PET was crucial for the development of the first AD disease-modifying drugs shown to be efficacious in slowing cognitive decline. It remains essential to confirm the presence of brain amyloid prior to commencing an anti-amyloid therapy once these drugs are approved and available.”

Meet the LMI team at booth #504 at AAIC in Amsterdam.

Datasets involving LMI compounds presented at the AAIC conference include the following presentations:
Amyloid-PET Neuroimaging presentations involving Neuraceq® (florbetaben F18 injection):

July 15, 2023 (AIC)

  • Holy et al., Non-invasive kinetic modeling of [18F]-florbetaben and [18F]-PI-2620 with total-body dynamic EXPLORER PET (AIC-P-059)
  • Johns et al., Impact of florbetaben acquisition timing on continuous and dichotomous measures of amyloid burden: implications for real-world amyloid PET interpretation (AIC-P-242)
  • Tanner et al., Predictors and Outcomes of Discordance Between Initial Clinical Diagnosis and Amyloid-PET Results in the Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study (AIC-P-072)
  • Windon et al., Comparison of Expert Reads vs. Local Clinical Reads of Amyloid PET Scans in IDEAS (AIC-P-125)
  • Bollack et al., A Centiloid cut-off to help predict true amyloid accumulation (AIC-P-256)
  • Vállez García Amyloid-PET Centiloid quantification predicts cognitive functioning in a pre-dementia population: findings from AMYPAD-PNHS (AIC-P-139)
  • Mastenbroek et al., Biological and methodological factors underlying a continuous amyloid CSF/PET imbalance model and its association with longitudinal cognition (AIC-P-048)
  • Heeman et al., Comparing parametric methods for longitudinal measurement of β-amyloid pathology with PET in elderly individuals (AIC-P-186)
  • Mahnaz Shekari et al., Evaluating the sensitivity of Centiloid quantification to pipeline design and image harmonization (AIC-P-255)

July 16, 2023

  • Rizzo et al., Prediction of longitudinal cortical amyloid deposition based on cerebrospinal fluid biomarkers for Alzheimer’s disease in cognitively unimpaired individuals: the role of APOE-ε4 (P1-306)
  • Windon et al., Comparison of Expert Reads vs. Local Clinical Reads of Amyloid PET Scans in IDEAS (P1-459)
  • Tanner et al., Predictors and Outcomes of Discordance Between Initial Clinical Diagnosis and Amyloid-PET Results in the Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study (P1-429)

AMYPAD featured research session “Towards clinical implementation of Centiloid quantification: Lessons learned from the AMYPAD consortium”, July 16th 9:15-10:30 am (Hall 2)

  • Shekari et al., Evaluating the sensitivity of Centiloid quantification to pipeline design and image harmonization
  • Bollack et al., A Centiloid cut-off to help predict true amyloid accumulation
  • Collij et al., Quantification supports visual assessment of challenging amyloid–PET images
  • Quenon et al., Evaluating the global cortical Centiloid value for predicting functional decline

July 17, 2023

  • Zeyen et al., AMYPAD: Correlation of Amyloid PET results with anxiety and depressive symptoms in SCD+, MCI and dementia patients (P2-487)
  • Pieperhoff et al., Amyloid predicts longitudinal atrophy in non-demented individuals: Results from the AMYPAD Prognostic & Natural History study (P2-918)
  • La Joie et al., Quantitative Amyloid-PET in Real-World Practice: Lessons from the Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) study (P2-922)
  • Booncharoen et al., Association between topographic distribution of dilated perivascular spaces and Alzheimer’s disease pathologies measured by 18F-florbetaben and PI-2620 PET (P2-048)
  • Bhattarai et al., Comparison of delay correction methods to estimate 18F-florbetaben kinetics in the brain using an image derived input function on total-body EXPLORER PET (P2-427)
  • Holy et al., Non-invasive kinetic modeling of [18F]-florbetaben and [18F]-PI-2620 with total-body dynamic EXPLORER PET (P2-363)

July 18, 2023

  • Luckett et al., Differential associations between regional amyloid PET and Alzheimer’s disease polygenic risk scores (P3-003)

July 19, 2023

  • Vállez García et al., Amyloid-PET Centiloid quantification predicts cognitive functioning in a pre-dementia population: findings from AMYPAD-PNHS (P4-383)
  • Mastenbroek et al., Biological and methodological factors underlying a continuous amyloid CSF/PET imbalance model and its association with longitudinal cognition (P4-334)
  • Johns et al., Impact of florbetaben acquisition timing on continuous and dichotomous measures of amyloid burden: implications for real-world amyloid PET interpretation (P4-440)

Virtual Poster only

  • Regy et al., The association between Aβ aggregation and age depends on APOE genotype: Findings from the AMYPAD cohort (P1-00)
  • Wilkins et al., A Comprehensive, Community-Engaged Recruitment Strategy to Increase Minority Representation in New IDEAS – an Amyloid Imaging Study (P1-00)


Tau-PET Neuroimaging presentations involving 18F-PI-2620:

July 15, 2023 (AIC)

  • Holy et al., Non-invasive kinetic modeling of [18F]-florbetaben and [18F]-PI-2620 with total-body dynamic EXPLORER PET (AIC-P-059)
  • Winer et al., Cortical and substantia nigra 18F-PI-2620 tau PET signal in Lewy body disease (AIC-P-162)

July 16, 2023

  • Dilcher et al., Biomarker interplay between CSF p-tau and 18F-PI-2620 PET in Alzheimer’s disease and 4R-tauopathy (P1-428)
  • Winer et al., Cortical and substantia nigra 18F-PI-2620 tau PET signal in Lewy body disease (P1-471)

July 17, 2023

  • Booncharoen et al., Association between topographic distribution of dilated perivascular spaces and Alzheimer’s disease pathologies measured by 18F-florbetaben and PI-2620 PET (P2-048)
  • Holy et al., Non-invasive kinetic modeling of [18F]-florbetaben and [18F]-PI-2620 with total-body dynamic EXPLORER PET (P2-363)

July 19, 2023

  • Palleis et al., Prognostic value of Neurofilament light chain, [18F]-PI2620 PET and [18F]GE-180-PET in amyloid-negative Corticobasal Syndrome (P4-343)

July 20, 2023

  • Pegueroles et al., [18F]PI2620 tau deposition increases along the Alzheimer’s disease continuum in Down Syndrome and in presence of amyloid (Hall 2)

Virtual Poster only

  • Aliaga et al., [18F]MK6240 and [18F]PI2620 autoradiography on postmortem human brain tissue in AD (P1-00)

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

  • A positive Neuraceq® scan does not independently establish a diagnosis of AD or other cognitive disorder, since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (AD, Lewy body dementia, Parkinson’s disease dementia).
  • The efficacy of florbetaben (18F) for predicting development of AD or monitoring response to therapy has not been established.
  • Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blurs, which could lead to interpretation errors.
  • Increased uptake has been identified in extracerebral structures such as face, scalp and bone in some cases. Residual activity in the midsagittal sinus can be sometimes observed.

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.

For more information please visit: https://www.ema.europa.eu/en/medicines/human/EPAR/neuraceq

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 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/

For media queries contact:

Brittany Hahn |
Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 |  b.hahn@life-mi.com 

Neuraceq® - Product Indications And Use

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

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    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. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

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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