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

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):

  • Altomare et al., The use of amyloid-PET in memory clinic patients: AMYPAD Diagnostic and Patient Management Study. OP-135, Sunday, October 16, 2022, 09:45 – 11:15, Hall 212 (Oral).
  • Gispert et al., The Centiloid scale applied to 18f-florbetaben and 18f-flutemetamol PET renders comparable estimates of amyloid burden in memory clinic patients. OP-136, Sunday, October 16, 2022, 09:45 – 11:15, Hall 212 (Oral).
  • Giovacchini et al., Machine Learning Model To Predict Diagnosis Of Mild Cognitive Impairment By Using Radiomic And Amyloid Brain PET. OP-309, Monday, October 17, 2022, 08:00 – 09:30, Hall 211 (Oral).
  • Saint-Aubert et al., Prevalence of amyloidopathy in frailty elderly subjects: the CogFrail study. EPS-156, Monday, October 17, 2022, 16:45 – 18:15, Hall 111 (ePoster).
  • D’Amico et al., Reproducibility of SUV-ratio (SUVr) dependent and independent methods for semiquantification of Amyloid PET included in DOlab Platform. EPS-157, Monday, October 17, 2022, 16:45 – 18:15, Hall 111 (ePoster).
  • Donegani et al., Beyond steady-state amyloid PET to detect demyelination in multiple sclerosis (MS). OP-763, Tuesday, October 18, 2022, 16:45 – 18:15, Hall 115 (Oral).
  • Roé-Vellvé et al., Impact of error propagation in the development of the centiloid conversion equation. EP-297, During Congress Opening Hours, e-Poster Area (ePoster).
  • Solis-Urra et al., Whole-brain gray matter differences according to brain amyloid status: Preliminary findings from the AGUEDA trial. EP-299, During Congress Opening Hours, e-Poster Area (ePoster).
  • Rivas-Navas et al., [18F]F-florbetaben-PET/CT study of a sample of cognitive normal older adults: Description and characteristics of AGUEDA project participants. EP-300, During Congress Opening Hours, e-Poster Area (ePoster).
  • Leonhardi et al., Differential Diagnosis between Alzheimer’s Disease-Related Depression and Pseudo-Dementia in Depression – A New Indication for Amyloid-b Imaging? EP-311, During Congress Opening Hours, e-Poster Area (ePoster).

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

  • Camacho et al., [18F]PI-2620 staging tau pathology in Down Syndrome. OP-133, Sunday, October 16, 2022, 09:45 – 11:15, Hall 212 (Oral).
  • Hong et al., Single Tracer Recovery using Neural Ordinary Differential Equation: a step forward for dual-tracer studies. EP-456, During Congress Opening Hours, e-Poster Area (ePoster).

Neuroinflammation-PET Imaging involving 18F-DED

  • Hummel et al., Specific loss of NPC1 in myeloid cells drives single cell 18kDa translocator protein expression in microglia and leads to reactive astrocytosis and loss of synaptic function. OP-559, Tuesday, October 18, 2022, 08:00 – 09:30, Hall 114 (Oral).

Cardiovascular PET Imaging with 18F-GP-1

  • Hugenberg et al., [18F]GP1 PET/CT in Patients with Prosthetic Valve Thrombosis – Diagnosis – Therapy – Follow up. OP-840, Wednesday, October 19, 2022, 08:00 – 09:30, Hall 115 (Oral).

Oncologic PET Imaging with 18F-RM2

  • Duan et al., Modified PROMISE Criteria for Standardized Interpretation of GRPR-targeted PET. OP-892, Wednesday, October 19, 2022, 09:45 – 11:15, Hall 117 (Oral).
  • Duan et al., A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Biopsy Guidance in Patients with Suspected Prostate Cancer. EP-147, During Congress Opening Hours, e-Poster Area (ePoster).
  • Duan et al., A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Evaluation of Prostate Cancer Response to High Intensity Focused Ultrasound (HIFU) Therapy. EP-176, During Congress Opening Hours, e-Poster Area (ePoster).

 

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.

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/

For media queries

Alya Schalabi
Marketing Europe | Life Molecular Imaging
Tel#: +49 151 1456 9895
a.schalabi@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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