Our Focus

Life molecular imaging

Molecular Imaging

Providing detailed images of the physiological, cellular and molecular state of the body.

Molecular imaging agents (radiopharmaceuticals) are smart compounds developed specifically for a particular tissue, organ, or molecular process. Such diagnostic radiopharmaceuticals are labeled with positron-emitting radionuclides (e.g., 18F) and distribute throughout the body. After intravenous injection, they disperse throughout the body and accumulate in disease areas. Positron emission tomography (PET), a noninvasive imaging technique, can be used to obtain images of the distribution of labeled tracers.

Molecular imaging offers unique insights into the human body that enable physicians to improve diagnosis and personalize patient care. It can provide information that is not available with other imaging modalities or that would require more invasive procedures such as biopsy or surgery. Molecular imaging can detect disease in its earliest stages and pinpoint its exact location, often before symptoms appear or abnormalities can be detected with other diagnostic tests.

life molecular imaging

Neuroimaging

Providing an opportunity to directly visualize and measure brain function and to depict pathophysiological processes of neurodegenerative diseases.

Neuraceq<sup>®</sup> – Beta Amyloid Imaging
Neuraceq® – Beta Amyloid Imaging

Extracellular deposits of β-amyloid peptides (Aß) (or plaques) are one of the pathological hallmarks of Alzheimer's disease (AD). The recent development of molecular imaging tracers that bind to Aß plaques in the brain has enabled in vivo detection of Aß plaque deposits by PET. The noninvasive detection of Aß deposits may potentially contribute to better diagnosis and management of patients with cognitive impairment suspected of having neurodegenerative diseases. In addition, confirming the presence of Aß deposition in subjects and monitoring changes in Aß deposition could be critical during therapeutic trials specifically aimed at removing Aß deposits in the brain.

18F-PI-2620 – Tau Imaging
18F-PI-2620 – Tau Imaging

Abnormal accumulation of misfolded tau protein underlies several neurodegenerative diseases and is associated with various clinical syndromes. In addition to Alzheimer's disease (AD), several neurodegenerative disorders have been described in which the deposition of tau aggregates is a dominant pathology. These include atypical Parkinson's syndromes such as progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS), chronic traumatic encephalopathy, and some variants of frontotemporal lobar degeneration or subtypes of frontotemporal dementia.

Pl-2620 is a small molecule designed for binding and PET imaging of aggregated tau protein in the human brain. This innovative and differentiated diagnostic tool is available to physicians and patients worldwide and can already be used as an investigational tracer in research studies with tauopathy patients.

FDA Fast Track Designation
Life Molecular Imaging has received FDA Fast Track for clinical development of PI-2620 tau PET imaging in patients being evaluated for Alzheimer's disease (AD), progressive supranuclear palsy (PSP), or corticobasal degeneration (CBD). While we continue to advance our research and development efforts, please note that Expanded Access is not currently available for PI-2620.

For selected publications please go to.

*Under clinical investigation – not yet approved by regulatory agencies

18F-DED – MAO-B Imaging
18F-DED – MAO-B Imaging

As an early component of neuroinflammation, astrogliosis is implicated in neurodegenerative diseases such as Alzheimer's disease (AD), multiple sclerosis, amyotrophic lateral sclerosis, and Parkinson's disease. PET imaging of activated astrocytes during neuroinflammation could improve characterization and monitoring of disease progression and therapy.

18F-labeled deuterated deprenyl (18F-DED) is a neuroimaging product candidate that specifically targets activated astrocytes during neuroinflammation..

For selected publications please go to.

*Under clinical investigation – not yet approved by regulatory agencies

Life Molecular Imaging

Cardiovascular Imaging

Molecular imaging also has potential diagnostic applications in cardiovascular diseases. Critical components of a pathology can be selectively visualized and exploited using targeted molecular imaging approaches.

18F-GP1 – Thrombus Imaging
18F-GP1 – Thrombus Imaging

Life Molecular Imaging and its collaborators are studying 18F-GP1, a small molecule labeled with fluorine-18. It binds with high affinity to activated GPllb/llla receptors, which represent one of the key processes in thrombus formation and progression. 18F-GP1 is the first PET tracer shown to be able to detect acute thromboembolic events in patients.

For selected publications please go to.

*Under clinical investigation – not yet approved by regulatory agencies

Florbetaben – Cardiac Amyloid Imaging
Florbetaben – Cardiac Amyloid Imaging

Cardiac amyloidosis is a life-threatening, progressive, infiltrating, rare disease that is often overlooked as a cause of heart failure. Multiple proteins with unstable structures misfold and aggregate to form amyloid fibrils that are deposited in the heart and other organs. Florbetaben is an 18F-labeled stilbene derivative that binds to amyloid deposits and is studied in patients with suspected cardiac amyloidosis.

For selected publications please go to.

*Under clinical investigation – not yet approved by regulatory agencies

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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