BOSTON and CULVER CITY, Calif., Sept. 14, 2018 /PRNewswire-iReach/
Life Molecular Imaging (LMI) and SOFIE Inc. announce that the clinical trial supply production of LMI's 18F-labeled Tau PET imaging agent PI-2620 has commenced at SOFIE sites in the US. LMI and SOFIE leveraged their joint resources to establish broad availability for clinical trial supply supporting LMI's product development efforts, academic clinical studies and pharmaceutical drug development trials.
LMI under its new ownership remains dedicated to the development and global commercialization of innovative molecular imaging agents. As an emerging leader in molecular imaging LMI is developing products that address major clinical needs in neurology, oncology, and cardiovascular diseases.
SOFIE Inc. is a molecular imaging company specializing in novel tools for PET imaging and radiosynthesis of PET compounds. Their Contract Manufacturing Organization and national GMP radiopharmacy network complement SOFIE's imaging and radiochemistry product lines, bringing innovative technologies and theranostic production together within one company.
"PI-2620 is a next generation investigational PET tracer with favorable clinical properties designed to identify pathological tau deposits in the brain", said Andrew Stephens, M.D., Ph.D., Chief Medical Officer of Life Molecular Imaging. "Tau deposits, in conjunction with beta-amyloid plaques, represent the critical pathologies in Alzheimer's disease (AD) with Tau further playing an important role in other neurodegenerative diseases. Visualizing the tau deposits and their spread in cognitively impaired subjects has the potential to provide a better understanding of the disease and to enable an earlier and more accurate diagnosis of AD and other neurodegenerative disorders. Ongoing clinical trials have shown high brain uptake, rapid washout and low off-target binding."
SOFIE is manufacturing both Neuraceq, LMI's approved amyloid-beta PET tracer, and PI-2620 in the US providing non-invasive biomarkers for both amyloid plaques and tau tangles.
"Life Molecular Imaging continues to expand the availability of innovative molecular imaging agents for clinical investigations," said Ludger Dinkelborg, Ph.D., Managing Director at LMI. "We are truly proud and excited to move our PI-2620 tau program forward with our US radiopharmacy partner. This is a major step forward as we continue to extend our global PI-2620 clinical supply network."
"We are excited to provide Life Molecular Imaging's new imaging agent, continuing the partnership established with Neuraceq, towards better understanding the biology of disease associated with AD," said Melissa Moore, SOFIE CTO. Philipp Czernin, SOFIE CRO added, "By utilizing our radiopharmacy network and relationships with key academic institutions, we aim to fully support physicians and patients that can benefit from this new tracer."
About Neuraceq™ (florbetaben F18 injection)
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 impairment. Neuraceq is an adjunct to other diagnostic evaluations. For the full indication statement and other important safety information, please refer to the approved prescribing information. 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%).
PI-2620 is an 18F-labeled investigational PET tracer that was discovered in a research collaboration between Piramal Imaging and AC Immune, a Swiss-based clinical stage biopharmaceutical company focused on neurodegenerative diseases. 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)
LMI (formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG, and is now part of the Alliance Medical Group, 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. LMI 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
The early vision for molecular imaging was to revolutionize clinical diagnostics and therapeutics to better understand and treat the biology of disease. Today, SOFIE brings that vision to life by increasing the adoption and application diversity of theranostics by removing the cost and complexity traditionally associated with the technology. With a full line of imaging and radiochemistry systems and a premier radiopharmacy network and contract manufacturing organization to supply novel agents for diagnosis and therapy, SOFIE is dedicated to improving patient health.
For more information, please visit https://sofie.com or contact us at email@example.com.
Nicole Fletcher, Life Molecular Imaging, +1 (857) 202-1122, firstname.lastname@example.org
Media Contact: Aleksandar Jovalekic, Life Molecular Imaging, +49 (0)30 461 124 619, email@example.com
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SOURCE Life Molecular Imaging