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Developing new molecules to aid in detecting neurodegenerative diseases and enabling early treatment.
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Ceremark Pharma, LLC (Ceremark) announces that Invicro LLC, a Konica Minolta company will collaborate to offer clinical development support and services to help advance a pivotal clinical trial for Ceremark’s investigational new drug Fluorine-18 FDDNP (also known as Flornaptitril F-18).
As a leading provider of imaging biomarkers and core lab services, Invicro will provide Ceremark their medical and scientific expertise, coupled with operational excellence to guide and facilitate this multisite Phase 3 clinical trial. This clinical trial is instrumental to studying the capabilities of Flornaptitril F-18 as a predictive tool in the assessment of cognitive change associated with suspected Alzheimer’s disease and other neurological diseases, including Chronic Traumatic Encephalopathy (CTE).
Ceremark holds exclusive rights to Flornaptitril F-18 through license from UCLA and has successfully completed Phase 1 and Phase 2 human clinical studies. These studies evaluated the use of [F-18] FDDNP imaging in the study of degenerative neurological diseases that involve the pathological processes of beta amyloid plaques and tau macroaggregates.
Previous studies of Flornaptitril F-18 provided PET images of subjects with mild cognitive change in individuals with histories of percussive and concussive traumatic brain injury (TBI), as well as those without evidence of TBI. Ceremark’s Phase 3 pivotal study is designed to support a New Drug Application (NDA) to the US FDA for marketing approval of Flornaptitril F-18.
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For additional information please contact: info@ceremarkpharma.com
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