Los Angeles, California – August 2, 2022: CereMark Pharma LLC (“CereMark”) today announced that additional patents have been awarded to the University of California at Los Angeles (‘UCLA”) associated with a unique, selective imaging biomarker, [F-18]FDDNP, for the detection, development and progression of Alzheimer’s Disease, Chronic Traumatic Encephalopathy, and other neurodegenerative diseases. The new patents [#10,626,083B2 in the United States, and #. 3538161 in the European Union] cover a unique method of synthesizing [F-18]FDDNP that provides high radiochemical yields and short manufacturing times for [F-18]FDDNP, ready for human administration. CereMark is UCLA’s exclusive licensee for the development and commercialization of [F-18]FDDNP which is now ready for its single Phase 3 clinical multi-site study required for U.S. approval. [F-18]FDDNP (also known by its USAN-designated name Flornaptitril F-18) is unique because it simultaneously co-images two key pathological neuroproteins (beta amyloid plaque and tau aggregates) that are associated with the development and progression of Alzheimer’s Disease, Chronic Traumatic Encephalopathy (CTE) and other neurodegenerative diseases.
Commenting on the announcement, CereMark’s Chief Executive Officer, Henry (“Hank”) Chilton, PharmD, said, “An estimated 5+ million individuals in the United States likely have Alzheimer’s disease, and the prevalence of dementia could triple from 2019-2050. In the world of brain injury, dementia and cognitive-related diseases there is currently no technology that provides for simultaneous co-imaging of beta amyloid plaque and tau aggregates. Co-imaging of these proteins represents a significant step forward in the battle against neurodegeneration and cognitive decline.” Dr. Chilton then stated that simultaneous co-imaging of the two neuroproteins should provide for better management of these life-debilitating diseases, confirmation of which is currently made only at autopsy. William C. Putnam, PhD, CereMark’s Chief Regulatory Officer joined Dr. Chilton by commenting: “CereMark’s PET imaging agent, [F-18] FDDNP, once approved by the FDA, will be the first PET biomarker to co-image both amyloid plaque and tau aggregates”.