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CereMark Pharma, LLC is a West Virginia Limited Liability Company with headquarters in Wheeling WV and an office in Lexington KY. It is a developmental and clinical stage pharma company that focuses upon neurodegenerative diseases, including early diagnosis and management, as well as preventative, non-invasive management of chronic neurological impairment from events associated with traumatic brain injury.

CereMark Pharma is privately-held with 100% ownership by company founders and officers.

Flornaptitril F-18, our unique PET imaging radiopharmaceutical, is primed for the Phase 3 clinical investigative trial as a tool to better aid prediction of worsening mental impairment in individuals presenting with mild-moderate cognitive status.

August 2, 2022

CereMark Pharma Announces New Patents on Selective Imaging Agent of Alzheimer’s Disease, Chronic Traumatic Encephalopathy and Other Neurodegenerative Diseases

CereMark to Commence Phase 3 FDA Clinical Study

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”.

April 30, 2021

Patent Awarded for PET Radiopharmaceutical for Neurodegeneration Imaging

CereMark Pharma, LLC (CereMark) has been notified of a new U.S. patent award for Flornaptitril F-18, its investigational new Positron Emission Tomography (PET)imaging radiopharmaceutical licensed exclusively to CereMark by the patent owner, the University of California Los Angeles (UCLA).

CereMark clinical research studies show that Flornaptitril binds with both tau aggregates and beta amyloid plaque in the brain to enhance PET scan imaging. The distribution patterns of these pathological proteins are significant in both Chronic Traumatic Encephalopathy (CTE)and Alzheimer’s Disease (AD). Through two phases of clinical research, several hundred subjects with cognitive impairment from either traumatic brain injuries or disease have been safely studied with Flornaptitril. CereMark has reached agreement with regulators on Phase 3 clinical investigational studies.
“Neurodegenerative brain disorders are a growing concern for doctors, patients and families, with everyone wanting to find better ways to address the needs of those patients presenting with mild to severe cognitive decline. We are excited that research we are accomplishing with Flornaptitril could represent a significant breakthrough in both diagnosis and charting responses to treatments, and better management for neurodegenerative diseases” said Dr. Henry M. Chilton, CEO of CereMark.

Additionally, Dr. William C. Putnam, Chief Regulatory and Science Officer commented “We are well positioned for continued success in the Phase 3 trial for Flornaptitril as no single PET imaging agent yet approved by FDA simultaneously detects both tau aggregates and beta amyloid plaque in neurodegeneration in a single scan. We are close to finalizing with FDA the protocol for our Phase 3 multi-site clinical trial for this truly unique PET imaging radiopharmaceutical.”

RELATED NEWS: The CereMark announced this week Dr. Donna J. Cross, an internationally recognized researcher in neurological pathology, has joined CereMark Pharma’s Medical and Science Advisory Board (MSAB). Dr. Cross, a principal investigator in research programs in Alzheimer’s disease, traumatic brain injuries, dementia, and aging, is an Associate Professor at the University of Utah’s Neuroimaging and Biotechnology Laboratory (NIBL). In addition, Dr. Cross was recently elected as President of the Society of Nuclear Medicine and Molecular Imaging’s (SNMMI)Brain Council. Dr. Cross joins other accomplished clinicians and researchers on CereMark’s MSAB, including:

• Dr.Satoshi Minoshima (Chairman, Department of Radiology, University of Utah; and past president of the Society of Nuclear Medicine and Molecular Imaging).

• Dr. John Lee (Chair, Neurosciences, NorthShore University HealthSystem; Editor-in-Chief, Journal of Neuropathology and Experimental Neurology).

• Dr. Edward Hall (Marksbery Chair in Neurotrauma Research, Spinal Cord and Brain Injury, University of Kentucky).