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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.  

June 28 2023

CereMark Pharma and Invicro to Collaborate on Development of F-18 Flornaptitril

May 3, 2023

CereMark Pharma Announces F-18 Flornaptitril Supply Agreement with SpectronRx for Continued Product Development and Phase 3 Clinical Trials

May 3, 2023

May 3, 2023

CereMark Prepares for Phase 3 Clinical Studies, Evaluating Prediction of Cognitive Decline in Alzheimer’s Disease, Chronic Traumatic Encephalopathy and Other Neurodegenerative Diseases

New York, New York – May 3, 2023:

CereMark Pharma LLC (“CereMark”) today announced that it has entered into a supply agreement with SpectronRx for the production of [F-18]Flornaptitril (formerly known as [F-18]FDDNP), an investigational new Positron Emission Tomography (PET) imaging radiopharmaceutical that is being studied for usefulness in the management of neurodegenerative diseases including the development and progression of Alzheimer’s Disease (AD), Chronic Traumatic Encephalopathy (CTE), and other diseases associated with cognitive impairment.  Previous clinical studies with [F-18]Flornaptitril have demonstrated unique imaging abilities – as seen on PET scans – to simultaneously detect both beta-amyloid plaques and tau macroaggregates.   The presence and distribution of these proteins in the brain have been linked to the development and progression of life-threatening neurodegenerative diseases such as AD and CTE.  Under the new agreement, SpectronRx will manufacture [F-18]Flornaptitril for CereMark using the patented radiochemical synthetic technique (#10,626,083B2 in the United States and #. 3538161 in the European Union) held exclusively by CereMark under license from UCLA.  CereMark plans to use [F-18]Flornaptitril manufactured by SpectronRx in its pivotal Phase 3 multi-site clinical investigational study that is planned to start later this year.   

Commenting on the announcement, CereMark’s Chief Executive Officer, Henry (“Hank”) Chilton, PharmD, said, “We are pleased to be working with SpectronRx for the manufacture, supply and distribution of [F-18]Flornaptitril.  SpectronRx is a leader in the cyclotron-assisted production and clinical trial support of investigational new radiopharmaceuticals and is globally respected for its clinical development capabilities and manufacturing services.  Our engagement of SpectronRx is another significant milestone towards fulfilling the regulatory requirements for the development and approval of this unique, dual-targeting, short-lived PET imaging biomarker.”

Anwer Rizvi, President of SpectronRx commented, “SpectronRx is delighted to offer its services to support the manufacturing and distribution of [F-18]Flornaptitril for CereMark’s clinical trials and to create the necessary radiochemistry synthesis platform that could be used in commercializing Flornaptitril when approved by FDA.”

Julian Bailes, MD, CereMark’s Chief Medical Officer, joined Dr. Chilton by commenting, “Major medical and research publications increasingly report that the presence of both beta-amyloid plaque and tau aggregates are associated with progression to mild cognitive impairment (MCI) and risk of further serious cognitive decline, even in individuals without current cognitive impairment.  This finding is the premise upon which CereMark is working to demonstrate the role a single PET imaging agent can play in defining the presence of both neuroproteins in the predictive likelihood of the clinical development of neurodegenerative diseases.  That is our goal,” he said.

About CereMark Pharma LLC

CereMark is incorporated in Delaware.  Its management team includes Dr. Henry (“Hank’) Chilton (formerly Vice President, Business Development, Cardinal Health (NYSE: CAH), and PETNet Solutions); Dr. Julian Bailes (Chair, Department Neurosurgery, Co-Director NorthShore Neurological Institute; Clinical Professor of Neurosurgery, University of Chicago Pritzker School of Medicine).

About SpectronRx

SpectronRx is a Radiopharmaceutical Contract Manufacturing/Contract Development and Manufacturing Organization (RCMO/RCDMO) with 140,000 sq. ft. of manufacturing space in Indiana, with an additional facility in Danbury, Connecticut.  SpectronRx supplies therapeutic and diagnostic radiopharmaceuticals to six Continents, has been EMA and FDA inspected, can both produce and procure any currently used radioisotopes.  The company performs all scales of development, from initial conjugations through scale-up and commercial distribution, as well as the capability of running clinical trials.  With a large staff of radiochemists, radiopharmacists, scientists, engineers, and dozens of qualified clean rooms, SpectronRx has a broad capability to develop and distribute diagnostic and therapeutic radiopharmaceuticals. More information can be found at or on LinkedIn.

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).


CereMark’s products are in various stages of pre-clinical and clinical investigational new drug studies and are not yet approved for human use.

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