CereMark Pharma Begins Phase III Trial of F-18 Flornaptitril, a Novel Diagnostic Radiopharmaceutical Focused on Neurodegeneration

F-18 Flornaptitril was designed to simultaneously detect tau aggregates and beta-amyloid plaques within a single PET scan

CereMark Pharma (CereMark), a clinical-stage radiopharmaceutical company focused on the detection, diagnosis and management of neurodegenerative diseases, will commence a Phase III clinical study of its innovative drug candidate, F-18 Flornaptitril, at Endeavor Health’s Neurosciences Institute based in Evanston IL. This novel Positron Emission Tomography (PET) imaging agent is being studied for effectiveness in the management of neurodegenerative diseases, including the ability to predict development and progression of Alzheimer’s Disease and Chronic Traumatic Encephalopathy (CTE). F-18 Flornaptitril is a novel radiopharmaceutical candidate with a unique mechanism of action detecting both tau aggregates and beta-amyloid plaques simultaneously within a single PET scan.

“The Phase III clinical study marks a significant milestone in CereMark Pharma's ongoing pursuit to revolutionize the field of neurodegenerative disease management,” said CereMark Pharma CEO, Dr. Henry “Hank” Chilton. “Visualizing and quantifying both tau aggregates and beta-amyloid plaques in the brain using a single PET scan will advance the understanding of these debilitating conditions and, we also believe, will allow precise quantitative assessment of therapeutic efficacy of newer drug products.”

F-18 Flornaptitril has already been tested safely in clinical investigational studies involving over 550 patients with traumatic brain injuries or other neurological diseases. Research supports F-18 Flornaptitril’s unique ability to target both beta-amyloid plaques and tau aggregates thus enabling a distinctive imaging pattern for neurodegenerative diseases that is not found in any other single PET imaging diagnostic radiopharmaceutical available today. This is revolutionary, as an emerging consensus in major medical and research publications is that the pathological coexistence of beta-amyloid plaque and tau aggregates is linked to the progression of mild cognitive impairment and the increased risk of severe cognitive decline.

“Physicians and researchers want better ways to diagnose and treat patients with neurological diseases,” said Dr. Chad Yucus, a clinical neurologist at Endeavor Health’s Neurosciences Institute in Evanston IL where he specializes in neurodegenerative diseases and dementia. A single PET imaging agent like CereMark’s F-18 Flornaptitril that can be used to determine the precise location of the principal pathological neuroproteins in the living brain and predict the clinical development of neurodegenerative diseases is so important for patients and the medical community. We look forward to the data that will come from F-18 Flornaptitril’s Phase III trial and improved pharmacological treatments.”  CereMark will shortly announce opening at additional clinical sites in the Midwest.

More than 16 million Americans are currently affected by neurodegenerative diseases. According to the World Health Organization (WHO), neurological diseases like Alzheimer’s and those associated with TBI are now the leading cause of disability and the second leading cause of death globally. The organization also estimates that 1 in 3 people will suffer from some form of neurodegenerative disease in their lifetime.

While these diseases pose considerable challenges for patients as well as their families, advancements in diagnostic imaging research for new and improved PET biomarkers, such as F-18 Flornaptitril, offer hope that newer and effective management, potentially including therapeutics, will soon follow for these life-threatening diseases.

For more information visit CereMarkPharma.com. You can also follow the company on LinkedIn.

 

 

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