As investors and founding members of the radiopharmaceutical venture CereMark Pharma, LLC, they are proud to announce the commencement of a pivotal Phase III clinical study for an innovative drug candidate, F-18 Flornaptitril. This groundbreaking Positron Emission Tomography (PET) imaging agent is being studied for its potential to revolutionize the management of neurodegenerative diseases. F-18 Flornaptitril’s unique mechanism of action allows it to detect both tau aggregates and beta-amyloid plaques simultaneously within a single PET scan. This imaging agent could play a critical role in predicting the development and progression of conditions like Alzheimer’s Disease and Chronic Traumatic Encephalopathy (CTE).
CereMark Pharma Begins Phase III Trial of F-18 Flornaptitril, a Novel Radiopharmaceutical Focused on Neurodegeneration
CereMark Pharma<http://www.ceremarkpharma.com/> (CereMark), a clinical-stage radiopharmaceutical company focused on the detection and management of neurodegenerative diseases, has commenced 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.
Natchitoches native and Chief Medical Officer for CereMark Pharma, Dr. Julian Bailes stated:
“Work has been ongoing the last 15 years in finding a method to make a living diagnosis of CTE in both former contact sport athletes and military veterans. The ability to hopefully diagnose and potentially one day treat sufferers would be a critical discovery which could lead to better disease management and therapy for these individuals. Our quest continues”.
CereMark CEO, Dr. Henry “Hank” Chilton states: “The Phase III clinical study marks a significant milestone in CereMark Pharma’s ongoing pursuit to revolutionize the field of neurodegenerative disease management. 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 been studied in 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.”
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 imagiing 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<http://www.ceremarkpharma.com/>. You can also follow the company on LinkedIn<https://www.linkedin.com/company/ceremark-pharma>.
About CereMark Pharma
CereMark Pharma<http://www.ceremarkpharma.com/> is a clinical-stage radiopharmaceutical company focused on the detection, diagnosis and management of neurodegenerative diseases that involve tau aggregates and beta-amyloid plaques and its unique PET biomarker, F-18 Flornaptitril (Clintrials.gov NCT 06254469). Our significant scientific, medical and regulatory expertise, combined with our openness to creative collaboration, make CereMark Pharma an ideal partner for organizations that are enthusiastic about innovation and improved therapeutic and diagnostic options for patients who suffer the consequences of neurodegeneration and debilitating brain injury. CereMark is a limited liability company incorporated in Delaware.
