CereMark Pharma, a clinical-stage radiopharmaceutical company specializing in the development of novel Positron Emission Tomography (PET) imaging radiopharmaceuticals that bring highly precise visibility into the progression of neurodegenerative diseases in living brains, and Hall of Fame Health, a healthcare concierge and care coordinator formed in 2020, have teamed up to support CereMark’s planned upcoming clinical studies aimed to help improve outcomes for athletes and soldiers battling neurodegenerative diseases.
As part of the new collaborative relationship, Hall of Fame Health will work with CereMark Pharma to support its planned upcoming Phase 3 clinical trials of its investigational new diagnostic radiopharmaceutical F-18 Flornaptitril, a novel PET imaging agent that has been demonstrated in research to target the two principal pathological proteins that occur in the development of Alzheimer’s Disease and Chronic Traumatic Encephalopathy. The planned Phase 3 investigational trial will study the new PET imaging agent in patients presenting with the initial indicators of Mild Cognitive Impairment (MCI). CereMark’s Phase 3 clinical trial program of F-18 Flornaptitril is targeted to begin later this year, 2024.
“Partnering with Hall of Fame Health represents a pivotal step forward in our mission to provide patients, their families and the healthcare community with precise and actionable insights into cognitive health, including Alzheimer’s Disease and Chronic Traumatic Encephalopathy,” said CereMark Pharma CEO, Dr. Henry “Hank” Chilton.
He continued, “This relationship will not only help us in our work to further study F-18 Flornaptitril within the professional sports and military communities, but it will also help us generate greater awareness about neurodegenerative diseases. Together, we are positioned to make significant contributions to the understanding and treatment of diseases like Alzheimer’s Disease and Chronic Traumatic Encephalopathy, ensuring better care for those in need.”
To date, no radiopharmaceutical has been approved by the FDA that can differentiate whether individuals with MCI will develop further neurodegeneration. The need, therefore, is a method to predict the likely course of disease development as early as possible when patient management and treatments can be most effective. Providing quantification, localization, anatomical uptake density, and progression analysis of these proteins could lead to greater confidence in the decision-making process regarding how best to manage these life-debilitating diseases.
“To date, we may see symptoms of what we may believe to be CTE, but until an individual passes away and we can study their brain, we can’t know for sure,” said Jeremy Hogue, CEO of Hall of Fame Health. “The promise of Ceremark Pharma is to let living individuals know now, track the progression, and be ready for therapies that we hope are coming soon.”
Hall of Fame Health was established in response to concerns expressed by Pro Football Hall of Famers who witnessed their teammates’ healthcare struggles and issues. It now aims to connect former NFL players, military veterans, and their families with a nationwide network of hospitals, health systems, and behavioral health providers who specialize in mental health, substance abuse, and crisis management. Hall of Fame Health partners offer the finest specialty healthcare services in the country. Additionally, Hall of Fame Health provides guidance on benefits, advocates for individuals and families, and educates them about insurance, benefits, and care options.
Hall of Fame Health has also formed alliances with collegiate alumni groups and veteran organizations like the Special Forces Foundation, and it plans to expand to serve athletic departments, collegiate conferences, and additional sports and veteran communities.
The CDC estimated that there are 1.7 to 3.8 million traumatic brain injuries (TBIs) each year. These injuries are often sustained from activities like automobile accidents, recreational lifestyles, sports injuries, and domestic abuse. Additionally, The RAND Corporation estimates that 20% of all veterans from the Iraqi and Afghan wars suffered a TBI, some of which may result in CTE manifestations.
