A “first-in-human” clinical trial being conducted at The University of Tennessee Medical Center may lead to earlier, more accurate diagnosis for patients affected by amyloidosis.
This rare and devastating disease is associated with the accumulation of complex protein clumps or aggregates in the heart, kidneys, nerves and other organs. More than 30 amyloid-associated diseases have been identified but significant challenges remain in accurate diagnosis and treatment. The protein that forms amyloid aggregates and the pattern of organ involvement can be different in each patient and the condition is often first detected in its late stages.
Another challenge is that the U.S. Food and Drug Administration has not yet approved any methods that allow doctors to comprehensively detect the specific locations of amyloid accumulation in patients. This capability could aid in more accurate and timely diagnoses, improve patient management, and potentially increase the patient’s quality of life and survival once the extent of disease is better understood.
To address these barriers, the research team in the Amyloidosis and Cancer Theranostics Program (ACTP) at the University of Tennessee Graduate School of Medicine, led by Jonathan Wall, PhD, Director and Professor of Medicine, has been working to develop a new reagent capable of imaging the diverse forms of systemic amyloidosis in organs and nerves throughout the body. This research has resulted in the identification of a synthetic peptide, designated “p5+14” which, when labeled with iodine-124, can be used to detect amyloid using positron emission tomographic (PET) imaging of patients.
In 2014, Dr. Wall obtained early grant support from the National Heart, Lung, and Blood Institute at the National Institutes of Health to produce human-grade peptide p5+14 and gather data in support of using this peptide in an amyloid imaging clinical trial. In 2018, the FDA approved his application to perform the ongoing safety and efficacy trial in patients with all of the major forms of systemic amyloidosis.
ACTP is collaborating with teams from the Cancer Institute, Department of Radiology and Nuclear Medicine, to recruit patients to the trial, perform the imaging studies, and evaluate results. The first patient was imaged in late fall 2018. Ronald Lands, MD, Associate Professor and oncologist, monitored the patient for several days as the team collected serial imaging and safety data. Since then, two additional patients have been imaged for the study. While the three patients are from Tennessee, Dr. Wall anticipates that, over the next 18 months, the trial will recruit a total of 43 patients from all over the U.S.
Dr. Wall hopes the results of this clinical trial will lead to expanded clinical studies using larger patient populations. He hopes this technique may one day be approved by the FDA and made available to clinicians in order to allow them to confirm, localize and quantify the presence of amyloid in the body. Ultimately, Dr. Wall and his multi-disciplinary UT team hope to improve the prognosis and quality of life for patients with amyloidosis through the development of additional imaging agents, and most importantly, new treatments designed to clear the amyloid aggregates from the body.
Pictured (First row from left): Dr. Emily Martin, Tina Richey, Sallie Macy, Angela Williams, Alan Stuckey, Brian Whittle, Dr. Dustin Powell, Dr. Yitong Fu
(Second row from left): Dr. Eric Heidel, Jennifer Ferris, Steve Foster, Craig Wooliver, Dr. Myrwood Besozzi, Dr. Jonathan Wall, Dr. Ronald Lands, Dr. Stephen Kennel, Barbara Marine, Dr. Dustin Osborne
Posted April 1, 2019
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