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New Amyloid Imaging Study at UTGSM Paves the Way in Diagnosis and Therapy

From left to right: (Back row) Steve Kennel, Steve Foster, Jonathan Wall, Craig Wooliver and Trevor Hancock (Front Row) Tina Richey, Joseph Jackson, Emily Martin, Sallie Macy, Manasi Balachandran, Alan Stuckey and Angela Williams

In a significant stride toward improving the challenges faced by patients with systemic amyloidosis, the Amyloidosis and Cancer Theranostics Program (ACTP) at the University of Tennessee Graduate School of Medicine (UTGSM), under the direction of Jonathan Wall, PhD, University Distinguished Professor and Assistant Dean of Research embarked on their latest groundbreaking research. The ACTP team initiated the first-in-human study of a novel diagnostic imaging agent for the detection of cardiac amyloidosis at the UT Medical Center, ushering in a new era in amyloid imaging research.

The new study, UTGSM-164388-101, will investigate a novel amyloid-specific imaging agent, 99mTc-p5+14 - a small amyloid-binding protein labeled with a commonly used radioactive molecule, technetium-99m - for the diagnosis of cardiac amyloidosis. Designed to evaluate the dosimetry and biodistribution of 99mTc-p5+14 in patients with systemic light chain (AL) or transthyretin-associated (ATTR) amyloidosis and including healthy volunteers, this investigator-initiated, Phase 1 study, performed at the University of Tennessee Medical Center, marks a monumental step forward in amyloid imaging research.

"The early and accurate diagnosis of amyloidosis remains challenging and often requires multiple doctor visits and a battery of tests. A rapid, non-invasive test for the presence of cardiac amyloidosis that would be performed in the community setting could be of huge benefit," said Dr. Wall.

The goal of ACTP team’s research is the development of a clinical agent, specifically the amyloid-binding peptide p5+14, labeled with various forms of radioactivity for the early and accurate diagnosis of amyloidosis using imaging.

Their intensive efforts have already resulted in the creation of iodine-124-evuzamitide, a radiotracer showing immense clinical promise for PET/CT imaging of amyloid in systemic organs, including the heart.  In 2018, the ACTP embarked on the investigator-initiated Phase 1/2 AMY1001 study, a pioneering endeavor supported by the NHLBI/NIH's translational research SMARTT program, aimed at examining the safety and efficacy of the iodine-124-evuzamitide imaging agent in patients with amyloidosis. Over the course of the 3-year study, patients with AL, ATTR and many of the rarer hereditary types of amyloidosis, underwent PET/CT imaging with iodine-124-evuzamitide. The compelling data generated during this study led to both the European Medicines Agency (EMA) and the US Food & Drug Administration (FDA) granting orphan drug designation to iodine-124-evuzamitide for the diagnosis of AL and ATTR amyloidosis.

Following the success of the AMY1001 study, the team continued their research journey. A subsequent study, UTMC-AT01-163117, delved into repeat PET/CT imaging of patients with systemic amyloidosis using iodine-124-evuzamitide. This study not only reinforced the activity of the imaging agent but also demonstrated its potential use for monitoring response to therapy. Presently, iodine-124-evuzamitide is also being utilized in research studies by clinician-researchers at prestigious institutions such as Brigham and Women’s Hospital in Boston, Columbia University Irving Medical Center in New York, and the Oregon Health and Science University in Portland.

This extraordinary progress by the ACTP group not only underscores the determination, creativity, and focus of the research team but also highlights what can be achieved for patients with these devastating disorders through collaboration at UTMC.

Posted: November 1, 2023


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