The University of Missouri School of Medicine and MU Health Care initiated their first clinical trial utilizing a radiopharmaceutical developed and manufactured on campus at the university's research reactor. This marks a significant development in cancer care, demonstrating the research capabilities across the campus to advance a radiopharmaceutical from development through human clinical trials.
Clinical Trial Details
In collaboration with ABK Biomedical, School of Medicine cancer researchers enrolled the first patient in a human clinical trial at MU Health Care's Ellis Fischel Cancer Center. The treatment, using Eye90 microspheres, began on February 9. This trial expands Mizzou's capacity for conducting radiopharmaceutical clinical trials, aligning with the NextGen Precision Health initiative.
Mun Choi, President of the University of Missouri, stated that the trial highlights the university's research strength, leveraging the nation's largest university research reactor and facilities in veterinary medicine, the School of Medicine, and NextGen Precision Health. This infrastructure facilitates partnerships with industry to develop and test treatments, bringing them to patients more quickly.
Eye90 Microspheres and Production
Eye90 microspheres are radiopaque glass beads containing the radioisotope yttrium-90 (Y-90). They are designed for the treatment of unresectable liver tumors, including hepatocellular carcinoma and metastatic colorectal cancer. The University of Missouri Research Reactor (MURR) functions as the sole domestic source of Y-90 and produces the microspheres for ABK Biomedical.
Ryan Davis, associate professor of clinical radiology at Mizzou's School of Medicine and on-site study coordinator, noted that this is Ellis Fischel's first radiopharmaceutical clinical trial. He emphasized that such studies offer early access to therapies for patients and contribute to leadership in translational research, recognizing the increasing importance of targeted radiotherapy for metastatic tumors.
The Eye90 microspheres are engineered for precise visualization during delivery, allowing interventional radiologists and oncologists to accurately target liver tumors with localized radiation therapy. This aims to enhance treatment efficacy while minimizing exposure to surrounding healthy tissue.
Matt Sanford, executive director of MURR, commented on the collaborations with companies like ABK Biomedical, which advance cancer patient care locally and globally. He noted MURR's role in supporting advancements in nuclear medicine through radioisotope production, aiding in the transition of innovative cancer treatments from laboratory to clinic.
Collaborative History and Preclinical Research
Mizzou has been involved in the development and production of glass microspheres for Y-90 therapy since the 1980s. The initial microsphere treatment, TheraSphere, resulted from a collaboration between Delbert Day (Missouri University of Science & Technology) and Gary Ehrhardt (MURR). TheraSphere received full FDA approval in 2021, with MURR remaining its sole U.S. producer.
For the Eye90 technology, ABK Biomedical partnered with MURR for on-site irradiation and processing of their microspheres, establishing a capability to provide necessary doses for preclinical and clinical trials.
Mizzou researchers also conducted effectiveness and safety studies for the Eye90 microspheres. ABK funded research and preclinical trials led by Jeffrey Bryan, professor of oncology in Mizzou's College of Veterinary Medicine. Bryan's work included initial small animal model studies and a clinical trial in dogs with hepatocellular carcinoma, in partnership with Davis, to monitor treatment effectiveness and safety.
Future Outlook
This therapy represents a notable advancement in treating unresectable liver tumors. The Mizzou clinical trial is part of a broader effort to evaluate the safety and effectiveness of Eye90 microspheres in patients with these conditions.
The study involves a single administration of the microspheres, followed by a year-long monitoring period to assess outcomes like tumor response and quality of life. Similar studies have been initiated by ABK Biomedical, including one in Auckland Hospital, New Zealand. Mizzou and Ellis Fischel continue to prioritize advanced treatments and patient care through research and collaboration.