In a major leap for cancer care at the University of Missouri, the School of Medicine and MU Health Care have launched their first clinical trial using a leading-edge therapy manufactured on campus at the university’s research reactor. The achievement also showcases the breadth of research capabilities across campus to bring a radiopharmaceutical from development, through testing, to human clinical trials.
Working with ABK Biomedical, School of Medicine cancer researchers enrolled their first patient in a human clinical trial at MU Health Care’s Ellis Fischel Cancer Center using Eye90 microspheres® and treatment began Feb. 9. This clinical trial represents a major step forward as Mizzou expands capabilities to conduct radiopharmaceutical clinical trials, in collaboration with the NextGen Precision Health initiative.Â
This clinical trial is significant for Mizzou because it shows the power of our campus research. We have the nation’s largest university research reactor and unmatched research facilities in veterinary medicine, at our School of Medicine, and at NextGen Precision Health. This allows our faculty and researchers to partner with industry to develop and test ground-breaking treatments and get them to patients faster, all from one campus.”
Mun Choi, President, University of Missouri
Eye90 microspheres are radiopaque glass beads embedded with the radioisotope yttrium-90 (Y-90) used to treat unresectable liver tumors, including hepatocellular carcinoma and metastatic colorectal cancer. The University of Missouri Research Reactor (MURR) is the only domestic source of Y-90 and creates the microspheres for ABK Biomedical.
“While we participate in many different clinical studies, this is the first radiopharmaceutical clinical trial for Ellis Fischel,” said Ryan Davis, associate professor of clinical radiology in Mizzou’s School of Medicine and on-site study coordinator. Studies like this provide early availability of therapies for our patients, and they continue our leadership in translational research. We are excited to be part of this study because we recognize the growing significance of targeted radiotherapy for metastatic tumors.”
What sets Eye90 apart is its unique design. Engineered for precise visualization during delivery, Eye90 enables interventional radiologists and oncologists to accurately target liver tumors with localized radiation therapy. This approach aims to enhance treatment efficacy while minimizing exposure to surrounding healthy tissue.
“Our collaborations with companies like ABK Biomedical are advancing the care and treatment of cancer patients right here in Columbia, as well as patients across the country and around the world,” Matt Sanford, executive director of MURR, said. “We are proud to support ground-breaking advancements in nuclear medicine. By leveraging our expertise in radioisotope production, we are helping bring innovative cancer treatments from laboratory to the clinic, offering new hope for cancer patients.”
Partnering for success with microspheres
Mizzou has been a pioneer in the development and production of glass microspheres for Y-90 therapy since the 1980s. The first microsphere treatment, TheraSphere, was created through a collaboration between Delbert Day, Missouri University of Science & Technology (formerly University of Missouri-Rolla) and Gary Ehrhardt, MURR. Together, they combined their ceramic and nuclear chemistry expertise to create radioactive glass beads. TheraSphere received full FDA approval in 2021, and MURR continues to be the only U.S. producer today.Â
For the new technology, ABK Biomedical worked with MURR to irradiate and process their microspheres on-site. This established the reliable capability to provide necessary doses for preclinical and clinical trials.
Mizzou researchers also performed the effectiveness and safety studies for the Eye90 microspheres that made the human clinical trial possible. ABK funded research and preclinical trials conducted by Jeffrey Bryan, professor of oncology in Mizzou’s College of Veterinary Medicine and associate director of comparative oncology at Ellis Fischel Cancer Center.
Bryan was the principal investigator on initial small animal model studies to show that the microspheres performed well in living animals. He then led a clinical trial in dogs with hepatocellular carcinoma, partnering with Davis to treat companion animals who had developed liver tumors. The treatment effectiveness and safety were monitored, and the animals were imaged using scanning equipment at the MU Veterinary Health Center’s PET Imaging Center.
Looking to the future
The new innovative therapy represents a significant advancement in the treatment of unresectable liver tumors, including hepatocellular carcinoma and metastatic colorectal cancer.
The Mizzou clinical trial is part of a broader effort to evaluate the safety and effectiveness of Eye90 microspheres in patients with unresectable liver tumors. The study involves a single administration of the microspheres, followed by a year-long monitoring period to assess patient outcomes, including tumor response and quality of life measures.
ABK Biomedical has previously initiated similar studies, with the first patient treated at Auckland Hospital in New Zealand. The ongoing research aims to gather comprehensive data to support regulatory approvals and broader clinical adoption of this promising therapy.
Mizzou and Ellis Fischel remain committed to pioneering advanced treatments and improving patient care through cutting-edge research and collaboration.
Source: