ABK Biomedical, a medical device company dedicated to the research, development, and commercialisation of advanced imageable embolic medical devices, has announced the first patient treated in its Route90 US investigation device exemption (IDE) pivotal study. The Eye90 microspheres radioembolization procedure was performed by Eric A Wang (Charlotte Radiology, Charlotte, USA).
“This is an exciting time for multidisciplinary, liver cancer treatment teams.” said Wang. “Hepatocellular cancer (HCC) is a severe form of cancer. Over the past 40 years, liver cancer incidence rates have more than tripled, and death rates have more than doubled during that time period. Eye90 radioembolization represents an advancement in liver-directed HCC therapy. Eye90 microspheres with multimodality imaging, controlled visible administration, and personalised dosimetry is advancing the field of radioembolization. We are excited to be a part of this pivotal study and look forward to establishing the effectiveness and safety of this new Y90 radioembolization technology.”
The Route90 pivotal clinical study is designed to evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable HCC. The study will evaluate HCC tumours’ response rates and duration of response from Eye90 microspheres treatment as co-primary endpoints. Eye90 microspheres is the first and only in-procedure imageable Y90 microspheres device. The study also includes endpoints to evaluate safety, the potential benefits of intra-procedural visualisation, and the ability to perform post-treatment computed tomography dosimetry with imageable microspheres, the press release outlines.
“While Y90 radioembolization is established as a safe and effective therapy for the treatment of HCC, rigorous prospective clinical studies are needed to establish credible data to support US Food and Drug Administration (FDA) premarket approval,” said David Dobrowski, vice president of clinical and regulatory affairs, ABK Biomedical. “The Route90 study will collect the high-quality data long needed with Y90 radioembolization therapy establishing a new standard of treatment. We are enthusiastic to treat our first patient and continue to work diligently with the top Y90 treatment centres in the USA and all of our highly motivated investigators on enrolling patients to complete the study”.
Andrew Kennedy (Sarah Cannon Cancer Institute, London, UK) is principal investigator for the Route90 study and one of the early pioneers of Y90 radioembolization research and treatment. “The Route90 pivotal study will not only confirm the effectiveness of Eye90 treatment but will also establish the importance of three-dimensional (3D) radiation dosimetry in advancing therapy and patient outcomes.
This is a significant milestone for all those involved at ABK, the clinical research team at Charlotte Radiology, and the multiple other sites that are about to begin patient enrolment. We look forward to rigorously and efficiently completing this important trial to offer the HCC community a long-overdue, advanced Y90 radioembolization therapy”, said Kennedy.