ABK Biomedical has received approval for its investigational device exemption (IDE) application from the US Food and Drug Administration (FDA) to commence a multicentre pivotal clinical study in the USA for its Eye90 microspheres yttrium-90 (Y90) radioembolization therapy.
The pivotal clinical study, Route90, is designed to evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable hepatocellular carcinoma (HCC). The Route90 study will evaluate HCC tumour response rates and duration of response from Eye90 microspheres treatment as co-primary endpoints. Eye90 microspheres is the first and only imageable Y90 microspheres device. The study also includes endpoints to evaluate safety, the potential benefits of intraprocedural visualisation, and the ability to perform post-treatment computed tomography (CT) dosimetry with imageable microspheres.
Andrew Kennedy is physician-in-chief of radiation oncology at Sarah Cannon Cancer Institute (Nashville, USA) and will serve as principal investigator for the Route90 study. Kennedy is one of the early pioneers of Y90 radioembolization research and treatment. “I am excited to participate and lead the Route90 study. Eye90 microspheres is a significant and meaningful technology advancement to Y90 radioembolization therapy not seen in over almost two decades since the current therapies became clinically available,” said Kennedy.
“We are motivated to begin this pivotal study and assess the Eye90 microspheres technology in a large well-controlled, well-designed study. We continue to build upon the results of our first-in-man Eye90 microspheres study conducted recently in New Zealand. The initial results from this study are highly encouraging with an excellent safety profile and robust tumour response rates”, said Aravind Arepally, ABK Biomedical’s chief medical officer.
Mike Mangano, president, and CEO, ABK Biomedical, said: “[US] FDA approval of this pivotal study is a significant milestone for ABK. The ABK team has worked tirelessly to develop this unique technology. We have created extensive manufacturing and supply-chain efficiencies, established robust quality assurance in all our processes, and collaboratively engaged regulatory bodies for proper guidance. We believe this will become a seminal study for treating patients with unresectable HCC. We designed our Y90 radioembolization technology to align with the most recent, advanced Y90 treatment methods, techniques, and appropriate patient populations. This has the promise to significantly improve outcomes for targeted patients living with unresectable HCC”.