ABK Biomedical this week announced it received FDA investigational device exemption approval for its Eye90 microspheres yttrium 90 radioembolization therapy.
The FDA IDE approval allows the Halifax, Nova Scotia–based company to commence a multi-center pivotal clinical study in the U.S. involving patients with an especially tough-to-treat form of liver cancer.
“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,” CEO Mike Mangano said in a news release. “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.”
The Route90 study will evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable hepatocellular carcinoma (HCC). It will also evaluate HCC tumors’ response rates and duration of response from Eye90 microspheres treatment as co-primary endpoints.
“We’re 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 tumor response rates,” Chief Medical Officer Aravind Arepally said.
The endpoints of the study will evaluate safety, the potential benefits of intra-procedural visualization and the ability to perform post-treatment CT-dosimetry with imageable microspheres.
“I’m 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 Andrew Kennedy, physician in chief of radiation oncology at Sarah Cannon Cancer Institute and principal investigator on the Route90 study.
