The study will evaluate the safety and efficacy of Eye90 microspheres in patients with unresectable hepatocellular carcinoma (HCC) or metastatic colorectal cancer (mCRC)
ABK Biomedical has commenced liver tumour trial with Eye90 microspheres. (Credit: doodlartdotcom from Pixabay)
ABK Biomedical has commenced the enrollment of patients in the clinical study with Eye90 microspheres for the treatment of liver tumours.
The approved study, which is claimed to be the first-in-human clinical trial, is being conducted in collaboration with New Zealand’s Auckland Hospital Research Unit.
The company has designed the prospective, single-centre and open-label study to assess the safety and efficacy of Eye90 microspheres in patients with unresectable hepatocellular carcinoma (HCC) or metastatic colorectal cancer (mCRC).
ABK Biomedical president and CEO Mike Mangano said: “Our Eye90 microspheres device is designed with key advancements over the currently marketed Y90 radioembolization therapies with the goal of improving the physician experience and patient outcomes.
“Eye90 microspheres combine in-procedure, tumor-targeting visualization of radiopaque microspheres, and an advanced delivery system allowing physician control of administration, with the proven clinical benefits of Y90 radioembolization therapy.”
As part of the trial, patients will be provided with single Eye90 microspheres radioembolisation treatment with follow-up visits for one year to evaluate safety, effectiveness, and quality of life measures.
Eye90 microspheres are radiopaque glass microspheres, which are noticed on x-ray and CT imaging and contain the Yttrium 90 (Y90) radiotherapeutic element.
Y90 radioembolization, a local brachytherapy, is presently used for the treatment of malignant liver tumours.
The trial principal investigator Dr Andrew Holden said: “We are enthusiastic to partner with ABK Biomedical to conduct this important First-in-Human clinical study. We are eager to evaluate the advancements of the Eye90 device and report on the initial safety and efficacy for the treatment of HCC and mCRC liver tumours.”
In April 2019, ABK Biomedical secured $30m in series B financing round to focus on the product development of its Eye90 microspheres, which are designed for transarterial radiation therapy for liver tumours.