ABK Biomedical Announces First Patient Treated in First-in-Human Clinical Study with Eye90 Microspheres for Treatment of Liver Tumours

ABK Biomedical Inc., an innovative, clinical-stage medical device company dedicated to the research, development and commercialization of advanced imageable embolic therapies, announced the first patient treated in ABK's First-in-Human study with Eye90 microspheres, a Y90 radioembolization device for the treatment of liver cancers. This study is being conducted in collaboration with Auckland Hospital Research Unit, New Zealand.

The prospective, single-centre, open-label study is evaluating the safety and effectiveness of Eye90 microspheres in patients with unresectable hepatocellular carcinoma (HCC) or metastatic colorectal cancer (mCRC). Patients will receive a single Eye90 microspheres radioembolization treatment with follow-up visits for one year to assess safety, effectiveness, and quality of life measures.

Eye90 microspheres are radiopaque glass microspheres visible on x-ray and Computed Tomography (CT) imaging and contain the Yttrium 90 (Y90) radiotherapeutic element. Y90 radioembolization, a local brachytherapy, is currently used to treat malignant liver tumours. Primary liver cancer is the sixth most diagnosed cancer and the third leading cause of cancer death worldwide, with approximately 906,000 new cases annually. HCC is the most common primary liver cancer comprising 75%-85% of all primary liver cancer cases with the majority of patients diagnosed with unresectable disease. Colorectal cancer (CRC) is the third most diagnosed cancer, approximately 22% of CRCs present as mCRC at initial diagnosis, and about 70% of patients will eventually develop metastatic relapse.

Mike Mangano, president and CEO of ABK Biomedical, said, "We are excited that our clinical collaboration with Dr. Andrew Holdenand Auckland Hospital, NZ, has reached this important milestone. We believe that Eye90 microspheres have the potential to advance Y90 radioembolization therapy into a new era of improved patient outcomes. Specifically, we look forward to studying the key technical advances that Eye90 microspheres offer over conventional Y90 radioembolization devices. These include an advanced delivery system allowing physician administration control, tumour-targeting visualization, and the potential of x-ray-based imaging data for high resolution, CT-based, Eye90 microspheres precision dosimetry‚Ñ¢."

Dr. Robert Abraham, chief medical officer and co-founder of ABK Biomedical said, "It has been an amazing journey to take a company from concept to patient treatment. We are enthusiastic and optimistic about the future of ABK and Eye90 microspheres."

Andrew Holden, MD, MBChB, FRANZCR, EBIR, ONZM, study principal investigator, said, "We are honoured to be the first to treat patients with this advanced technology and to lead this important clinical study assessing this new technology. There are a growing number of published Y90 radioembolization studies demonstrating clinical efficacy in appropriately selected patients.  We're enthusiastic to assess how Eye90 microspheres, with its proprietary delivery system and advanced imaging characteristics may impact Y90 clinical results in the treatment of patients with HCC and mCRC liver tumours."

About ABK Biomedical Inc.
ABK Biomedical is focused on researching, developing, and commercializing breakthrough medical device therapies to improve treatment outcomes and the lives of patients with benign and malignant hypervascular tumours. ABK Biomedical holds intellectual property in the areas of inorganic polymer microspheres, and unique administration systems. The company possesses advanced intellectual capital and its own R&D and manufacturing facilities for developing and commercializing unique embolotherapy products. ABK Biomedical products are considered investigational products and are not approved for use in any regulatory jurisdiction outside of approved clinical trials.