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Arbutus begins dosing in Phase IIa expansion group trial of TKM-PLK1 to treat HCC

Canadian biopharmaceutical firm Arbutus Biopharma has started dosing in a 20 subject expansion group of a Phase IIa clinical trial of TKM-PLK1 for the treatment of hepatocellular carcinoma (HCC).

Currently underway in multiple sites in Canada, the US and Asia, the trial is designed to evaluate TKM-PLK1’s safety and efficacy in treating patients with HCC.

In the trial, TKM-PLK1 is administered weekly with each four-week cycle including three once-weekly doses followed by a rest week, and the efficacy will be evaluated in about 20 subjects.

The company noted that the HCC efficacy endpoint of the study is tumor response rate.

Arbutus president and CEO Dr Mark Murray said: "This is an important milestone for the company as we continue the execution of our strategy to progress our HBV-related clinical candidates.

"HCC is one of the most common cancers in the world, primarily caused by an underlying chronic HBV infection.

"The goal of this study is to further evaluate the anti-tumor efficacy of TKM-PLK1 in treating HCC patients."

TKM-PLK1 targets polo-like kinase 1 (PLK1), a protein involved in tumor cell proliferation and a validated oncology target.

Currently, the company is evaluating TKM-PLK1 in trials with patients who have gastrointestinal neuroendocrine tumors (GI-NET), adrenocortical carcinoma (ACC) and hepatocellular carcinoma (HCC).