Polaris doses first patient in phase III ADI-PEG 20 trial
Polaris Group has dosed the first patient in a phase III clinical trial evaluating its lead cancer therapeutic, pegylated arginine deiminase (ADI-PEG 20), in hepatocellular carcinoma (HCC) patients.
Over 600 patients who have failed prior systemic therapy will be enrolled in the randomized, double-blind, placebo-controlled study at sites in China, Taiwan, the U.S., Italy and the U.K.. Patients will receive weekly intramuscular injections of ADI-PEG 20 until disease progression. The primary endpoint of the study is overall survival, and secondary endpoints will include progression-free survival and time to progression.