Polaris Group (Polaris) today announced that it has dosed the first patient in a pivotal Phase 3 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 United States, 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.
"Based on our recently approved Special Protocol Assessment from the FDA, this pivotal Phase 3 study is significant as it will hopefully serve as the basis for approval in the U.S.," said John Bomalaski, M.D., executive vice president, medical affairs, of Polaris. "We believe ADI-PEG 20 is a promising cancer therapeutic not only for HCC, but also other arginine-dependent cancers such as leukemia, lymphoma, sarcoma and prostate cancer. We look forward to continuing clinical development in all of these areas to understand the full potential for this therapeutic."
Ghassan Abou-Alfa, M.D., of Memorial Sloan-Kettering Cancer Center in New York, the principal investigator of the study, said, "We are delighted to be involved in a pivotal study for ADI-PEG 20, which has the potential to become a much needed treatment option for HCC patients. There is no currently approved therapeutic for HCC patients who have failed first line therapy. Thus there is a significant unmet need in this patient population."