Polaris Announces Results of a Phase 2 Trial of ADI-PEG 20 in Relapsed/Refractory or Poor-risk Acute Myeloid Leukemia

SAN DIEGO, September 12, 2017 – Polaris Group announced today that its lead therapeutic ADI-PEG 20 (pegylated arginine deiminase) demonstrated a good safety profile and an efficacy signal as monotherapy in a phase 2 trial in relapsed/refractory or poor-risk acute myeloid leukemia (AML) patients, as reported in the journal Scientific Reports. The study was conducted at multiple sites in Taiwan and at MD Anderson Cancer Center in the US.

Among the 21 evaluable patients enrolled in this study, two patients had complete response to the treatment, with response duration of 7.5 and 8.8 months. Seven patients had stable disease in response to the treatment. The treatment appeared to be safe and well tolerated.

“Based on the encouraging efficacy signal from this ADI-PEG 20 monotherapy study, we have initiated a phase 1 trial combining ADI-PEG 20 with low-dose cytarabine in poor-risk AML patients,” said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc.

About ADI-PEG 20

ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI-PEG 20.

About Polaris Group

Polaris Group specializes in the research and development of protein drugs to treat cancer and other debilitating diseases. In addition to the ADI-PEG 20 program, Polaris Group is developing other biotherapeutic agents including a small molecule drug program that utilizes a rational structure-based approach to design novel compounds that inhibit the biological function of cancer-related protein targets.