Ludwig Institute for Cancer Research Initiates Clinical Trial of Polaris’ ADI‑PEG 20 for the Treatment of Melanoma

Polaris today announced the enrollment of the first patient in a Phase I/II study using ADI‑PEG 20 to treat patients with advanced metastatic melanoma. This new study utilizes PET scans to monitor the metabolic state of tumor cells. Ludwig Institute for Cancer Research, partner of Polaris in the clinical development of ADI‑PEG 20, is the sponsor of the study. Study sites will be Memorial Sloan-Kettering Cancer Center and New York University School of Medicine.

The primary outcomes of the study are to establish further the safety and tolerability of ADI‑PEG 20 and to determine the clinical efficacy of ADI‑PEG 20 in patients with advanced melanoma. The secondary outcomes of the study are to evaluate the metabolic activity of ADI‑PEG 20 by [18F]-FDG PET, to determine the pharmacodynamics of ADI‑PEG 20, to correlate immunogenicity of ADI‑PEG 20 with clinical response, and to correlate tumor expression of argininosuccinate synthetase with clinical response. This will be an open-label, dose-escalation study with an estimated enrollment of 38 patients.

Memorial Sloan-Kettering Cancer Center
Principal Investigators:
Jedd Wolchok, M.D., Ph.D. [646-888-2395]
Gary Schwartz, M.D. [212-639-5098]

NYU Clinical Cancer Center
Principal Investigator:
Anna Pavlick, D.O.
Julie Escalon, RN [212-731-5402]

About Polaris Group
Polaris Group is a privately held multinational biopharmaceutical company specializing in the research and development of protein drugs to treat cancer and other debilitating diseases. The company also utilizes a rational structure-based approach for the design of novel small molecule inhibitors of cancer-related protein targets.