Polaris Begins AML Trial

Polaris Group has filed an IND application with the FDA to begin Phase I trials to test ADI-PEG 20, arginine deiminase formulated with polyethylene glycol, for the treatment of acute myeloid leukemia (AML). The FDA has reviewed the application, waived the 30-day review period and allowed treatment to begin.

Polaris Group has previously filed other INDs under which it is conducting clinical trials on ADI-PEG 20 for the treatment of multiple other indications, including metastatic melanoma, prostate cancer, and hepatocellular carcinoma. The latter indication is in a global Phase III study.

The company contends that ADI-PEG 20 has a novel mechanism of action and well documented tolerability that makes it a good candidate both as monotherapy and to combine with other agents, including cytotoxics.