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Polaris Group Files New IND for ADI-PEG 20 in Leukemia

SAN DIEGO, Dec. 2, 2013 /PRNewswire/ -- Polaris Group announced today that it has filed an Investigational New Drug Application (IND) application with the United States Food and Drug Administration (FDA) to begin Phase 1 clinical trials to test ADI-PEG 20, arginine deiminase formulated with polyethylene glycol, for the treatment of acute myeloid leukemia. The FDA has reviewed this 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 already in a global Phase 3 study.

"This is another IND that expands the portfolio of indications for which ADI-PEG 20 is under development to hematologic malignancies," said John Bomalaski, M.D., Executive Vice President of Medical Affairs at Polaris Group. "Studies in leukemia and lymphoma will expand the studies currently underway with ADI-PEG 20, in addition to the solid tumors already under study. ADI-PEG 20 has a novel mechanism of action and well documented tolerability that we believe makes ADI-PEG 20 an ideal candidate both as monotherapy and to combine with other agents, including cytotoxics."

About ADI-PEG 20

ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers, especially those carrying a major metabolic defect that renders such cancer cells, unlike normal cells, unable to internally synthesize arginine. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, it is believed these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to systemically deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency.

About Polaris Group

Polaris Group is a privately held biopharmaceutical company that specializes in the research and development of protein drugs to treat cancer and other debilitating diseases. The company's lead therapeutic, ADI-PEG 20, is currently being evaluated in a pivotal Phase 3 trial for hepatocellular carcinoma. Polaris Group is also investigating ADI-PEG 20 as a treatment for other cancers. In addition to the ADI-PEG 20 program, Polaris Group is researching and developing other biotherapeutic agents and is advancing 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.

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