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Polaris Group Files New IND for ADI-PEG 20 in Breast Cancer

SAN DIEGO, Oct. 22, 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 breast cancer. Polaris Group has previously filed another IND under which it is conducting clinical trials on ADI-PEG 20 for the treatment of multiple other indications, including hepatocellular carcinoma. The latter indication is already in a global Phase 3 study.

"We are pleased to file another IND with the FDA and expand the portfolio of indications for which ADI-PEG 20 is under development. We look forward to initiating a clinical study of ADI-PEG 20 in breast cancer, and also to initiating other studies of ADI-PEG 20," said John Bomalaski, M.D., Executive Vice President of Medical Affairs at Polaris Group. "The proposed breast cancer study will combine ADI-PEG 20 with doxorubicin, a first-line therapy in breast cancer. ADI-PEG 20 combination studies are currently underway with docetaxel in prostate cancer and non-small cell lung carcinoma, and with cisplatin in melanoma. We believe its novel mechanism of action and well documented tolerability makes ADI-PEG 20 an ideal candidate 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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