Polaris Group Lead Therapeutic Candidate ADI-PEG 20 Receives Orphan Drug Designation in the United States and the European Union for the Treatment of Malignant Pleural Mesothelioma

Dec 18, 2014, 13:30 ET from Polaris Group

SAN DIEGO, Dec. 18, 2014 /PRNewswire/ -- Polaris Group announced today that its lead product candidate ADI-PEG 20 (pegylated arginine deiminase) has received orphan drug designation for the treatment of malignant pleural mesothelioma (MPM) in the United States and in the European Union.  Orphan drug designation grants special status to a drug or biological product to treat a rare disease or condition. Having completed a successful randomized phase 2 trial in argininosuccinate synthetase -deficient MPM patients with ADI-PEG 20 as monotherapy, Polaris is currently conducting a phase 1 trial of ADI-PEG 20 in combination with pemetrexed and cisplatin, the approved first-line treatment for MPM, for the treatment of MPM and non-squamous non-small cell lung carcinoma.  Polaris Group is also conducting clinical trials on ADI-PEG 20, both as monotherapy and in combination with other agents, for the treatment of several other indications, including breast cancer, melanomas, ovarian cancer, and hepatocellular carcinoma. The latter indication is currently in a global Phase 3 study featuring ADI-PEG 20 as a monotherapy.

"MPM is a cancer that is primarily associated with exposure to asbestos, and its incidence continues to increase in many parts of the world," said John Bomalaski, M.D., Executive Vice President of Medical Affairs at Polaris. "We are delighted to receive orphan drug designation in these markets. We hope that ADI-PEG 20, together with conventional chemotherapy, will provide a better treatment option than what is currently available for this deadly disease."

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 deplete the external supply of arginine, which causes 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.

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, such as leukemia, lymphoma, melanoma, mesothelioma, non-small cell lung cancers, sarcoma, breast, ovarian, and pancreatic cancer. 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.

For additional information please visit www.polarispharma.com

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SOURCE Polaris Group