Polaris gaining spotlight on prospective HCC trial

Polaris Group to Highlight Clinical Development Plans for Phase 3-Ready Candidate, ADI-PEG 20, During Symposium in Taiwan

SAN DIEGO, May 12, 2011 /PRNewswire/ -Presentations to Provide Details about Pivotal Phase 3 Trial in Hepatocellular Carcinoma, Future Development Plans for ADI-PEG 20- Polaris Group (Polaris) today announced that the Company will highlight clinical development plans for its Phase 3-ready pegylated arginine deiminase, ADI-PEG 20, during a symposium held on Tuesday, May 24, at 1:30 p.m. China Standard Time in Taipei, Taiwan. Details about Polaris' upcoming pivotal Phase 3 clinical trial of ADI-PEG 20 in hepatocellular carcinoma (HCC) will be presented by the principal investigator, Ghassan Abou-Alfa, M.D., of Memorial Sloan-Kettering Cancer Center in New York. This presentation will include plans for enrollment in the global trial with sites in the United States, Taiwan, China and parts of Europe. Additional presentations during the symposium will provide updates for ongoing Phase 2 studies in small cell lung cancer and mesothelioma, as well as an outline of future development plans for ADI-PEG 20. "This symposium comes at an important time for Polaris as we prepare for a global Phase 3 trial of ADI-PEG 20 treating hepatocellular carcinoma patients for which our Special Protocol Assessment was recently approved by the FDA," said Bor-Wen Wu, Ph.D., president and chief executive officer of Polaris Group. "We are proud to have multiple distinguished physicians present at this event and discuss the next steps in advancing ADI-PEG 20 through clinical development." Presentations will focus on various aspects of the plan to investigate the potential for ADI-PEG 20 in indications beyond HCC.  Wu will present a broad overview of future clinical development plans for the therapeutic candidate, while individual physicians will discuss specific studies. Background about the ongoing Phase 2 clinical trials of ADI-PEG 20 in small cell lung cancer and mesothelioma will be presented by the lead investigator of the mesothelioma study, Peter Szlosarek, M.D., Ph.D., of the Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London.  Additionally, Li-Zong Chen, M.D., Ph.D., of the National Institute of Health, and Jien-Fong Lee, M.D., of Chimei Hospital in Taiwan, will present data about ASS1 deficiency in sarcoma and its potential use as an indicator for cancer prognosis and treatment.  John Bomalaski, M.D., executive vice president, medical affairs, of Polaris Group will present data demonstrating the effectiveness of ADI-PEG 20 as a treatment for leukemia, lymphoma and sarcoma.  In addition, Hsing-Jien Kung, Ph.D., of UC Davis Cancer Center will present data about ADI-PEG 20, autophagy and apoptosis, and implications for prostate cancer treatment.Individuals interested in attending the symposium should e-mail ivylin@tdwpharma.com to register for the event.

About ADI-PEG 20  ADI-PEG 20 is a biologic being developed by Polaris to treat cancers carrying a major metabolic defect that renders them, unlike normal cells, unable to make arginine internally. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 works by systemically depleting the external supply of arginine which causes these 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. Phase 2 clinical trials have yielded positive results in patients with hepatocellular carcinoma or metastatic melanoma, and Phase 2 trials for small cell lung cancer and mesothelioma are currently ongoing. Polaris also plans to initiate clinical studies in prostate cancer, pancreatic cancer, leukemia, lymphoma and sarcoma this year.

About Polaris Group  Polaris Group is a privately held multinational 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 advancing into a pivotal Phase 3 trial for hepatocellular carcinoma. Polaris is also investigating ADI-PEG 20 as a treatment for other arginine-dependent cancers, such as melanoma, prostate cancer, leukemia, lymphoma, sarcoma and pancreatic cancer. In addition to the ADI-PEG 20 project, Polaris is researching and developing other biotherapeutic agents and has 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