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FDA Approves Special Protocol Assessment for Phase 3 Trial of Polaris Group's Cancer Therapeutic, ADI-PEG 20, in the Treatment of Hepatocellular Carcinoma
Date:3/31/2011

dy Group, added, "Approximately half of the liver cancer-related deaths in the world are in China. We have been watching the development of this drug, and we are excited to become an active participant in this pivotal global study."

ADI-PEG 20 is a biologic being developed 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 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 and causes these arginine-dependent cancer cells to die while leaving the normal cells unharmed.

In addition to HCC, multiple other cancers have been reported to have a high degree of arginine-dependency. Early-to-mid-stage clinical trials have yielded positive results in patients with metastatic melanoma, and Phase 2 trials for small cell lung cancer (SCLC) and mesothelioma are currently ongoing. Polaris also plans to initiate clinical studies in prostate cancer, pancreatic cancer, leukemia, lymphoma and sarcoma this year.

About Hepatocellular Carcinoma

Hepatocellular carcinoma (primary liver cancer) is one of the most common cancers worldwide, resulting in approximately 700,000 deaths annually. Infection with hepatitis B or C and alcohol consumption are highly associated with the development of hepatocellular carcinoma. The prognosis for patients with this disease is poor as chemotherapy often does not result in prolonged survival, and liver transplantation only increases the survival of selected patients. Despite all forms of current treatment, life expectancy for most patients is only one year post-diagnosis.

About Polaris Group

Polaris Group is a privately held multinational biopharmaceutical company that specializes in the researc
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SOURCE Polaris Group
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