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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

SAN DIEGO, March 31, 2011 /PRNewswire/ -- Polaris Group (Polaris) today announced that the U.S. Food & Drug Administration (FDA) has approved the company's Special Protocol Assessment (SPA) for a Phase 3 clinical trial of pegylated arginine deiminase (ADI-PEG 20) in patients with advanced hepatocellular carcinoma (HCC). The randomized, placebo-controlled, global trial will enroll approximately 600 patients who have failed prior systemic chemotherapy. The primary endpoint of the study is overall survival.

Ghassan Abou-Alfa, M.D., of Memorial Sloan-Kettering Cancer Center in New York, is the principal investigator of the study.  

"ADI-PEG 20 has demonstrated medical benefit in prior studies in multiple indications with a remarkable safety profile," said Dr. Abou-Alfa. "I am delighted to lead this study to explore ADI-PEG 20 as a viable option for patients with advanced liver malignancies."

SPA is a mechanism that allows the FDA and drug developers to reach an agreement prior to study initiation about the design and size of a Phase 3 trial. It will form the primary basis of an efficacy claim in a marketing application.

"The SPA agreement with the FDA is a key step in our plans for the clinical development of ADI-PEG 20," said John Bomalaski, M.D., executive vice president, medical affairs, of Polaris. "We are pleased to move ADI-PEG 20 into a pivotal Phase 3 trial and to be working with such well-established hepatocellular carcinoma experts."

Leo Chen, M.D., the lead investigator of the Phase 2 HCC study in Taiwan, stated, "Our Phase 2 study demonstrated that ADI-PEG 20 was effective and well-tolerated in patients with advanced liver cancer, and we look forward to the opportunity to further assess the efficacy and safety of this drug in a large randomized Phase 3 study."

The lead investigator in China, Shukui Qin, M.D., president of the Chinese Society of Clinical Oncology and chair of the Chinese Liver Cancer Stu
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SOURCE Polaris Group
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