Polaris set to start Phase III study under SPA agreement with US FDA
This article was originally published in Scrip
Privately held Polaris reached a special protocol assessment agreement with the US FDA on the design of the firm's Phase III trial of its investigational pegylated arginine deiminase product ADI-PEG 20 in patients with advanced hepatocellular carcinoma (HCC), a cancer associated with infection with hepatitis B or C and alcohol consumption and for which the prognosis for patients is poor, with life expectancy of only about one year post-diagnosis.
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