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By Dross at 2007-12-28 00:05
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Progen Pharmaceuticals Limited (NASDAQ:PGLA) today provided an update on clinical trial enrollment associated with its phase 3 hepatocellular carcinomaterm (HCC, primary liver cancer) study. The study has begun initiating sites and is now open for patient recruitment, though a thorough examination of available surgical cases has not yet found any eligible patients who are able to be enrolled by 31 December 2007. Consequently, the Company now anticipates that first patient in will be achieved early in the new year. Given the delay is solely due to the first site being initiated so close to year-end, the Company does not expect that this will have any impact on overall study timelines or registration strategy.
At this point in time, Progen has received regulatory approval to conduct the phase 3 trial in several countries. The Company has also obtained ethics approval at five trial centres, one of which has been initiated and is open to recruitment. Further regulatory and ethics approvals will follow early in 2008, and sites will be initiated as soon as they are able to begin enrollment.
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