Progen opens enrollment for HCC trials

Australia's Progen Pharmaceuticals says that a Phase III hepatocellular carcinoma study of its drug candidate PI-88, 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 as of December 31, 2007. The company now anticipates that the first subject will be recruited early in the new year.

Given the delay is solely due to the first site being initiated so close to year-end, the firm does not expect that this will have any impact on overall study timelines or registration strategy. At this time, Progen has received regulatory approval to conduct the Phase III trial in several countries. The company has also obtained ethics approval at five trial centers, 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.

The agent is one of a new class of multi-targeted cytostatic cancer therapeutics with a first-in-class mechanism as a heparan sulfate mimetic. Its anti-tumor activity is based on inhibition of two biological processes - angiogenesis and metastasis - which are critical to the growth and progression of cancer, Progen noted.