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news.Australia-based Progen Pharmaceuticals has announced positive findings from the Phase II liver cancer study of its novel anticancer compound with a first-in-class mechanism as a heparan sulfate mimetic.
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As the Phase II trial’s study period covered 48 weeks from curative surgery, the data analysis was performed to evaluate the treatment’s impact when patients with a low risk of experiencing a liver cancer recurrence within 12 months are removed from the analysis population.
The resultant analysis of those patients who had a high risk of recurrence in the 12-month period shows that the drug, PI-88, at least doubled the time to disease recurrence calculated at the 60th percentile (p=0.0107) (control (n=33): 24 weeks versus 160mg PI-88 (n=36): 48 weeks). This compares to a 76% improvement at the 70th percentile (p=0.0867) if all patients are included.
The double-blind placebo-controlled Phase III study is designed to assess, as its primary endpoint, improvement in disease free survival, among approximately 600 patients in countries across North America, Europe and Asia, following surgery to remove liver cancer tumors. Half of the patients in this study will be administered PI-88 after surgical removal of tumors and the remaining patients will receive a placebo so that a direct statistical comparison between the placebo and PI-88 can be made.