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news.Progen Pharmaceuticals has started a global Phase III study that will investigate PI-88 as an adjuvant treatment for primary liver cancer, following curative resection with the first patient having been randomized onto the study.
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The study globally known as Pathway, is a double-blinded, placebo-controlled study that has been designed to establish the efficacy and safety of PI-88 in the post resection liver cancer setting.
The trial will recruit approximately 600 patients at about 65-70 hospitals in more than a dozen countries. Disease-free survival, a measure of the average length of time that patients remain free of tumor recurrence, is the primary endpoint. Upon completion of this trial, the results are expected to form the basis of global registration filings for PI-88.