BRISBANE, Australia, March 11 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) today announced the commencement of its global phase 3 study investigating PI-88 as an adjuvant treatment for primary liver cancer (hepatocellular carcinoma, HCC) following curative resection with the first patient having been randomized onto the study. The study is known globally as PATHWAY (PI-88 in the adjuvant treatment of HCC). The first patient to enter the trial is from Singapore.
Dr. Ronnie Poon, Ph.D., M.D., global lead investigator for PATHWAY, commented, "My colleagues and I are encouraged by the phase 2 data that Progen has generated for PI-88 in this challenging disease, for which there are no approved treatment options. If PATHWAY is successful, PI-88 could change the standard of care for resected liver cancer patients."
PATHWAY, a double-blinded, placebo-controlled study, 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.
Justus Homburg, Progen's CEO, said, "Commencement of this trial represents a significant milestone for Progen. We have designed this trial in collaboration with world experts in this field of medicine, and with USA FDA Fast Track and EU EMEA Orphan Drug Status, its initiation underscores our commitment to making this important drug rapidly available to patients who currently have few treatment options available."
Liver cancer is one of the top five causes of cancer deaths in the
world, with over half a million new cases per year. Although surgical
resection is one of the few treatme
|SOURCE Progen Pharmaceuticals Limited|
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