Progen Announces Commencement of Global Phase 3 Study for PI-88 in Post- Resection Li...(nt options with curative potentialrecurr...),Health

Dr. James Garner, Progen's Vice President of Clinical and Medical Affairs, added, "Since the release of our promising phase 2 data last year, our team has worked tirelessly to design a world-class phase 3 trial for PI-88 in liver cancer. We are very thankful for the support of key opinion leaders and clinicians all over the world, many of whom will now be serving as investigators in PATHWAY. While the study is starting later than we had hoped as a result of some delays opening sites due to a greater-than-expected impact from holidays over the past couple of months, Progen continues to aggressively drive country regulatory and hospital ethics approvals to conduct this phase 3 trial."

The study now has regulatory approval in almost half of the participating countries and more than a dozen sites have been granted approval by ethics committees. Sites are being initiated so as to be able to commence patient recruitment as soon as these necessary approvals have been granted.

About PI-88: PI-88 is one of a new class of multi-targeted cytostatic cancer therapeutics. It is a novel anti-cancer compound with a first-in-class mechanism as a heparan sulfate mimetic. Its anti-tumor activity is based on inhibition of two biological processes -- angiogenesis (the growth of new blood vessels) and metastasis (the spread of cancer to other sites) -- critical to the growth and progression of cancer. In April 2007, data from a randomised phase 2 trial in the post resection liver cancer setting was presented at the European Association for the Study of the Liver (EASL) meeting in Barcelona, Spain. PI-88, in this disease setting, has been granted Orphan Drug designation by the European Medicines Evaluation Agency (EMEA) and Fast Track designation by the United States Food and Drug Administration (FDA).
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