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US FDA Fast Tracks PI-88 for the Treatment of Post Resection Liver Cancer
Date:9/24/2007

to late disease diagnosis, currently only about 25% of patients are eligible for surgery and half of those patients will have their disease recur within 12-15 months. No products have been approved by the FDA to prolong the time a patient remains disease free following surgery.

The fast track designation is fully aligned with Progen's Phase 3 trial design. The double blinded, placebo-controlled Phase 3 trial will be powered for the primary endpoint of disease-free survival determining if PI-88 can prevent early recurrence following curative hepatic surgery. The trial will begin later this year and targets 600 patients with liver cancer post resection, in more than a dozen countries.

About Progen:

Progen Pharmaceuticals Limited is an Australian-based globally focused biotechnology company committed to the discovery, development and commercialization of small molecule therapeutics primarily for the treatment of cancer.

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 a Phase 2 trial in post-resection liver cancer, PI-88 demonstrated a 25% improvement in the primary endpoint of disease-free rate at 48 weeks and 78% improvement in secondary endpoint of disease-free survival. These results, combined with positive feedback from the FDA, provide Progen with confidence in the potential of PI-88 for this indication and we are therefore aggressively pursuing its development towards registration and commercialization.

Progen Information:

Justus Homburg

Progen Pharmaceuticals Limited

T: +61 7 3842 3333

E: justush@progen-pharma.com

Noreen Dillane<
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SOURCE Progen Pharmaceuticals Limited
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