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Progen's Phase 2 Liver Cancer Trial Exceeds Efficacy Objective

- Phase 3 Patient Enrolment Planned for Second Half of 2007 -

BRISBANE, Australia, April 16, 2007 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited today announced the final stage 1 results of its Phase 2 trial of PI-88 in patients who had previously undergone surgical removal of liver cancer. The 48 week data demonstrated that 160 mg of PI-88 showed an improvement in disease-free rate, the primary endpoint, of 25 percent and prolonged the time to tumour recurrence (disease- free survival) from 27 to 48 weeks, or by 78 percent, building on the 30-week results announced in December 2006.

The first stage of the randomised, two-stage multi-centre Phase 2 trial was designed to determine the appropriate dosage and possible efficacy of PI- 88 in reducing tumour recurrence in liver cancer patients who had previously undergone surgical removal of the cancer. Patients in this stage of the Phase 2 trial were randomly assigned to one of three groups to receive either the standard of care (with no PI-88 treatment), 160 mg of PI-88, or 250 mg of PI- 88, over 36 weeks with a 12 week follow-up period.

    Summary of results

    -- Treatment with 160 mg of PI-88 increased the disease-free rate by

       approximately 25 percent, from 50 percent to 63 percent at 48 weeks

    -- Treatment with 160 mg of PI-88 increased the time to recurrence of

       disease (disease-free survival) by approximately 78 percent, from 27 to

       48 weeks

    -- The final results confirmed the trend identified in the 30-week

       assessment that PI-88 delayed the recurrence of disease and increased

       the likelihood that the patient would be disease free for a longer

       period

    -- The 160 mg dosing level of PI-88 revealed a strong safety and

       tolerability profile and few adverse events directly or possibly

       related to treatment

As the 160mg dose was well tolerated and showed
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TAG: Progen Phase Liver Cancer Trial Exceeds Efficacy Objective
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