13 December 2006
Progen Reports Positive Results for Phase 2 Liver Cancer Trial
• First results from PI-88’s largest randomised Phase 2 trial provides a clear trend of activity against liver cancer
• PI-88 treatment after surgery, delays tumour recurrence in patients by 76%
• For 30-week data, the risk of recurrence was reduced from 1 in 3 to 1 in 5
• Data strongly supports progression of PI-88 to Phase 3
Brisbane, Australia 13 December 2006. Progen Industries (ASX: PGL; NASDAQ: PGLA) today announced positive preliminary results demonstrating that in this trial PI-88 increased disease-free survival – time to tumour recurrence – by 76%.
The Phase 2 trial was designed to assess the efficacy and safety of PI-88 administered to patients that have had their primary liver cancer tumours removed via surgery. Progen targeted this indication in large part because of the high disease recurrence rate these patients experience. PI-88 was administered at the two different dose levels of 160mg and 250mg.
At the 30 week time point, the preliminary results showed the risk of recurrence to be 1 in 5 for the 160mg PI-88 treatment group (disease-free rate of 79%), down from 1 in 3 for the untreated ‘control’ group (disease-free rate of 65%). For the patients in the 160 mg group that recurred, time to recurrence was 76% longer than for the untreated ‘control’ group. This represents disease-free survival – time to recurrence – of 30 weeks for the 160 mg PI-88 compared with 17 weeks for the untreated ‘control’ group.
Within the group that received the higher dosage of 250mg there were several patients who dropped out for a variety of reasons, including tolerability. This was not an unexpected result and confirms the highest, safe and effective dose of PI-88 to be 160mg.
"These results are clinically very encouraging. It’s hard to overstate the importance to the patient’s quality of life of each day that they remain free of liver cancer. It is well known that once liver cancer recurs, the patient’s survival prognosis is poor and the quality of life deteriorates dramatically,” said Professor John Zalcberg, Chief Clinical Advisor to and Non-executive Director of Progen.
Justus Homburg, Chief Executive Officer of Progen stated "We conducted this preliminary data analysis of all 168 evaluable patients at the 30-week time point to assist us now with a timely Phase 3 trial design. These results offer excellent support as we proceed to Phase 3 development, with the guidance of the FDA, as rapidly as possible. These 30-week data will not change and will be expanded upon as final 48 week data are analysed.”
The final data for this Phase 2 trial (at 48 weeks – comprising 36 weeks of treatment and a 12-week follow-up period) are expected to be available by the second quarter of 2007, once the final data from all trial sites have been checked, processed and statistically analysed. We conducted this preliminary data analysis to guide our Phase III trial design.
“We would like to thank all those who have contributed to the trial so far, particularly our Taiwanese clinical trial collaborator, Medigen Biotechnology Corporation, and Professor Pei-Jer Chen, this study’s Principal Investigator,” Mr Homburg went on to say.
About Progen's Phase 3 trial and regulatory approval: Progen will use the data from this preliminary analysis to guide the development of the Phase 3 trial. The Progen clinical development team are currently in the process of discussing the Phase 3 trial protocol design with the FDA through the Special Protocol Assessment (SPA) process. The approved SPA will contain the protocol design, clinical end-points and statistical analyses acceptable to the FDA to support regulatory approval.
Progen recently held an End of Phase 2 Chemical, Manufacturing and Control meeting with the FDA, with the FDA clearing the Phase 3 manufacturing of PI-88. Progen has manufactured, at its Darra facility, sufficient quantities of the intermediate material for the Phase 3 trial. A Contract Manufacturing Organisation (CMO) will produce the final active ingredient (API) in its FDA accredited cGMP manufacturing facility.
Further details on Progen’s Phase 3 trial design and plans will be released over the coming months.
An investor call-in will take place tomorrow at 2pm (Sydney time) – full details to follow. |
