Progen Announces PI-88 Phase 2 Lung Cancer Results
Brisbane, Australia. 24 September 2007:
Progen Pharmaceuticals Limited (ASX: PGL;NASDAQ: PGLA) today announced that the Phase 2 trial administering 250mg of PI-88 in combination with the chemotherapeutic agent docetaxel to patients with advanced non small cell lung cancer did not meet its primary endpoint of significantly improving the progression-free rate at six months compared to docetaxel alone. The trial also did not meet its secondary endpoints of improvement in time to progression, response rate, overall survival and quality of life measures.
The overall data from this trial suggests that no further investigation of PI-88 in combination with docetaxel in patients with non small cell lung cancer that have failed platinum based first line therapies is warranted. However, nine patients in the study switched to PI-88 after experiencing toxicity or disease progression with docetaxel monotherapy. The data for this patient group suggests a potential survival benefit that Progen intends to investigate further with, amongst others, the clinicians involved in this study.
"We are disappointed, first and foremost, for the patients with non small cell lung cancer that have disease progression following platinum based chemotherapy as treatment options are limited," said Justus Homburg, Progen's Chief Executive Officer. “The outcome of this study has no impact on our Phase 3 registration strategy for patients with post-resection liver cancer which we announced today has been granted fast-track status designation by the U.S. FDA.”
“It is quite common for new drugs to show benefit in one patient group but limited benefit in another. To date, PI-88 has shown evidence of benefit in patients with melanoma, multiple myeloma and post-resection liver cancer. In particular, PI-88 may be more active for tumors that are at an earlier disease stage, such as has been demonstrated in the PI-88 Phase 2 primary liver cancer trial” added Homburg. “In that trial, patients were at high risk of disease recurrence but had no demonstrable disease present at the time of starting therapy with PI-88” he said. “We remain committed to the ongoing development of PI-88, especially given the exciting Phase 2 data seen in the primary liver cancer trial.”
