BRISBANE, Sept. 24 Progen PharmaceuticalsLimited (ASX: PGL; Nasdaq: PGLA) today announced that the Phase 2 trialadministering 250mg of PI-88 in combination with the chemotherapeutic agentdocetaxel to patients with advanced non small cell lung cancer did not meetits primary endpoint of significantly improving the progression-free rate atsix months compared to docetaxel alone. The trial also did not meet itssecondary 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 ofPI-88 in combination with docetaxel in patients with non small cell lungcancer that have failed platinum based first line therapies is warranted.However, nine patients in the study switched to PI-88 after experiencingtoxicity or disease progression with docetaxel monotherapy. The data for thispatient group suggests a potential survival benefit that Progen intends toinvestigate further with, amongst others, the clinicians involved in thisstudy.
"We are disappointed, first and foremost, for the patients with non smallcell lung cancer that have disease progression following platinum basedchemotherapy as treatment options are limited," said Justus Homburg, Progen'sChief Executive Officer. "The outcome of this study has no impact on our Phase3 registration strategy for patients with post-resection liver cancer which weannounced 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 butlimited benefit in another. To date, PI-88 has shown evidence of benefit inpatients with melanoma, multiple myeloma and post-resection liver cancer. Inparticular, PI-88 may be more active for tumors that are at an earlier diseasestage, such as has been demonstrated in the PI-88 Phase 2 primary liver cancertrial" added Homburg. "In that trial, patients were at high risk of diseaserecurrence but had no demonstrable disease present at the time of startingtherapy with PI-88" he said. "We remain committed to the ongoing developmentof PI-88, especially given the exciting Phase 2 data seen in the primary livercancer trial."
Progen Pharmaceuticals Limited is an Australian-based globally focusedbiotechnology company committed to the discovery, development andcommercialization of small molecule therapeutics primarily for the treatmentof cancer.Progen Information: Justus Homburg Progen Pharmaceuticals Limited T: +61 7 3842 3333 E: email@example.com Sarah Meibusch Progen Pharmaceuticals Limited T: +61 7 3842 3333 E: firstname.lastname@example.org Media and Investor Relations Australia: Rebecca Piercy Buchan Consulting T: +61 2 9237 2800 / +61 422 916 422 E: email@example.com Rebecca Wilson Buchan Consulting T: +61 417 382 391 E: firstname.lastname@example.org Media Relations USA: Robert D. Stanislaro Financial Dynamics T: 212-850-5657 E: email@example.com Investor Relations USA: Evan Smith Financial Dynamics T: 212-850-5606 E: firstname.lastname@example.org
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