PGLAF Progen Industries

Progen Commences Third PI-88 Phase II Trial BRISBANE, Australia, Feb. 10 /PRNewswire-FirstCall/ -- Progen Industries Ltd , a progressive Australian oncology drug discovery and development company, announced the commencement of the third of a series of four Phase II clinical studies evaluating its lead compound PI-88, this time in lung cancer patients. Following the successful completion of two Phase I trials - assessing PI- 88 safety and tolerability as a single agent and in combination with chemotherapy respectively, Progen has now initiated both follow-on Phase II components of each trial. The start of the single agent (melanoma) Phase II trial was announced on January 21st. Today marks the beginning of a 90 patient, multi-center Phase II trial of PI-88 in combination with Taxotere(R) for the treatment of advanced non-small cell lung cancer. This combination trial is recruiting patients at the following nine Australian clinical centers: Royal North Shore Hospital (Sydney); Sydney Cancer Centre, Royal Prince Alfred Hospital (Sydney); Sir Charles Gairdner Hospital (Perth); Mater Adult Hospital (Brisbane); Queen Elizabeth Hospital (Adelaide); Prince of Wales Hospital (Sydney); The Alfred Hospital (Melbourne); Prince Charles Hospital (Brisbane); and Newcastle Mater Misericordiae (Newcastle). Cancer drugs are commonly used in combination regimens and this PI-88 clinical program is exploring synergies between the antiangiogenic nature of PI-88 (a VEGF, FGF-1, FGF-2 and heparanase inhibitor) and Taxotere(R) (an established cytotoxic cancer drug marketed by Aventis). Additionally, two completed trials in which PI-88 was delivered as a single agent have shown good safety and signs of activity - particularly in melanoma and multiple myeloma. The Phase I study of PI-88 administered in combination with Taxotere(R), was concluded this week by the University of Colorado Health Sciences Center, Denver. The Phase I trial was designed to determine the appropriate dose for the Phase II trial and to evaluate the safety of the combination of PI-88 given subcutaneously on four consecutive days every week and docetaxel 30 mg/m2 administered intravenously once a week, for 3 weeks out of a 4 week cycle. The safety profile of the combination was very good with no drug-related serious adverse events recorded. 16 patients were enrolled in the Phase I study (median age 53 (range 40-67) and 250 mg was established as the appropriate dose for the Phase II trial. Rob Don, Progen's VP of R&D commented: "Similar to the way that Genentech's new anti-angiogenic drug, Avastin(R), was evaluated in combination with a chemotherapy regimen in treating patients with advanced colorectal cancer, this trial has been designed to determine PI-88's ability to showefficacy in combination with chemotherapy. We have seen positive signs in the Phase I single agent trial where over 40% of the melanoma patients showed tumor growth retarded for periods up to 30 months and from the Phase II multiple myeloma trial where 39% of patients have shown cancer stabilization for periods up to 2 years. These data provide us with confidence to embark on the Phase II clinical program, looking at benefits of PI-88 single agent therapy as well as in combination with chemotherapy." In July 2003 we concluded the PI-88 Phase II trial in multiple myeloma and January 2004 signified the commencement of a second Phase II trial targeting advanced melanoma. This Phase II lung cancer trial is the third of four PI-88 Phase II clinical trials that have been initiated to date in different cancers. The fourth and final Phase II trial of the series, PI-88 will be used as an adjuvant therapy in post-operative liver cancer patients (conducted by Medigen Biotechnology Corporation -Taiwan). DATASOURCE: Progen Industries Ltd CONTACT: Sarah Meibusch of Progen, +61-7-3273-9100,

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