re: + + phase ii, nsclc trial + +...

re: + + phase ii, nsclc trial + + http://stocknessmonster.com/news-item?E=ASX&S=PGL&N=158268

Extract:

Progen commences third PI-88 Phase II trial
Brisbane, Australia Wednesday, February 11, 2003. Progen Industries Limited (ASX: PGL, NASDAQ: PGLAF), 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 anti-cancer compound PI-88, this time in lung cancer patients.

Following the recent 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, multicenter Phase II trial of PI-88 in combination with Taxotere® for the second-line treatment of advanced non-small cell lung cancer (NSCLC). 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® (an established cytotoxic cancer drug with broad antitumour
activity and marketed by Aventis).

Additionally, two completed trials in which PI-88 was delivered
as a single agent have shown a good safety profile and signs of activity against solid tumorsparticularly
melanoma and multiple myeloma.
The Phase I study of PI-88 administered in combination with Taxotere®, was concluded this week by
the University of Colorado Health Sciences Center, Denver, USA.

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. Sixteen 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®, 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 show efficacy
in combination with chemotherapy.

We have seen positive signs in the PI-88 Phase I single agent
trial where over 40% of the melanoma patients showed tumor growth retarded for periods lasting 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 the additional confidence
to embark on the PI-88 Phase II clinical program, looking at benefits of PI-88 single agent therapy
as well as in combination with chemotherapy.”

July 2003 represented the conclusion of the first 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 cancer categories. The fourth and final Phase II trial of the series will be used as
Page 2/2 an adjuvant single agent therapy in post-operative liver cancer patients (conducted by Medigen
Biotechnology Corporation -Taiwan).