Progen Commences Third PI-88 Phase II Trial

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, [phone],

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