Progen Expand PI-88 Clinical Development to Prostate Cancer
09 Agosto 2005 - 6:00AM
PR Newswire (US)
BRISBANE, Australia, Aug. 9 /PRNewswire-FirstCall/ -- Australian
cancer drug development company Progen Industries Limited
(ASX:PGLASX:Nasdaq:ASX:PGLAF) announced today the expansion of the
Phase II clinical trial program of its lead anti-cancer product
PI-88 into prostate cancer. The first patients will commence
treatment this week at the Royal North Shore Hospital in Sydney and
the Sydney Haematology and Oncology Clinics and further clinical
centres around Australia will be added in the coming weeks. This
new Phase II trial, where PI-88 will be combined with the
chemotherapy agent Taxotere(R) (docetaxel) from the global
pharmaceutical company Sanofi-Aventis, will assess the efficacy and
safety of PI-88 in 82 patients with androgen-independent prostate
cancer (patients whose condition continues to worsen despite having
received hormone therapy.). Key points: - The goal of combining
proven therapy (Taxotere(R)) and experimental drugs such as PI-88
is to increase efficacy over Taxotere(R) when used alone in this
disease. - Clinical trial initiated at the request of clinicians
who are actively seeking to improve treatment for this type of
cancer through investigation of new and novel drug combinations. -
Recruitment is expected to be rapid due to limited available and
approved treatments for patients with advanced androgen-independent
prostate cancer. - Sanofi-Aventis will supply Taxotere(R) and
financial support for the trial. - Progen will supply PI-88 and
trial management support. Progen is conducting the trial with the
support of Sanofi-Aventis. Sanofi-Aventis are providing a financial
grant to the clinical investigators as well as the supply of
Taxotere(R). Progen will be monitoring trial progress and providing
safety reporting under the IND (Investigational New Drug)
guidelines of the United States FDA (Food & Drug
Administration). Dr Brian Creese, Ph.D., Progen's Head of Clinical
Development commented. "We are excited about the opportunity to
investigate PI-88 in another cancer indication. The trial was
instigated by clinical investigators involved in the current PI-88
lung cancer trial. It further demonstrates their enthusiasm in
exploring the potential of PI-88 in a wide range of cancer
indications. Investigators worked together with both Progen and
Sanofi-Aventis to design the clinical protocol and we are very
appreciative of their support." Dr Gavin Marx, lead investigator on
the clinical trial said, "We are looking forward to working with
both Progen and Sanofi-Aventis on this trial. Treatment options for
androgen-independent advanced prostate cancer have been very
limited until recently. The 2004 FDA approval of Taxotere(R) for
the treatment of androgen-independent metastatic prostate cancer
(AIPC) on the basis of improved survival over palliative care is
considered a breakthrough. The aim of this study therefore is to
determine if Taxotere(R) combined with PI-88 is even more effective
in controlling advanced prostate cancer than by giving Taxotere(R)
on its own." Contact: Sarah Meibusch (Progen) T: +61-7-3273-9100 E:
DATASOURCE: Progen CONTACT: Sarah Meibusch of Progen,
+61-7-3273-9100, or
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