Progen (NASDAQ:PGLAF)
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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