The first patients will commence treatment in early August at the Royal North Shore Hospital in Sydney and the Sydney Haematology and Oncology Clinics and further clinical centers around Australia will be added in the following weeks.
The new phase II trial, where PI-88 will be combined with the chemotherapy agent Taxotere (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).
Sanofi-Aventis is providing a financial grant to the clinical investigators as well as the supply of Taxotere. Progen will be monitoring trial progress and providing safety reporting under the IND guidelines of the FDA.
Dr Gavin Marx, lead investigator on the clinical trial said: “Treatment options for androgen-independent advanced prostate cancer have been very limited until recently.
“The 2004 FDA approval of Taxotere 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 combined with PI-88 is even more effective in controlling advanced prostate cancer than by giving Taxotere on its own.”