The approved trial is a randomized, placebo controlled, double-blind Phase II trial investigating 1mg/day of Tasq (ABR-215050) versus placebo in 200 patients. The trial will be performed in asymptomatic patients with metastatic, castrate resistant, prostate cancer. This is a similar patient population as that previously treated in Active Biotech’s Phase I program, which the company previously reported as showing encouraging anti-tumor effects.
The primary endpoint will be the reduction of the number of patients with disease progression after six months of Tasq therapy. Secondary clinical endpoints of importance for this group of patients include time to clinical progression and initiation of treatment with cytostatics.
The study will be carried out as a multi-center trial in the US and Europe. Coordinating investigator will be Dr Roberto Pili at Johns Hopkins Medical Institution, Baltimore, US.
“With this study design we expect to deliver robust efficacy data on the anti-tumor effect of Tasq during 2009,” says Sven Andreasson, CEO at Active Biotech.