By step-wise dose escalation, a safe dose of 1mg/day of TASQ was achieved, which corresponds to a doubling of the previously reported maximum tolerated dose level of 0.5mg/day. This enables a dose of 1 mg/day to be administered in future trials.
The ongoing study comprises patients with hormone-refractory prostate cancer. This is an advanced stage of prostate cancer where the tumor cells no longer respond to hormone treatment. All patients entering the study had rising serum levels of Prostate Specific Antigen (PSA), which is a surrogate marker for tumor progression.
PSA measurements were recorded and three of these five patients exhibited a decrease in absolute PSA levels.
The objective of the TASQ project is to develop a pharmaceutical product that can be administered orally for the long-term treatment of prostate cancer. Phase II studies are scheduled to start during 2007. The Medical Products Agency has approved the new maximum tolerated dose to be used in the continued clinical program of TASQ.