Lund, Sweden, December 14, 2009 – A first analysis of the primary endpoint based on data from at least six months’ treatment of more than 200 patients, has been performed in Active Biotech AB’s (NASDAQ OMX Nordic: ACTI) ongoing Phase II clinical study of TASQ, in patients with asymptomatic, castrate resistant, metastatic prostate cancer.
In this analysis, safety, efficacy and certain biomarkers were evaluated. The primary endpoint, to show a difference in the number of patients with disease progression at six months, was reached. The fraction of patients with disease progression during the six month period was 43 % for patients treated with TASQ compared to 67 % for placebo treated patients. The median progression free survival was 24.7 weeks for the TASQ group, compared to 12.9 weeks (p=0.0001) for the placebo group.
TASQ treatment also had a positive effect on several biomarkers relevant for prostate cancer progression and was generally well tolerated. No safety concerns significantly affecting the risk/benefit ratio for TASQ were identified.
“This is a very important milestone for TASQ and Active Biotech. I am looking forward to the further development of this novel, non-cytotoxic treatment. “, says Professor Tomas Leanderson, CEO Active Biotech “.
The top line data are based on the local review of disease progression and an additional central review is currently ongoing. Complete results from the trial including additional details and data from the central review will be presented at an upcoming scientific conference and in scientific publications.