The updated analysis confirmed an improved Progression Free Survival (PFS) of 7.6 vs. 3.3 months for patients on TASQ vs. placebo (p=0.004). Detailed analysis showed significant PFS improvements in most subgroups, particularly subsets of men with CRPC and bone or visceral metastatic disease. TASQ was generally well tolerated and the incidence of serious side effects was low. TASQ treatment did not affect cardiovascular risk factors such as hypertension or QTc prolongation, and the rate of cardiovascular side effects was acceptably low. A longer half-life in elderly patients was observed, leading to an increased exposure. By selective dose reduction in this cohort increased side effects may be avoided in future trials.
"The observed balance of efficacy and safety of TASQ are encouraging at this stage of clinical study", says principal author Andrew Armstrong, MD ScM, Assistant Professor of Medicine and Surgery at Duke University and the Duke Prostate Center. "We look forward to ultimately seeing the data from the phase III studies that will provide the clearest assessment of overall survival in CRPC patients receiving TASQ, as well as the compound's overall risk/benefit profile."
For more detailed information, please see go read the complete poster, please visit wwwactivebiotech
A Phase III trial investigating TASQ in a pre-chemotherapy (docetaxel) setting in men with metastatic CRPC is being initiated during first quarter 2011 to further confirm the overall clinical benefit in this population.
Active Biotech AB (publ)
Tomas Leanderson
President and CEO
For further information, please contact Göran Forsberg VP Investor Relations & Business Development Tel: +46 (0)46 19 11 54 goran.forsberg@activebiotech.com
Notes to editors
About the TASQ Phase II study