The study is a 2:1 randomized, placebo-controlled, double-blind Phase II study of 1 mg/day TASQ versus placebo. The study encompasses symptom-free patients with metastatic, hormone-resistant, prostate cancer.
The primary endpoint of the study is to measure the proportion of patients that do not display disease progression after six months of TASQ therapy compared with placebo. Secondary clinical endpoints of importance for this group of patients include time to clinical progression, safety and to measure changes in PSA (Prostate Specific Antigen) blood levels. Documentation of such endpoints is of importance for future TASQ development and registration.
Results from this study are expected by the end of 2009/beginning of 2010.
Lund den 8 June 2009
Active Biotech AB (publ)
Tomas Leanderson
President & CEO
About TASQ
The development of TASQ is principally focused on the treatment of prostate cancer. TASQ is an antiangiogenic compound, meaning that it cuts off the supply of nutrients to the tumor and does not belong to the most frequently occurring group of tyrosine kinase inhibitors. Positive results for the concluded Phase I trial show that TASQ is well-tolerated and has a favorable safety profile. In September 2008, the follow-up efficacy data from the Phase Ib trial of TASQ was presented. Patients treated with TASQ developed few new bone metastases and displayed a reduced rate of increase of the disease marker PSA (Prostate-Specific Antigen). For further information, view the presentation from the UBS Global Life Sciences conference. Within this project, a placebo-controlled Phase II trial is being performed in the US, Canada and Sweden. In February 2009, an independent international expert group, a Data Safety Monitoring Board (DSMB), evaluated the ongoing clinical Phase II trial of TASQ. The board had access to the study's unblinded safety data and studied the side effect profile of TASQ. After analyzing long-term data concerning more than 50 patients treated with TASQ, DSMB recommended that the trial continue in accordance with the established protocol. Information about the ongoing clinical trial is available at www.activebiotech.com and www.clinicaltrials.gov.
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer targeted therapy, primarily of renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex(TM) for RA. Please visit www.activebiotech.com for more information.
Active Biotech AB
PO Box 724, SE-220 07 Lund
Sweden
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 11 00
Active Biotech is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08:30 am CET on June 8, 2009.