Primary endpoint reached in Active Biotech's TASQ Phase II clinical trial in prostate cancer patients
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.
Lund, December 14, 2009
Active Biotech AB (publ)
President and CEO
For further information, please contact:
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Tel +46 (0)46-19 11 54
The development of TASQ is primarily focused on the treatment of prostate cancer. TASQ is a small molecule from the quinoline family of compounds that binds to the target molecule S100A9. TASQ has anti-angiogenic properties, meaning that it cuts off the supply of nutrients to the tumor but it does not belong to the most frequently occurring group of tyrosine kinase inhibitors. The dosing is one tablet a day.
Results from a Phase I trial of TASQ were recently published in the British Journal of Cancer, where TASQ was studied in patients with castrate resistant prostate cancer. The results showed that long-term continuous oral administration of TASQ seems to be safe and that TASQ might delay disease progression.
About the Phase II trial
The reported clinical trial is a 2:1 randomized, placebo controlled, double-blind Phase II trial investigating 1 mg/day of TASQ (tasquinimod, ABR-215050) versus placebo in 206 asymptomatic patients with metastatic, castrate resistant, prostate cancer. The trial is conducted in the US, Canada and Sweden under an IND (Investigational New Drug) application.
The primary endpoint of the Phase II trial is to measure the proportion of patients that display disease progression after six months of TASQ therapy compared with placebo. For more detailed information please see http://clinicaltrials.gov
. Secondary clinical endpoints of importance for this group of patients include progression free survival, safety and effects on biomarkers. Documentation of such endpoints is of importance for future TASQ development and registration.
About Active Biotech
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 is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was provided to the media for publication on December 14, 2009 at 08:30 a.m.
Active Biotech AB
PO Box 724, SE-220 07 Lund
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 11 00
Primary endpoint reached in Active Biotechs TASQ Phase II clinical trial