Final results from Active Biotech's 10TASQ10 Phase 3 study of tasquinimod presented at the ECC conference
Lund (Sweden) 28 September 2015 - Active Biotech (NASDAQ STOCKHOLM: ACTI) today announces, at the European Cancer Congress (ECC 2015) held in Vienna 25-29 September, the presentation of final results from the 10TASQ10 tasquinimod phase 3 trial.
Final results show that tasquinimod treatment resulted in a prolonged radiographic progression free survival (rPFS), 7.0 vs. 4.4 months (central assessment) similar to an earlier Phase 2 study. However, the positive effect on rPFS did not translate into an improved OS (HR 1.097, 95% CI: 0.938-1.282). Tasquinimod safety was in general manageable and similar to what was observed during the Phase 2 study.
The abstract "A phase 3, randomized, double-blind, placebo-controlled study of tasquinimod (TASQ) in men with metastatic castrate resistant prostate cancer (mCRPC), M. Carducci et al" was selected by the 18th ECCO - 40th ESMO European Cancer Congress Scientific Committee as a Best Abstract presentation in a Presidential Session (28 September 2015 at 2:35 pm CEST).
About tasquinimod
Tasquinimod is a novel oral immunotherapy that targets the tumor microenvironment by binding to S100A9 and modulating regulatory myeloid cell functions, exerting immunomodulatory, anti-angiogenic and anti-metastatic properties. The development of tasquinimod principally has been focused on the treatment of prostate cancer, but early clinical studies in other cancer indications has been performed.
About the 10TASQ10 trial
The 10TASQ10 trial is a randomized, double-blind, placebo-controlled, global Phase III clinical trial which evaluated tasquinimod in patients with metastatic castration resistant prostate cancer (mCRPC) who had not yet received chemotherapy. The aim of the 10TASQ10 study was to confirm tasquinimod`s efficacy, with radiological Progression Free Survival (rPFS) as primary endpoint and overall survival (OS) as key secondary endpoint. In April 2015, top line data was presented which showed that tasquinimod reduced the risk of radiographic cancer progression or death compared to placebo (rPFS, HR=0.69, CI 95%: 0.60 - 0.80) in patients with metastatic castration resistant prostate cancer (mCRPC) who have not received chemotherapy, but did not extend overall survival (OS, HR=1.09, CI 95%: 0.94 - 1.28). The efficacy results did not support positive benefit risk balance in this patient population.
For further information, please contact:
Tomas Leanderson, President & CEO
Tel +46 46 19 20 95
Hans Kolam, CFO
Tel +46 46 19 20 44
Active Biotech AB (publ) (Nasdaq Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in pivotal phase III development for the treatment of relapsing remitting multiple sclerosis. Also, laquinimod is in phase II development for the treatment of primary progressive multiple sclerosis and Huntington`s disease. Furthermore, commercial activities are ongoing for the projects ISI, ANYARA and paquinimod. Please visit www.activebiotech.com for more information.