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Final results from Active Biotech's 10TASQ10 Phase 3 study of tasquinimod presented at the ECC conference

2015-09-28

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.

Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00

Active Biotech's Safe Harbor Statement in Accordance with the Swedish Securities Market Act:
This press release contains certain forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of the company, or industry results, to differ materially from any future results, performance or achievement implied by the forward-looking statements. The company does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this press release.

Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act and/or the Financial Instruments Trading Act. This information was provided to the media for publication at 8:30 a.m. CEST on Sep 28, 2015.


pdfFinal results from Active Biotech’s 10TASQ10 Phase 3



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