Active Biotech's Prostate Cancer Project TASQ in Phase I Combination Therapy Trial
Lund, Sweden, January 23, 2012 - a Phase I Investigator sponsored clinical trial, led by Principal Investigator Dr.Andrew Armstrong at Duke University Hospital, US, has been announced for Active Biotech's (NASDAQ OMX Nordic: ACTI) prostate cancer project TASQ. The primary objective for the CATCH trial (Cabazitaxel (Jevtana) And Tasquinimod in Men with Castration-Resistant Heavily pre-treated Prostate Cancer) is to determine the recommended dose of TASQ in combination with cabazitaxel based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC). Secondary objectives include efficacy as measured by progression free survival, and overall survival. The study will include about 30 CRPC patients. For further information about the study, please see www.clinicaltrials.gov..
Given previous significant activity observed with both TASQ and taxane chemotherapy in CRPC, there is a strong rationale for the study of the combined use of these agents. In preclinical model systems of castrate-resistant prostate cancer, TASQ combined with taxane-based chemotherapy has been shown to further delay tumor progression.
A global, pivotal, randomized, double-blind, placebo-controlled Phase III study of TASQ in patients with metastatic CRPC is ongoing. The aim of the study is to confirm TASQ's effect on the disease, with radiological PFS as the primary endpoint and overall survival as secondary endpoint. The study will include about 1,200 patients in more than 250 clinics.
Active Biotech AB (publ)
Tomas Leanderson
President & CEO
For further information, please contact
Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
tomas.leanderson@activebiotech.com
Notes to editors
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. Studies have concluded that TASQ exhibits anti-tumor activity via inhibition of tumor angiogenesis. It was announced in December 2009 that the primary endpoint of the Phase II clinical study, to show a higher fraction of patients with no disease progression during the six-month period of treatment using TASQ, had been met. Final Phase II results were published in Journal of Clinical Oncology in September 2011. It was concluded that TASQ significantly slowed disease progression and improved Progression Free Survival (PFS) in patients with metastatic castrate-resistant prostate cancer (CRPC), alongside an acceptable side effect profile. Six month progression free proportion of patients for TASQ and placebo treatment groups were 69% and 37%, respectively (p<0.0001), with a median PFS of 7.6 vs. 3.3 months (p=0.0042).
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, TASQ for prostate cancer and ANYARA for use in cancer targeted therapy, primarily of renal cell cancer. In addition, laquinimod is in Phase II development for Crohn's and Lupus. Further projects in clinical development comprise the two orally administered compounds, 57- 57 for Systemic Sclerosis as well as RhuDexTM for RA. 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 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 a.m. CET on January 23, 2012.
