Active Biotech's TASQ prostate cancer project presented at 2011 Genitourinary Cancers SymposiumFebruary 18, 2011 08:30 (CET)
Lund, Sweden, February 18, 2011 - Active Biotech AB's (NASDAQ OMX Nordic:ACTI) prostate cancer trial has been presented at the scientific conference 2011 Genitourinary Cancers Symposium held February 17-19, 2011 in Orlando, Florida.
The presentation included an update on data from a randomized placebo-controlled double blind clinical Phase II study of TASQ - an oral antiangiogenic agent with S100A9 as a molecular target - in patients with asymptomatic metastatic castrate-resistant prostate cancer (CRPC). S100A9 is an immune regulatory protein that has been related to cancer progression and immune evasion and has emerged as a potential anti-cancer target in recent years.
The updated analysis confirmed an improved Progression Free Survival (PFS) of 7.6 vs. 3.3 months for patients on TASQ vs. placebo (p=0.004). Detailed analysis showed significant PFS improvements in most subgroups, particularly subsets of men with CRPC and bone or visceral metastatic disease. TASQ was generally well tolerated and the incidence of serious side effects was low. TASQ treatment did not affect cardiovascular risk factors such as hypertension or QTc prolongation, and the rate of cardiovascular side effects was acceptably low. A longer half-life in elderly patients was observed, leading to an increased exposure. By selective dose reduction in this cohort increased side effects may be avoided in future trials.
"The observed balance of efficacy and safety of TASQ are encouraging at this stage of clinical study", says principal author Andrew Armstrong, MD ScM, Assistant Professor of Medicine and Surgery at Duke University and the Duke Prostate Center. "We look forward to ultimately seeing the data from the phase III studies that will provide the clearest assessment of overall survival in CRPC patients receiving TASQ, as well as the compound's overall risk/benefit profile."
A Phase III trial investigating TASQ in a pre-chemotherapy (docetaxel) setting in men with metastatic CRPC is being initiated during first quarter 2011 to further confirm the overall clinical benefit in this population.
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Notes to editors
About the TASQ Phase II study
The concluded 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 was conducted in the US, Canada and Sweden under an IND (Investigational New Drug) application. For more information, please see www.clinicaltrials.gov.
The primary endpoint of the Phase II trial was to measure the proportion of patients that display disease progression after six months of TASQ therapy compared with placebo. Secondary clinical endpoints of importance for this group of patients include progression free survival, safety and effects on biomarkers. Results were presented at 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2010.
TASQ binds to a molecule called S100A9 which is expressed in some white blood cells involved in the regulation of immune responses. S100A9 interacts with two known pro-inflammatory receptors (Toll like receptor 4 (TLR4) and receptor of advanced glycation end products (RAGE)) and this interaction is inhibited by TASQ (Björk et al PLoS Biology, April 2009).
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. Up-regulation of thrombospondin-1 (TSP1) has been identified as one important component in order to understand and explain the anti-angiogenic mechanism of TASQ treatment of prostate cancer (Olsson et al, Mol Cancer May 2010).
A phase III trial of TASQ in men with metastatic castrate-resistant prostate cancer will be initiated during first quarter 2011. For more information, please see www.clinicaltrials.gov.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in or entering 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 SLE and Systemic Sclerosis as well as RhuDexTM for RA. Please visit www.activebiotech.com for more information.
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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 February 18, 2011.