Two open-label phase I clinical trials in patients with castration-resistant prostate cancer were conducted to evaluate the safety and tolerability of TASQ, with additional pharmacokinetic and efficacy assessments.
The results showed that long-term continuous oral administration of TASQ seems to be safe, and the overall efficacy results indicate that TASQ might delay disease progression.
A total of 32 patients were enrolled; 21 patients were maintained for >=4 months. The median PSA progression-free time was 19 weeks. In 15 patients, radiologic imaging with bone scan was done at screening and every 2 months until the final visit. It is noteworthy that there was no finding of bone scan progression at end of study in 80% of the patients (median treatment time 34 weeks; range 15 - 54 weeks).
TASQ is presently in development for the treatment of metastatic castration-resistant prostate cancer. A phase II study, which has completed enrollment of over 200 patients, is currently ongoing. The results from this study are expected in late 2009/early 2010.
Active Biotech AB (publ)
Tomas Leanderson
President & CEO
For further information, please contact
Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
Göran Forsberg, VP IR & Business Development
Tel: +46 46 19 11 54
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 but it does not belong to the most frequently occurring group of tyrosine kinase inhibitors. Positive results for the concluded Phase I trial show that TASQ is well-tolerated and has a favorable safety profile. In September 2008, the follow-up efficacy data from the Phase Ib trial of TASQ was presented, which showed that patients treated with TASQ developed few new bone metastases and displayed a reduced rate of increase of the disease marker PSA (Prostate-Specific Antigen). The project is currently in a clinical Phase II trial in progress in the US, Canada and Sweden. The trial is a 2:1 random, placebo-controlled, double-blind study of 1mg/day TASQ, compared with placebo. The study includes symptom-free patients with metastasized, hormone-resistant prostate cancer. Information about the ongoing clinical trial is available at www.activebiotech.com and 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 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 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 September 25, 2009.