Active Biotech (ACTI.ST). An interim analysis of the ongoing TASQ Phase I study shows a treatment effect for all evaluated prostate cancer patients. Phase II/III studies are planned to start in year 2007.
The Phase I study comprises a total of 24 patients with so called hormone refractory prostate cancer. This is an advanced stage of prostate cancer where the tumor cells no longer respond to hormone treatment. All patients entering the study had rising serum levels of Prostate Specific Antigen (PSA), which is a surrogate marker for tumor progression.
The current interim analysis was made after ten patients had passed four months of TASQ treatment. Treatment with 0.5 mg TASQ daily led to a reduced rate of PSA increase for all ten patients. In nine out of ten patients this decrease was larger than 50%. Four out of the ten patients showed a decreased serum level of PSA after four months TASQ treatment.
The results also showed that treatment with TASQ was well tolerated with only mild and transient side-effects.
"The interim results definitely indicate an interesting effect of TASQ as the drug clearly inhibits the rising PSA" says the Principal Investigator in the study Professor Jan-Erik Damber at the Sahlgrenska University Hospital in Gothenburg.
As earlier communicated, the maximum tolerated dose (MTD) of TASQ was reached at the dose level 0.5 mg/day. The patients has since continued their treatment in a follow-up study with the primary aim to document the drug's long-term tolerance and safety, but where also PSA levels have been monitored as a surrogate marker for response to treatment.
The study is being conducted in the urology clinics at the Sahlgrenska University Hospital in Gothenburg and the University Hospitals in Uppsala, Lund and Malmö.
The objective for the TASQ project is to develop a pharmaceutical product that can be administered orally for chronic treatment of prostate cancer. Phase II/III studies are planned to start 2007.
Lund September 20, 2006
Active Biotech AB (publ)
Sven Andréasson
President & CEO
Active Biotech AB is a biotechnology company focusing on research and development of pharmaceuticals. Active Biotech has a strong R&D portfolio with pipeline products focused on autoimmune/inflammatory diseases and cancer. Most advanced projects 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 immunotherapy with the primary indication non-small cell lung cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer 57-57 for SLE and RhuDex® for RA. In addition, the preclinical development of the I-3D project is being conducted in cooperation with Chelsea Therapeutics.
Active Biotech AB
Box 724, SE-220 07 Lund
Tel: +46 46-19 20 00
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www.activebiotech.com