In addition, a number of biological markers will be monitored to determine the effect of 57-57 on disease progression.
This multi-centre dose-escalation study is being conducted at three hospitals in Sweden - the Karolinska University Hospital in Stockholm, the Uppsala University Hospital in Uppsala, and the Lund University Hospital in Lund. Dr. Anders Bengtsson of the Lund University Hospital is the principal investigator for the trial.
SLE is a chronic rheumatic disease that affects joints, muscles and other parts of the body. An estimated 500,000 Americans have been diagnosed with SLE; however, surveys indicate that the prevalence may be much higher.
Phase II/III clinical trials of 57-57 are planned for 2007.
As previously reported, Active Biotech completed the first Phase I study of 57-57 earlier this year. That study, which examined the safety and pharmacokinetics of the drug in 30 healthy volunteers, was conducted at the Karolinska University Hospital in Stockholm. Results from the study showed that 57-57 was very well tolerated in all of the studied dose levels, both as single and repeated doses, and it is well suitable to be administered orally as a daily treatment.
Lund 19 December, 2005
Active Biotech AB (publ)
Sven Andréasson
President & CEO
For further information, please contact:
Sven Andréasson, President & CEO, phone: +46 46-19 20 49
Tomas Leanderson, CSO, phone: +46 46-19 20 95
Cecilia Hofvander, Manager Corporate Communication, phone: +46 46-19 11 22
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.
Active Biotech AB
Box 724, SE-220 07 Lund
Tel: +46 46-19 20 00
Fax: +46 46-19 20 50
www.activebiotech.com