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Release issued 19th December 2005
Lund, Sweden - 19 December 2005 - Active Biotech (Stockholm: ACTI.ST) has commenced screening of patients in a Phase I clinical trial of the 57-57 Project for Systemic Lupus Erythematosus (SLE). Also patients with Reumatoid Arthritis (RA) will be included in the study. The clinical trial, the second of a planned series of Phase I studies, will primarily examine the safety and pharmacokinetics of 57-57.
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
If you want to find out more about the company visit Active Biotech profile.
(13th May 2008) Active Biotech advances ANYARA into Phase III clinical trial.
(15th April 2008) Preclinical data presented for Active Biotech's ANYARA technology
(24th October 2007) Active Biotech's Cancer Project ANYARA Proven Safe in Combination with Taxotere®
(10th August 2007) FDA Approves IND for Phase II Studies of TASQ
(26th July 2007) EMEA Grants Orphan Drug Status to Active Biotech's Cancer Treatment ANYARA