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Active Biotech starts selecting patients for phase 1 trial of 57-57 for systemic lupus erythematosus
New York, Dec. 19 - Active Biotech AB said it has started screening patients in its phase 1 clinical trial of 57-57 for systemic lupus erythematosus.
Patients with rheumatoid arthritis will also be included in the study.
The trial, the second of a planned series of phase 1 research, will primarily examine the safety and pharmacokinetics of 57-57.
Active Biotech will also monitor a number of biological markers to determine the effect of 57-57 on disease progression.
The multi-center 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. Anders Bengtsson of the Lund University Hospital is the principal investigator for the trial.
The first phase 1 trial, examining the safety and pharmacokinetics of the drug in 30 healthy volunteers, was completed earlier in the year and found 57-57 to be very well tolerated in all of the studied dose levels, both as single and repeated doses, and to be well suitable for oral administration as a daily treatment.
Phase 2/3 trials are planned for 2007.
Active Biotech is a Lund, Sweden, biotechnology company.
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