"The results strengthen the further clinical development of 57-57 for the treatment of SLE and show the possibility to reduce the use of steroids. Phase II clinical trials are planned to be initiated before year end", commented Sven Andréasson, President & CEO Active Biotech.
The new pre-clinical data presented show that 57-57, in an experimental model of the disease systemic lupus erythematosus (SLE), can replace prednisolone, an anti-inflammatory corticosteroid widely used in a broad range of different inflammatory diseases, among them SLE.
Several symptoms commonly associated with SLE, such as hematuria (blood in the urine) and glomerulonephritis (inflammation in the kidneys) could be significantly reduced when combining 57-57 and a lower dose of steroid.
Lund, June 18, 2007
Active Biotech AB (Publ)
Sven Andréasson
President & CEO
About SLE and 57-57
Systematic Lupus Erythematosus (SLE) is a disease of the connective tissues that can cause inflammation and damage to the connective tissue in many different organs. The disease, which progresses in "flare-ups" interspersed with relatively symptom-free periods, primarily affects women of child-bearing age. Progress and symptoms of the disease vary widely, depending on the organs affected. Without treatment, SLE can be life-threatening. Active Biotech has decided to estimate the market conservatively at 1,000,000 patients in the US and Europe. The market potential for the SLE indication is estimated at approximately USD 6 billion.
The clinical program for the 57-57 project with the main indication SLE is proceeding according to plan. This study comprises patients with SLE or rheumatoid arthritis (RA). This is a multi-center study and is being conducted at three hospitals in Sweden - the Karolinska University Hospital in Stockholm, Uppsala University Hospital and Lund University Hospital, in addition to clinics in Russia. Phase II studies are planned to start during 2007.
57-57 has been given the international generic name (INN) paquinimod by the World Health Organization (WHO).
* For further information and to take part of the complete poster "Steroid Sparing Effect of Paquinimod (ABR-215757) in Disease Development of Experimental Lupus in MRLlpr/lpr Mice", please visit www.activebiotech.com .
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 targeted therapy, the primary indication being renal 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 conducted in cooperation with Chelsea Therapeutics.
Active Biotech AB (org. no. 556223-9227)
P.O. Box 724, SE-220 07 Lund, Sweden
Tel +46 46-19 20 00
Fax +46 46-19 20 50