Active Biotech Presents Data regarding the 57-57 SLE Project at EULARJune 11, 2009 08:30 (CEST)
The patients in the Phase Ib trial were treated daily for 12 weeks with 57-57. The maximum tolerable dose (MTD) was, as earlier communicated, defined at 4.5 mg/day. The overall safety profile throughout the study was favorable.
In a subset of patients treated with 4.5 mg/day 57-57 the global gene expression pattern was investigated after various treatment periods. New results strengthen previous data which indicated that treatment with 57-57 could normalize pathways known to be important in SLE pathogenesis.
Lund, June 11, 2009
Active Biotech AB (Publ)
President & CEO
* For further information and to take part of the complete poster "A Phase I, Dose-Escalation Study to Evaluate the Tolerability of ABR-215757 in patients with Systemic Lupus Erythematosus (SLE)", please visit www.activebiotech.com .
About SLE and 57-57
SLE - Systemic Lupus Erythematosus (SLE) - is a disease that can cause inflammation and damage to the connective tissue in many different organs. The disease, which progresses in "flare-ups" interspersed by relatively symptom-free periods, primarily affects women of childbearing age. An estimated 500,000 Americans have been diagnosed with SLE; however, surveys indicate that the prevalence may be much higher. The autoimmune attack affects many different organ systems and may eventually lead to severe secondary symptoms, such as kidney failure. Progress and symptoms of the disease vary widely, depending on the organs affected. Without treatment, SLE can be life-threatening.
The 57-57 compound is an oral immunomodulatory quinoline compound for chronic treatment of SLE. A clinical Phase Ib trial for 57-57 has been concluded. The study proceeded to the highest permitted dose level in the study protocol to ensure that the documentation concerning the compound is as comprehensive as possible ahead of continued clinical development. The Phase Ib study was a dose-escalation, multi-center study in which the compound's safety was studied using step-wise increases in dose levels. The total treatment duration was 12 weeks and the study principally documented the candidate drug's safety and pharmacokinetic properties. In addition, various efficacy parameters were studied in the form of biomarkers for disease activity. It was performed at three hospitals in Sweden - the Karolinska University Hospital in Stockholm, Uppsala University Hospital and Lund University Hospital, in addition to a number of clinics in Russia.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase 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, primarily of renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex(TM) for RA. Please visit www.activebiotech.com for more information.
Active Biotech AB
PO Box 724, SE-220 07 Lund
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 11 00
Active Biotech is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08:30 am CET on June 11, 2009.