Active Biotech Presents New Data regarding the 57-57 SLE Project at American College of Rheumatology MeetingOctober 28, 2008 12:43 (CET)
In a completed Phase Ib trial twelve patients have been treated for 84 days at various dose levels of ABR-215757. The maximum tolerable dose (MTD) for ABR-215757 was defined as 4.5 mg/day. The overall safety profile throughout the study was very favorable.
In a subset of patients treated with 4.5 mg/day ABR-215757 the global gene expression pattern was investigated at various time points after treatment. The new data presented indicate that treatment with ABR-215757 modulates gene expression related to immune function. Among these genes were a set of interferon (IFN) responsive genes, the expression of which are often altered in SLE patients and may contribute to the disease development. The results also suggest a number of candidate genes that could be used to follow effects of ABR-215757 in the further clinical development using RNA expression analysis.
"These results confirm previous data and strengthens the role for ABR-215757 as a future treatment of SLE", commented Tomas Leanderson, President & CEO Active Biotech.
Lund, October 28, 2008
Active Biotech AB (Publ)
President & CEO
* For further information and to take part of the complete poster "Effect on Interferon-inducible Gene Expression Signature by ABR-215757, a New Drug in Development for 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 a novel oral immunomodulatory quinoline compound for chronic treatment of SLE. A clinical Phase Ib trial for 57-57 has been concluded and the data are currently being compiled. 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.
A Phase II/III trial is planned to start mid 2009.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC: ACTI), headquartered in Sweden, is a biotechnology company with R&D 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 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. Please visit www.activebiotech.com for more information.
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 a.m. CET on October 28, 2008.
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 11 00