Presse Release: Further interim analyses confirm good clinical efficacy of the BT-061 monoclonal antibody.
- Marked improvement in symptoms even after short period of treatment - Over 240 individuals treated with BT-061
Dreieich, 7 July 2009. After the ongoing clinical development in the indication of psoriasis has provided evidence of the efficacy of the BT-061 monoclonal antibody, this has now also been confirmed for the indication of rheumatoid arthritis. In the current placebo-controlled trial, patients with rheumatoid arthritis are treated with BT-061 over a period of 6 weeks. In addition to examining the tolerability of the preparation and determining various clinical parameters, the trial also investigates the effectiveness of BT-061 monotherapy.
During the clinical trial, progressively higher dosages of the antibody are tested. An interim analysis has shown a marked improvement in the symptoms of the disease following subcutaneous administration of the relevant dosage ranges for a comparatively short six-week period of treatment. These observations were made in more than 50% of patients on the basis of the American College of Rheumatology (ACR) criteria, with an improvement of up to 70%. Biotest also has initial data from a clinical trial in which BT-061 is combined with methotrexate. The trial has substantiated the efficacy of this combined treatment approach. Methotrexate plays a significant role in the basic treatment for patients with rheumatoid arthritis. In addition to its good efficacy, tolerability of the antibody has also been good in general.
The positive assessment of the safety profile based on the clinical trial in the indication of psoriasis and in healthy volunteers has been confirmed. In the meantime, over 240 individuals have been treated with BT-061. The BT-061 monoclonal antibody represents an innovative approach to treating diseases such as rheumatoid arthritis and psoriasis. These autoimmune diseases cause the body's immune system to attack healthy cells. BT-061 activates a specific sub-group of immune cells, the so called regulatory T cells. As a result, the immune system is modulated so as to inhibit the harmful overreaction and therefore prevent the malfunction which would trigger the disease. Preparations currently used to treat autoimmune diseases often also suppress normal immune responses, whereas BT-061 acts on the basis of a mechanism which restores the original balance of the immune system (immunomodulation).
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About Biotest
Biotest is a company that researches and manufactures pharmaceutical, biotherapeutic and diagnostic products and has specialised in the areas of application of immunology and haematology. In its Plasma Protein segment, Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. The products of the Microbiological Monitoring segment are primarily used in hygiene monitoring, while those of Medical Diagnostics are used, for example, in blood transfusions and transplants. Biotest has around 2,000 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de Dr. Monika Buttkereit tel.: +49 (0) 6103 801-4406, e-mail: investor_relations@biotest.de fax: +49 (0) 6103 801-347
Securities' ID No., ISIN ordinary shares: 522720, DE0005227201 Securities' ID No., ISIN preference shares: 522723, DE0005227235 Listing: Prime Standard/Official traded Frankfurt, Berlin, D?sseldorf, Hamburg, Stuttgart
Biotest AG
Dr. Monika Buttkereit Head of Investor Relations
Biotest AG Landsteinerstr. 3-5 D- 63303 Dreieich Tel.: +49 (0) 6103 - 801 4406 Fax: +49 (0) 6103 - 801 347 email: investor_relations@biotest.de
