Home News DGAP-News: Biotest AG: monoclonal antibody BT-061 shows efficacy in psoriasis

DGAP-News: Biotest AG: monoclonal antibody BT-061 shows efficacy in psoriasis


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Monoclonal antibody BT-061 shows efficacy in Psoriasis
ð § Final analysis of data from Phase I / IIa show
prolonged therapeutic effect after a single Administration in
relevant dose range
ð § Extensive studies confirm good Safety profile
ð § First Patient in New Phase II trial of Multiple integrated
Dreieich, 17 March 2009. Biotest has an important Milestone in the development of monoclonal antibody BT-061 achieved. From a clinical phase I / IIa is now analyzing the final unblinded data. In the context of this placebo-controlled Dose-escalation study was Einfachgabe the antibody in the Treatment of chronic plaque psoriasis in moderate to severe form of testing. The focus of the study were to determine the pharmacokinetic Properties of the antibody, and the study of safety and Effectiveness.
The study enrolled 55 patients were involved, of which 75% BT-061 and 25% were given a placebo, respectively, the application was made intravenously (iv) or subcutaneously (sc). The drug has been in seven different Doses between 0.5 mg and 25 mg (per dose group, seven tested respectively), eight patients.
The highest clinical efficacy, calculated on the basis of PASI * score was determined by subcutaneous administration. For 60% of Patients who had received BT-061 at doses of 25 mg, was 75 days after improvement of administration by at least 50% (PASI 50) at . Watch In the placebo group was at 25% of the participants such To monitor improvement. During the same period and at the same dosage joined 20% of the drug-treated patients had improvement at least 75% (PASI 75) at, in the placebo group had no patients experienced an to observe such an improvement.
The clinical effect persisted in individual patients up to 90 days. Biotest will detail the results obtained in the framework of international Congresses present.
‘We are very pleased that the final analysis of The study collected data such a promising improvement in PASI score shows, "said Dr. Frank Osterroth, Head of Segment Biotherapeutics for bio-assay data. ‘The conclusion of this study, a Phase I / IIa for the further development of BT-061 in the Treatment of Psoriasis is of great importance. "
The study was through extensive security tests accompanied by the DSMB (Data Safety Monitoring Board) and by bioassay in Consultation with the Paul-Ehrlich-Institut has been made. Since this no evidence of risk occurred, it was possible, the dosage in the course of the study to the highest level of planned . increase In order to ensure maximum security for the Ensure patients, the study was subject to strict import and Exclusion criteria. For this reason, 950 patients were examined in order 55 patients were finally included in the study. ‘This high security requirements were essential to the long Study, ‘says Dr. Osterroth.
Based on the encouraging data is applied in a single Biotest initiated a new clinical phase II trial, the BT-061 each Patients will be administered several times. Participants will receive eight consecutive weeks, each one injection per week. This study is placebo-controlled, the active ingredient is available in six different Doses tested. The aim of the study is to further insights into the safety and tolerability profile of BT-061 at multiple doses to preserved. Moreover, the effective dose is the preferred subcutaneous administration are determined.
Additional information
BT-061 BT-061 enhances a natural function of Body at suppressing excessive immune responses will. It is therefore developed to treat diseases on an overreaction of the immune system decline. Current run in the Leitindikationen rheumatoid arthritis and chronic Plaque psoriasis, three clinical studies. Based on previously This data was both a promising indications Efficacy and a generally good safety and tolerability are shown.
Psoriasis: Chronic plaque psoriasis affects approximately 1 to 3% population in Europe and North America and is a hornbildenden excessive growth of cells (keratinocytes) back the most common) in the epidermis (outer skin cell type. Clinical Symptoms include red, scaly and itchy skin. The Disease is often associated with other long-term complications such as Psoriatic arthritis, heart disease or diabetes associated.
* Is the PASI score (PASI = psoriasis area and severity) index is a internationally accepted procedures, the severity of psoriatic disease . determine He describes the average redness, thickness and Spalling of the affected skin (in the forms 0 to 4) weighted by their size.
This document contains forward-looking statements to overall economic development and the business, earnings, financial and Asset situation of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and thus subject to risks and Uncertainties that may cause the actual deviates significantly from the expected patterns. The forward – Statements are only at the time of publication Validity. Biotest does not intend to update the forward-looking statements update and assumes no obligation.
About Biotest
Biotest is a provider of pharmaceutical and biotherapeutic medicines as well as reagents and systems for the microbiological monitoring. With a value chain, from the preclinical and clinical development to global commercialization enough Biotest has been a priority in immunology and Hematology experts. Developed in the segment plasma proteins and Biotest immunoglobulins, clotting factors and albumins based on Human blood plasma are produced and in diseases of the immune system or haematopoietic system are used. In Biotherapeutics segment, Biotest driving the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and Blood cancer. The products of the segment Microbiological Monitoring are primarily used for hygiene monitoring. Biotest employs more than 1,900 employees. The preference shares of Biotest AG are listed on the SDAX of the German Stock Exchange.
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de Dr. Monika Buttkereit, Telephone: +49 (0) 6103 801-4406, E-mail: investor_relations@biotest.de Fax: +49 (0) 6103 801-347
WKN, ISIN ordinary share: 522720, DE0005227201 WKN, ISIN preference share: 522723, DE0005227235 Listed: Prime Standard / official trading Frankfurt, Berlin, Dusseldorf, Hamburg, Stuttgart
17.03.2010 11:59 Ad-hoc news, financial news and Press releases transmitted by DGAP. Media archive at http://www.dgap-medientreff.de and http://www.dgap.de
Language: German Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Germany Phone: 0 61 03 – 8 01-0 Fax: 0 61 03 – 8 01-150 E-mail: investor_relations@biotest.de Internet: http://www.biotest.de ISIN: DE0005227235, DE0005227201 WKN: 522723, 522,720 Indices: SDAX Listed: Regulated Market in Frankfurt (Prime Standard); OTC
in Berlin, Dusseldorf, Hamburg, Stuttgart
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