Biotest AG: Biotest: monoclonal antibody BT-061 shows clear indications of efficacy in the treatment of Psoriasis
Biotest AG / Research Update
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Biotest: monoclonal antibody BT-061 shows clear indications of efficacy in
the treatment of Psoriasis
- First analysis of clinical Phase I/IIa trial
- Clear improvement of symptoms already at low dosages
- Development in Rheumatoid Arthritis according to plan
Dreieich, 08 September 2008. Biotest has achieved another major milestone
in its biotherapeutic research and development projects. During the
clinical development the monoclonal antibody BT-061 has shown efficacy
within the current Phase I/IIa trial in the treatment of Psoriasis. A clear
improvement of the clinical symptoms could be observed.
In the current placebo-controlled study, patients suffering from Chronic
Plaque Psoriasis are treated with a single dose of BT-061. In addition to
testing for tolerability and pharmacokinetic properties, BT-061 is also
analysed for its efficacy as a monotherapy. Even at lowest dosages, the
blinded analysis conducted after a single application showed a significant
improvement of the symptoms in over half of the patients for up to eight
weeks. The groups also include 25% of patients given a placebo control.
Therefore Biotest anticipates that the actual response rate will be even
higher. In general, the antibody was well tolerated, the positive
assessments of the safety profile from a trial with healthy volunteers have
been confirmed. In the current trial dosages will be gradually increased.
Parallel to the study in Psoriasis, a clinical Phase II trial is also
carried out for the indication Rheumatoid Arthritis. In a pilot study,
BT-061 has already proven its potential as a safe and highly effective
therapeutic agent when administered intravenously to these patients.
Biotest intends to develop BT-061 for Rheumatoid Arthritis as a
subcutaneous application form. After regulatory approval, patients will be
able to self-administer the drug, making daily use much easier. Rheumatoid
Arthritis is a chronic disease and requires continuous treatment.
However, compared to intravenous application, subcutaneous administration
necessitates higher dosages to achieve the same degree of efficacy of
BT-061. Also in this clinical trial, the antibody dosages will be gradually
increased and repeatedly injected several times over an extended period of
time. An interim analysis will be carried out at a later point of time,
when relevant treatment dosages have been reached.
The monoclonal antibody BT-061 represents a completely new approach for the
treatment of autoimmune diseases. In these diseases the immune system
attacks healthy cells. BT-061 activates so called regulatory T cells,
thereby modulating the immune system, which leads to inhibition of a
harmful overreaction. While current drugs used in the treatment of
autoimmune diseases generally suppress the common immune system, BT-061
acts by immune modulation.
Disclaimer
This document contains forward-looking statements on overall economic
development as well as on 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 are
thus subject to risks and elements of uncertainty that could result in
deviation of actual developments from expected developments. The
forward-looking statements are only valid at the time of publication.
Biotest does not intend to update the forward-looking statements and
assumes no obligation to do so.
About Biotest
Biotest AG, Dreieich, Germany, is a company that researches and
manufactures pharmaceutical, biotherapeutic and diagnostic products and has
specialised in immunology and haematology. In its Pharmaceutical segment,
Biotest develops immunoglobulins, clotting factors and albumins based on
human blood plasma. These are used for diseases of the immune system or
haematopoietic system. In the Biotherapeutic segment, Biotest researches
into the clinical development of monoclonal antibodies, including in the
indications of rheumatoid arthritis and blood cancer. The Diagnostic
segment spans reagents and immunological diagnostics which are used, for
example, in blood transfusions and transplants. Biotest has around 1,850
employees worldwide and its shares are listed in the Stock Exchange's SDAX.
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Michael Ramroth
Tel: +49 (0) 6103 801-520
Fax: +49 (0) 6103 801-347
e-mail: michael_ramroth@biotest.de
WKN, ISIN ordinary share: 522720, DE0005227201
WKN, ISIN preference share: 522723, DE0005227235
Listed: Prime Standard/official trading
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart
08.09.2008 Financial News transmitted by DGAP
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Language: English
Issuer: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Deutschland
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: DE0005227201, DE0005227235
WKN: 522720, 522723
Indices: SDAX
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, Hamburg, Stuttgart
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