Biotest AG: Further interim analyses confirm good clinical efficacy of the BT-061 monoclonal antibody.
Biotest AG / Miscellaneous/Miscellaneous
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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).
Disclaimer
This document contains forward-looking statements on overall economic
development as well as on the business, earnings, financial and assets
position 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
significant 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 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, Düsseldorf, Hamburg, Stuttgart
07.07.2009 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: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, Hamburg, Stuttgart
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