DGAP-News: Biotest AG: Biotest decides to move into biggest Phase IIb trial in company history
(firmenpresse) - DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: Biotest decides to move into biggest Phase IIb trial in
company history
21.03.2013 / 09:00
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PRESS RELEASE
Biotest decides to move into biggest Phase IIb trial in company history
Dreieich, 21 March 2013. Biotest announced today that Biotest intends to
start an additional Phase IIb trial with up to 350 patients with
Tregalizumab (BT-061), a monoclonal antibody in development for the
treatment of Rheumatoid Arthritis. Tregalizumab, which activates regulatory
T-cells of the patient's immune system with its unique mechanism of action,
will be administered in combination with methotrexate for a treatment
period of six months. Patients showing a therapeutic response can be
treated for an extended period (so called 'Extension Phase'). The drug is
manufactured at Biotest's own facility in Boca Raton, Florida. The patients
will receive multiple subcutaneous administrations. The study will be
conducted in multiple clinical centers in different regions of the world
including the USA, Canada and Europe.
The decision for Biotest's biggest Phase IIb trial ever, is based on first
results of an interim analysis of the currently ongoing clinical trial
(study 979) in which patients are being treated over twelve weeks with the
antibody in combination with methotrexate.
The company can only disclose the data of the interim analysis once all
data will be unblinded. Otherwise a risk that doctors and patients involved
in the ongoing part of the study might be biased - can not be excluded.
The new study will be called TREAT 2b (T cell REgulating Arthritis Trial
2b). The submission of this study to the regulatory bodies is planned for
spring 2013.
Prof. Dr. Gregor Schulz, CEO of Biotest AG, calls the decision to proceed
with this new clinical trial an important milestone in the development of
Treglizumab and emphasizes the importance of the project for the company.
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 provider of pharmaceutical and biotherapeutic drugs. With a
value added chain that extends from pre-clinical and clinical development
to worldwide sales, Biotest has specialised primarily in the areas of
application of clinical immunology, haematology and intensive medicine. In
its Plasma Protein portfolio 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. Biotest also
researches into the development of monoclonal antibodies, including in the
indications of rheumatoid arthritis and cancer of plasma cells. Biotest has
more than 1.600 employees worldwide. The preference shares of Biotest AG
are listed in the SDAX on the Frankfurt stock exchange.
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations(at)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
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover,
München, Stuttgart
End of Corporate News
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21.03.2013 Dissemination of a Corporate News, transmitted by DGAP - a
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Language: English
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(at)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
End of News DGAP News-Service
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204639 21.03.2013
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