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Biotest AG: Biotest: Promising start of clinical trial with BT062

Biotest AG / Research Update

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Biotest: Promising start of clinical trial with BT062

- Monoclonal antibody was generally well tolerated at the first dose level
- Clinical study in indication multiple myeloma can proceed as planned
- High medical need

Dreieich, September 22nd, 2008. Treatment of first patients with BT-062
commenced in the US. The drug – which is developed in the indication of
multiple myeloma - was generally well tolerated at the administered dose in
severely ill patients. Further therapy of these patients with the antibody
as well as recruitment of additional patients is proceeding as planned.

The multi-centre Phase I clinical trial has been initiated in the US, with
patients to be enrolled at four clinical centres. In April 2008, Biotest
was notified by the US Food and Drug Administration (FDA) that, based on
Biotest’s Investigational New Drug (IND) application for BT-062, clinical
testing can commence with the compound for the treatment of multiple
myeloma. This open label, dose escalation, repeated single dose Phase I
study in patients with relapsed or relapsed/refractory multiple myeloma is
designed to establish safety parameters (the dose limiting toxicities and
maximum tolerated dose) of BT-062 as a primary objective. Further
objectives of the study are to define the pharmacokinetic properties of
BT-062 in humans, to determine potential toxicities and to generate initial
information on the activity of the compound in the described patient
population. The outcome of this study will be the basis for the further
BT-062 clinical development strategy.

Multiple myeloma, an aggressive malignant disease of the bone marrow, still
lacks a curative therapy. BT-062, in development at Biotest, is an
immunoconjugate consisting of a monoclonal antibody and a highly potent
cell-killing agent called DM4, developed by ImmunoGen, Inc. The antibody
enables BT-062 to selectively bind to a protein found in high density on
the surface of the cancer cells, while the cytotoxic agent, DM4, kills the
rapidly dividing cancer cells. This design differs significantly from the
untargeted chemotherapy treatment regimens commonly employed today and is
expected to result in a significantly improved safety profile. Multiple
myeloma is the second most prevalent haematologic malignancy.

Biotest licensed exclusive worldwide rights to use ImmunoGen’s proprietary
(patent protected) maytansinoid Tumor-Activated Prodrug (TAP) technology
for the target of BT-062. Biotest has filed additional patent applications
to further enhance its own patent position.

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
22.09.2008  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
 
End of News                                     DGAP News-Service
 
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