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Biotest AG: Biotest: Pre-clinical studies demonstrate high efficacy of BT-062 in solid tumours

Biotest AG  / Key word(s): Miscellaneous

17.11.2010 14:00
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Biotest: Pre-clinical studies demonstrate high efficacy of BT-062 in solid
tumours

 Immunoconjugate induces complete remission of human solid tumours in
  mouse models
 High anti-tumour activity against aggressive human breast, pancreas,
  bladder and lung carcinoma
 Data show efficacy in indications with a particularly great medical need

Dreieich, Germany, 17 November 2010. Today Biotest presented pre-clinical
data to a specialist public, showing the efficacy of the immunoconjugate,
BT-062, against solid tumours. These data indicate that the immunoconjugate
might have great potential in the treatment of certain tumours for which
there is currently no adequate treatment option. The results, obtained in a
mouse model, were presented at the 22nd EORTC-NCI-AACR Symposium on
'Molecular Targets and Cancer Therapeutics' in Berlin, Germany.

BT-062 is currently in clinical development in its lead indication multiple
myeloma and a phase I/II clinical trial is underway. A preceding evaluation
of a phase I clinical trial provided initial evidence of clinical efficacy
and good tolerability up to a dose of
160 mg/m2 at three-week intervals. 

In addition to multiple myeloma tumours, many solid tumors over-express the
target antigen of BT-062 (CD138) Biotest therefore initiated pre-clinical
trials to investigate the potential of BT-062 to treat solid tumours.
Within this context, mice previously implanted with tumour material were
treated with BT-062. For the trial, Biotest used primary tumours of human
origin to obtain the most relevant data on the anti-tumour activity of
BT-062. The investigations were undertaken with implanted breast, pancreas,
bladder, and lung carcinoma material.

The mice were treated once weekly at two different doses (4 mg/kg and 24
mg/kg). BT-062 caused complete elimination of the tumours in all animals,
with no recurrence of the tumours throughout the follow up periods, which
ranged between 14 and 39 days depending on the study. In all four
indications, the tumour stopped growing or began to shrink after the first
injection of BT-062.

'These promising pre-clinical results indicate, that BT-062 might also have
great potential as a therapy for certain solid tumours', Dr. Frank
Osterroth, Head of the Biotherapeutics business unit at Biotest, commented.
'Especially encouraging is the fact that the complete remissions were
achieved at equivalent dosages that were below the maximum tolerated dose
established in clinical testing.' The tumours used in these studies
represented highly aggressive tumours, in particular pancreatic carcinoma.
Tumours of human origin with only limited treatment options were used in
these studies. Moreover, the breast cancer studies employed a triple
negative phenotype. These tumours do not respond to treatment with other
monoclonal antibodies which are currently available clinically,
representing an indication with a high unmet medical need.

Further investigations are ongoing to identify the most appropriate solid
tumour indications for possible clinical evaluation.

About BT-062:
BT-062 is an immunoconjugate consisting of a monoclonal antibody and a
highly effective cytotoxic maytansinoid derivative (DM4) using the Targeted
Antibody Payload (TAP) technology developed by ImmunoGen, Inc. The antibody
binds specifically to the antigen CD138, which is over-expressed on
multiple myeloma cells and a variety of solid tumours.

Once the immunoconjugate is internalized into the target cell, DM4 is
released from the targeting molecule, thereby restoring the original
killing potency of the drug. This combination of high efficacy and
specificity, while exhibiting low systemic toxicity and damage to healthy
tissue, sets BT-062 apart from most of the other therapies that are used at
present to treat cancer.


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 as well as
reagents and systems for microbiology. 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 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. Biotest has more than 1,900 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/regulated market
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart 


17.11.2010 Dissemination of a Corporate News, transmitted by DGAP - 
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Language:     English
Company:      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 Hamburg, Berlin, Düsseldorf, Stuttgart
 
End of Announcement                             DGAP News-Service
 
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