Biotest AG: Clinical and pre-clinical data emphasise the potential of
Biotest AG / Key word(s): Miscellaneous
Biotest AG: Clinical and pre-clinical data emphasise the potential of
06.12.2010 / 01:00
Clinical and pre-clinical data emphasise the potential of
BT-062 in multiple myeloma
Phase I clinical trial: BT-062 leads to clinical benefit in more than
50 % of patients with continued good tolerability
Pre-clinical data show the potential of BT-062 in combination therapy
with approved drugs
Presentation of the data at the 52nd annual conference of the American
Society of Hematology
Dreieich, 5 December 2010. Biotest presented clinical and pre-clinical data
derived from the development of the monoclonal antibody BT-062 in the
indication multiple myeloma on the occasion of the 52nd annual conference
of the American Society of Hematology (ASH) in Orlando.
The clinical data were obtained within a phase I trial (study no.: 969).
This study includes 32 patients with relapsed or relapsed refractory
multiple myeloma ; the recruitment phase has been concluded. In this study,
the patients are treated with BT-062 once every three weeks and the
treatment is stopped if there is progression of the underlying disease.
BT-062 continues to be well tolerated in the administered dose range and
schedule over several cycles. According to the data analysed so far, more
than 50 % of the treated severely ill patients benefited from the therapy.
A temporary regression of the disease was achieved in two patients and
stabilisation for up to 24 weeks in a further 11 patients. One other
patient is currently on ongoing treatment with BT-062 on account of the
sustained regression of the disease. Based on the encouraging efficacy
results a further phase I/IIa clinical trial was initiated in which BT-062.
In this trial, recruitment of patients has started.
Since combination therapies in particular are used in multiple myeloma,
Biotest has undertaken a corresponding pre-clinical trial. In it,
combinations of BT-062 and the approved drugs Revlimid(R) and Velcade(R)
were investigated in the mouse MOLP-8 xenograft model. The combination of
Revlimid(R) (100 mg/kg) and BT-062 (5.3 mg/kg - 21.2 mg/kg) led to a more
than additive (synergistic) delay in tumour growth. Similar results were
achieved with combined treatment with Velcade(R) (1 mg/kg) and BT-062 (5.3
mg/kg - 21.2 mg/kg). Biotest presented these results also as part of the
ASH annual conference.
These pre-clinical results and the safety profile data collected so far
make BT-062 a promising partner for combination with licensed treatments.
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 thus sparing
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
End of Corporate News
06.12.2010 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.medientreff.de and www.dgap.de
---------------------------------------------------------------------
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
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, Stuttgart
End of News DGAP News-Service
---------------------------------------------------------------------
105341 06.12.2010
