DGAP-News: Biotest AG: BT-062 demonstrates rapid and complete tumor eradication in preclinical studies
(firmenpresse) - DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: BT-062 demonstrates rapid and complete tumor eradication
in preclinical studies
22.03.2012 / 10:00
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PRESS RELEASE
BT-062 demonstrates rapid and complete tumor eradication in preclinical
studies
- Pronounced anti-tumor activity against aggressive solid tumors, e.g.
human breast, pancreas, bladder and lung cancers in preclinical studies
- Data show efficacy in indications with a particularly high medical need
- Project proposal selected for application to center of excellence
cluster CI3, an innovation initiative of the German Federal Ministry of
Education and Research
Dreieich, Germany, 22 March 2012. Today Biotest announced pre-clinical data
showing the efficacy of the immunoconjugate BT-062 against several types of
solid tumors. These data indicate that the immunoconjugate might have a
significant potential in the treatment of certain solid tumor types for
which there is currently no adequate treatment option.
BT-062 is in clinical development in its lead indication multiple myeloma
and two monotherapy clinical trials are ongoing. A third clinical trial
investigating BT-062 for this cancer as part of a combination regimen was
submitted to the FDA (Food and Drug Administration) in December 2011. In
initial clinical testing, BT-062 has been found to provide evidence of
clinical efficacy and good tolerability at doses up to 160 mg/m2 at
three-week intervals and 120 mg/m2 given at days 1, 8 and 15 of a 4-week
cycle.
In addition to multiple myeloma, many solid tumors over-express CD138, the
target antigen (target on the tumor, to which BT-062 binds) of BT-062.
Biotest therefore initiated pre-clinical studies to investigate the
potential of BT-062 to treat such solid tumors. Within this context, mice
implanted with patient derived tumors were treated with BT-062. For the
study , Biotest used primary tumors of human origin to obtain the most
relevant data on the anti-tumor activity of BT-062. The investigations were
performed using human breast, pancreas, bladder, and lung carcinoma
material.
The mice received BT-062 once weekly at alternative study doses (between 2
mg/kg to 13 mg/kg). BT-062 caused complete elimination of the tumors in all
animals, with no recurrence of the tumors throughout the follow up periods.
Especially striking results were obtained for triple negative breast
cancer. These tumors do not respond to treatment with estrogen-,
progesterone-, or HER2 (Herceptin2)-targeted therapies thus leaving few
treatment options. In triple negative breast cancer models, BT-062
completely eradicated the tumor burden in all animals at doses starting
well below of the maximum tolerated dose established in the multiple
myeloma clinical trials. These results suggest effective treatment of such
tumors can be achieved at doses that can be used in patients . Similar
responses in comparable tumor model are rarely observed with other
compounds, highlighting the potential of BT-062 for the treatment of
malignancies with a high medical need.
'These are very exciting pre-clinical results which have not been
demonstrated up to now with other compounds in our well characterized
mammary cancer model MAXF 1322', said Prof. Heinz-Herbert Fiebig, an
oncology expert from the university of Freiburgand CEO of Oncotest. These
tumor models provided by Oncotest GmbH can be highly predictive for the
clinical effect of the tested compound. Additionally Biotest submitted a
project application for BT-062 to the center of excellence cluster CI3
Rhine-Main 'Individualized ImmuneIntervention' and passed the scientific
review board successfully. CI3 is a cluster initiative of more than 100
partners of universities, biotechnology start-ups and pharmaceutical
industry, which is supported by the German Federal Ministry of Education
and Research. The focus of this initiative is a strengthening of
innovations in Germany by building bridges between science and business in
order to bring new technologies to the market. The CI3 cluster received
amongst more than EUR 80 million of BMBF (German Federal Ministry of
Education and Research) funding.
Biotest will continue to focus its resources on the development of BT-062
in the lead indication multiple myeloma. For the clinical development in
solid tumor indications Biotest intends to collaborate with a strategic
partner.
About BT-062:
BT-062 is an antibody drug conjugate consisting of a monoclonal antibody
and a highly potent cytotoxic maytansine 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 tumors.
Once the conjugate is internalized into the target cell, the DM4 is
released from the targeting molecule, thereby restoring its original
cytotoxic potency. This combination of high efficacy and specificity with
low systemic toxicity sets BT-062 apart from most therapies currently used
to treat multiple myeloma.
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 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. 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, D-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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22.03.2012 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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