DGAP-News: Biotest AG: Biotest AG starts combination therapy study with BT-062 in multiple myeloma
(firmenpresse) - DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: Biotest AG starts combination therapy study with BT-062 in
multiple myeloma
16.07.2012 / 10:00
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PRESS RELEASE
Biotest AG starts combination therapy study with BT-062 in multiple myeloma
- Antibody-drug conjugate BT-062 continues to show good tolerability in
monotherapy
- First patient treated in phase I/IIa combination therapy study (no.
983) in multiple myeloma
- Funding for further activities in solid tumours approved by excellence
cluster CI3 Rhine-Main 'Individualized ImmuneIntervention'
Dreieich, Germany, 16 July 2012. Biotest AG is pursuing an innovative
therapeutic strategy to treat multiple myeloma using the antibody-drug
conjugate (ADC) BT-062.
BT-062 is currently in clinical development for treating patients with
relapsed or relapsed/refractory multiple myeloma. Two clinical trials
investigating different dose schedules of BT-062 as monotherapy have shown
good tolerability and have provided evidence for anti-tumor activity.
Whereas treatment of 32 patients within the first monotherapy study 969 is
finished, Biotest continues to investigate BT-062 as monotherapy in study
975. In study 975 about 50 patients with relapsed or relapsed/refractory
multiple will be treated at a more frequent dose schedule, receiving
intravenous administration of BT-062 on days 1, 8, and 15 every 4 weeks.
The patient recruitment of the first seven dose levels has been completed.
So far BT-062 continued to be well tolerated. In addition, initial evidence
of efficacy was confirmed.
Combination therapies are widely used to treat multiple myeloma and other
cancers to improve overall response rates. Preclinical studies using in
vitro and in vivo animal models show a strong increase of efficacy when
BT-062 is combined with widely used multiple myeloma drugs such as
lenalidomide, suggesting an additive or even synergistic anti-tumor effect
of such combinations in patients.
Currently, Biotest expands the clinical development of BT-062 into
combination therapy. The phase I/IIa study (study no. 983) investigates
safety and efficacy of BT-062 when administered on days 1, 8, and 15 every
4 weeks in combination with lenalidomide and dexamethasone in patients with
relapsed or relapsed/refractory multiple myeloma.A few days ago the first
patient in study 983 started treatment.
Additionally, Biotest will receive funding to evaluate BT-062 in
preclinical solid tumor models by the center of excellence cluster CI3
Rhein-Main 'Individualized ImmuneIntervention'. 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.
Biotest will continue to focus its resources on the development of BT-062
in the lead indication multiple myeloma. For further clinical development
in solid tumor indications Biotest intends to collaborate with a strategic
partner.
About Multiple Myeloma:
Multiple myeloma is a malignant and aggressive bone marrow disease for
which no cure has been developed so far.
About BT-062:
BT-062 is an antibody-drug conjugate that consists of a monoclonal antibody
attached by an engineered linker to a highly potent cytotoxic maytansine
derivative (DM4) using the Targeted Antibody Payload (TAP) technology
developed by ImmunoGen, Inc, Boston. 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 antibody, thereby restoring its original
cytotoxic potency. This combination of 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 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
develops monoclonal antibodies, including in the indications of rheumatoid
arthritis and multiple myeloma. 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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16.07.2012 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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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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