Biotest AG: Development of BT-062 makes further progress with start of a new clinical trial
Biotest AG / Miscellaneous
11.08.2010 10:00
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Biotest: Development of BT-062 makes further progress with start
of a new clinical trial
- Phase I clinical study completes patient recruitment
- Encouraging results concerning efficacy and tolerability
- Phase I/IIa clinical trial in multiple myeloma has started
Dreieich, Germany, 11. August 2010. Biotest AG is pursuing an innovative
therapeutic strategy to treat multiple myeloma using the monoclonal
antibody BT-062. The current prospective, open label, dose-escalation phase
I trial includes a total of 32 patients with relapsed or
relapsed/refractory multiple myeloma who have failed several previous
treatments. The patient recruitment for this study has now been completed.
The patients are treated with BT-062 once every three weeks (repeated
single dose). Treatment is only discontinued if the underlying disease
progresses.
In the present phase I trial, BT-062 shows good tolerability across several
cycles with seriously ill patients in the different dose ranges and dosage
schedule addressed.
Results so far show that the progression of the disease can be delayed by
BT-062 with lasting effect in seriously ill myeloma patients. In 13 out of
30 patients (43%) the disease was stabilised for up to 30 weeks, two
patients demonstrated a partial clinical response with reduction of the
tumor load. These data are very encouraging because the patients had up to
15 pretreatments with currently available drugs. Further two patients are
still undergoing treatment. Biotest will be presenting details of the
clinical trial at international conferences.
Based on the encouraging efficacy results and the good tolerability
observed in the phase I trial, a further phase I/IIa clinical trial was
initiated in which BT-062 is now, as planned, being tested using a more
intensive dosage schedule. In this trial, recruitment of patients has
started.
For the phase I/IIa trial approved by the US Food and Drug Administration
(FDA) patients are undergoing treatment with BT-062 at several clinical
centres in the United States. In this dose escalation trial patients are
treated with repeated infusions of BT-062 in shorter intervals. Therefore,
an optimisation of efficacy and tolerability is expected. In this trial
patients with relapsed or refractory multiple myeloma for whom previous
treatments, including the group of IMiD(R) agents and proteasome
inhibitors, have been ineffective are treated with BT062. The results will
be used as a basis to plan the trials that are relevant for approval.
Multiple myeloma is a malignant and aggressive bone marrow disease for
which no cure has been developed so far. BT-062 is an immunoconjugate
consisting of a monoclonal antibody and the highly effective cytotoxic
agent maytansinoid (DM4) using the Targeted Antibody Payload (TAP)
technology developed by ImmunoGen. The antibody binds specifically to the
antigen CD138, which is overexpressed on malignant plasma cells. 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 potency and specificity, while
exhibiting low systemic toxicity and damage to healthy tissue sets BT-062
apart from the other therapies that are mainly used at present 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 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
11.08.2010 Ad hoc announcement, Financial News and Press Release distributed by DGAP.
Media archive at www.medientreff.de and www.dgap.de
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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 News DGAP News-Service
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