Biotest AG: Clinical development of BT-062 in multiple myeloma expands into combination therapy
Biotest AG / Key word(s): Miscellaneous
12.12.2011 / 16:30
---------------------------------------------------------------------
Clinical development of BT-062 in multiple myeloma expands into combination
therapy
Efficacy and tolerability data from monotherapy studies 969 and 975
presented at 53rd annual conference of the American Society of
Hematology
Clinical benefit already seen in more than 50 % of patients receiving
repeat single-dose regimen
Good tolerability confirmed with multi-dose regimen at doses up to at
least 100 mg/m2
Application for phase I/IIa combination therapy study (no. 983) in
multiple myeloma will be submitted to FDA
Dreieich, 12 December 2011. Biotest AG is pursuing an innovative
therapeutic strategy using the antibody drug conjugate BT-062 to treat
multiple myeloma, an aggressive malignant hematologic disease.
New clinical data with BT-062 in the indication multiple myeloma were
featured in an oral presentation at the 53rd annual meeting of the American
Society of Hematology (ASH) in San Diego.
The clinical data were obtained from two ongoing studies assessing BT-062
as monotherapy: A phase I repeated single-dose trial (study no. 969) and a
phase I/IIa multiple-dose trial (study no. 975). In both trials, patients
suffering from multiple myeloma receive repeated treatments with BT-062
until progression of the underlying disease or occurrence of unacceptable
toxicities.
In study 969, 32 patients with relapsed or relapsed/refractory multiple
myeloma were treated with BT-062 administered once every three weeks.
Preliminary findings reveal that more than 50 % of the treated, heavily
pretreated patients benefited from the therapy. Among these is a patient
who achieved a sustained clinical benefit for more than one and a half
years and is still under treatment with BT-062. Data show that BT-062 is
well tolerated at doses of up to 160 mg/m², even when administered over a
long treatment period of currently 26 treatment cycles.
Based on these results study 975 is underway to treat about 50 patients
with relapsed or relapsed/refractory multiple myeloma in an intensified
dose schedule. BT-062 is given on days 1, 8 and 15 of 4-week cycle. At the
first 5 dose levels of up to 100 mg/m² per dose tested so far, BT-062 was
well tolerated and initial evidence of efficacy was observed. To date, no
dose limiting toxicities have been observed and escalation towards higher
doses is ongoing.
Based on the promising clinical results from these two monotherapy studies
and supported by the preclinical combination studies, Biotest will submit
its first clinical BT-062 combination study in multiple myeloma to the FDA.
The phase I/IIa study (study no. 983) will investigate BT-062 in
combination with lenalidomide and dexamethasone in relapsed or
relapsed/refractory patients.
Combination therapies are widely used in oncology to improve overall
response rates, in particular in multiple myeloma. Preclinical studies
using in vitro und in vivo model systems show a strong increase of efficacy
when combining BT-062 with widely used multiple myeloma drugs such as
lenalidomide and bortezomib, suggesting a synergistic effect of such
combinations in human.
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@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
---------------------------------------------------------------------
12.12.2011 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
Germany
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
---------------------------------------------------------------------
149434 12.12.2011
