Biotest AG: Immunoconjugate BT-062 shows first data of clinical efficacy
Biotest AG / Miscellaneous
07.12.2009
Dissemination of a Corporate News, transmitted by
DGAP - a company of EquityStory AG.
The issuer / publisher is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Immunoconjugate BT-062 shows first data of clinical efficacy
* Presentation of preliminary data of a multicenter Phase I Study in
Multiple Myeloma at the 51st Annual Meeting of the American Society of
Hematology
* Further development in more intensive dosage programme
Dreieich, 7 December 2009. At the Annual Meeting of the American Society of
Hematology in New Orleans, Biotest presented preliminary data from a US
Phase I clinical trial with its immunoconjugate BT-062 in the lead
indication of Multiple myeloma (MM). This is an aggressive cancer of
certain blood cells, for which there is, so far, no permanent cure.,
Biotest is pursuing an innovative therapeutic strategy, which aims to
allow the tumour cells to be combated more effectively. Pre-clinical
investigations had already shown significant anti-MM activity by BT-062 in
vitro and in vivo 1.
Preliminary data from this Phase I clinical trial show an acceptable
toxicity profile for BT-062. The most frequently reported adverse events
relate to the underlying disease. Some adverse events have been observed
involving skin and mucosa at higher doses. Grade 4 toxicities were not
reported. The trial showed the first evidence for efficacy of BT-062: in
the case of two patients, a reduction of more than 50% in the M-protein
values in urine or reduced serum FLC values were observed. In the case of a
further seven patients, stable disease was monitored by early stabilisation
of the M-protein level in serum or urine over several cycles. For 53% of
patients, time to progression was more than six weeks and for one patient
even 30 weeks.
The prospective, open-label, dose-escalation multicenter trial is currently
being conducted in patients with relapsed or relapsed/refractory multiple
myeloma, where previous treatment with the group of IMiD(R) agents and/or
proteasome inhibitors has failed. The aim of the trial is to determine the
maximum tolerable dose, dose-limiting toxicities and the pharmacokinetics
as well as anti-MM activity . During a 21 day cycle, patients received
10mg/m2 to 200mg/m2 BT-062 on day 1. Treatment over additional cycles took
place until disease progression was observed. From a regulatory viewpoint,
this treatment programme is described as repeated single dose. The clinical
response was determined in accordance with internationally recognised and
standardised criteria² .
To date, 25 patients have been treated with one of seven different dosage
levels. The dose-limiting toxicities (DLT) were observed at 200mg/m². To
extend the safety and efficacy data, the recruitment of patients will be
continued at the current maximum tolerated dose level of 160mg/m².
On the basis of the encouraging results on the efficacy and the acceptable
tolerability observed to date, Biotest will pursue the development of
BT-062 with a trial involving a more intensive dosage programme.
BT-062 is an immunoconjugate, which is manufactured from a monoclonal
antibody and the highly effective cytotoxic agent DM4 using the Targeted
Antibody Payload (TAP) technology developed by ImmunoGen [Nasdaq: IMGN].
The antibody binds to the antigen CD138, which appears in particularly high
concentrations on the surface multiple myeloma and certain other cancer
cells. Only after it is absorbed into the target cell, DM4 is released,
which effectively destroys the rapidly growing cancer cells. This
combination of accuracy and great efficacy distinguishes BT-062 from the
treatments currently used as a matter of choice against multiple myeloma.
________________
1 Ikeda et al. The Monoclonal Antibody nBT062 Conjugated to Cytotoxic
Maytansinoids Has Selective Cytotoxicity Against CD138-Positive Multiple
Myeloma Cells In vitro and In vivo. Clin Cancer Res 2009;15(12):4028-4037.
2 Durie BGM et al. International uniform response criteria for multiple
myeloma. Leukemia (2006):1-7.
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 diagnostics and 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, while those of Medical Diagnostics are used, for
example, in blood transfusions and transplants. Biotest has more than 2,000
employees worldwide. The preference shares of Biotest AG are listed in the
SDAX on the Frankfurt stock exchange.
For further information please contact:
Biotest AG
Dr. Monika Buttkereit
Investor Relations
Investor_Relations@biotest.de
tel.: +49 6103 801 4406
Fax: +49 (0) 6103 801-347
07.12.2009 Financial News distributed by DGAP. 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
Indices: SDAX
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, Hamburg, Stuttgart
End of News DGAP News-Service
---------------------------------------------------------------------------
