Biotest AG: Monoclonal antibody BT-061 shows efficacy in patients with rheumatoid arthritis
Biotest AG / Miscellaneous
20.10.2009
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Monoclonal antibody BT-061 shows efficacy in patients with rheumatoid
arthritis
* Unblinded data from analysis of 40 patients in a clinical Phase II
trial indicates efficacy and good tolerability
* Positive response rates at week 9 (after 8-week treatment) in patients
receiving treatment with BT-061 in combination with methotrexate (MTX)
Dreieich, 20th October 2009. In the unblinded first part of a Phase II
combination trial with methotrexate, the Biotest Group's BT-061 monoclonal
antibody provided positive results in the indication of rheumatoid
arthritis (RA). As part of this clinical trial, so far the data of 40
patients with acute, moderate to severe RA, with inadequate response to one
or more disease-modifying antirheumatic drugs (DMARDs) have been analysed.
Patients included in the clinical trial were randomly assigned to three
different treatment groups in a ratio of 1:3:1. For a period of 8 weeks, 8
patients received by weekly intravenous application 0.5mg of BT-061 and 24
patients 2.0mg of BT-061, both groups in combination with methotrexate, a
substance commonly used in the treatment of RA. The 8 patients in the
placebo group only received methotrexate. The response rate of patients at
week 9 (after 8 weeks of treatment) was evaluated on the basis of the ACR
score, the internationally accepted standard rating system developed by the
American College of Rheumatology.
In the group receiving 2mg of BT-061, the efficacy at week 9 was higher
than in the 0.5mg group and the placebo arm. In 75% of patients of the 2mg
group symptoms improved by 20% (ACR 20 response), compared with 50% of
patients in the placebo group. A reduction in symptoms of at least 50% was
achieved in 41.7% of patients receiving the combination therapy (ACR 50:
41,7%) and 16.7% of patients showed an improvement of symptoms of a minimum
of 70% (ACR 70: 16.7%). For treatment with methotrexate alone (placebo
group), the relevant values were 25% and 0% respectively. The relatively
high response rate of the placebo drug is most probably caused by the
simultaneous administration of methotrexate, known to be effective in the
treatment of RA.
According to the clinical trial protocol, additional patient data will now
be unblinded and analysed within the next weeks. Additional 40 patients
will then be included in part 2 of this clinical trial and treated
subcutaneously with 50mg of BT-061 in combination with methotrexate. The
subcutaneous application of biotherapeutics enables patients to
self-medicate at home after marketing authorisation.
Furthermore, the results demonstrated the good overall tolerability of
BT-061. No serious side effects caused by the drug were observed. There was
no need to discontinue infusion of BT-061 in any patient due to undesirable
effects. The comprehensive data from parts 1 and 2 as well as the detailed
analysis of the clinical trial, which in addition to the efficacy data also
comprises data on pharmacokinetics, pharmacodynamics and a profile of
possible side effects, will be presented to experts in the context of
international conferences following completion of the second part of the
trial.
ACR response rates/scores
The ACR score is based on a scoring system developed by the American
College of Rheumatology (ACR) to evaluate the response of patients to
antirheumatic therapies. This standard validation method measures the
percentage improvement of a series of symptoms and parameters that are
specific to the disease to determine the medical condition of patients. An
ACR of 20, for example, reflects a 20% decrease in symptoms. A reduction of
50% or 70% in RA symptoms is described with ACR 50 and ACR 70 respectively.
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.
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/Official traded
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart
20.10.2009 financial News transmitted by DGAP
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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 Berlin, Düsseldorf, Hamburg, Stuttgart
End of News DGAP News-Service
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