01.11.2016
Biotest AG DE0005227235
DGAP-News: Biotest AG: Interim analysis supports continuation of clinical phase IIa trial in Systemic Lupus Erythematosus (Study No. 990)
DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: Interim analysis supports continuation of clinical phase IIa
trial in Systemic Lupus Erythematosus (Study No. 990)
01.11.2016 / 07:00
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
Interim analysis supports continuation of clinical phase IIa trial in
Systemic Lupus Erythematosus (Study No. 990)
- Independent Data Safety Monitoring Board (DSMB) recommends to start
part 2 of clinical study No. 990
- DSMB did not identify any safety concerns
- SLE is an indication with remaining high medical need
Dreieich, 1 November 2016. Biotest AG announced today that the Data Safety
Monitoring Board (DSMB) has recommended to continue as planned with part 2
of Biotest's phase IIa clinical study of BT-063 for the treatment of
systemic lupus erythematosus (SLE). This recommendation is based on an
interim analysis after part 1 of study 990.
The clinical Study No. 990 is a double-blinded, placebo-controlled,
multicenter trial. The primary goal of this clinical study is to
investigate the safety and tolerability of the monoclonal antibody BT-063
in SLE patients versus placebo. As per protocol the study has 2 parts where
an interim analysis was planned after finalisation of part 1 to decide on
the continuation and the preferred dosage for part 2.
The DSMB did not identify any safety concerns in part 1 and therefore has
recommended to continue with part 2 of this clinical study as planned in
the study protocol. In order to keep the study blinded, the clinical study
team, the clinical trial sites and the patients will have no access to
results of the interim analysis until part 2 of the trial has been
completed.
SLE is an autoimmune disease which may affect various organs. Chronic
inflammation may occur resulting in potentially severe organ damage.
Approximately 5 million people worldwide suffer from this autoimmune
disease. Despite the use of current standard of care about 60% of SLE-
patients continue to experience persistent symptoms. Up to date patients
with SLE have only seen one new treatment for their disease in almost 60
years.
'With BT-063 Biotest pursues a completely new therapeutic approach to treat
SLE patients. I am very impressed by the large range of mechanistic and
pharmacological investigations conducted in parallel to the clinical study
No. 990' says Prof. Dr. Ronald van Vollenhoven, Director of the Amsterdam
Rheumatology and Immunology Center (ARC).
Biotest is currently preparing to continue with part 2 of study No. 990.
About BT-063
The humanized monoclonal antibody BT-063 specifically neutralizes
interleukin 10 (IL-10), which plays a crucial role in the development of
Systemic Lupus Erythematosus. With BT-063 Biotest pursues a completely new
therapeutic approach to treat SLE patients.
About DSMB
The DSMB is comprised of independent medical experts and a statistician and
was established by Biotest as part of the company's compliance with good
clinical practice guidelines. At predetermined points in time the DSMB is
responsible for the regular monitoring of patient safety and for conducting
interim analyses of trial results. Raw data had been analysed, audited and
provided to the DSMB by an independent unblinded statistician of the
contract research organisation (CRO) managing the trial.
About Biotest
Biotest is a provider of plasma proteins and biological 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 clinical
immunology, haematology and intensive medicine. 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 addition Biotest develops monoclonal antibodies in the
indications of cancer of plasma cells and systemic lupus erythematosus
which are produced by recombinant technologies. Biotest has more than 2,400
employees worldwide. The preference shares of Biotest AG are listed in the
SDAX on the Frankfurt stock exchange.
IR contact
Dr. Monika Buttkereit
phone: +49-6103-801-4406
email: [email protected]
PR contact
Dirk Neumüller
phone: +49-6103-801-269
email: [email protected]
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.de
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hanover,
Munich, Stuttgart
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.
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01.11.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group 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: [email protected]
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange
End of News DGAP News Service
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