25.01.2017
Biotest AG DE0005227235
DGAP-News: Biotest AG: First patient treated in the next clinical phase III study of IgG Next Generation in the indication Primary Immune Thrombocytopenia (ITP)
DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: First patient treated in the next clinical phase III study of
IgG Next Generation in the indication Primary Immune Thrombocytopenia (ITP)
25.01.2017 / 07:00
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
First patient treated in the next clinical phase III study of IgG Next
Generation in the indication Primary Immune Thrombocytopenia (ITP)
- Study no. 992 is the second pivotal phase III study in the clinical
program for IgG Next Generation, a novel development of our polyvalent
immunoglobulin G
- Study design was agreed with European regulatory authorities and
results will serve as basis for European approval
- Clinical data from Primary Immunodeficiencies (PID) and ITP will
automatically lead to the approval of additional indications in Europe
Dreieich, 25 January 2017. Biotest AG today announced that the first
patient has been treated in study no. 992 - a phase III study investigating
IgG Next Generation as immunomodulatory therapy in patients diagnosed with
chronic primary immune thrombocytopenia, an autoimmune disease in which the
immune system attacks and destroys the body's own platelets, the cells that
prevent bleeding in blood vessels and facilitate clotting.
The study is planned to include approximately 40 patients and will be
conducted in a total of 18 study sites in Germany, Hungary, Spain,
Bulgaria, Czech Republic and Serbia.
According to the European Guideline on the clinical investigation of human
normal immunoglobulin for intravenous administration (IVIG), there are two
key studies required for the licensing of an IVIG in the European markets.
Clinical data on efficacy and safety have to be generated in PID and
primary immune thrombocytopenia (ITP) - to provide evidence as replacement
therapy and to prove the immunomodulatory effect of immunoglobulines,
respectively.
Following approval, IgG Next Generation can be marketed additionally in the
following established indications of IVIG:
- Replacement therapy in secondary immunodeficiency disease e.g.
- chronic lymphocytic leukaemia,
- multiple myeloma and
- after allogeneic haematopoietic stem cell transplantation
- Immunomodulatory therapy in
- Guillain Barré Syndrome (GBS) and
- Kawasaki disease
IgG Next Generation is manufactured using a brand new production process
and will serve as the master product or the new Biotest Next Level
manufacturing facility currently under construction. This new manufacturing
facility, which uses state of the art technologies, represents Biotest's
latest commitment to the global immunoglobulin markets.
In 2014 the market volume of immunoglobulins for the indication PID in US
and EU amounted to approximately EUR 1.5 billion. The additional market
volume of ITP and the supplementary indications in Europe amounted to
approximately EUR 0.8 billion.
About study no. 992
Study no. 992 is a phase III, open label, prospective, multicenter trial
investigating the clinical efficacy and safety of IgG Next Generation as
immunomodulatory therapy in adult patients diagnosed with chronic primary
immune thrombocytopenia (ITP) at high risk of bleeding or before surgery to
correct the platelet count.
Subjects will be randomized in a 1:1 ratio to receive either 1 g/kg
bodyweight per day for 2 consecutive days or 0.4 g/kg bodyweight per day on
5 consecutive days. The primary objective of this study is to determine the
percentage of patients who achieve response. A response is defined as a
platelet count of >=30×109/L and at least a 2-fold increase of the baseline
count and the absence of bleeding.
More information about the study design can be found at
www.clinicaltrialsregister.eu (EudraCT Number: 2015-003653-17)
About Primary Immune Thrombocytopenia (ITP)
Primary immune thrombocytopenia - also formerly known as idiopathic
thrombocytopenic purpura or Immune thrombocytopenic purpura is an
autoimmune-mediated condition, in which autoantibodies with specificity for
one or more platelet membrane glycoproteins (GPs), binds to circulating
platelet membranes. The coating of platelets with autoantibodies renders
them susceptible for elimination from the blood.
Because patients suffering from ITP have a low platelet count, they may
bruise easily and experience bleeding that is hard to stop. ITP is a rare
blood disorder that affects about five to nine in 100,000 adults each year.
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 derived from
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 2,500 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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25.01.2017 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.
The DGAP Distribution Services include Regulatory Announcements,
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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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