Biotest AG: Interim analysis of the Cytotect(R) Phase III trial in congenital cytomegalovirus (CMV) infection shows clear indication of efficacy
Biotest AG / Key word(s): Miscellaneous
27.01.2011 / 10:00
Interim analysis of the Cytotect(R) Phase III trial in congenital
cytomegalovirus (CMV) infection shows clear indication of efficacy
Positive results justify continuation of the Phase III trial
7,000 pregnant women have been included in the trial so far
Dreieich, 27 January 2011, Biotest has conducted an interim analysis of a
Phase III clinical trial with the anti-cytomegalovirus (CMV)
hyperimmunoglobulin (Cytotect(R)), which was intended to serve as the basis
for deciding on whether to continue the trial. By the end of 2010,
approximately 7,000 pregnant women had been included in the Phase III
trial.
About 4,200 out of the 7,000 pregnant women (60%) included in the trial
were CMV-negative at the start of the pregnancy. Of these CMV-negative
pregnant women, 0.8% became infected with the cytomegalovirus for the first
time during the pregnancy. From the group of pregnant women infected for
the first time, 30 children have now been born and are being continually
examined for possible resulting signs of disease such as deafness, visual
impairment as well as disorders of mental and motor development.
The results available so far from the children show clear indication of
Cytotect(R) efficacy when the treatment group is compared with the control
group. This trend should now be further confirmed with the continuation of
the trial in 2011. Biotest's aim is to establish a therapy with the
anti-CMV hyperimmunoglobulin (Cytotect(R)) as the standard treatment for
congenital CMV infections.
Cytomegalovirus disease is a widespread viral infection, which usually
follows a harmless course with flu-like symptoms. However, if women become
infected with the cytomegalovirus (CMV) for the first time during
pregnancy, damage to the baby can occur before it is born. As a result,
some children suffer from deafness or visual impairment, and exhibit
disorders of mental or motor development. Treatment with the
hyperimmunoglobulin (Cytotect(R)) after infection has been diagnosed in a
pregnant woman is intended to protect against transmission of the virus to
the unborn child and thereby prevent injury to the child. Well respected
clinical study centres in Germany, Belgium, Austria and Hungary are
participating in the trial.
About anti-CMV hyperimmunoglobulin (Cytotect(R)) The hyperimmunoglobulin
Cytotect(R) is currently used mainly in transplantation medicine to avoid
infections with the cytomegalovirus. The product is licensed and marketed
in many European countries.
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 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. Biotest has more than 1,900 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
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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
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, Stuttgart
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