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Biotest AG: Cytotect(R) CP prevents transmission of Cytomegalovirus (CMV) to the unborn baby in pregnant women who are infected with CMV for the first time

(August 15, 2018)

DGAP-News: Biotest AG / Key word(s): Research Update

15.08.2018 / 07:00
The issuer is solely responsible for the content of this announcement.


/
PRESS RELEASE

Cytotect(R) CP prevents transmission of Cytomegalovirus (CMV) to the unborn baby in pregnant women who are infected with CMV for the first time

- Transmission of CMV from pregnant women to the foetus is a main cause of post-natal complications in newborns

- High medical need as 700 - 1,400 babies are born with developmental disorders due to CMV in Germany every year



- Studycoordinated by the University of Tübingen shows strong reduction of maternal-foetal CMV transmission from 35.2% to 2.5% (primary endpoint)

- Cytotect(R) CP shown to be effective and safe for use in pregnant women

Dreieich, 15 August 2018. The results of a recently published study by Kagan et al. indicate excellent efficacy and safe use of Cytotect(R) CP in pregnant women1. The study was conducted independently and without financial support from Biotest.

Cytomegalovirus (CMV) causes a life-long infection, which is usually unproblematic in healthy individuals. In CMV-negative pregnant women, however, who get infected with CMV for the first time ("primary infection"), there is a ~40% risk that the virus gets transmitted to the foetus, potentially causing neurological and developmental defects. In Germany about 700-1,400 babies with developmental disorders due to CMV are born each year. Prevention of CMV transmission to the foetus protects from those negative effects. Currently, there is no medicine authorised for use in this setting.

In a new prospective observational study coordinated from the University of Tübingen, Cytotect(R) CP was given to pregnant women with primary CMV infection during early pregnancy. Cytotect(R) CP, a CMV-specific hyperimmunoglobulin, has a high content of antibodies that specifically target CMV. In 40 women treated in this study, transmission of the virus to the foetus occurred in only one case at time of amniocentesis around gestational week 20 (primary endpoint). This corresponds to a transmission rate of 2.5%, which is significantly lower compared to a historical control group with a transmission rate of 35.2% (38 of 108 women). Additionally, there were two late CMV transmissions, thus, a total of three infected babies were observed, all without symptoms at birth. The administration of Cytotect(R) CP was safe and no serious adverse problems were observed. The authors of the study conclude that administration of a CMV hyperimmunoglobulin is safe end efficacious when administered to pregnant women before gestational week 20, even at a relatively high dose.

In contrast to previous studies with CMV hyperimmunoglobulin in this setting, only women with an early primary CMV infection were included and treatment was started as soon as possible in biweekly intervals. Notably, the risk for symptomatic babies is highest, when primary infection occurs during the first 20 weeks of pregnancy.

A different clinical trial with BT094, an investigational CMV hyperimmunoglobulin, was conducted by Biotest in the same indication (Study 963). As part of this study, more than 15,000 pregnant women were screened. However, the study was terminated early due to lower than expected case numbers. Therefore, the calculated sample size to achieve statistical significance was not reached. In contrast to the study by Kagan et al., the Biotest study treated pregnant women whose primary infection occurred up to the 35th week of pregnancy.

Despite low case numbers, a trend towards prevention of foetal CMV infection was observed in the treatment group compared to the control group. Treatment with BT094 was well tolerated with no unexpected safety findings. No new risks or signals were identified in pregnant women, foetuses, and newborns/infants in this clinical trial. Biotest is currently in the process of analysing all data of this clinical trial and will prepare a manuscript for publication of the results in the near future.

1 Karl Oliver Kagan et al. Ultrasound in Obstetrics & Gynecology, doi:10.1002/uog.19164

About Cytotect(R) CP
Cytotect(R) CP is a cytomegalovirus (CMV)-specific hyperimmunoglobulin preparation with a high antibody titre against CMV. The product is approved for prophylaxis of clinical manifestations of CMV infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.

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 1,600 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
Mail: [email protected]

PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: [email protected]

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

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.



15.08.2018 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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