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(August 15, 2018)
DGAP-News: Biotest AG / Key word(s): Research Update
- 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.
About Cytotect(R) CP
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