DGAP-News: Biotest AG
/ Key word(s): Study
26.08.2021 / 07:00
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Biotest receives approval for phase III clinical trial in pregnant women for prevention of CMV infection of the unborn baby
Dreieich, 26 August 2021. Biotest today announced that their application to conduct the clinical trial PreCyssion (Prevention of maternal-foetal Cytomegalovirus transmission after primary maternal infection) was approved by the Competent Authority and the responsible Ethics Committee in Germany.
“We are very pleased that the regulatory agencies recognize the urgent need for a treatment option to prevent CMV transmission from a pregnant women to the unborn baby and we are committed to address this unmet need. With this trial, Biotest will make a significant contribution to prevent the most frequent congenital infection.” said Dr Silke Aigner, responsible Head of Clinical Strategy & Development at Biotest.
Cytomegalovirus causes a life-long infection, which is usually unproblematic in healthy individuals. In CMV-negative pregnant women, however, who are infected with CMV for the first time (“primary infection”), there is a ~30-40% risk that the virus gets transmitted to the foetus, potentially causing neurological and developmental defects. Notably, the risk for symptomatic babies is highest, when primary infection occurs during the first 20 weeks of pregnancy. In Europe and the USA it is estimated that more than 50,000 babies are born with CMV infection each year. CMV infection is the leading cause of non-genetic childhood sensorineural hearing loss and more than 10% of infected unborn babies may suffer from symptomatic developmental disorders at birth. Currently, there is no medicine authorised for prevention of maternal-foetal CMV transmission.
This open-label, single-arm, prospective phase III clinical trial is investigating the efficacy and safety of Biotest’s CMV hyperimmunoglobulin (CMVIG) Cytotect CP Biotest(R) for treatment of CMV infected pregnant women to prevent CMV transmission to the foetus. The trial will be conducted in Germany and enrol approximately 80 women with confirmed primary CMV infection in early pregnancy (gestational age <= 14 weeks). After confirmation of primary CMV infection, the women will be treated with 2ml of Cytotect CP Biotest(R) per kg body weight every second week until about 18 weeks’ gestation. For the assessment of CMV status of the foetus (primary endpoint), each woman will undergo amniocentesis after end of treatment at about 20 weeks’ gestation.
The clinical concept of this pivotal phase III trial builds on strong data from an observational study coordinated by the University of Tübingen. In this study, Cytotect CP Biotest(R) was given to pregnant women with primary CMV infection during early pregnancy. In 149 women treated (153 foetuses), transmission of the virus to the foetus occurred in ten cases at time of amniocentesis (around gestational week 20). This corresponds to a transmission rate (primary endpoint) of 6.5%, which is substantially lower compared to a historical group with a transmission rate of 35.2%.
About Cytotect CP Biotest(R)
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
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