Biotest treats first CMV-positive pregnant woman in Phase III clinical trial to prevent transmission of CMV infection to the unborn child
- Cytomegalovirus (CMV) infection of the foetus is one of the most common congenital infections and may cause severe developmental retardation and hearing loss in new-borns
- High unmet medical need due to large amount of new-borns born with CMV-related disorders
- Significant reduction in CMV transmission from mother to foetus expected with treatment with CMV hyperimmunoglobulin
Dreieich, 14 December 2021. Biotest today announced today that the first pregnant woman in Germany has been treated with Cytotect CP Biotest(R) for the prevention of CMV infection of her unborn child in the clinical trial PreCyssion (Prevention of maternal-foetal Cytomegalovirus transmission after primary maternal infection).
"We are very pleased that we were able to treat the first subject with a CMV hyperimmunoglobulin in this trial," said Prof. Karl Oliver Kagan, MD, (University of Tübingen, Germany), the Coordinating Investigator of the PreCyssion trial. "Recently published results from an observational study show a CMV transmission rate of 6.5% after treatment with a CMV hyperimmunoglobulin, which is significantly lower than the previously known rate of 35.2%. We would like to confirm this result in the clinical trial now underway."
The PreCyssion 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.
Cytomegalovirus belongs to the herpes viruses and causes a life-long infection, which is usually unproblematic in healthy individuals. However, women who first become infected with CMV in early pregnancy ("primary infection") have a
~30-40% risk of transmitting the virus to the foetus. The virus can damage numerous organ systems and cause neurological and developmental defects, some of which are severe. New-borns infected in utero may experience growth retardation and especially hearing loss. In addition, neurological late damage is frequently observed, and retinitis with blindness can also occur.
In Europe and the USA it is estimated that more than 50,000 babies are born with CMV infection each year. Currently, there is no approved therapy for this indication. Early treatment with a CMV hyperimmunoglobulin is intended to prevent an early transmission of the virus from mother to the unborn child. With a successfully completed trial, Biotest is seeking to extend the market authorisation for Cytotect CP Biotest(R).
About Cytotect CP Biotest(R)
Cytotect CP Biotest(R) is a cytomegalovirus-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. The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis. Cytotect CP Biotest(R) is also marketed as Megalotect(R), Megalotect CP(R), Cytomegatect(R) and NeoCytotect(R) in different countries.
About the PreCyssion trial
The open-label, single-arm, prospective Phase III clinical trial PreCyssion (Prevention of maternal-fetal Cytomegalovirus transmission after primary maternal infection) is evaluating the efficacy and safety of Biotest's CMV hyperimmunoglobulin Cytotect CP Biotest(R) for the treatment of pregnant women with CMV infection to prevent the transmission to the foetus. The clinical concept of this pivotal Phase III trial is based on convincing data from an observational study coordinated by the University of Tübingen. In this study, pregnant women with primary CMV infection in early pregnancy were treated with Cytotect CP Biotest(R). In 149 treated women (153 foetuses), transmission of the virus to the foetus occurred in ten cases by the time of amniocentesis (around gestational week 20). This corresponds to a transmission rate (primary endpoint) of 6.5%, which is significantly lower than the rate of 35.2% of a historical control group.1
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 care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.
Dr Monika Buttkereit
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
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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.
 Karl Oliver Kagan et al. Ultrasound Obstet Gynecol 57 (4) 560-7 (2021)
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