Biotest AG is conducting a clinical phase III study PreCyssion (Prevention of maternal-fetal Cytomegalovirus transmission after primary maternal infection) with a CMV hyperimmunoglobulin (Cytotect CP Biotest-) for the prevention of a CMV infection in the unborn child in Germany. Currently, there is no approved therapy for this indication. Early treatment with a CMV hyperimmunoglobulin is intended to prevent the transmission of the virus from the mother to the unborn child.

Dr. Kolb's work thus contributes to making this important topic visible and to establishing the mode of action of the use of CMV hyperimmunoglobulins in CMV infection during pregnancy. Dr. Kolb has already successfully established the cell culture model for the studies with CMV on placental cells in his laboratory. Cytotect CP Biotest® 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® is also marketed as Megalotect®, Megalotect CP®, Cytomegatect® and NeoCytotect® in different countries.

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® 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®.

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.