Development pipeline

CMV-Hyperimmunoglobulin (CMVIG)

CMV-Hyperimmunoglobulin (CMVIG) is a plasma-derived polyclonal immunoglobulin preparation containing large amounts of antibodies directed against human cytomegalovirus (CMV).

While infection with CMV is usually unproblematic in healthy individuals, women who become infected with CMV for the first time during pregnancy have a ~30-40% risk of transmitting the virus to the fetus. Infection of the unborn child, particularly in the first few weeks of pregnancy, can lead to neurological damage such as hearing loss and developmental problems. Currently, there is no medicine authorised for prevention of maternal-foetal CMV transmission, though Cytomegalie is the most common infectious disease transmitted from pregnant woman to the unborn child and may lead to permanent damage of the child.

Biotest is developing CMVIG for the treatment of pregnant women with CMV primary infection in order to prevent transmission of the virus to the unborn child.

Press releases

Biotest receives approval for phase III clinical trial ...

26.08.2021,

26.08.2021 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.The DGAP Distribution Services incl ... [More]

Clinical trials

Title

Indication

Status

 
CMV Hyperimmunoglobulin (CMVIG) (Study 997; PreCyssion) Prevention of prenatal CMV transmission Trial approved

Prevention of maternal-fetal Cytomegalovirus transmission after primary maternal infection with gestational age ≤ 14 weeks - an open-label, single-arm, prospective trial investigating efficacy and safety of CMVIG CP Biotest.

Link clinicaltrialsregister.eu