Date: 2011-01-27
Type of information:
phase: 3
Announcement: interim analysis
Company: Biotest (Germany)
Product: Cytotect® (anti-cytomegalovirus hyperimmunoglobulin)
Action mechanism:
Disease: cytomegalovirus infection
Therapeutic area: Infectious diseases
Country: Germany, Belgium, Austria and Hungary
Trial details:
Latest
news: * On January 27, 2011, Biotest has announced that it has conducted an interim analysis of a Phase III clinical trial with the anti-cytomegalovirus (CMV) hyperimmunoglobulin (Cytotect®), which was intended to serve as the basis for deciding on whether to continue the trial. By the end of 2010, approximately 7,000 pregnant women had been included in the Phase III trial. About 4,200 out of the 7,000 pregnant women (60%) included in the trial were CMV-negative at the start of the pregnancy. Of these CMV-negative pregnant women, 0.8% became infected with the cytomegalovirus for the first time during the pregnancy. From the group of pregnant women infected for the first time, 30 children have now been born and are being continually examined for possible resulting signs of disease such as deafness, visual impairment as well as disorders of mental and motor development. The results available so far from the children show clear indication of Cytotect® efficacy when the treatment group is compared with the control group. This trend should now be further confirmed with the continuation of the trial in 2011. Biotest\'s aim is to establish a therapy with the anti-CMV hyperimmunoglobulin (Cytotect®) as the standard treatment for congenital CMV infections.The hyperimmunoglobulin Cytotect(R) is currently used mainly in transplantation medicine to avoid infections with the cytomegalovirus. The product is licensed and marketed in many European countries.
