CSL partners US agency on key study to prevent common causes of abnormalities in newborns
CSL Limited announced today that it is partnering with the world's largest health research agency, the US National Institutes of Health (NIH), to study a potential new treatment for the prevention of congenital CMV infection, one of the most common known causes of congenital (i.e., present at birth) abnormalities in the developed world.
Cytomegalovirus (CMV) is a common virus present in saliva, urine, tears, blood and mucus, and is predominantly carried by healthy infants, preschoolers, and children who contract the virus from their peers. Approximately one to two percent of pregnant women are infected with CMV for the first time during their pregnancy, and one in three will pass the CMV infection on to their developing unborn child. The risk of CMV infection is reduced by hand washing and general hygiene.
In Australia, CMV is one of the leading causes of disabilities in infants, including deafness, blindness, cerebral palsy, mental and physical disabilities, seizures, and even death. The symptoms of CMV may not be immediately apparent at birth, and even well beyond. There is currently no proven therapeutic prevention for congenital CMV.
Starting this month, the NIH will initiate a large multi-site clinical trial in the US involving more than 150,000 women to test whether CMV immunoglobulin (antibodies collected from human plasma) is an effective preventative of mother to baby transmission of CMV.
CSL is donating product made at its Swiss plant to the NIH for use in this trial as part of its commitment to addressing significant public health issues through collaborative research.
Professor Bill Rawlinson, Senior Medical Virologist at UNSW and CMV expert welcomed the study: "Robust information about prevention of congenital CMV is needed now. One to two babies are born every day with profound medical problems from congenital CMV that might be able to be prevented."
"The commitment by the NIH and CSL to conduct a large study like this will hopefully provide more definitive answers and options for the prevention of mother to baby transmission of CMV."
Dr Andrew Cuthbertson, Chief Scientific Officer of CSL added: "This is a very large, complex and long-term trial that requires the resources of a research agency like the NIH. CSL is very pleased to be able to support this important research, which could ultimately improve pre-natal care around the world."
Mother of four children, including twins born with congenital CMV in 2010, Kate Daly was unaware of CMV during her pregnancy but is now very much aware of its impact. Her son William is profoundly deaf and has a significant developmental delay due to congenital CMV. His twin Emmaline has a mild developmental delay due to the virus.
"It is great to see an Australian company supporting important research in the area of CMV infection during pregnancy. Women also need to be better educated on steps they can take to avoid contracting the infection themselves, in the first place."