Mothers who initially become infected with CMV during pregnancy can transmit the virus to their unborn children. Infants born with CMV infection can be affected by blindness, deafness, and mental retardation, which are frequently undiagnosed until the child reaches several years of age.
The second product in our CMV franchise is a Vaxfectin®-formulated vaccine called CyMVectin™, which is intended to elicit immunity in women before they become pregnant, thereby reducing the possibility of transmitting CMV to the fetus during pregnancy. We believe the market potential for a prophylactic vaccine is significant, with more than 30 million CMV-seronegative women of childbearing age in the United States alone. A recent preclinical study indicated that this vaccine is capable of generating neutralizing antibodies that block CMV infection of epithelial cells, an important activity because epithelial cells are a major portal of entry for CMV transmission.
We have designed a Phase 1 trial of CyMVectin™, and the Investigational New Drug application has been allowed by the FDA. We are exploring the best way to advance, whether independently or with a corporate partner.