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Vical Completes Enrollment and Reports Positive Interim Data in CMV Vaccine Phase 2 Trial
Date:11/12/2008

donor-recipient arm were inconclusive because of the small sample size. Independent data(1) have shown that increased CMV-specific T-cell responses following stem cell transplants are predictive of favorable clinical outcome, including limited levels of active CMV and reduced CMV disease.

The Phase 2 trial included two arms. In one arm, vaccine or placebo was administered to both the donors and recipients undergoing stem cell transplants (the donor-recipient arm). In the other arm, vaccine or placebo was administered only to the stem cell transplant recipients (the recipient-only arm). The recipient-only arm of the trial recently achieved full enrollment of 80 subjects. Based on the results of the interim immunogenicity analysis, the company determined that there was no need to continue enrollment in the donor-recipient arm.

About CMV

CMV is a herpes virus that infects more than half of all adults in the United States by age 40, and is even more widespread in developing countries. While a healthy immune system typically protects an infected person against CMV disease, it rarely succeeds in completely eliminating the infection, and those whose immune systems are not fully functional are at high risk of CMV proliferation, potentially leading to severe illness or death. These include transplant patients who take immunosuppressive drugs, and fetuses and newborns of mothers who first become infected during pregnancy.

CMV infection affects 30 to 60 percent of the patients undergoing various transplant procedures, causing transplant rejection, serious illness and even death if untreated. Expensive and toxic antiviral drug therapy is used to control the disease, but does not eliminate the infection. Congenital CMV infection affects one out of every hundred infants, and causes severe consequences in about 3,600 infants and death in about 400 each year in the United States.

There is no approved vaccine against CMV. Vaccine approaches that pr
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SOURCE Vical Incorporated
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