Update on Phase II/III Clinical Trial of Investigational Staphylococcus aureus Vaccine, V710
WHITEHOUSE STATION, N.J., and VIENNA, April 11, 2011 /PRNewswire/ -- Merck (NYSE: MRK ), known as MSD outside the United States and Canada, and Intercell AG (VSE: ICLL) today announced that following a pre-specified interim analysis from the Phase II/III clinical trial evaluating V710, an investigational vaccine for the prevention of Staphylococcus aureus (S. aureus) infection, the independent Data Monitoring Committee (DMC) recommended suspension of enrollment. Although the trial did not meet the pre-specified futility criteria, the DMC nonetheless recommended suspension of enrollment pending further analyses of the benefit/risk profile of the vaccine candidate. Merck and Intercell plan to provide a further update when analyses have been completed.
S. aureus is a leading cause of hospital-acquired infections. In addition to bloodstream infections with a mortality rate of up to 35 percent, infections of bone, heart and other inner organs can often lead to serious health complications and death. Today, approximately 50 percent of S. aureus strains isolated in hospitals worldwide are resistant to multiple antibiotics, rendering staphylococcal disease management increasingly difficult and challenging.
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