In another disappointment, US drug giant Merck (NYSE: MRK) and Austrian firm Intercell AG (VSE: ICLL) yesterday announced that, following a detailed analysis of the data from the Phase II/III clinical trial evaluating V710, an investigational vaccine for the prevention of Staphylococcus aureus infection, the independent Data Monitoring Committee (DMC) has unanimously recommended termination of the study.
Though a blow for Intercell, this must come as no surprise, as earlier this year, the two companies revealed 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 infection, the independent DMC recommended suspension of enrolment (The Pharma Letter April 12).
At that time, the Vienna-based firm’s then chief executive, Gerd Zettlmeissl (who last month was replaced by Thomas Lingelbach), said the suspension was not necessarily bad news and that the vaccine had met the pre-defined criteria for efficacy in the study, which has so far involved 7,700 patients. “It can be very positive in a sense that we have a result that the vaccine is very beneficial and this needs to be analysed. It can also mean there is something in the study which needs reflection and maybe change in the way forward," he said.
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