Startled by the unexpected failure of a mid-stage trial of its vaccine adjuvant patch, Intercell AG is changing up the vaccine it used in the study along with the hemagglutinin inhibition assay used to evaluate the adjuvantive effect provided by the patch.
The Phase II H5N1 study found no difference in seroprotection rates between one group which was given a vaccine provided by Solvay and another group which relied on the Vaccine Enhancement Patch, an investigational adjuvant technology designed to reduce the amount of vaccine needed to ward off an influenza pandemic. Reducing the amount of vaccine needed to protect a population would go a long way to stretching limited stockpiles, a subject that dominated the headlines during last year's swine flu pandemic.
"Obviously we are investigating still," Reinhard Kandera, chief financial officer at Vienna, Austria-based Intercell, told BioWorld International. "We had difficulty and delays in getting a read-out of the study because of the problem with the flu test."
Intercell obtained the vaccine patch technology through its acquisition of Iomai in Maryland, which used a hemagglutinin inhibition assay which is no longer available in its study. Iomai's trial demonstrated a statistically significant response over vaccine alone. Intercell has since struck a major vaccine development deal with GlaxoSmithKline and will now turn to GSK's hemagglutinin inhibition assay and a GSK vaccine for future studies.
Shares of Intercell slumped after the Phase II failure was announced. "Its a clear disappointment, given the fact that there were some justified hopes after positive first-stage clinical trials," Macquarie analyst Peter Duellmann told Reuters.