Cerus Intercept trial update
This article was originally published in The Gray Sheet
FDA's Blood Products Advisory Committee recommended Nov. 16 more stringent safety margins in Cerus' proposed Phase III trial design for its Intercept blood pathogen inactivation system, which might require the company to enroll more patients than expected, according to the firm. Otherwise, the committee agreed with Cerus' proposed hemostatic efficacy and safety endpoints in the planned trial comparing Intercept-treated platelets and conventional platelets used in transfusions. The firm already completed a similar Phase III study for Intercept, enrolling 645 patients, which met its primary endpoint, but FDA had concerns with the trial design. "We now need to conduct further discussions with the FDA to agree upon a final protocol," Cerus CEO Claes Glassell said
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