Cerus clinical data not sufficient, plans for additional phase 3 trial

By Elaine Rigoli

Tampa, Fla., March 27 - Cerus Corp. officials, following a meeting with the Food and Drug Administration on Friday, said the company expects the FDA will require an additional phase 3 clinical trial for its Intercept blood system for platelets.

The trial will evaluate the hemostatic efficacy and safety of the platelet system, using the company's final commercial product design, as compared to conventional platelets, according to a news release.

Based on the meeting, Cerus understands that its reassessment of its previously completed phase 3 clinical trial data will not be sufficient to address the apparent differences observed in that trial between the treatment groups in the category of pulmonary adverse events, and that data on such events would need to be gathered in the additional phase 3 trial.

The additional clinical trial would need to be completed and data from the trial submitted to the FDA before the company could complete a premarket approval application to the FDA, the release said.

Before Cerus can begin an additional clinical trial, it will need to gain concurrence with the FDA on the company's trial design.

Concord, Calif.-based Cerus develops technologies to provide more effective options to patients, particularly within the fields of cancer, infectious disease and blood safety.

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