Cerus says Phase 3 red-blood-cell trial met main efficacy goal

Cerus Corporation (Nasdaq: CERS) said Monday that its Phase 3 RedeS trial of the INTERCEPT Blood System for red blood cells met its primary efficacy endpoint, showing the treated cells were non-inferior to conventional red blood cells. These are topline results announced by the company. They have not been peer reviewed or independently validated.

The endpoint was adjusted hemoglobin increment, a common measure of how well a red blood cell transfusion works. On a modified intent-to-treat basis, the increment was 1.996 g/dL in the INTERCEPT group (195 patients) and 2.050 g/dL in the control group (199 patients), a difference of -0.054 g/dL. The lower end of the 95% confidence interval was above the trial's prespecified non-inferiority margin of -0.32 g/dL.

On safety, Cerus said 3.4% of patients in the INTERCEPT group (9 of 267) had treatment-emergent adverse events judged related to a study transfusion, compared with 2.5% in the control group (7 of 276). The company said the difference was not statistically significant.

Cerus also reported that low-titer, transient INTERCEPT-specific antibodies were detected in 2.2% of patients in the INTERCEPT group (6 of 267) and in none of the control group. The company said it saw no evidence of hemolysis or clinical impact from them, and that it has ongoing studies on the antibodies.

Cerus said it expects to submit full results to a peer-reviewed journal. It also said the FDA has not yet reviewed the final study report and that the agency's assessment may differ from the company's. The system for red blood cells remains investigational in the United States and is not FDA approved, and the company said the results do not establish approval or its timing.

(The photo is a generic file photo of blood collection tubes. It does not show the trial or any Cerus product.)