Xoma reports Phase III Neuprex data

XOMA published in The Lancet results of its Phase III study of Neuprex opebecan recombinant bactericidal/permeability-increasing protein (rBPI-21) in 393 pediatric patients with severe meningococcemia, showing that Neuprex did not significantly affect mortality rate compared to placebo (7.4 percent with Neuprex versus 9.9 percent with placebo, p=0.48). XOMA previously said that the trial showed a clinical benefit in mortality and morbidities, but did not provide statistical analysis at that time (see BioCentury, Aug. 23, 1999). XOMA and partner Baxter Healthcare (BAX) subsequently announced that the Phase III data were not sufficient to support the submission of a BLA for the product to the FDA (see BioCentury, May 1).

XOMA said that the majority of the deaths in the trial occurred after enrollment but prior to treatment, leading to exclusion of those patients and a lower mortality rate in the placebo group than expected. As a result, XOMA said, the trial was underpowered to detect a significant difference in mortality. ...