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Executive Summary

XOMA's SECOND E5 STUDY IS UNDER REVIEW AT FDA, the company reported April 15. FDA sent the firm a letter during the first week of April stating that the agency's analysis of data from a second Xoma multicenter trial for E5 is "ongoing." In the same letter, FDA told Xoma that the company's first large study of the anti-endotoxin for treatment of septic shock "does not provide sufficient evidence of efficacy to support product licensure." FDA's determination that the original trial alone will not support licensure is not a surprise: the agency's Vaccines and Related Biological Products Advisory Committee reviewed that study at its Sept. 4 meeting ("The Pink Sheet" Sept. 9, p. 17). The advisory committee requested further analysis of E5's efficacy. FDA's findings on the first trial do not "in any way imply a delay or setback in the agency's review of E5," Xoma maintained. Xoma presented data from the second study to the advisory committee, and the initial response of the committee was that the results apparently did not substantiate the efficacy results of the first trial. Xoma VP-Clinical Research Samuel Saks, MD, told the panel, however, that an analysis of the two studies together showed an increase in survival among septic shock patients. Xoma has presented the agency with data from the second trial as well as a "meta-analysis" of the two studies, the company said. "When the two trials are combined," the company added, "we believe the safety and effectiveness of E5 are clearly demonstrated." FDA's review of the meta-analysis also is under way, Xoma explained.

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