XOMA seeks regulatory approval for Neuprex in United States, Europe

By Elaine Rigoli

Tampa, Fla., Aug. 15 - XOMA Ltd. unveiled its strategy and provided an update on the status of its efforts to advance Neuprex (opebacan) toward regulatory approval in Europe and the United States in multiple disease indications.

"Our strategy to find clear approval opportunities for Neuprex is beginning to demonstrate some meaningful progress. We have ongoing activities in a number of different indications based on Neuprex's established activity as a potent neutralizer of bacterial endotoxin. With recent accomplishments here and in Europe, we are pleased to provide our shareholders with an update on our strategy for the approval of Neuprex," chairman of the board, president and chief executive officer Jack Castello said in a news release.

In Europe, XOMA said it is implementing a two-part regulatory strategy that leverages the large body of clinical data, including phase 3 studies, that already exists for Neuprex in meningococcemia. The two elements of this strategy are pursuit of an orphan-drug designation, and a marketing authorization of Neuprex in meningococcemia under the "exceptional circumstances" mechanism established by the European Medicines Agency, the release said.

The company added that because U.S. regulatory pathways differ from Europe's, its U.S. strategy is based on the identification of acute clinical indications in which endotoxin has been documented in the disease process; the time from disease onset to administration of Neuprex is known; and administration of Neuprex can occur in time to have a meaningful clinical impact.

XOMA said it will proceed with a strategy that requires only a limited financial investment until convincing clinical benefit has been observed.

In keeping with these criteria, XOMA said it is supporting two U.S. investigator-initiated clinical trials in pediatric open heart surgery and severe burns and will soon start a XOMA-sponsored trial at prominent academic medical centers in allogeneic hematopoietic stem-cell transplantation (initially in donor bone-marrow transplantation), pending approval of the Investigational Review Boards at these institutions.

XOMA is a pharmaceutical company based in Berkeley, Calif.

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