XOMA (US) LLC (XOMA) Finalizes Plans For Gevokizumab Phase 3 Clinical Program In Pyoderma Gangrenosum
4/28/2014 9:04:04 AM
BERKELEY, Calif., April 28, 2014 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today that based on its meeting with the U.S Food and Drug Administration (FDA), the Company is finalizing its plans for a gevokizumab Phase 3 program in pyoderma gangrenosum (PG), a rare neutrophilic dermatosis of painful expanding necrotic skin ulcers. During the meeting, the Company and the FDA reviewed the data generated from XOMA's pilot trial in six PG patients. The pilot study was designed to determine if gevokizumab, an IL-1 beta modulating antibody, should be explored in pivotal studies in patients with active PG. XOMA is incorporating the FDA's verbal and written responses regarding the clinical design of the studies into a final Phase 3 program, which it will submit to the Agency for any final comments.
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