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April 28, 2014
09:16 EDTXOMAXOMA finalizes plan for gevokizumab Phase 3 clinical program in PG
XOMA announced that based on its meeting with the FDA, the company is finalizing its plans for a gevokizumab Phase 3 program in pyoderma gangrenosum, or 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. The Phase 3 program is expected to include two double-blind, placebo-controlled clinical studies, each of which is designed to enroll approximately 60 patients with active PG. The primary endpoint is complete wound closure of the target ulcer at approximately four months. XOMA anticipates conducting these parallel studies in the United States and several other countries.
News For XOMA From The Last 14 Days
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October 20, 2014
07:16 EDTXOMAAmerican Academy of Ophthalmology to hold annual meeting
AAO Annual Meeting 2014 is being held in Chicago on October 18-21.
October 16, 2014
07:23 EDTXOMAIBF Conferences to hold a summit
Ophthalmology Innovation Summit is being held in Chicago on October 16.
October 10, 2014
13:01 EDTXOMAXOMA management to meet with Maxim
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October 9, 2014
09:08 EDTXOMAXOMA initiates dosing in XOMA 358 Phase 1 study
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