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Replies to post #161041 on Biotech Values
05/13/13 1:03 PM
06/13/13 9:21 AM
XOMA…has opened enrollment in a pilot study to determine gevokizumab's potential to treat acute inflammatory pyoderma gangrenosum. Pyoderma gangrenosum (PG) is one of the several rare diseases that are classified under the broader cluster of neutrophilic dermatoses. XOMA's pilot study is designed to enroll up to eight patients who are experiencing acute inflammatory PG. An inflammatory episode of PG is characterized by recently developed active ulcers and ulcer-related pain.
"We had previously indicated that XOMA and our partner SERVIER would evaluate the potential to test gevokizumab in a couple of rare disease areas, neutrophilic dermatosis and Schnitzler syndrome. Since the majority of Schnitzler patients are in Western Europe, SERVIER has been actively exploring the potential to pursue this indication in this orphan disease while we have been working with the experts in the neutrophilic dermatosis field to identify which subset of this rare disease class might respond best to gevokizumab. They believe acute inflammatory pyoderma gangrenosum is an ideal candidate, as a significant number of the patients tend to have an underlying inflammatory disease that results in PG's hallmark skin lesions," stated John Varian, Chief Executive Officer of XOMA.
"We sought FDA's input on PG prior to deciding if this disease condition should be pursued. Our pilot study will help us understand gevokizumab's ability to treat these patients. With positive results from a small pilot study in PG, we believe we will be able to have a productive End of Phase 2 meeting with FDA to finalize the design of a potential pivotal program."
06/14/13 8:00 AM
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