XOMA Corporation
XOMA, a leader in the discovery and development of therapeutic
antibodies, today announced it 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."
XOMA's pilot study is designed to enroll up to eight patients who are
experiencing acute inflammatory PG. The study is designed to evaluate the
response in the first four patients and be able to make decisions to continue
the study with a higher dosing regimen. Patients will be assessed on Day 28 to
determine gevokizumab's efficacy in controlling the acute inflammatory
symptoms of PG, and on Day 84 to determine gevokizumab's longer-term effect on
skin ulcers. Both investigator and patient global assessments will be
evaluated throughout the study.
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