A Pivotal Phase III Gevokizumab Study is Initiated in Patients With Pyoderma Gangrenosum

November 4, 2014

The Phase III gevokizumab study in patients with active pyoderma gangrenosum, a rare neutrophilic dermatosis of expanding necrotic skin ulcers, is open for patient enrollment.

The objective of the study is to assess the efficacy and safety of gevokizumab in treating the active ulcers caused by this rare and debilitating disease. The FDA granted orphan drug designation to gevokizumab for PG in February 2014.

Paul Rubin, MD, Senior Vice President, Research and Development and Chief Medical Officer at XOMA said, "We have reached another important milestone in our gevokizumab development activities with the launch of the first of two pivotal gevokizumab studies in pyoderma gangrenosum, one of the indications under the neutrophilic dermatoses umbrella for which there are no available therapies approved by the FDA. Patients with PG experience deep and painful skin ulcers that often become chronic wounds. In our pilot study, five of the six patients enrolled responded to gevokizumab, and four experienced complete wound closure by three months."

The Phase III randomized, placebo-controlled study will enroll 58 patients with active PG to receive gevokizumab 60 mg or placebo dosed subcutaneously once monthly, in addition to their current treatment regimen of low-dose corticosteroids and/or immunosuppressants.

The primary endpoint is complete closure of the PG target ulcer determined at Day 126 with confirmation a minimum of two weeks later at Day 140.

For more information go to: www.xoma.com.

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