Xoma reports Phase II data for gevokizumab

Xoma Corp. (NASDAQ:XOMA) reported data from a pair of Phase II trials evaluating the company's gevokizumab ( XOMA 052) for erosive osteoarthritis (OA) of the hand and acute inflammatory pyoderma gangrenosum, a rare disorder that results in painful expanding necrotic skin ulcers. In four patients with pyoderma gangrenosum, once-monthly gevokizumab for three months led to an improvement in the investigator's assessment of the target pyoderma gangrenosum ulcer in three patients by day 28. One patient had complete resolution by day 84 and a second patient had a 93% improvement in ulcer size by day 56. Xoma said it plans to request a meeting with FDA to review the data and discuss requirements for accelerated development of gevokizumab for the indication, with a single Phase III trial potentially forming the basis of a BLA.

In a separate trial in 85 patients with erosive OA of the hand and C-reactive protein (CRP) levels of 2.5 mg/L or greater, once-monthly gevokizumab led to a 23% reduction in mean composite score of self-reported assessment of pain, disability and joint stiffness from baseline to three months vs. a 14% reduction for placebo. Servier (Neuilly-sur-Seine, France) has worldwide rights to develop and commercialize the humanized IgG2 mAb against IL-1 beta for Type II diabetes and cardiovascular indications and rights outside the U.S. and Japan to all other indications. ...