Phase III Results With Xoma's CD5 Plus

Results of a Phase III trial of Xoma's CD5 Plus product for the treatment of graft-versus-host disease have been presented at the annual meeting of the American Society of Hematology in Nashville, Tennessee. The results are somewhat equivocal, but suggest that the agent may be an effective treatment for patients with GVHD.

Results of the randomized, prospective study were presented at the ASH meeting by Paul Martin of the Fred Hutchinson Cancer Research Center, where the trial was conducted. A total of 243 patients were included in the trial, all of whom developed GVHD after bone marrow transplantation. Around half of the patients received CD5 Plus (0.1mg/kg for 14 days) and a standard steroidal immunosuppressant therapy (methylprednisolone), while the other half received the steroid and placebo.

As part of the study's prospective analysis, the primary endpoint was defined as no evidence of acute GVHD at day 43 post starting treatment. The percentage of patients with no evidence of GVHD was higher in the CD5 Plus group than in the placebo group during the entire 43-day period of observation, although while the differences between the groups were significant at days 22, 29 and 36, this was not the case at day 43 (see table for results).