Phase III data with Genentech/Xoma's Xanelim show efficacy in psoriasis

Genentech and Xoma have reported data from a second Phase III trial oftheir humanized anti-CD11 monoclonal antibody Xanelim (efalizumab) at the American Academy of Dermatology meeting in Anaheim that support the efficacy of the drug as a treatment for adult patients with moderate-to-severe plaque psoriasis.

The results of the new study (2059) were comparable to those seen in the earlier 2058 trial, which was presented a few weeks ago (Marketletter June 4), and sets the Xanelim program on track for a regulatory filing later this year or early in 2002. Shares in Xoma climbed 10% to $12.64 on the news, while Genentech also went up slightly (2%) to $42.72, reflecting the renewed importance that Xanelim has for the firm now that it is experiencing delays with its asthma drug Xolair (omalizumab; Marketletter July 16).

The study enrolled 597 patients who were randomized to receive either 1mg/kg or 2mg/kg Xanelim, given once a week by subcutaneous injection, or placebo for 12 weeks. The primary endpoint in the trial was a 75% or better improvement on Psoriasis Area and Severity Index scores. A second 12-week follow-up period involved randomizing responders to either 2mg/kg Xanelim given weekly, the same dose every other week or placebo, with patients given the option to try to self-administer the drug at home.