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Study Consistent with Previous Raptiva Findings

Genentech, Inc., and XOMA, Ltd., announced on Sept. 17 that findings from a recently completed phase III study with efalizumab (brand name Raptiva, formerly known as Xanelim) were consistent with previous phase III findings: more patients treated with the drug had 75 percent or better improvement in their psoriasis, compared to patients treated with placebo.

Genentech and XOMA will present the data from this study at an upcoming medical meeting. The recent study was in response to an FDA request for more information about the chemical components of the drug. The companies plan to submit the data to the U.S. Food and Drug Administration (FDA) by the end of 2002 in its application for drug approval.

"The data from this trial, conducted with Genentech material, are consistent with data obtained from previous phase III studies with Raptiva that used both Genentech and XOMA material," said Hal Barron, M.D., FACC, Genentech's vice president, Medical Affairs.

The previous phase III studies involved 12-week tests of more than 1,000 patients with moderate to severe psoriasis in the U.S. and Canada. Patients received one of two doses of Raptiva or placebo by weekly injections. Raptiva was reported to be well tolerated, but side effects observed during the trials included mild-to-moderate headache, nausea, chills and pain.

The safety profile in this latest study was similar to previous Raptiva trials conducted with both Genentech and XOMA material. Reported side effects included mild-to-moderate headache, general aches/pains, chills, nausea and fever.

Raptiva is designed to block a key immune-system reaction involved in the development of psoriasis. It is part of a new generation of targeted therapies called "biologics" that selectively fight psoriasis at the cellular level. These drugs appear to have a more promising short-term safety profile than the treatment options now available to people with moderate to severe psoriasis, but long-term effects are unknown.

The FDA requested that the current phase III study be completed before the application's filing after results from a study suggested that Genentech-produced Raptiva had a slightly different chemical makeup than XOMA-produced Raptiva. Previous phase III trials were conducted with both Genentech and XOMA material. Phase III clinical trials are large-scale studies to confirm the effectiveness and safety of a drug. They are usually the last stage of clinical research conducted before companies seek approval for their drug.

This double-blind, placebo-controlled, multicenter efficacy study enrolled 556 patients with moderate-to-severe plaque psoriasis who were randomized to receive either 12 weekly subcutaneous injections of Raptiva or placebo.