Roche/Aspreva’s CellCept Fails Lupus Trial

July 3, 2007

Roche’s preventative organ rejection treatment CellCept failed to meet its primary endpoint in a Phase III clinical trial for the treatment of lupus nephritis, development partner Aspreva Pharmaceuticals announced.

The trial tested the product head-to-head against intravenous cyclophosphamide (IVC), an old chemotherapy treatment considered by specialists as the current standard of care in lupus, Aspreva Chief Medical Officer Usman Azam said. 

Although the product failed to demonstrate superiority to IVC, CellCept is known to have fewer side effects than the current standard of care. The common side effects of CellCept observed during the trial were diarrhea, headaches and peripheral edema, the abnormal buildup of fluid in the ankles, feet and legs, Azam said.

Part two of the study, which is a double-blind comparison of CellCept with azathioprine, another chemotherapy agent, is still ongoing, the company said.