Rituxan fails Ph III lupus nephritis trial

Biotechnology major Genentech and fellow US firm Biogen Idec said that Rituxan (rituximab) plus mycophenolate mofetil and corticosteroids in  patients with lupus nephritis missed its primary endpoint of  significantly reducing disease activity at 52 weeks in a late-stage  clinical evaluation.

The trial evaluated improvements in kidney response as measured by  standard laboratory tests used to assess kidney health. A preliminary  analysis of the safety data did not reveal any new or unexpected safety  signals in patients receiving Rituxan, the firms noted.

"We are disappointed that Rituxan did not show a significant benefit in  patients with lupus nephritis, a complex and serious disease. Using the  insights from this study, we will continue to look for new approaches to  the treatment of lupus," said Hal Barron, Genentech's senior vice  president, development, and chief medical officer. Evan Beckman,  Biogen Idec's senior vice president of immunology R&D added: "we plan to  analyze the full set of data from this study and share the findings at  an upcoming scientific meeting."