Roche announces preliminary phase III CellCept results

In conjunction with Aspreva Pharmaceuticals, Roche has presented the preliminary results of a phase III clinical trial comparing the use of CellCept (mycophenolate mofetil, MMF) to intravenous cyclophosphamide (IVC) in lupus nephritis patients.

CellCept is an immunosuppressant from Roche that is used in combination with cyclosporine and corticosteroids to prevent the rejection of organs in transplant patients.

Roche notes that a similar response was exhibited by both patient groups, with those administered with MMF showing a 56.2 per cent response rate and those receiving IVC displaying a response rate of 53 per cent.

The companies will now conduct further analyses of these results to assess the likelihood of a submission to regulatory authorities, while Aspreva Pharmaceuticals will prepare the final results for presentation at an appropriate scientific forum.

“Although response rates were similar in both arms, the trial did not meet its primary objective of demonstrating that MMF was superior to IVC in inducing treatment response in this disease,” Roche reports.

The company adds that the adverse event profile was comparable in both patient groups and also consistent to those seen in lupus nephritis patients administered with an immunosuppressive therapy.

In June 2006, Roche announced that CellCept had been granted orphan drug designation by the US Food and Drug Administration, as the compound is designed for rare diseases and is unlikely to experience large sales.