Aspreva Pharmaceuticals Corporation announced that the company and Roche would not proceed with a regulatory submission for CellCept as an induction therapy for lupus nephritis, as of now.
Earlier, in June 2007, the company had released preliminary results from the induction stage of its phase III clinical trial comparing CellCept (oral mycophenolate mofetil, MMF) to intravenous cyclophosphamide (IVC) for inducing treatment response in patients with lupus nephritis. These initial results showed that, although response rates were similar in both arms of the study, the induction stage of the trial did not meet its primary objective of demonstrating that MMF was superior to IVC in inducing treatment response in this disease, a company press release said.
Aspreva has plans to present the full results and analysis of the induction phase of the trial at an upcoming scientific forum, the release added.
"Although we believe that the data from this first part of the study does not adequately support a regulatory submission, we are proud of the increased spotlight that lupus nephritis has received thus far as a result of our work to evaluate a treatment option for this disease, for which there has not been a new drug approved in over forty years," said Dr. J. William Freytag, chairman and CEO, Aspreva.
"By conducting this trial, Aspreva has and will continue to have an impact on informing clinical decisions in the treatment of lupus nephritis and, with the maintenance phase of our lupus nephritis trial still in progress, we are committed to further increasing the body of scientific evidence to support the better understanding of the treatment options available to patients with this disease," he added.
Aspreva's lupus nephritis study is one of the largest phase III studies ever conducted in lupus nephritis. This two-phase induction to maintenance study was designed as a randomised open label comparison of MMF with IVC for the first six months (induction phase), followed by a double-blind comparison of MMF to azathioprine for up to three years (maintenance phase).
The patients who were successfully completed the induction phase of the lupus nephritis study were re-randomised into the maintenance phase, a blinded study comparing MMF to azathioprine in maintaining remission and renal function in subjects with lupus nephritis. Patients will remain in this study until they have a relapse of disease, need a treatment that the protocol does not allow, or withdraw for any other reason. The study will continue until a predetermined number of patients have left the study or for a maximum of 36 months.
Systemic lupus erythematosus (SLE), commonly called lupus, is a chronic autoimmune disease that causes the body to attack its own tissues and joints.
CellCept (mycophenolate mofetil, MMF) is an immunosuppressant or anti-rejection drug approved for use in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving kidney, heart and liver transplants.