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Patient Dosing Begins for Phase 3 Study of Mycophenolate Mofetil
Aspreva's phase III Lupus Management Study will be one of the largest Phase III studies conducted in lupus nephritis. The study aims to enrol 358 patients with biopsy proven lupus nephritis in over 100 centres worldwide.
Systemic lupus erythematosus (SLE), commonly called lupus, is a chronic autoimmune disease that causes the body to attack its own tissues and joints. Lupus nephritis is the most serious manifestation of this disease which left untreated, can lead to kidney failure, requiring dialysis. It is a complicated disease as patients typically fluctuate between periods of intense disease activity when the patient's own immune system is actively attacking and causing damage in their kidney, interspersed with periods of remission.
The two-phase induction to maintenance study is a randomized open label comparison of CellCept with the current standard of care cyclophosphamide for the first six months, followed by a double-blind comparison of CellCept to azathioprine for up to three years. This study will assess the efficacy and safety of CellCept in inducing and maintaining remission in patients with lupus nephritis. Results from the first phase of the study are expected in late 2006, submission of a regulatory filing is expected in mid to late 2007.
"Our goal is to develop a new treatment option for patients with lupus nephritis; it has been over 30 years since these patients have had hope for a new treatment with better efficacy and fewer side effects compared with the current standard of care. This is the third and largest phase III pivotal program Aspreva has initiated for autoimmune indications over the past 15 months and is a testament to the tremendous collective effort of the Roche and Aspreva collaboration," said Richard M. Glickman, Aspreva's Chairman and Chief Executive Officer.
"This study marks an important milestone in this innovative partnership with Aspreva. It demonstrates our collective success in developing globally supported clinical programs for CellCept for complex autoimmune diseases," said Peter Hug, Global Head of Roche Pharma Partnering. "Together we are working to extend the use of our leading transplant medicine to meet the needs of underserved patients."
Systemic lupus erythematosus (SLE), commonly referred to as lupus, is a complex autoimmune disease affecting numerous organs and tissues. The immune system, which typically fights off viruses and bacteria, loses the ability to differentiate between foreign substances (antigens) and its own cells and tissues. The involvement of the kidney, known as lupus nephritis, is considered to be the most serious manifestation of SLE.
There has been no new approved treatment for SLE or lupus nephritis in the United States in the last thirty years. Current treatments involve the off-label use of existing cancer drugs such as cyclophosphamide, steroids, and other immunosuppressant drugs such as azathioprine.
CellCept is an immunosuppressant or "anti-rejection" drug used in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving heart, kidney and liver transplants. CellCept was first approved for use in combination therapy for the prevention of acute organ rejection in kidney transplantation in 1995 and has since been approved worldwide for prevention of organ rejection in adult kidney, heart and liver transplantation. In some countries, it is also approved for paediatric kidney transplantation. This therapeutic success represents 10 years of clinical experience and patient benefits, including reduced toxicities and prolonged graft and patient survival. Over the last decade, CellCept has become the world's most widely studied immunosuppressant and research is ongoing both in organ transplantation and related areas, such as autoimmune disease, to help provide clinical benefit to a wider range of patients.
CellCept is not currently approved for the treatment of either lupus erythematosus or lupus nephritis.
Source: Aspreva Pharmaceuticals Corporation