Preliminary Results For Phase III Study Evaluating CellCept In Lupus Nephritis

Main Category: Lupus
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 16 Jul 2007 - 0:00 PDT

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Aspreva Pharmaceuticals Corporation and Roche today released preliminary results for a clinical phase III trial comparing CellCept (oral mycophenolate mofetil, MMF) to intravenous cyclophosphamide (IVC), which is the current standard of care, for inducing treatment response in the induction phase of patients suffering from lupus nephritis.

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. The results relate to the induction phase of this study, which was designed to measure treatment response in patients after 24 weeks of induction therapy with 185 patients in the MMF arm and 185 in the IVC arm. The results indicate similar treatment responses were observed, with 56.2% in the MMF arm and 53% in the IVC arm. Additional analyses are ongoing to determine the potential for regulatory submission, and Aspreva plans to present the final results at an appropriate scientific forum in the future.

Based on preliminary analysis, it appears that, in general, the adverse events experienced by patients in both arms of the study are consistent with those observed in lupus nephritis patients receiving immunosuppressive therapy. Overall incidence of adverse events was comparable in both treatment arms.

About Lupus Nephritis

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, considered life threatening but rare, is the most serious manifestation of the disease, which, if left untreated, can lead to kidney failure, requiring dialysis and potentially death. 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. Clinicians estimate that one third to one half of lupus patients have lupus nephritis. There has been no new approved treatment for SLE or lupus nephritis in the United States in over forty years. Current treatments involve the off-label use of existing cancer drugs such as cyclophosphamide, steroids, and other immunosuppressant drugs such as azathioprine.

About CellCept

CellCept is Roche's leading immunosuppressant or "anti-rejection" drug. It is 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. This therapeutic success in the prevention of organ rejection in adult kidney, heart and liver transplantation represents 11 years of clinical experience and patient benefits, including reduced toxicities and prolonged graft and patient survival. In July 2003, Aspreva signed a collaboration agreement with Roche for the exclusive worldwide rights (excluding Japan) to develop and, upon regulatory approval, commercialise CellCept for all autoimmune disease applications. It is important to note that CellCept has not been approved by the FDA for the treatment of any autoimmune disease.

About Aspreva Pharmaceuticals

Aspreva is a global pharmaceutical company focused on identifying, developing, and, upon approval, commercialising evidence-based medicines for patients living with less common diseases. Aspreva common stock is traded on the NASDAQ Global Select Market under the trading symbol "ASPV" and on the Toronto Stock Exchange under the trading symbol "ASV". Learn more at http://www.aspreva.com.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at http://www.roche.com.