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Aspreva Completes Expanded Patient Enrollment In Phase III Clinical Trialfor CellCept In Pemphigus Vulgaris
06/04/07
Aspreva Pharmaceuticals Corporation (NASDAQ: ASPV; TSX: ASV) today announced successful completion of patient enrollment in their global phase III clinical trial designed to assess the safety and efficacy of CellCept(R) (mycophenolate mofetil) in association with corticosteroids to achieve remission in patients with active pemphigus vulgaris. The total number of patients enrolled in this pemphigus vulgaris study is 96. Today's announcement represents a new patient total for this trial following the re-opening of patient recruitment in late 2006 as a result of a protocol amendment requested by the US Food & Drug Administration to increase the statistical power of the study. Dr. Usman Azam, Aspreva's Chief Medical Officer, said: "By strengthening the statistical power of this study, we have improved our ability to assess the potential efficacy of mycophenolate mofetil in the treatment of this complicated and rare disease. Ultimately our goal is to add to the pool of evidence-based treatment options for patients with less common diseases and this study is another step towards that goal." This randomized, double-blind, placebo-controlled comparison study is designed to investigate the efficacy and safety of mycophenolate mofetil in patients with active pemphigus vulgaris over a treatment period of 52 weeks. The primary end-point encompasses both minimal disease activity, defined as no new persistent lesions, with a low steroid dose. Aspreva expects to complete the study in 2008. About Pemphigus Vulgaris Pemphigus Vulgaris is a rare, severe, and chronic autoimmune disease that causes blisters of the skin and mucous membranes. According to the International Pemphigus Foundation, the disease affects approximately 40,000 people worldwide. People suffering from this disease develop fragile skin blisters which may burst, leaving raw, crusted areas, which may cover large areas of the body's surface. Pemphigus vulgaris often begins with oral lesions, which may become painful, leaving patients unable to eat or drink, which may lead to malnutrition and debilitation. 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. 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. In July 2003, Aspreva signed a collaboration agreement with Roche for the exclusive worldwide rights (excluding Japan) to develop and, upon regulatory approval, commercialize 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, including pemphigus vulgaris. About Aspreva Pharmaceuticals Aspreva is a global pharmaceutical company focused on identifying, developing, and, upon approval, commercializing 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

(Author: http://www.aspreva.com)

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