Aspreva completes enrollment for phase 3 trial of CellCept for myasthenia gravis

New York, Nov. 28 - Aspreva Pharmaceuticals Corp. said that it completed enrollment of 176 patients in its phase 3 clinical study to assess the safety and efficacy of CellCept (mycophenolate mofetil) to maintain or improve symptom control with reduced corticosteroids in patients with myasthenia gravis.

The Vancouver, B.C.-based pharmaceutical company said the trial is on schedule and it expects to complete the research late in 2006.

The randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of CellCept to maintain or improve symptom control with reduced corticosteroids in patients with myasthenia gravis over a treatment period of 36 weeks. The primary endpoint is both minimal disease activity and low steroid dose.

Myasthenia gravis affects 70,000 to 100,000 people worldwide, including 36,000 in the United States. It is a debilitating, chronic autoimmune neuromuscular disease in which the body produces auto-antibodies which prevent the nerves from sending messages to the muscles. It frequently involves muscles controlling eye movements, chewing, swallowing, coughing and facial expressions, but can be more severe in some of the affected patients.

CellCept is F. Hoffmann-La Roche's leading 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.

In October 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.

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