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Enrollment Complete for Phase 3 Study of Mycophenolate Mofetil To Assess Safety, Efficacy in Patients With Myasthenia Gravis
The randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of MMF to maintain or improve symptom control with reduced corticosteroids in patients with myasthenia gravis over a treatment period of 36 weeks. The primary endpoint of responder status in the trial encompasses both minimal disease activity and low steroid dose. The company expects to complete the trial in late 2006.
"The completion of enrolment for our global phase III study of MMF in MG has been achieved on schedule. This success reflects the strong interest from both patients and clinical investigators in the potential of MMF in treating this debilitating and life-threatening condition as well as our expertise in developing and executing effective clinical programs for rare diseases. We look forward to completing the study late next year," said Dr. Reinhard Baildon, M.D., Ph.D., Executive Vice President, Clinical & Regulatory Affairs at Aspreva.
About Myasthenia Gravis
According to the Myasthenia Gravis Foundation, myasthenia gravis (MG) affects approximately 70,000 to 100,000 people worldwide, including approximately 36,000 people in the United States. MG is a debilitating, chronic autoimmune neuromuscular disease in which the body produces auto- antibodies which prevent the nerves from sending messages to the muscles.
Although MG can affect any voluntary muscle, it frequently involves those controlling eye movements, chewing, swallowing, coughing and facial expressions, but can be more severe in some of the affected patients.
Complete remission is infrequent and long-term immunosuppression is usually required. Current treatments of MG include the use of cholinesterase inhibitors, steroids and other immunosuppressant drugs such as azathioprine.
Source: Aspreva Pharmaceuticals Corporation