Aspreva Pharmaceuticals Announces Preliminary Results of Phase III Trial of CellCept for Myasthenia Gravis
Aspreva Pharmaceuticals Corporation today announced that based on a preliminary review of the data, CellCept® (mycophenolate mofetil or MMF) in treating myasthenia gravis (MG) failed to meet both primary and secondary endpoints in its phase III trial.
The randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of MMF in maintaining or improving symptom control with reduced doses of corticosteroids in patients with myasthenia gravis over a treatment period of 36 weeks. The primary endpoints in the trial included minimal disease activity while maintaining a designated low steroid and cholinesterase inhibitor doses.
The preliminary analysis of the results from Aspreva's phase III trial indicates that MMF failed to meet both the primary and secondary endpoints. Aspreva's analysis also showed that MMF appeared to be generally well tolerated by the patients in the study. The most frequent adverse events were diarrhea, muscle spasms and other symptoms related to the disease.
As previously announced, Aspreva will hold a conference call and webcast beginning at 5:00 pm Eastern Time (2:00 p.m. Pacific Time) on Wednesday, November 1st, and will use this opportunity to discuss these results and to release its full financial and business results for the third quarter 2006.
Myasthenia gravis is a disease of the immune system attacking the own body. Antibodies to the acetylcholine receptor (a transmitter of cell signals) at the neuromuscular junction block the transmission of nerve impulses that normally acetylcholine would provide. This causes a progressive weakness to the patient.
MMF is an immunosupressive drug that prevents T and B lymphocytes from being able to proliferate and grow and stops antibody production from B cells.
(NASDAQ: ASPV; TSX: ASV)closed todays trading down 14% to $18.99.
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