Aspreva Pharmaceuticals Corporation, an emerging pharmaceutical company focused on increasing the pool of evidence-based medicines available for patients living with less common diseases, today announced completion of patient enrolment in a global phase III clinical study. The study is designed to assess the safety and efficacy of CellCept (mycophenolate mofetil) in association with corticosteroids to achieve remission in patients with active pemphigus vulgaris (PV).
The randomized, double-blind, placebo-controlled comparison study will investigate the efficacy and safety of mycophenolate mofetil in 77 patients with active PV 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. The Company expects to complete the study in 2007.
"With the completion of patient enrolment in the second of our three global, phase III clinical trials currently underway, Aspreva has clearly demonstrated expertise in the development and execution of challenging clinical programs, and further reinforced the value proposition the Company offers to potential partners in the pharmaceutical industry. We are now one step closer in the development of a potentially new evidence-based treatment option for patients living with this rare disease," said Dr. Reinhard Baildon, M.D., Ph.D., Executive Vice President, Clinical & Regulatory Affairs at Aspreva.