Aspreva completes enrollment in CellCept trial studying rare blister disease

By Elaine Rigoli

Tampa, Fla., March 30 - Aspreva Pharmaceuticals Corp. has completed its patient enrollment in a global phase 3 clinical study to assess the safety and efficacy of immunosuppressant CellCept (mycophenolate mofetil) in association with corticosteroids to achieve remission in patients with active pemphigus vulgaris.

The randomized, double-blind, placebo-controlled comparison study will investigate the efficacy and safety of mycophenolate mofetil in 77 patients with active pemphigus vulgaris over a treatment period of 52 weeks, according to a news release.

The primary endpoint encompasses both minimal disease activity defined as no new persistent lesions, with a low steroid dose, the release said.

Aspreva said it expects to complete the study in 2007.

Pemphigus vulgaris is a rare, severe, chronic autoimmune disease that causes blisters of the skin and mucous membranes. According to the International Pemphigus Foundation, the disease affects about 40,000 people worldwide.

Aspreva is an emerging pharmaceutical company focused on identifying, developing and, upon regulatory approval, commercializing new indications for approved drugs and late-stage drug candidates for patients living with less-common diseases.

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