Alexion Completes Phase I Dermatomyositis Pilot Safety Study.(Brief Article)

2002 JAN 16 - (NewsRx.com & NewsRx.net) -- Alexion Pharmaceuticals, Inc., announced that it has completed a two-month Phase I pilot safety trial in dermatomyositis patients with its humanized monoclonal antibody C5 complement inhibitor, 5G1.1.

In this 13 patient pilot trial, 5G1.1 appeared to be well tolerated and to be associated with an improvement in skin rash. Dermatomyositis is a connective tissue disease associated with both skin and muscle inflammation resulting in severe skin rash and muscle weakness. Alexion has previously received orphan drug status for 5G1.1 in this disease setting.

"This exploratory pilot trial fulfilled our expectations of identifying a positive signal of 5G1.1 treatment in these dermatomyositis patients. We are pleased by the consistency of both the clinical and biopsy skin results, particularly as they were obtained with only two months of treatment," stated Leonard Bell, MD, Alexion. "We are encouraged by the results of this initial trial and are eager to continue development in this orphan indication, pending discussions with the U.S. Food and Drug Administration (FDA)."

In this randomized, placebo-controlled multicenter trial, 13 patients with persistent dermatomyositis undergoing concomitant treatment with moderate doses of methotrexate or steroids were evaluated in either a placebo (n=3) or a single drug treatment (n=10) arm. Drug treatment consisted of 5G1.1 at 8 mg/kg intravenous injection once per week for five weeks and then every two weeks for up to two months. The patients were evaluated after two months of treatment for safety and for trends in clinical improvement.

The primary ...