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Published on 7 February 2008

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Results announced for phase III trial of Gamunex in CIDP patients

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In the largest trial ever reported in CIDP (chronic inflammatory demyelinating polyradiculoneuropathy), Gamunex® (immune globulin intravenous [human], 10% caprylate/chromatography purified) offered positive results.

The medication shown to reduce functional disability, while also demonstrating a prolonged time to relapse and a decreased probability of relapse longer-term (up to one year).

The primary endpoint, response in functional disability, was observed in 54 percent of subjects treated with Gamunex (2g/kg loading dose, followed by 1g/kg maintenance dose every three weeks) compared to 21 percent on placebo when assessed up to six months in the first treatment period.

Longer-term (up to one year), the probability of relapse was lower with Gamunex compared to placebo, 13 percent versus 45 percent, respectively. The use of Gamunex in the treatment of CIDP is investigational and has not been approved by the FDA.

The study, published last week in The Lancet Neurology entitled “Intravenous immune globulin (10 percent caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomized, placebo-controlled trial,” was sponsored by Talecris Biotherapeutics, Inc.

Conducted as a multicentre, multinational clinical trial in centres in Europe, the Middle East, and North and South America, the trial randomised 117 subjects with CIDP.

CIDP is a progressive or relapsing disease affecting two to seven individuals per 100,000 worldwide. Its course is variable. The most common symptom patients experience is progressive weakness in the arms and legs resulting in disability.

“The ICE study is important for two key reasons,” said Peter Donofrio, MD, study co-author and Professor of Medicine, Department of Neurology, Vanderbilt University, Nashville, Tennessee, USA.

“First, it shows that Gamunex was superior to placebo in this study in reducing functional disability and improving grip strength in CIDP subjects. Second, Gamunex was shown to lengthen the time to relapse during the six month to one year period of the study.”

Talecris Biotherapeutics



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