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Positive interim analysis of blisibimod (Anthera Pharma) clinical trial for SLE

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Last updated: 7th Mar 2012
Published: 7th Mar 2012
Source: Pharmawand
The Phase IIb PEARL-SC clinical study of blisibimod, from Anthera Pharma, for Systemic Lupus Erythematosus (SLE) is recommended for continuation following an interim analysis of all safety and efficacy data. Following the review by the Company's Data Safety Monitoring Board, the study will proceed as planned without modification. PEARL-SC is examining the therapeutic benefit of weekly and monthly subcutaneous injections of blisibimod in patients with active and antibody positive SLE. The clinical study enrolled 547 patients in 11 countries and 72 clinical sites worldwide. The primary endpoint is clinical improvement at 24 weeks in an SLE responder index � a composite responder index evaluating various patient and physician reported clinical disease activity. Top line efficacy data from the study is expected in the second quarter of 2012.
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