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Anthera Pharmaceuticals Reports 2011 Fourth Quarter Financial Results and Provides Clinical Progress Update
Date:2/21/2012

core, no worsening in physician global assessment, and no new BILAG A or two new BILAG B organ domain scores.  Details regarding the study can be found at http://www.clinicaltrials.gov.
  • After the completion of enrollment in the PEARL-SC study, an independent statistician confirmed that weekly and monthly subcutaneous doses of blisibimod resulted in statistically significant reductions of B-cells. Elevations in these B-cells have been associated with an increased risk of disease activity in lupus patients. These findings are consistent with data from previous clinical studies of blisibimod. The Company remains blinded to primary efficacy data.
  • Subsequent to the end of the fourth quarter, the 350th enrolled patient in the PEARL-SC study reached the 24-week time point, triggering an interim efficacy analysis to be conducted in the first week of March 2012.  The interim efficacy analysis plan for PEARL-SC allows for a recommendation by the independent statistician to stop the study should there be a statistically significant improvement in the pooled blisibimod arm versus the pooled placebo treatment arm (p<0.0108) at the 24-week primary efficacy endpoint and at least one other time point, including week 16, 20 or 28, using the SLE responder index.  The SLE responder index is a composite responder index evaluating various patient and physician reported clinical disease activity including a SELENA/SLEDAI* improvement of five (5) points or greater, no increase in a physician's global assessment of more than 0.3 points, and no new BILAG A or two new BILAG B organ domain flares.  In conjunction with the interim analysis, the DSMB will meet for the fourth time to evaluate all available patient safety data.

  • Manufacturing

  • The Company completed its second 3,000 liter blisibimod manufacturing campaign.  Both lots have passed all release testing having
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  • SOURCE Anthera Pharmaceuticals, Inc.
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