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Anthera Pharmaceuticals Reports 2011 First Quarter Financial Results and Operational Update
Date:5/3/2011

Clinical

  • Enrollment and site initiations continue according to the Company's estimated timelines in the PEARL-SC study.  Active enrollment is underway in the following countries: United States, Mexico, Peru, Chile, the Philippines, Argentina and Colombia. PEARL-SC is examining the therapeutic benefit of A-623, which utilizes a subcutaneous formulation and modulates both soluble and membrane-bound BAFF in patients with systemic lupus erythematosus (lupus). The primary endpoint of the PEARL-SC study is an SLE responder index (SRI). Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01162681.
  • The PEARL-SC open label extension protocol has been submitted to FDA. This would allow Anthera to capture important long term safety data and optimize enrollment by giving study subjects an option to continue participation on active therapy beyond the PEARL-SC duration.
  • In the Phase 3 VISTA-16 study, enrollment surpassed the 1000 patient threshold during the first quarter, triggering a pre-defined, blinded biomarker analysis conducted by an independent statistician. The statistician examined four predefined biomarkers of cardiovascular risk and one composite responder index including sPLA2, IL-6, CRP, LDL-C and a composite analysis comparing the proportion of patients achieving an LDL-C < 70 and a CRP < 1. Subsequent to the end of the first quarter, the Company announced a favorable outcome from the biomarker analysis. The VISTA-16 clinical study is designed to reduce inflammation and the risk of subsequent secondary Major Adverse Cardiovascular Events (MACE) in high-risk patients following an ACS. Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01130246. The next substantial review of clinical safety and efficacy data is planned once 50
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  • SOURCE Anthera Pharmaceuticals, Inc.
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