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News Breaks | | | | February 11, 2013 | | 07:02 EDT |  | GEVA, LH | Synageva initiates dosing in Phase 3 Sebelipase Alfa trial
Synageva BioPharma (GEVA) announced that the first patient initiated treatment in the ARISE trial, a global, Phase 3, randomized, double-blind, placebo-controlled study of sebelipase alfa in children and adults with late onset lysosomal acid lipase deficiency. The ARISE trial will enroll 50 patients with late onset LAL Deficiency. Patients enrolled in the trial are randomized on a one-to-one basis to every other week infusions of sebelipase alfa, or placebo for the double-blind treatment period of 20 weeks. The primary endpoint of the trial is the proportion of patients relative to placebo who achieve normalization of alanine aminotransferase, a marker of liver damage, at the completion of the double-blind treatment period. Key secondary endpoints include the relative reduction from baseline to week 20 in LDL-C, non-HDL-C, triglycerides, the proportion of patients who achieve aspartate aminotransaminase normalization, and the relative increase in HDL-C. Additional secondary endpoints, including reductions in liver fat content and liver volume and improvements in liver pathology, will be examined in a proportion of patients who undergo these assessments. Deficiency of LAL enzyme activity will be confirmed during patient screening with a dried blood spot biochemical enzyme activity assay performed by Laboratory Corporation of America Holdings (LH), the central diagnostic testing laboratory performing the tests. | |
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News For GEVA;LH From The Last 14 Days Check below for free stories on GEVA;LH the last two weeks. |
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| May 20, 2013 | | 07:14 EDT | | GEVA | Synageva says FDA grants 'Breakthrough Therapy' designation to sebelipase alfa
 Subscribe for More Information | | | May 16, 2013 | | 08:28 EDT |  | GEVA | Synageva has a conference call hosted by JPMorgan
Subscribe for More Information | | | May 10, 2013 | | 14:43 EDT |  | LH | Proposed reimbursement rates positive for LabCorp, Quest, says Piper Jaffray
Subscribe for More Information | | | 08:05 EDT |  | GEVA | Synageva downgraded to Neutral from Overweight at JPMorgan
JPMorgan downgraded Synageva citing concerns that the enrollment could be challenging for the sebelipase alfa Phase 3 trial. The firm lowered its price target for shares to $50 from $57. | | | May 9, 2013 | | 07:15 EDT | | GEVA | Synageva's sebelipase alfa shows sustained effects and treatment tolerance
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