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March 3, 2014
07:33 EDTARWRArrowhead receives approval to begin ARC-520 Phase 2a trial
Arrowhead Research announced that it received regulatory approval to begin a Phase 2a clinical trial of ARC-520. The Hong Kong Department of Health issued a Certificate for clinical trial, allowing the company to proceed with its planned single-dose study of ARC-520 in two cohorts at two dose levels. A site initiation was completed and patient screening will initiate shortly. The company expects top line study results to be available in 3Q14. The Phase 2a study is a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to determine the depth and duration of hepatitis B surface antigen reduction after a single intravenous dose of ARC-520 in combination with entecavir in patients with chronic HBV infection. This study will be conducted in adult male and female patients aged 16 to 65 years, with immune active chronic HBV infection, HBV e antigen negativity, and ongoing entecavir therapy. The primary objective of the study is to evaluate the depth and duration of HBsAg decline in response to a single dose of ARC-520 in combination with entecavir. Secondary objectives include evaluation of safety and tolerability and pharmacokinetic measures.
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September 17, 2014
14:54 EDTARWRArrowhead Research November volatility elevated into Phase IIb trial data
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07:36 EDTARWRArrowhead outlook positive, says RBC Capital
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