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News Breaks
July 23, 2013
07:38 EDTARWRArrowHead begins phase 1 trial of ARC-520 for Hepatitis B infection treatment
Arrowhead Research announced that it has initiated dosing in a Phase 1 clinical trial of ARC-520, the companyís candidate for the treatment of chronic hepatitis B virus infection. Trial initiation followed successful completion of the Clinical Trial Notification regulatory process in Australia. The objectives of the study are to characterize the safety profile of ARC-520, determine maximum tolerated dose, and evaluate pharmacokinetics in healthy volunteers.The Phase 1 trial is a single-center, randomized, double-blind, placebo-controlled, single dose-escalation, first-in-human study of ARC-520 administered intravenously to healthy adult volunteers and is being conducted in Melbourne, Australia. Each dose cohort includes 6 subjects randomized at ratio of 1:2 to receive a single intravenous injection of either placebo or ARC-520. Arrowhead expects to complete this Phase 1 trial in Q4 and begin a Phase 2a trial in chronic HBV patients in 2014.
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December 15, 2014
07:33 EDTARWRArrowhead submits IND for ARC-520 to begin Phase 2b studies
Arrowhead Research announced that it submitted an Investigational New Drug application to the U.S. Food and Drug Administration for ARC-520, itís drug candidate for the treatment of chronic hepatitis B virus infection. Arrowhead plans to submit additional clinical trial authorization applications with regulatory authorities in various jurisdictions in Europe and Asia. Pending national regulatory review and approval, Arrowhead intends to initiate two Phase 2b, multicenter, randomized, double-blind, placebo-controlled, multi-dose studies to determine the depth of hepatitis B surface antigen reduction following ARC-520 injection in combination with entecavir or tenofovir in patients with chronic immune active HBV infection. The Heparc-2002 study is planned to include patients who are negative for hepatitis B e-antigen at screening and the Heparc-2003 study is planned to include patients who are positive for HBeAg at screening. The primary objective is to evaluate the depth of HBsAg decline in response to multiple doses of ARC-520 compared to placebo in patients with chronic HBV infection as a measure of drug activity. Secondary objectives are to assess measures of safety and tolerability and to evaluate multi-dose pharmacokinetics of ARC-520 in patients with chronic HBV infection when co-administered with a fixed dose of entecavir or tenofovir, in addition to other exploratory safety and pharmacodynamic objectives.
December 11, 2014
13:09 EDTARWRArrowhead mentioned positively by Agora Financial
Agora Financial believes investors can "double [their] money ó virtually overnight." and have a "realistic chance" to make "up to 10 times [their] money" by investing in Arrowhead Research, according to a new research report from the firm. Arrowhead shares are up nearly 10% to $5.98 in afternoon trading. Reference Link

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