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News Breaks
November 27, 2012
07:08 EDTARWRArrowHead Research publishes results regarding company's Dynamic Polyconjugate
Arrowhead Research announced the publication of data demonstrating that high level target gene knockdown with low doses of cholesterol-siRNA is possible in non-human primates using the company's Dynamic Polyconjugate delivery system and a novel co-injection strategy. This new delivery approach dramatically increases the efficacy of cholesterol-siRNA and, together with the co-injection strategy, simplifies the manufacturing process to enable a commercially scalable delivery vehicle for RNAi therapeutics. The company is using this strategy and a next generation DPC polymer in ARC-520, its hepatitis B clinical candidate. The paper titled, "Co-injection of a targeted, reversibly masked endosomolytic polymer dramatically improves the efficacy of cholesterol-conjugated siRNAs in vivo," was published online ahead of print in the journal Nucleic Acid Therapeutics to be featured in the December issue
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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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