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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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November 18, 2014
07:32 EDTARWRArrowhead files for regulatory permission to begin Phase I ARC-AAT trial
Arrowhead Research recently filed an application for approval to begin a Phase 1 clinical trial of its RNAi-based therapeutic candidate, ARC-AAT, for the treatment of liver disease associated with alpha-1 antitrypsin deficiency. Pending approval, Arrowhead intends to proceed with a double blind, placebo-controlled dose escalation, Phase 1 study to determine the safety, tolerability, pharmacokinetics and effect on circulating alpha-1 antitrypsin levels of ARC-AAT in healthy volunteers and patients with alpha-1 antitrypsin deficiency. The study is planned to start in Australia in healthy volunteers and will dose escalate until predetermined levels of alpha-1 antitrypsin reduction are reached. Once these levels of protein knockdown are achieved, the study will transition into a population of patients with ZZ genotype alpha-1 antitrypsin deficiency to further evaluate escalating doses of ARC-AAT. The study is designed to enroll up to 48 subjects, including healthy volunteers and alpha-1 antitrypsin deficiency patients. The application was submitted to an ethics committee in compliance with the Clinical Trial Notification process of the Australian Department of Health and Ageing, Therapeutic Goods Administration.
November 10, 2014
09:18 EDTARWRArrowhead announces presentation of ongoing Phase 2a ARC-520 data
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