Nanotechnology Now

Our NanoNews Digest Sponsors

Heifer International

Wikipedia Affiliate Button

Home > Press > Arrowhead Receives Regulatory Approval to Begin Phase 2a Trial of Chronic Hepatitis B Candidate ARC-520

Abstract:
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it received regulatory approval to begin a Phase 2a clinical trial of ARC-520, its RNAi-based drug candidate for the treatment of chronic hepatitis B virus (HBV) infection. 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 to be conducted at Queen Mary Hospital and Prince of Wales Hospital in Hong Kong. A site initiation was completed and patient screening will initiate shortly. The Company expects top line study results to be available in the third quarter of 2014.

Arrowhead Receives Regulatory Approval to Begin Phase 2a Trial of Chronic Hepatitis B Candidate ARC-520

Pasadena, CA | Posted on March 3rd, 2014

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 (HBsAg) reduction after a single intravenous dose of ARC-520 in combination with entecavir in patients with chronic HBV infection. Single doses of ARC-520 will be evaluated at up to two ascending doses of 1.0 mg/kg and 2.0 mg/kg. At each of the two dose levels to be evaluated, a cohort of 8 patients will be enrolled with 6 being dosed with ARC-520 and 2 being dosed with placebo. 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 (HBeAg) 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 (PK) measures. Additional exploratory pharmacodynamics (PD) objectives include evaluation of the effect of ARC-520 on HBV DNA serum titers and antibodies to HBsAg (anti-HBs).

####

About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary drug delivery technologies to develop targeted drugs based on the RNA interference mechanism that efficiently silence disease-causing genes. Arrowhead technologies also enable partners to create peptide-drug conjugates that specifically home to cell types of interest while sparing off-target tissues. Arrowhead's pipeline includes clinical programs in chronic hepatitis B virus and obesity and partner-based programs in oncology.

For more information please visit www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company's email list to receive news directly, please send an email to

About ARC-520

Arrowhead's RNAi-based candidate ARC-520 is designed to treat chronic HBV infection by reducing the expression and release of new viral particles and key viral proteins. The goal is to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. The siRNAs in ARC-520 intervene at the mRNA level, upstream of where nucleotide and nucleoside analogues act. In transient and transgenic mouse models of HBV infection, a single co-injection of Arrowhead's DPC delivery vehicle with cholesterol-conjugated siRNA targeting HBV sequences resulted in multi-log knockdown of HBV RNA, proteins and viral DNA with long duration of effect. Arrowhead has completed enrollment in a Phase 1 single ascending dose study in normal volunteers. The company is conducting a single dose Phase 2a study in chronic HBV patients, which it expects to follow with a multi dose, multi national Phase 2b study. Approximately 350 million people worldwide are chronically infected with the hepatitis B virus. Chronic HBV infection can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

For more information, please click here

Contacts:
Arrowhead Research Corporation
Vince Anzalone, CFA
626-304-3400

The Trout Group
Lauren Glaser
646-378-2972

Copyright © Arrowhead Research Corporation

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

Govt.-Legislation/Regulation/Funding/Policy

Researchers develop microbubble scrubber to destroy dangerous biofilms September 19th, 2018

Researchers managed to prevent the disappearing of quantum information September 14th, 2018

New photonic chip promises more robust quantum computers September 14th, 2018

Could a demon help to create a quantum computer? Physicists implement a version of Maxwell's famous thought experiment for reducing entropy September 5th, 2018

Nanomedicine

Nanobiotix: Update on Head and Neck Phase I/II Trial with NBTXR3 and Other program data presented at ImmunoRad 2018 September 20th, 2018

NUS researchers invent new test kit for quick, accurate and low-cost screening of diseases: Test results are denoted by a color change and could be further analyzed by a smartphone app, making it attractive as a point-of-care diagnostic device September 19th, 2018

Researchers develop microbubble scrubber to destroy dangerous biofilms September 19th, 2018

Halas wins American Chemical Society Award in Colloid Chemistry: Rice University nanophotonics pioneer honored for colloid research September 18th, 2018

Announcements

Nanobiotix: Update on Head and Neck Phase I/II Trial with NBTXR3 and Other program data presented at ImmunoRad 2018 September 20th, 2018

NUS researchers invent new test kit for quick, accurate and low-cost screening of diseases: Test results are denoted by a color change and could be further analyzed by a smartphone app, making it attractive as a point-of-care diagnostic device September 19th, 2018

Silver nanoparticles are toxic for aquatic organisms: A research team at the UPV/EHU-University of the Basque Country has analysed how zebrafish are affected in the long term by exposure to silver particles September 19th, 2018

Leti Announces EU Project to Develop Powerful, Inexpensive Sensors with Photonic Integrated Circuits: REDFINCH Members Initially Targeting Applications for Gas Detection and Analysis For Refineries & Petrochemical Industry and Protein Analysis for Dairy Industry September 19th, 2018

New-Contracts/Sales/Customers

Nanometrics Delivers 100th: Atlas III System for Advanced Process Control Metrology Atlas III: Systems are qualified and in production for advanced devices in DRAM, 3D-NAND and Foundry/Logic August 2nd, 2018

Picosunís ALD solutions make quality watches tick July 26th, 2018

Barium ruthenate: A high-yield, easy-to-handle perovskite catalyst for the oxidation of sulfides July 13th, 2018

Oxford Instrumentsí 22 Tesla superconducting magnet system commissioned at the UAM, making it the most intense magnetic field available outside a large international facility July 12th, 2018

NanoNews-Digest
The latest news from around the world, FREE



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project