- Program and Pipeline Highlights
- Submitted a pre-IND data package and subsequently completed a pre-IND meeting with the FDA on hepatitis B candidate ARC-520;
- Advanced ARC-520 into final IND-enabling steps, with IND filing expected in Q2 2013;
- Presented data on new DPC subcutaneous formulation showing 99% target gene knockdown in non-human primates without toxicity;
- Published studies in the journal Nucleic Acid Therapeutics demonstrating high levels of knockdown in non-human primates using cholesterol-conjugated siRNA, DPCs, and a novel co-injection strategy;
- Received additional patents on the DPC siRNA delivery system;
- Established a Clinical Advisory Board for hepatitis B including prominent hepatologist Dr. Robert G. Gish;
- Began dosing patients with anti-obesity treatment Adipotide ® in a phase 1 clinical trial;
- Completed patient dosing in a phase 1b trial of CALAA-01;
- Enrollment of a randomized phase 2 clinical study of partnered candidate CRLX101 (formerly IT-101) in non-small cell lung cancer completed by licensee Cerulean Pharma, with overall survival data expected in early 2013.
- Business Development Highlights
- Entered into a Collaboration and License Agreement with Shire for peptide-targeted therapeutics;
- Entered into an Evaluation Agreement with Merck for a monoclonal antibody candidate.
- Financial Highlights
- Strengthened the balance sheet through equity financings with gross proceeds of $10.5 million.
Arrowhead Reports Fiscal 2012 Fourth Quarter And Year-End Financial Results
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