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Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1/2 Study of ARO-HBV
PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it filed a regulatory submission to begin a Phase 1/2 study of ARO-HBV, which is being developed as a potentially curative therapy for patients with chronic hepatitis B virus (HBV) infection. Pending approval, Arrowhead intends to proceed with AROHBV1001, a Phase 1/2 single-dose escalation study to evaluate the safety, tolerability, and pharmacokinetic effects of ARO-HBV in healthy adult volunteers, as well as a multiple-dose escalation study to evaluate the safety, tolerability, and pharmacodynamic effects in HBV patients.
Chris Anzalone, Ph.D., president and CEO of Arrowhead Pharmaceuticals, said: "ARO-HBV is designed to silence all HBV gene products, including transcripts from both cccDNA and integrated DNA. We believe ARO-HBV, as a key component of combination therapies, may allow the body's natural immune defenses to control the virus and lead to a functional cure. The clinical data that we recently presented at HEP DART 2017 indicate that our prior generation compound, ARC-520, achieved a Sustained Host Response in half of the previously treatment-naïve patients chronically treated in that study, which we think bodes very well for ARO-HBV. The regulatory filing announced today is substantially ahead of schedule and we are excited to move into the clinic with multiple new compounds that leverage our Targeted RNAi Molecule, or TRiMTM, platform during 2018."
The application for approval of the clinical trial was submitted to the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for review by the Standing Committee on Therapeutic Trials (SCOTT), as well as the local Ethics Committee.
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发表于 2017-12-22 20:35
