NEW YORK (GenomeWeb) – Officials from Arrowhead Research disclosed
this week that it has submitted to the US Food and Drug Administration
an amended protocol for a planned Phase IIb trial of its siRNA-based
hepatitis B therapy ARC-520, which the agency had put on partial hold
amid concerns about the size of doses being tested.
According to
COO Bruce Given, the company does not expect the changes to impact the
overall timing of the company's ARC-520 development strategy, which
includes planned clinical trials in Europe and Asia. However, speaking
during a conference call held to discuss Arrowhead's fiscal first
quarter financial results, he stressed that the firm will not go forward
with its US trial "until the FDA has blessed the new design."
Read more...Labels: ARC-520 Phase 2b Study Update, Arrowhead