Oxford BioMedica gets FDA IND approval for UshStat therapy

19th October 2011 (Last Updated October 19th, 2011 18:30)

Oxford BioMedica has received US Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for the Phase I/IIa clinical development of UshStat, a gene-based therapy for the treatment of Usher syndrome 1B.

Oxford BioMedica has received US Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for the Phase I/IIa clinical development of UshStat, a gene-based therapy for the treatment of Usher syndrome 1B.

UshStat was developed using the company's proprietary LentiVector platform technology to deliver a corrected version of the MYO7A gene to address the vision loss associated with the disease.

The open label, dose escalation Phase I/IIa study will enroll around 18 patients with Usher syndrome type 1B at Oregon Health and Science University's Casey Eye Institute, Portland, Oregon, US.

The trial, which is likely to begin by the end of 2011, will assess three dose levels of UshStat for safety, tolerability and aspects of biological activity.