Oxford BioMedica Wins IND Approval for Gene-based Therapy
The Phase I/IIa study will enroll around 18 patients with Usher syndrome type 1B and assess three dose levels of UshStat for safety, tolerability and aspects of biological activity.
UK biopharmaceutical company Oxford BioMedica has received US FDA approval 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. The trial is likely to begin by the end of 2011.
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 study will assess three dose levels of
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