Oxford Biomedica announces US IND approval for ocular product in Stargardt disease

23-Mar-2011 - United Kingdom

Oxford BioMedica plc announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for the Phase I/IIa clinical development of StarGen™, a gene-based treatment for Stargardt disease.  StarGen™ was designed and developed by Oxford BioMedica using the Company's proprietary LentiVector® platform technology and is the second programme to enter clinical development under the Phase I/II ocular collaboration agreement signed with sanofi-aventis in April 2009.

The approval of the IND follows the decision by the US Recombinant DNA Advisory Committee (RAC) to approve the StarGen™ Phase I/IIa protocol in January 2011.  Oxford BioMedica will enrol up to 28 patients with Stargardt disease in a multinational, open label, dose escalation Phase I/IIa study with planned sites in France and the US.  The study is anticipated to be initiated in Q2 2011.  Three dose levels will be evaluated for safety, tolerability and aspects of biological activity.  In the US, the study will be led by Dr Peter Francis at the Oregon Health and Science University, Portland, Oregon.  In France, Professor Jose-Alain Sahel will lead the study at the Centre Hospitalier Nationale D’Opthalmologie des Quinze-Vingts, Paris.

Under the terms of the agreement signed with sanofi-aventis in April 2009, Oxford BioMedica is responsible for the pre-clinical and initial Phase I/II studies of four lentiviral vector-based product candidates in the field of ophthalmology: RetinoStat® for “wet” age-related macular degeneration, StarGen™ for Stargardt disease, UshStat® for Usher syndrome 1B and EncorStat® for corneal graft rejection.  Oxford BioMedica will receive committed funding of up to US$24 million over the initial phase of development.  Oxford BioMedica granted sanofi-aventis a license to develop the products and an option for further development, manufacture and commercialisation on a worldwide basis.  At any time prior to or within a defined period after completion of each Phase I/II study, sanofi-aventis can exercise its option to license the products and will then assume responsibility for on-going activities.  Sanofi-aventis also has rights to broaden its license to develop the four products in additional indications, and has rights of first refusal to license other lentiviral vector-based products for the treatment of ocular diseases.

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