— RetinoStat® Progress in Phase I Study in Wet Age-Related Macular Degeneration
Oxford, UK – 22 June 2011: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), a leading gene therapy company, today announces that the first dose level of RetinoStat® is safe and well-tolerated at one month following treatment. RetinoStat® is a novel gene-based treatment for neovascular “wet” age-related macular degeneration (AMD), designed and developed by Oxford BioMedica using the Company’s proprietary LentiVector® gene delivery technology. It is the lead programme of the ocular agreement the Company signed with Sanofi (EURONEXT: SAN and NYSE: SNY) in April 2009.
The on-going Phase I study will enrol 18 patients with wet AMD at the Wilmer Eye Institute at Johns Hopkins, Baltimore (USA). Led by Professor Peter Campochiaro, the study will evaluate three dose levels and assess safety, aspects of visual acuity and ocular physiology. Three patients received the first dose level of RetinoStat® and one-month results have been assessed by the study’s independent Data Safety Monitoring Board (DSMB). First results from the study are expected to be announced in H1 2012.
Highlights of first patient cohort at one month (dose level 1)
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “This clinical study is breaking new ground as the first to directly administer a lentiviral vector-based treatment to patients in the US and the favourable safety profile of RetinoStat® is encouraging. We continue to work closely with the regulatory bodies in order to advance our novel ocular programmes as rapidly as possible and, together with Sanofi, we look forward to further progress during 2011.”
The second ocular product to enter clinical development is StarGen™, a novel gene-based treatment for Stargardt disease, and the first patient in the Phase I/IIa study was treated in the US in June 2011 at the Oregon Health & Science University’s Casey Eye Institute. StarGen™ has received European and US Orphan Drug Designation which brings development, regulatory and commercial benefits and, with no currently approved treatment, this novel product brings significant hope for the future to Stargardt patients. The next product expected to enter Phase I/II clinical development is UshStat® for the treatment of Usher syndrome type 1B in H2 2011. UshStat® has also received European and US Orphan Drug Designation.
“We are delighted to see Oxford BioMedica’s lentiviral gene therapy products successfully moving into human studies,” said Stephen Rose, Ph.D., chief research officer of the Foundation Fighting Blindness, a US non-profit organisation that provided early funding for Oxford BioMedica’s pre-clinical ocular programme. “The Company’s innovative treatments hold great promise for saving vision in people affected by a broad range of devastating eye diseases for which current treatments are limited or non-existent.”