Oxford, UK – 5 May 2015: Oxford BioMedica plc (LSE: OXB), (“the Company”) the leading gene and cell therapy based biopharmaceutical company, today announces that results from the 21 patients in its Phase I study of RetinoStat®, a lentiviral vector based treatment for severe wet age-related macular degeneration AMD, was selected as a “Hot Topic” at the Association for Research in Vision and Ophthalmology (ARVO) conference on 4 May 2015 in Denver, USA and presented via a poster. The Annual Meeting Program Committee of ARVO selected Oxford BioMedica’s poster due to the study representing the newest and most innovative research being conducted in ophthalmology. This distinction was awarded to fewer than 6% of all 2015 Annual Meeting abstracts.
The Phase I study was primarily designed to evaluate the safety and tolerability of RetinoStat® for the treatment of severe wet AMD at six months post single injection. RetinoStat® was administered to 21 patients by subretinal injection, the first ever time a lentiviral vector has been administered to the human eye. The study consisted of a dose escalation phase and then an expanded final cohort at the highest tolerated dose, which was the maximum dose administered. The study enrolled subjects with high fibrotic retinas where there was a poor anti-VEGF response following a prior responsive history. Secondary endpoints to assess signs of clinical benefit were also measured. Additionally, aqueous tap samples were taken to quantify the expression of the transgenes at various time points and at each dose. Analysis of these samples showed that gene expression was dose-dependent and was stable over at least 12 months.
As previously announced, the results of the Phase I study demonstrated that RetinoStat®met the six month primary endpoints of safety and tolerability. Over the full forty eight week study, patients also showed signs of clinical benefit, with visual acuity stabilisation and a reduction in vascular leakage consistent with the mechanism of endostatin and angiostatin function in vivo in this severe wet AMD population.
Oxford BioMedica will work in consultation with the Principal Investigators of the study as well as Key Opinion Leaders in the retinal field at the ARVO conference and, following review of the complete data set, will look at all the possible indications for the product going forward. The data from the Phase I study will be published in a peer reviewed journal in due course.
John Dawson, Chief Executive Officer of Oxford BioMedica, said:
“The selection of our Phase I study results for RetinoStat® as a “Hot Topic” at the prestigious ophthalmology ARVO conference demonstrates that our LentiVector® platform can safely and effectively deliver genes to the retina resulting in robust and long term expression. We look forward to exploring the indications for RetinoStat® with world-leaders in this field.”