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news.Oxford Biomedica has presented encouraging preclinical data from its RetinoStat program. The study, set up to assess the ability of RetinoStat to reduce abnormal blood vessel growth or vessel leakage in the eye, as occurs in macular degeneration, achieved clinical efficacy endpoints.
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The gene therapy company, in collaboration with the Institute of Ophthalmology in London, has presented data showing that two versions of the RetinoStat product are efficacious in an industry standard model of age-related macular degeneration (AMD), the leading cause of vision loss in the developed world.
RetinoStat uses a LentiVector system to deliver, to the retina, genes, which block the formation of new blood vessels that cause AMD. Oxford BioMedica is evaluating two versions of RetinoStat with the anti-angiogenesis genes, endostatin and angiostatin, respectively. The preclinical data presented to the Association for Research in Vision and Ophthalmology (ARVO) assessed the ability of RetinoStat to reduce blood vessel complications which lead to the distortion and loss of central vision in AMD.
Both versions of RetinoStat were safe and well tolerated and both achieved the two efficacy endpoints. The results show a statistically significant improvement in all scores. The area of CNV was reduced by 50-60% and blood vessel leakage was reduced by 24-26%.
The researchers conclude that similar improvements in these parameters in patients with AMD may translate into a significant and sustained improvement in visual acuity (a measure of clarity of vision). Oxford BioMedica expects to complete additional preclinical efficacy studies and optimisation of the RetinoStat configuration for clinical trials in the second half of 2005. The company’s objective is to initiate clinical trials with RetinoStat in wet AMD in 2006-07.
Commenting on the data, Oxford BioMedica’s chief executive, Professor Alan Kingsman said: “RetinoStat is meeting its design objectives and is on track for clinical development. AMD is a devastating disease and there is a real unmet need for a long-lasting efficacious product. RetinoStat is aimed at this large and growing market”.