— Planned 21 patients dosed in “wet” age-related macular degeneration (wet AMD) US Phase I trial
Oxford, UK – 7 April 2014: Oxford BioMedica plc (LSE: OXB), (“the Company”) the leading gene-based biopharmaceutical company, today announces that it has completed the planned recruitment of 21 patients into its Phase I trial of RetinoStat®, a lentiviral vector based treatment for neovascular wet AMD. Each patient has been treated with a single subretinal administration of RetinoStat® which leads to the production of two anti-angiogenic proteins – endostatin and angiostatin.
The industry standard treatments for wet AMD and other related ocular conditions achieved global sales in excess of US$6.0 billion in 20131. On the basis of pre-clinical data, it is anticipated that RetinoStat® may require only a single administration. If confirmed, this would give the product a significant advantage over currently available treatments in the market that require frequent, repeated administration.
The ongoing open-label study is evaluating three dose levels, in four cohorts, to assess safety and aspects of biological activity in the eye. Analysis of patient samples has shown a substantial increase above baseline levels of both endostatin and angiostatin proteins in the eye following a single administration of RetinoStat®; protein expression has been sustained to 12 months (the longest time-point assessed to date in the first three cohorts); and a clear proportional dose response has been seen. All patients are being regularly followed up and indicative results from the study are expected towards the end of 2014. For further information see www.clinicaltrials.gov.
RetinoStat® is the remaining development programme under Oxford BioMedica’s 2009 ocular collaboration with Sanofi. Sanofi has an option under the collaboration to enter a development and commercialisation license for RetinoStat®. In February 2014, Oxford BioMedica concluded a licence agreement with Sanofi for the development and commercialisation of StarGen™ and UshStat®, the two other products covered by the collaboration agreement.
Commenting on the news, John Dawson, Chief Executive Officer of Oxford BioMedica, said:
“We are delighted to announce the completion of recruitment into the Phase I RetinoStat®study. This trial was the first to directly administer a lentiviral vector-based treatment in the eye and could pave the way to bringing life-changing eye treatments to patients. We now look forward to the results from the study and reviewing these with our partner Sanofi later this year.”
1 source: Novartis/Roche/Regeneron