(http://www.MacularDegenerations.com) Oxford BioMedica, the Oxford, England-based biopharmaceutical company developing gene-based medicines and therapeutic vaccines, and its partner Sanofi, the Paris, France-based diversified healthcare company, have announced a new development regarding testing of their age-related macular degeneration drug (AMD).
In an 8 August press release, Oxford and Sanofi announced an encouraging interim assessment of their RetinoStat Phase I study in neovascular wet AMD. According to the press release, RetinoStat was designed and created by Oxford, which leveraged its gene delivery solution known as LentiVector.
The following are some of the highlights mentioned in the press release:
- Nine patients have been treated so far
- There have been zero severe reactions to either RetinoStat or its administration process
- Data Safety Monitoring Board (DSMB) permission to go ahead with the last patient cohort has been secured
“The continued progress of our ophthalmology portfolio, supported by another positive DSMB review, is encouraging – particularly given that early RetinoStat data demonstrate sustained therapeutic protein expression in the eye following a single administration,” said John Dawson, chief executive officer of Oxford, in the press release. “The favorable safety profile of our novel ocular gene therapies further supports the wider LentiVector platform safety package with over 33 patients treated to date across the ocular and Parkinson’s disease programs.”
According to Oxford in the press release, the RetinoStat open label, dose escalation Phase I study will involve 18 patients who have been diagnosed with the wet version of AMD. The study will involve monitoring three dose levels to determine safety and aspects of ocular physiology. The press release noted that Professor Peter Campochiaro, who is affiliated with the Wilmer Eye Institute at Johns Hopkins in Baltimore, Maryland, is spearheading the study. Oxford, which has established another clinical site on the campus of the Oregon Health and Science University in Portland, Oregon, added in the press release that more study results are expected to be available in the final quarter of this year.
According to various reports, there are two types of AMD — wet and dry. The wet version, which can result in a detached retina, is the more serious of the two. AMD, an eye ailment that can lead to blindness, generally affects some people who are older than 50.