OXFORD, England, June 22, 2011 /PRNewswire/ —
Progress in Phase I Study in Wet Age-Related
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
- Favourable safety profile with no serious adverse events
related to RetinoStat® or its method of
- No signs of inflammation in the eye
- DSMB support received to proceed to dose level 2 in the next
John Dawson, Chief Executive Officer of Oxford BioMedica,