Oxford Biomedica PLC Publication of RetinoStat® (OXB-201) Phase I study
October 10 2016 - 2:21AM
RNS Non-Regulatory
TIDMOXB
Oxford Biomedica PLC
10 October 2016
Oxford BioMedica Announces Publication of Pioneering
RetinoStat(R) (OXB-201) Phase I Study Data in the Journal, Human
Gene Therapy
-- RetinoStat(R) met its primary endpoint, demonstrating
favourable safety and tolerability profiles
Oxford, UK - 10 October 2016: Oxford BioMedica plc (LSE:OXB)
("Oxford BioMedica" or "the Group"), a leading gene and cell
therapy group, today announces the publication in the journal Human
Gene Therapy of the previously announced ground-breaking results
from the RetinoStat(R) (OXB-201) Phase I study in patients with
advanced wet age-related macular degeneration (AMD) on 6 May 2016.
According to key published findings in the associated peer-reviewed
paper, RetinoStat(R) demonstrated a favourable safety profile and
led to robust, reproducible sustained expression of endostatin and
angiostatin in the eye.
The Phase I study was primarily designed to evaluate the safety
and tolerability of RetinoStat(R) for the treatment of severe wet
AMD following a single subretinal injection and represented the
first time a lentiviral based vector had been administered to the
human eye. Twenty-one subjects with highly fibrotic retinas who
were refractory to anti-VEGF therapy following a prior responsive
history were treated. As previously announced the results of the
Phase I study indicated that RetinoStat(R) met the primary endpoint
of safety and tolerability. Importantly, therapeutic gene
expression, measured in these patients as a secondary study
endpoint, was found to be dose-dependent and maintained at the last
measurement (2.5 years in 8 subjects and >4 years in two
subjects).
Peter A. Campochiaro, the Eccles Professor of Ophthalmology and
Neuroscience at the Wilmer Eye Institute was the lead author and
principal and coordinating investigator. Andreas K. Lauer (Oregon
Health Sciences Center of the University of Oregon) and Elliott H.
Sohn (University of Iowa) were the other investigators of the
study.
The online publication in Human Gene Therapy is entitled:
"Lentiviral Vector Gene Transfer of Endostatin/Angiostatin for
Macular Degeneration (GEM) Study". Please follow this link to read
the paper in full:
http://online.liebertpub.com/doi/full/10.1089/hum.2016.117
Highlights from the Phase I study:
Safety: RetinoStat(R) , the first ocular lentiviral gene therapy
to be administered in Man, has demonstrated a favourable safety
profile with no serious adverse events related to the product
observed to date.
Pharmacokinetics: significant expression of both therapeutic
transgenes was directly measured in patient aqueous humour samples
and showed a dose response that was stable and persistent in all
patients (out to 4.5 years so far in the earliest patient
enrolled).
Oxford BioMedica is evaluating the optimal way to progress the
clinical development for RetinoStat(R) .
Commenting on the publication, John Dawson, Chief Executive
Officer of Oxford BioMedica, said: "Like the ProSavin(R) trial
before it, the RetinoStat(R) First-in-Man study was a clinical
trial of 'firsts': the first ever trial to directly administer a
lentiviral vector-based product to the eye, the first directly
administered lentiviral vector trial in the USA, the first direct
measurement of an ocular gene therapy transgene during a study and
the first reporting of data showing direct demonstration of
long-lasting expression of an ocular gene therapy in human
subjects.
"These peer-reviewed published results further validate the
ground-breaking utility of our LentiVector(R) delivery platform for
the treatment of chronic disease."
-Ends-
For further information,
please contact:
Oxford BioMedica plc: Tel: +44 (0)1865
John Dawson, Chief Executive 783 000
Officer
Tim Watts, Chief Financial
Officer
Financial and corporate communications Tel: +44 (0)20 3709
enquiries: 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew
Neal/Chris Welsh/Laura Thornton
About Oxford BioMedica(R)
Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy
group focused on developing life changing treatments for serious
diseases. Oxford BioMedica and its subsidiaries (the "Group") have
built a sector leading lentiviral vector delivery platform
(LentiVector(R)) through which the Group develops in vivo and ex
vivo products both in-house and with partners. The Group has
created a valuable proprietary portfolio of gene and cell therapy
product candidates in the areas of oncology, ophthalmology and CNS
disorders. The Group has also entered into a number of
partnerships, including with Novartis, Sanofi, GSK, and Immune
Design, through which it has long-term economic interests in other
potential gene and cell therapy products. Oxford BioMedica is based
across several locations in Oxfordshire, UK and employs more than
230 people. Further information is available at
www.oxfordbiomedica.co.uk.
This information is provided by RNS
The company news service from the London Stock Exchange
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