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2005/OB/13
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OXFORD
BIOMEDICA PRESENTS ENCOURAGING PRECLINICAL EFFICACY DATA WITH
RETINOSTAT® IN AGE-RELATED MACULAR DEGENERATION
Presentation
at the 2005 Annual Meeting of the Association for Research
in Vision and Ophthalmology (ARVO) in Fort Lauderdale, Florida
Oxford
BioMedica (LSE: OXB), the leading gene therapy company, and
its collaborators from the Institute of Ophthalmology in London,
are today presenting encouraging preclinical data from the
RetinoStat programme at the Annual Meeting of the Association
for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale,
Florida, USA. The data show that two versions of the 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 being
presented at ARVO assess the ability of RetinoStat to reduce
the area of the eye with abnormal blood vessel growth (known
as the area of choroidal neovascularisation or CNV) and to
reduce blood vessel leakage in the eye, which leads 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% (p <0.05) and blood vessel leakage was
reduced by 24-26% (p <0.05). The authors of the scientific
abstract, from the Institute of Ophthalmology and Oxford BioMedica,
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).
In the
second half of 2005, Oxford BioMedica expects to complete
additional preclinical efficacy studies and optimisation of
the RetinoStat configuration for clinical trials. The results
from these studies will be published and presented at other
relevant conferences in 2005-06. 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”.
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Notes
| 1. |
Oxford
BioMedica |
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Oxford BioMedica (LSE: OXB) is a biopharmaceutical
company specialising in the development
of novel gene-based therapeutics with a
focus on the areas of oncology and neurotherapy.
The Company was established in 1995 as a
spin out from Oxford University, and is
listed on the London Stock Exchange.
Oxford
BioMedica has core expertise in gene delivery,
as well as in-house clinical, regulatory
and manufacturing know-how. In oncology,
the pipeline includes an immunotherapy and
a gene therapy in multiple Phase II trials,
and a preclinical targeted antibody therapy
in collaboration with Wyeth. In neurotherapy,
the Company’s lead product is a gene
therapy for Parkinson’s disease, which
is expected to enter clinical trials in
early 2006, and four further preclinical
candidates. The Company is underpinned by
over 80 patent families, which represent
one of the broadest patent estates in the
field.
The
Company has a staff of approximately 65
split between its main facilities in Oxford
and its wholly owned subsidiary, BioMedica
Inc, in San Diego, California. Oxford BioMedica
has corporate collaborations with Wyeth,
Intervet, Amersham, Viragen, MolMed and
Kiadis; and has licensed technology to a
number of companies including Merck &
Co and Biogen Idec.
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| 2. |
RetinoStat
and AMD |
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RetinoStat is Oxford BioMedica’s novel
gene-based treatment for wet age-related
macular degeneration and diabetic retinopathy.
The product uses a LentiVector system to
deliver genes to the retina, which block
the formation of new blood vessels that
cause retinopathy. The company is evaluating
two versions of RetinoStat with the anti-angiogenesis
genes, endostatin and angiostatin, licensed
from EntreMed of Rockville, Maryland, USA.
These two biological products have been
investigated extensively in various trials.
The published data suggest that endostatin
and angiostatin have very low toxicity,
are well tolerated long term, and can shut
down aberrant blood vessel growth.
Macular
degeneration is a retinal degenerative disease
that causes progressive loss of central
vision. The risk of developing macular degeneration
increases with age. Macular degeneration
is the most common cause of vision loss
in individuals over the age of 55. Wet age-related
macular degeneration (AMD) accounts for
about 10% of cases, but is responsible for
90% of severe vision loss.
There
are 15 million people in the United States
living with some form of AMD, with more
than 1.6 million experiencing the active
blood vessel growth and blood vessel leakage
associated with wet AMD. There are over
200,000 new cases of wet AMD each year and
this number is expected to increase significantly
as the baby boomer generation ages and overall
life expectancy increases. Presently, over
500,000 people worldwide lose their sight
annually from the disease.
The
preclinical studies with RetinoStat are
being conducted with the company’s
collaborators at the Institute of Ophthalmology
in London, UK, and at the Johns Hopkins
Hospital in Baltimore, USA, with financial
support from the US charity, Foundation
Fighting Blindness.
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further information please contact:
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Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive |
Tel: +44 (0)1865 783 000 |
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Baderoon/Mark
Court/Mary-Jane
Johnson
Buchanan Communications |
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Stout, Ashley
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College Hill - Life Sciences |
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