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Oxford,
UK: 6 May 2003. Oxford BioMedica and The Institute of Ophthalmology
are describing two key features of the Company’s vision-loss
product RetinoStat at The Annual Meeting of the Association
for Research in Vision and Ophthalmology (ARVO), held in Fort
Lauderdale, Florida, during May 4th-8th. This is the world’s
biggest forum for eye research and is attended by all principal
commercial and scientific players in the field, a total of
around 8,000 attendees.
In two
separate presentations the Company and the Institute’s
Ocular Gene Therapy Group, led by Dr. Robin Ali, are showing
data that confirm RetinoStat’s ability to target accurately
the retina using the Company’s LentiVector®
system. In addition, the Company’s Hypoxia Response
Element technology is shown to focus gene expression in those
parts of the retina that are local to the pathological changes
associated with age-related macular degeneration (AMD) and
diabetic retinopathy (DR), the two major causes of vision-loss
in the developed world. These data were generated in industry-standard
preclinical models for the two diseases, and demonstrate proof-of-principle
for delivery to the retina and regulation of the gene. These
are essential features required for a safe and effective product.
Hence, the encouraging preclinical results mean that the RetinoStat
programme is on track for clinical development in 2004.
Age-related
macular degeneration (‘AMD’) and diabetic retinopathy
(‘DR’) affect approximately 30 million people
in the developed world and the market potential is in excess
of $1.0 billion. In both AMD and DR, blindness is caused by
the defective formation of new blood vessels in the retina.
In AMD, new blood vessels extend from the inner retina beyond
the inner limiting membrane, which leads to haemorrhaging
and distortion of the specific area of the retinal surface
responsible for sharp, central vision. In DR, a similar process
occurs however, the new blood vessels appear on the vitreous
surface of the retina causing excessive accumulation of fluid
or ‘oedema’, which blurs vision and causes retinal
haemorrhage. RetinoStat is designed to halt this aberrant
growth of blood vessels before it begins. Currently, the only
available treatments for AMD and DR are limited and tend to
only slow the diseases’ progression.
The collaboration
between Oxford BioMedica and the Institute of Ophthalmology
was initiated in May 2002. It is a research and development
agreement using the Company’s proprietary technology
to develop novel treatments for vision loss. RetinoStat comprises
a LentiVector gene delivery system expressing an angiostatic
gene under the control of Oxford BioMedica’s Hypoxia
Response Element, which promotes gene expression under low
oxygen conditions.
Commenting
on the results Chief Executive, Professor Alan Kingsman said,
“We are delighted to be presenting at the major
vision conference of the year. Our RetinoStat data are exciting
and
this forum allows us to describe the results to the widest
possible audience including potential commercial partners.
This is the first public statement of progress from the collaboration
and we look forward to more developments in the coming months”.
Dr Robin
Ali, Head of the Ocular Gene Therapy Group at the Institute
of Ophthalmology said, “We are very pleased to
be working with Oxford BioMedica. Our recent results support
the use
of their LentiVector and Hypoxia Response Element technologies
for the treatment of ocular disorders and pave the way for
advancement to clinical trials”.
Background
to age-related macular degeneration (‘AMD’) and
diabetic retinopathy (‘DR’)
AMD is
now one of the major debilitating diseases of the ageing population.
About one in six people between the ages of 55 and 64 will
develop AMD while one in four between 64 and 74 will be affected.
One in three over the age of 75 will be affected. Each year
1.2 million of the estimated 12 million Americans with macular
degeneration will suffer severe central vision loss. Each
year 200,000 individuals will lose all central vision in one
or both eyes due to AMD.
DR is
the commonest cause of visual loss in people of working age
and the predominant cause of economic loss due to visual impairment.
Over 40% of people with insulin dependant and 20% of people
with non-insulin dependent diabetes eventually succumb to
diabetic retinopathy. In the US alone, where an estimated
16 million people have either type I or II diabetes, about
600,000 have retinopathy. Direct and indirect costs of diabetic
retinopathy totalled more than $ 2.8 billion in 1996. 2% of
insulin dependent diabetics are totally blind, many of them
in the younger age group.
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Established
in 1995 as a spin out from Oxford University, Oxford
BioMedica plc specialises in the development of novel
gene-based therapeutics for the treatment of cancer,
neuro-degenerative disease and other disorders with
major unmet clinical needs. The development pipeline
includes two novel anti-cancer products in clinical
trials and a gene therapy treatment for Parkinson’s
disease, which is in late preclinical studies. This
is underpinned by a broad research pipeline and over
70 patent families, about quarter of which are issued.
