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2006/OB/07
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OXFORD
BIOMEDICA REPORTS ENCOURAGING PRECLINICAL DATA WITH RETINOSTAT® IN RETINOPATHY AND DEMONSTRATES
THE POTENTIAL OF LENTIVECTOR® IN OTHER OCULAR DISEASES
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Data presented at Association for Research in Vision
and Ophthalmology meeting -View
Abstracts (60kb) Oxford
BioMedica (LSE: OXB), the leading gene therapy company,
and its collaborators at Johns Hopkins University School
of Medicine, Baltimore, Maryland, USA, are presenting three
posters at the Association for Research in Vision and Ophthalmology
(ARVO) Annual Meeting, which is being held from 30 April
to 4 May 2006 in Fort Lauderdale, Florida, USA. These posters
describe positive preclinical results of RetinoStat in
wet age-related macular degeneration and the potential
application of the LentiVector system in corneal endothelial
disorders.
RetinoStat is
a gene-based medicine based on Oxford BioMedica’s
proprietary LentiVector system, delivering two anti-angiogenic
genes that halt the aberrant growth of blood vessels that
leads to vision loss in wet age-related macular degeneration
(AMD), a leading cause of adult blindness in developed countries.
The preclinical data presented at ARVO confirm that RetinoStat
provides statistically significant efficacy in an industry-standard
in vivo model of wet AMD. In addition, by precisely engineering
gene switches in the product, the Company has achieved highly
specific gene expression in the target cells of the retina.
This substantially enhances the potential safety and efficacy
of RetinoStat. The new data also confirm that the optimised
configuration of RetinoStat, with two anti-angiogenic genes
(endostatin and angiostatin), has efficacy superior to configurations
based on single genes
Oxford BioMedica’s collaborators at Johns Hopkins
University also showed data from an in vitro study demonstrating
that the Company’s LentiVector system can be used
to deliver therapeutic genes safely and effectively to
human corneal endothelial cells. Hence, the LentiVector
system may have application in the development of gene-based
therapies for the treatment of corneal endothelial disorders
such as Fuchs’ dystrophy. This inherited disease
affects about 1% of the population, and leads to gradual
loss of vision as the inner layer of the cornea degenerates.
Today, the only real cure for Fuchs’ dystrophy is
a cornea transplant.
Oxford BioMedica and Johns Hopkins University, with support
from the Foundation Fighting Blindness and its translational-oriented
subsidiary, the National Neurovision Research Institute
(NNRI), are conducting further preclinical studies with
RetinoStat and commencing manufacturing scale-up and non-clinical
studies to support the start of clinical trials. The Company
is on track with its objective to start clinical trials
of RetinoStat in wet AMD in 2007.
“We are very encouraged by the results of this
successful collaboration,” said Stephen Rose, Ph.D.,
Foundation Fighting Blindness’ Chief Research Officer. “We
created the National Neurovision Research Institute subsidiary
to work with both commercial and academic institutions
to move promising treatments like RetinoStat into clinical
trials. As a constituent-driven organisation, we have
a strong commitment to getting treatments to market and
the people that need them. We look forward to further
collaborations with Oxford BioMedica on this and other
projects to bring treatments and cures to patients with
a variety of retinal degenerative diseases.”
Oxford BioMedica’s Chief Executive Officer, Professor
Alan Kingsman, commented: “The data being presented
at ARVO not only demonstrate the potential of RetinoStat
as a treatment of retinopathy but also highlight the
potential of our LentiVector system to treat other ocular
diseases. Oxford BioMedica is pleased to be working with
Johns Hopkins University and also to have the support
of the Foundation Fighting Blindness. The new data suggest
that a single injection of RetinoStat could provide long-term
shut-down of aberrant blood vessel growth, and hence,
could offer a safe, effective and more convenient treatment
than current approaches for wet AMD as well as diabetic
retinopathy, another leading cause of blindness. Given
the world’s aging population, there is a growing
need to find better treatments for these conditions.”
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| Notes
| 1. |
Oxford
BioMedica plc |
| |
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 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
70 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, Sigma-Aldrich, Viragen,
MolMed, Virxsys and Kiadis; and has licensed
technology to a number of companies including
Merck & Co, Biogen Idec and Pfizer.
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| 2. |
RetinoStat® |
| |
RetinoStat
is Oxford BioMedica’s novel gene-based
treatment for wet age-related macular
degeneration (AMD) and diabetic retinopathy
(DR). The product uses the LentiVector
system to deliver genes to the retina
that block the formation of new blood
vessels. Oxford BioMedica has exclusive
rights to two proprietary anti-angiogenic
genes, angiostatin and endostatin, for
use in treatments of ocular diseases
under a licensing agreement with Entremed
Inc. The Company has evaluated both genes
in its RetinoStat programme. The optimised
version of the product, which will proceed
to clinical development, carries both
the angiostatin and endostatin anti-angiogenic
genes and shows significantly greater
efficacy than versions containing single
genes. Preclinical development is being
conducted in collaboration with the Institute
of Ophthalmology, London, UK, and Johns
Hopkins University School of Medicine,
Baltimore, Maryland, USA, with support
from the Foundation Fighting Blindness.
The Company plans to start clinical trials
with RetinoStat in wet AMD in 2007.
TroVax is currently in five Phase II trials,
including an investigator initiated trial sponsored
by Cancer Research UK. Over 100 patients have been treated with TroVax
(collectively over
400 doses) in five clinical trials in colorectal
cancer and renal cell carcinoma. Clinical results have shown that the
product is safe and
stimulates an anti-tumour immune response against
5T4 in the majority of patients. Data from the completed Phase I/II
trial and ongoing Phase
II trials suggest that the magnitude of the
immune response induced by TroVax correlates with clinical benefit
including tumour responses
and time to disease progression, both of which
have exceeded expectation based on published historical data. Preliminary
analysis of data from Phase II trials in colorectal cancer with chemotherapy
indicates a potential survival benefit. A Phase III trial in renal
cell carcinoma is planned to start in 2006. |
| 3. |
Age-related macular degeneration
and other retinopathies |
| |
Age-related
macular degeneration (AMD) and diabetic
retinopathy (DR) are major causes of
blindness in the developed world. AMD
affects an estimated 25-30 million people
in the western world and DR affects approximately
50% of all Americans diagnosed with diabetes.
It is estimated that there are 17 million
diabetics in the USA. AMD is the most
common cause of visual loss in the elderly.
DR is the most common cause of visual
loss in the working population and is
the most common cause of acquired blindness
in people under 60 in the developed world.
Both wet AMD, the form of AMD which accounts for 90% of all severe vision
loss from the disease, and DR are caused by aberrant growth of leaky and
disruptive blood vessels in the retina. This growth is caused by a hyper-response
to localised regions of low oxygen arising from compromised blood supply
within the retina. Oxford BioMedica has shown that its LentiVector technology
can target these regions of the eye with great accuracy and deliver anti-angiogenic
proteins to treat these diseases.
Analysts’ estimates,
published in the Wall Street Journal, suggest
that sales
of an effective treatment for macular degeneration
could exceed US$1 billion per annum. |
| 4. |
The Foundation Fighting Blindness |
| |
The
Foundation Fighting Blindness, Inc. (FFB)
has a mission to drive the research that
will provide preventions, treatments
and cures for people affected by retinitis
pigmentosa, macular degeneration, Usher
syndrome, and the entire spectrum of
retinal degenerative diseases. The Foundation
has funded thousands of research studies
at hundreds of prominent institutions.
The Foundation funds leading-edge research
in promising areas such as genetics,
gene therapy, retinal cell transplantation,
artificial retinal implants, and pharmaceutical
and nutritional therapies. Since its
inception in 1971, the Foundation has
raised over US$240 million. FFB is ranked
as a “Top-Rated” charity
by the American Institute of Philanthropy
and was named one of Worth Magazine’s “100
Best Charities.”
Further information is available at www.fightblindness.org |
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