Preclinical Effiancy Data
Oxford Biomedica PLC
05 May 2005
FOR IMMEDIATE RELEASE 5 MAY 2005
OXFORD BIOMEDICA PRESENTS ENCOURAGING PRECLINICAL EFFICACY DATA WITH
RETINOSTAT(R) 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, UK: 5 May 2005 - 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(R) 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'.
-Ends-
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson
Buchanan Communications Tel: +44 (0)20 7466 5000
Scientific/Trade Press Enquiries
Sue Charles/ Katja Stout/ Ashley Lilly
Northbank Communications Tel: +44 (0)20 7886 8150
Notes to editors:
1. Oxford BioMedica
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.
Further information is available at www.oxfordbiomedica.co.uk.
2. RetinoStat and AMD
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.
This information is provided by RNS
The company news service from the London Stock Exchange