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2006/OB/14
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OXFORD
BIOMEDICA RECEIVES NOTICE OF ALLOWANCE FOR KEY US PATENT
COVERING PARKINSON’S DISEASE PRODUCT,
PROSAVIN®
Oxford
BioMedica (LSE:OXB), a leading gene therapy company, announced
today that it has received a Notice of Allowance from the
US Patent Office for a key patent application, which significantly
extends the protection of ProSavin, the Company’s
lead product candidate for Parkinson’s disease. It
is expected that the patent will be issued during 2006.
This patent describes the genetic composition of ProSavin,
and as such is an important addition to the portfolio of
patents that protect the product
The product
comprises the Company’s LentiVector® gene delivery
system carrying three genes that programme cells to produce
dopamine, the neurotransmitter that is lost during the
course of Parkinson’s disease. The assembly and configuration
of the three genes to achieve the optimal dopamine production
were major technical achievements, and these form the basis
of this key ProSavin patent.
Importantly,
the claims allowed by the US Patent and Trademark Office
are broad and not only cover the Company’s LentiVector-based
genetic configuration of ProSavin but also cover the basic
gene constructs central to the development of ProSavin.
In addition, the claims cover any LentiVector-based neurodegenerative
disease product that uses the same general configuration
with any therapeutic genes. Hence, the patent provides
protection for new product candidates that the Company
may develop for the treatment of other neurodegenerative
conditions such as Alzheimer’s disease.
ProSavin
is the lead product in Oxford BioMedica’s neurotherapy
pipeline and has shown promising, long term efficacy in
industry-standard preclinical models of Parkinson’s
disease. The Company has initiated regulatory consultation
for the start of Phase I/II trials in patients with the
disease.
Commenting
on the news, Oxford BioMedica’s Chief Executive,
Professor Alan Kingsman said: "ProSavin is one
of the major value drivers for Oxford BioMedica after TroVax.
This patent secures our control of the intellectual property
for the product, which has shown exceptional preclinical
efficacy.”
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| Notes
| 1. |
Oxford
BioMedica plc |
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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 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. |
ProSavin® |
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ProSavin is Oxford BioMedica’s
lead neurobiology candidate product for
the treatment of Parkinson’s disease.
ProSavin uses a LentiVector® system
to deliver the genes for three enzymes
that are required for the synthesis of
dopamine. The three genes are AADC (aromatic
amino acid dopa decarboxylase), TH (tyrosine
hydroxylase) and CH1 (GTP-cyclohydrolase
1). The product is administered locally
to the striatum, where these genes are
able to reprogramme transduced cells to
manufacture and secrete dopamine. Gene
expression is sustained over several months,
a key requirement for the product to be
clinically successful. This new endogenous
source of the neurotransmitter replaces
the patient's own lost source of dopamine.
The Company had demonstrated
preclinical efficacy with ProSavin in
an industry
standard in vivo model of Parkinson’s
disease. The preclinical studies suggest
that a single treatment with ProSavin
has a therapeutic effect after two weeks,
and restores almost normal movement after
five to eight weeks, which is then maintained.
This effect is seldom achieved in this
model according to the literature. The
clinical manufacturing process has been
finalised and the Company has commenced
regulatory consultation for the start
of clinical trials of ProSavin. |
| 3. |
Parkinson’s
disease |
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Parkinson’s disease affects
1% of the over 50 population and about 10%
of the over 60s. It is a progressive disease
requiring care over a period of 10-15 years.
The current worldwide market for Parkinson’s
disease products is about US$2 billion. None
of the currently available products provide
long-term relief from symptoms. |
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