Prosavin preclinical data
Oxford Biomedica PLC
13 November 2006
For Immediate Release 13 NOVEMBER 2006
OXFORD BIOMEDICA PRESENTS ENCOURAGING PRECLINICAL EFFICACY
DATA WITH PROSAVIN(R) IN PARKINSON'S DISEASE
- Presentation at the 14th Annual Congress of the European Society of Gene
Therapy, 9-12 November 2006, in Athens, Greece -
Oxford, UK - 13 November 2006: Oxford BioMedica (LSE: OXB), a leading gene
therapy company, announced today that new preclinical efficacy results with its
gene-based product for Parkinson's disease, ProSavin, were presented at the 14th
Annual Congress of the European Society of Gene Therapy (ESGT) in Athens,
Greece, which was held on 9-12 November 2006 (http://www.esgt.org). The data
showed, for the first time, that ProSavin outperformed the standard treatment
for Parkinson's disease, L-DOPA, in terms of efficacy without inducing any of
the disabling dyskinesias (movement disorders) that occur following prolonged
treatment with L-DOPA. Also, long-term data showed that ProSavin's therapeutic
benefit was maintained for at least 15 months, the most recent time point,
without any loss of effect.
ProSavin is administered locally to the region of the brain called the striatum,
delivering the genes for three enzymes that are required for the synthesis of
dopamine. These genes are able to reprogram the cells that they enter, enabling
these cells to manufacture and secrete dopamine. The treated brain region
becomes a new endogenous source of dopamine, replacing the patient's own lost
source of the neurotransmitter. Sustained expression of the genes is a key
requirement for the product to be clinically successful.
Dr Palfi, Head of Neurosurgery at Henri Mondor Hospital, Creteil is the
principal researcher conducting the preclinical in vivo evaluation of ProSavin.
At the ESGT meeting, Dr Palfi presented a comparison of ProSavin with L-DOPA in
an industry standard model of Parkinson's disease. In the early stages of
treatment, ProSavin gave high levels of efficacy when evaluated by a series of
clinically relevant parameters. In addition, the benefit of a single
administration of ProSavin was maintained after a prolonged period, whereas the
benefit of continuous L-DOPA therapy waned significantly. Dr. Palfi reported
that ProSavin has been effective to the most recent time point of 15 months.
The higher efficacy of ProSavin combined with the absence of side effects
suggest that ProSavin could be used to replace current standard therapy with
L-DOPA in late-stage Parkinson's disease. These new data add to the extensive
preclinical data package that supports advancement of the product into human
trials.
Oxford BioMedica is planning to start a European Phase I/II trial of ProSavin in
2007 in patients with late-stage Parkinson's disease and has proposed a clinical
plan to progress to a Phase III trial following success in the Phase I/II trial.
The Phase III trial, which is designed to support product registration, could
commence in 2009. Discussions with relevant regulatory agencies are ongoing.
Commenting on the ProSavin data, Oxford BioMedica's CEO, Professor Alan Kingsman
, said: 'These new results substantially strengthen the already impressive
preclinical data set for ProSavin and confirm its potential as a treatment for
Parkinson's disease, particularly when other therapies fail. Its duration of
action and lack of side effects are particularly promising. We are now working
towards the start of human trials and have been encouraged by discussions with
the regulatory agencies.'
-Ends-
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865 783 000
Professor Alan Kingsman, Chief Executive
City/Financial Enquiries: Tel: +44 (0)20 7466 5000
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson
Buchanan Communications
Scientific/Trade Press Enquiries: Tel: +44 (0)20 3008 7555
Gemma Bradley/ Susan Yu/ Katja Stout
Northbank Communications
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 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 two clinical candidates and a preclinical targeted antibody therapy,
which is being developed in collaboration with Wyeth. The Company has started
Phase III development of its lead cancer immunotherapy product, TroVax, in renal
cancer and multiple Phase II trials in various cancer settings are ongoing or
planned. In neurotherapy, the Company's lead product, ProSavin, is expected to
enter clinical trials in Parkinson's disease in 2007. The preclinical pipeline
includes gene-based products for vision loss, motor neuron disease and nerve
repair.
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.
Further information is available at www.oxfordbiomedica.co.uk
2. ProSavin(R)
ProSavin is Oxford BioMedica's lead neurobiology candidate product for the
treatment of Parkinson's disease. ProSavin uses a LentiVector(R) 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 reprogram
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
Parkinson's disease affects 1% of people over 50 and about 10% of the over 60s.
It is a progressive disease caused by the loss of dopamine-producing neurons in
a region of the brain called the substantia nigra. Dopamine is required for
coordination of movement, and the symptoms of the disease include tremor
(shaking), slowness of movement, rigidity (stiffness), and difficulty with
balance. Patients with Parkinson's often require 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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