Update on ProSavin
Oxford Biomedica PLC
23 June 2003
OXFORD BIOMEDICA DESCRIBES THE MANUFACTURING
PROCESS FOR PROSAVIN AT BIO2003
Oxford, UK: 23 June 2003. Oxford BioMedica announced today the details of its
novel manufacturing process for ProSavin(R), for the treatment of Parkinson's
disease, that will be presented at the BIO 2003 Annual Convention in Washington
DC on 25 June. The new manufacturing process has the capacity to satisfy all of
the Company's requirements up to Phase II clinical trials and the team is
currently working on a refinement of the process to scale-up for Phase III
trials and commercial production.
This will be the first time that Oxford BioMedica has disclosed details of its
novel production approach for LentiVector(R)-based products. LentiVector is able
to deliver genes to non-dividing cells, such as brain cells, and ProSavin
delivers the genes for dopamine synthesis directly to the striatum of the brain,
thereby creating endogenous production of dopamine, the neurotransmitter that is
lost in Parkinson's patients. The target market is late stage disease where
ProSavin could offer significant advantages over existing therapy.
Dr. Carlos Ibanez, Director of Process and Product Development at Oxford
BioMedica's US subsidiary BioMedica Inc., will give a presentation during a
panel discussion on innovative manufacturing strategies for viral and non-viral
gene based therapies. The establishment of effective manufacturing processes
represents a key milestone on the path to the IND submission that is planned for
ProSavin later in 2003 following the completion of preclinical efficacy and
toxicity studies. Phase I trials are planned for 2004.
Commenting on the development Dr. Doug Jolly, CEO of BioMedica Inc. said 'We are
delighted to have brought the LentiVector production system successfully from
laboratory bench to manufacturing for clinical trials. The process has been
developed following constructive dialogue with the FDA and UK regulatory
authorities and through close collaboration with the technical team in Oxford.
Gene therapy has been limited in the past by production problems. This will not
be the case for Oxford BioMedica's products'.
During the past 18 months the technical team at BioMedica Inc has been
developing a cost effective, GMP-compatible manufacturing process that can be
used for ProSavin and all of the Company's other LentiVector(R)-based products.
The vector production process is at the 40 litre scale by transient
transfection. The clinical trial material is processed by chromatographic
methods and packaged in single use glass vials containing 100-200 ul of
product. This yields 2-5 ml of high titre product (>109 TU/ml), which is
sufficient for 15-40 human dose equivalents. It can be transported and stored at
-70oC with an expected shelf life in excess of 12 months.
The obvious regulatory issues for a novel gene therapy such as appropriate
safety and product release assays, including those for replication-competent
virus, have been discussed with the FDA. Based on these discussions, relevant
assays have been developed.
Ends-
Oxford BioMedica plc
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
City/Financial Enquiries:
Mike Wort, James Chandler: Beattie Financial Tel: +44 (0)20 7398 3300
Scientific/Trade Press Enquiries:
Sue Charles, Katja Stout: Northbank Communications Tel: +44 (0)20 7886 8150
Notes to Editors
Oxford BioMedica
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.
Oxford BioMedica's products use genes as the mediators of a therapeutic effect
and/or immune response. The Company's gene therapy products deliver therapeutic
molecules in vivo whilst its gene-based immunotherapy products deliver genes
that recruit the patient's immune system to mediate a therapeutic effect. The
genes are delivered by the Company's highly engineered viruses or cells.
BioMedica's lead product TroVax(R) is an anti-cancer therapeutic vaccine
expected to be useful against a broad range of tumour types. It is entering
Phase II trials in a number of indications including colorectal and renal
cancer, and is expected to be ready for Phase III trials at the end of 2003. The
Company's second cancer product, MetXia(R), is completing Phase I/II studies in
breast cancer.
Oxford BioMedica is headquartered in Oxford, UK and has a wholly-owned
subsidiary in San Diego, USA. BioMedica has corporate collaborations with Wyeth,
IDM, Intervet, Aliga Pharmaceuticals, Amersham, Arius Research and Viragen.
Oxford BioMedica plc was floated on the Alternative Investment Market of the
London Stock Exchange in December 1996, and was promoted to the United Kingdom
Listing Authority Official List in April 2001 following a successful £35.5
million fund-raising.
Further information is available at http://www.oxfordbiomedica.co.uk
ProSavin(R) and the LentiVector(R) technology
ProSavin is Oxford BioMedica's most advanced programme that uses the proprietary
LentiVector(R) gene delivery system.
Oxford BioMedica's LentiVector gene delivery technology is arguably the most
potent system currently available for treating diseases of the central nervous
system, particularly chronic neurodegenerative disorders. LentiVector is a new
gene delivery vector that is based on lentiviruses. The system contains only the
few viral components that are required for efficient gene delivery. Oxford
BioMedica has shown that minimal lentiviral vectors are able to deliver genes to
a wide range of dividing and non-dividing cells, including neurones in the
brain. Oxford BioMedica has granted and pending patents on the technology which
provide a sound basis for freedom to operate in this field.
This technology forms the delivery system for several of the Company's products
that are approaching the clinical development stage. In addition to ProSavin,
there are three further research/preclinical stage programmes using the
LentiVector system: RetinoStatTM, for retinopathy (vision loss), InnurexTM,
for nerve repair in spinal cord injury, and MoNuDinTM, for motor neuron
disease.
This information is provided by RNS
The company news service from the London Stock Exchange
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