AGM Statement
Oxford Biomedica PLC
15 April 2003
OXFORD BIOMEDICA PLC
('Oxford BioMedica'or 'the Company')
COMPANY UPDATE AT AGM
Oxford, UK: 15 April 2003. Oxford BioMedica is hosting its Annual General
Meeting for shareholders today at 11.30am. The meeting will be held at the
offices of Weil, Gotshal & Manges, 2nd floor, One South Place, London, EC2M 2WG.
At the AGM, Oxford BioMedica will review its 2002 financial results and its
product pipeline.
In addition to the corporate update released with the preliminary results on 4th
March 2003, the Company today announces the following information:
TroVax(R)
The expansion of the TroVax clinical programme, the Company's lead cancer
immunotherapeutic, is proceeding according to plan. Regulatory approval from
GTAC and MCA has been received to commence a Phase II trial in colorectal cancer
patients. Initial data are anticipated later in 2003. In the US, the Company is
planning a Phase I/II trial in renal cancer patients. A pre-IND meeting with the
FDA is scheduled for May and the trial is expected to start in Q3 2003.
MetXia(R)
Preliminary data from the second Phase I/II study of MetXia in late stage breast
cancer patients are encouraging. MetXia is Oxford BioMedica's lead gene-based
cancer therapeutic. The initial results show that the higher potency version of
MetXia substantially increases the efficiency of gene transfer to tumour tissue.
This is exactly what the Company expected from its preclinical studies. Patient
recruitment is ongoing and will shortly include patients from additional centres
that will accelerate the trial. The Company intends to make a detailed
announcement on the results of the study later in the year.
ProSavin(R)
Oxford BioMedica's lead neurobiology product, ProSavin, for treatment of
Parkinson's disease is progressing in late preclinical studies. The Company is
on-track to complete the first regulatory submission for the start of clinical
trials by the end of 2003. The Company is securing cost efficient GMP
manufacturing and identifying suitable clinical sites in readiness for initial
human studies in 2004.
Cash reserves extended
The Company continues to restructure its research and development to focus on
clinical and advanced preclinical products. As part of this process, Oxford
BioMedica is reducing further its expenditure on early stage programmes, which
includes neurobiology research in its San Diego facility, and other research
activities in Oxford. In total the Company anticipates that its operating costs
will be reduced by an annual £3.5 million, which extends the cash reserves until
mid-2005 in a worst case scenario of there being no revenue from milestones on
current collaborations or new deals in the meantime. This represents an
extension of more than six months on previous estimates. The Company's cash
position at 31st December 2002 was £21 million. The reduction in expenses
anticipated by this restructuring will provide Oxford BioMedica with greater
flexibility in its product development strategy and will not affect the progress
of the lead programmes. The restructured San Diego operation will focus on the
clinical development of ProSavin, interactions with the FDA and business
development in the USA.
Commenting on these new developments, Chief Executive, Professor Alan Kingsman
said; 'TroVax and ProSavin are on course, and the initial MetXia results are
encouraging. We are entering a very exciting phase in the Company's development
with our major products reaching key stages. We must provide the resources to
maximise their chances of success and to strengthen our negotiating position
with potential partners. The restructuring of our research achieves those two
goals'
For further information, please contact:
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 7321 3870
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 on the World Wide Web at
http://www.oxfordbiomedica.co.uk
2. Regulatory approval for clinical trials
In the UK, gene therapy trial protocols are evaluated by the Gene Therapy
Advisory Committee on the basis of the quality of the science, the details of
the clinical protocol and ethical considerations. GTAC comprises technical
experts and lay members. Following GTAC approval, clinical trial protocols and
the products used by them are then reviewed by the Medicines Control Agency
(MCA). On approval by the MCA, a clinical trial exemption certificate (CTX) is
issued and the products can be entered for clinical trials.
In the USA there is a similar process culminating in the issue of an
Investigative New Drug certificate (IND) by the Food and Drug Administration
(FDA).
This information is provided by RNS
The company news service from the London Stock Exchange