|
2003/OB/08
|
Oxford
BioMedica - 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®
| 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®
| 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®
| 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.” |
Return to the News
| Notes
| 1. |
Oxford
BioMedica plc |
| |
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® 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®, 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 and Arius Research.
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.
|
| 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).
|
| |
|
| 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
Enquiries
Sue
Charles, Katja
Stout,
College Hill - Life Sciences |
Tel:
+44 (0)20 7321 3870 |
|
|
|
Top
of page
Website by College Hill - Life Sciences
|
| |
|
|
