AGM Statement
Oxford Biomedica PLC
20 April 2004
For immediate release 20 April 2004
OXFORD BIOMEDICA
ANNUAL GENERAL MEETING 2004
Oxford, UK: 20 April 2004 - At Oxford BioMedica's Annual General Meeting, held
today in London, all resolutions were duly passed. Following the meeting, the
Company's CEO, Professor Alan Kingsman made the following statement:
'The first quarter of 2004 has built on the product development and commercial
progress described in the 2003 Annual Report. There have been several
encouraging developments since the full year results.
For the TroVax(R) cancer immunotherapy product, the Phase II trials programme is
advancing as planned. Recruitment has been expanded from fifteen to twenty
patients in the first Phase II trial, alongside chemotherapy agents
5-fluorouracil and irinotecan in colorectal cancer. Data from this trial are
expected around mid-2004. The second trial, with chemotherapy agents
5-fluorouracil and oxaliplatin in colorectal cancer, is similarly progressing
with data expected in H2 2004. Three additional Phase II trials are on schedule
to start in 2004. The Cancer Research UK funded trial in colorectal cancer is
expected to start recruitment shortly. The first US trial with TroVax, which is
in metastatic renal cancer, is on track to start in Q3 2004 or earlier and the
US Southwest Oncology Group funded trial in late stage breast cancer is
similarly planned for Q3 2004.
The manufacturing scale-up of TroVax is moving ahead. 12,000 doses of TroVax
have now been successfully produced by a major biologicals manufacturer. The
Company is conducting small bridging studies with this material, which will
otherwise be used for Phase III trials.
Planning for initial Phase III trials in 2005 is ongoing with three main options
under consideration: TroVax with chemotherapy in colorectal cancer, based on the
current Phase II studies; TroVax in colorectal cancer post chemotherapy, based
on the evaluation of the Phase I/II trial data (following the encouraging
survival analysis reported in March 2004); and TroVax in renal cancer, based on
the initial Phase II trial data due to emerge from the US study in early 2005.
The Company is in discussion with potential development partners and definitive
plans for Phase III trials depend on the outcome of these discussions.
The MetXia(R) Phase II trial in patients with pancreatic cancer is underway,
slightly ahead of schedule. Initial results from the first stage of the trial
are expected in Q4 2004.
ProSavin(R) for Parkinson's disease has generated additional, exciting
preclinical data and has attracted significant interest from potential partners.
As part of the process of moving ProSavin into clinical trials, a pre-submission
meeting is due to be held with the UK Gene Therapy Advisory Committee (GTAC) on
21 April to discuss regulatory plans for this innovative product. As set out in
the 2003 Annual Report, the Company expects to start clinical development with
ProSavin by the end of 2004.
During this first quarter initial data have been obtained showing that
RetinoStat(R) is efficacious in an industry standard preclinical model of
age-related macular degeneration. The full preclinical efficacy data pack is on
schedule for completion around the middle of the year.
Preclinical development of MoNuDinTM for the treatment of motor neuron disease
and SMN-1G for spinal muscular atrophy is progressing according to plan. Today
the Company is announcing that its Innurex(R) programme for nerve regeneration
in spinal cord injury has been awarded $150,000 from the Christopher Reeve
Paralysis Foundation. The Company has recently generated encouraging preclinical
data with Innurex demonstrating aspects of nerve repair in models of stretch
injury. As stated in the 2003 Annual Report, data that show restoration of limb
function following injury is expected around mid-2004.
Following the signing of the LentiVector(R) research license with Merck & Co. in
February 2004, additional licensing opportunities for the technology have
emerged. Discussions have been initiated with four new potential licensees. Two
of these are in the field of transgenics.
On 29 March 2004, the Company reported that the UK Department of Health had
awarded the Company a grant of £500,000 to develop its LentiVector technology
for use in the treatment of haemophilia A, a condition caused by a defective
gene for Factor VIII, a key component of the mechanism for forming blood clots.
The Company has continued to make clinical and technical progress and has
achieved further product endorsement from independent funding organisations. The
award of the Christopher Reeve grant means that Oxford BioMedica now has five of
its seven products supported by independent research or charitable
organisations. In addition, a new product opportunity in the field of
haemophilia is being funded entirely by the Department of Health. This level of
backing of Oxford BioMedica's products and technologies provides credibility and
added value for potential partners while at the same time reducing the Company's
cash consumption. This is all achieved without any loss of commercial rights.
In terms of financials, Oxford BioMedica has made a strong start to the year.
Based on unaudited management accounts, the cash balance was £29.3 million at 31
March 2004 (31 March 2003: £18.2 million), which is better than budget. The cash
outflow for the three months to 31 March 2004 was £2.6 million (Q1 2003: £2.8
million). Looking forward, the Company is on track to stay within its financial
forecasts. The Company has sufficient cash resources to 2007 without taking into
account expectations for increased revenue.
Overall 2004 is set to be an exciting year'.
-Ends-
2004/OB/05
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 7886 8150
Notes to editors
Oxford BioMedica
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.
In addition to its technical expertise in gene delivery, Oxford BioMedica has
in-house clinical, regulatory and manufacturing know-how. The development
pipeline includes two novel anti-cancer products in clinical trials; and two
neurotherapy products in advanced preclinical development for Parkinson's
disease and retinopathy. The Company is underpinned by an extensive preclinical
and research portfolio and about 70 patent families, which represents one of the
broadest patent estates in the field.
The Company has a staff of around 65 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, Merck & Co,
Amersham and Kiadis.
Further information is available at http://www.oxfordbiomedica.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange