Research Update
Oxford Biomedica PLC
15 October 2001
For immediate release
2001/OB/17
15 October 2001
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 7831 3113
Melanie Toyne Sewell/Fiona Noblet
Financial Dynamics
Scientific/Trade Press Enquiries: Tel: +44 (0)20 7496 3300
Chris Gardner, HCC De Facto Group
OXFORD BIOMEDICA: SUCCESSFUL INTERIM
PHASE I/II TROVAX(R) RESULTS
Oxford, United Kingdom - 15 October 2001. Oxford BioMedica plc (LSE:OXB) ('
BioMedica') today announced interim results from the Phase I/II trial of its
anti-cancer therapeutic vaccine, TroVax(R), at the 9th Annual BioPartnering
Europe conference in London. The results will also be presented at the SMi
conference on Research Based Oncology, also in London, on 17 October 2001.
Initial results show TroVax(R) to be safe and well tolerated and the vaccine
induced an immune response against the tumour antigen, OBA1 in colorectal
cancer. These results represent the successful achievement of the primary
end-points of the trial.
TroVax(R) is a gene-based therapeutic vaccine that is designed to stimulate
the patient's immune system to mount a powerful response to recognise and
destroy cancer cells. The immune system plays a key role in fighting
infections and disease. However with cancer, the patient's immune system often
fails to react to the existence of a tumour and as a result an effective
immune response is not triggered.
The product is based on a gene that encodes a protein, OBA1, that exists on
the surface of tumour cells and not on normal cells - such proteins are known
as Tumour Associated Antigens (TAAs). When the OBA1 gene is expressed by
Oxford BioMedica's highly engineered virus-based delivery system, it induces
an anti-tumour response. OBA1 is present on a wide range of tumours. Although
the first clinical trials of TroVax(R) have been conducted in colorectal
cancer patients, TroVax(R) is also expected to be applicable to many other
solid tumours.
In preclinical model systems the results have been very striking, with TroVax
(R) breaking immune tolerance to tumours and protecting against further tumour
growth. This first Phase I/II clinical trial of TroVax(R), which started in
January 2001, confirms that TroVax(R) also causes immune responses against
OBA1 to be raised in cancer patients.
The Phase I/II TroVax(R) clinical trial comprises 12 patients at the Dukes D
stage of colorectal cancer. The patients are divided into low, medium and high
dose groups. The low dose group has now been completed and it is these initial
results that the Company is reporting.
In all four patients in the low dose group TroVax(R) was tolerated well with
no adverse effects. In three of these patients there are anti-OBA1 immune
responses. The fourth patient has, so far, been unable to mount a response to
any antigen tested, for reasons unrelated to the trial. This is not unusual in
patients with advanced cancer that have previously received other forms of
therapy. This means that in all of the patients within this low-dose group who
were immunocompetent, an anti-OBA1 response was seen.
The Company has now escalated the dose for the next group which is already
fully enrolled. It is anticipated that preliminary results covering the medium
and high dose groups will be released in the first quarter of 2002.
Commenting on the results Chief Executive, Professor Alan Kingsman said
'We are pleased that the TroVax(R) trial has achieved its major goals so early
in the programme and we look forward to results from the other dose groups. We
have released these data now because we have had several requests to share the
results with the scientific and business communities, however it should be
remembered that there is still some way to go before TroVax(R) is shown to be
effective in treating human cancer.'
-Ends-
Notes to Editors
1. Oxford BioMedica plc
Established in 1995, the Company specialises in the application of gene-based
technology to the development of novel therapeutics. Its three principal
activities are in the fields of gene therapy, immunotherapy and genomics, and
its principal therapeutic areas are in cancer and neurodegenerative diseases.
Oxford BioMedica plc was floated on the Alternative Investment Market of the
London Stock Exchange in December 1996, and upgraded to the United Kingdom
Listing Authority Official List in April 2001 following a successful £35.5
million fund-raising.
Oxford BioMedica has operating centres in Oxford, UK and San Diego, USA
Currently Oxford BioMedica has corporate collaborations with Aventis,
AstraZeneca, IDM, Nycomed Amersham, Valentis, Virbac and Wyeth. BioMedica has
two products in Phase I/II clinical trials: MetXia(R) for late-stage breast
cancer and ovarian cancer, and TroVax(R) for late-stage colorectal cancer.
2. OBA1
OBA1 is an oncofetal glycoprotein with a broad tumour distribution. In
clinical surveys commissioned by Oxford BioMedica, OBA1 was found to be
present on greater than 75% of human tumours, including the most prevalent
types of cancer. OBA1 was not detected at significant levels on normal
tissues. Among the factors that limit many current forms of cancer therapy are
dose-limiting toxic side effects, or limited applicability. The unique
properties of OBA1 make it an ideal target for developing new, safer and more
powerful anti-cancer therapies.
In addition to TroVax(R), BioMedica has other collaborative programmes based
on aspects of OBA1. These include a collaboration, started in January 2001,
with Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home
Products, to develop antibody-based anti-cancer products. It is also in
collaborations with Virbac SA to develop a veterinary analogue of TroVax(R),
and with Nycomed Amersham to develop novel tumour imaging products.
Under an agreement with the UK Cancer Research Campaign Technology, BioMedica
has exclusive worldwide rights to therapeutic and diagnostic applications of
OBA1.
3. World Wide Web
This release is also available on the World Wide Web at http://
www.oxfordbiomedica.co.uk