TroVax to Enter Phase II
Oxford Biomedica PLC
03 March 2003
OXFORD BIOMEDICA OBTAINS APPROVAL FOR TROVAX(R) TO ENTER PHASE II TRIALS FOR
COLORECTAL CANCER
Oxford, UK: 3 March 2003 - Oxford BioMedica (LSE:OXB) announced today that it
had received ethical approval from the UK Gene Therapy Advisory Committee ('
GTAC') for its therapeutic cancer vaccine, TroVax, to enter a Phase II clinical
trial in patients receiving chemotherapy for colorectal cancer. The trial is
planned to start within two months.
TroVax is designed to stimulate a patient's immune system to recognise and
destroy cancer cells. The product is based on a gene that encodes a protein,
known as 5T4, which exists only on the surface of tumour cells and not on normal
cells. When this gene is expressed by Oxford BioMedica's highly engineered
virus-based delivery system, it induces a potent anti-tumour response. This
means that cells and antibodies of the immune system seek out the tumour cells
carrying 5T4 and destroy them.
TroVax has successfully completed a Phase I/II trial in metastatic colorectal
cancer patients and has been shown to be safe and well tolerated in these
patients. Furthermore, TroVax was shown to be immunogenic, inducing anti-5T4
antibodies and T-cells in 11 out of 12 patients. In addition disease
stabilisation, reduction in circulating tumour markers and tumour necrosis was
observed in some patients. These data form the basis for moving into Phase II.
The Phase II programme is designed to maximise the speed with which TroVax could
reach a cancer market of reasonable size. The strategy is to continue to focus
on colorectal cancer and to move quickly towards making TroVax ready for a Phase
III efficacy study. The target population will not be the very late stage,
post-chemotherapy group of the first trial but rather the somewhat earlier
patient population receiving chemotherapy for the first time for metastatic or
inoperable disease. The rationale is that TroVax might contribute to tumour
reduction via immune system-mediated cell killing and this could be amplified in
the presence of the cell death that is induced by chemotherapy. This would place
TroVax alongside current first-line chemotherapy and provide a relatively
simple, relatively short-term survival, or time-to-progression, end-point. In
order to get to a Phase III study in combination with chemotherapy, a short
Phase II study is required to show that TroVax induces an appropriate anti-5T4
response in this context. It is this study that has been approved by GTAC.
GTAC has approved an open label Phase II trial in up to 15 patients of 5 doses
of TroVax in patients receiving 5-fluorouracil, leukovorin and irinotecan. The
end-points of the trial will be the immune response to TroVax and safety in
conjunction with this chemotherapy. Therefore the trial is expected to last only
6 months after the recruitment of the last patient. The Company anticipates
rapid recruitment because of the large number of patients fulfilling the entry
criteria. The protocol is designed to give immunological readouts following
vaccination before, during and just after completion of chemotherapy. The trials
will take place at the Christie Hospital in Manchester and two other centres in
the UK. The overall aim is to provide data to finalise the design of a Phase III
protocol that could lead to product registration in 2007/8.
If TroVax is successful in this context and achieves product registration for
use in colorectal cancer patients receiving first line chemotherapy, it could
command a market of between $0.5-1.0 billion.
Commenting on GTAC's approval Chief Executive, Alan Kingsman said
'TroVax is an exciting product and it is very pleasing to see it progressing
towards the market. Making TroVax a potential phase III product for 2004 should
potentiate our ability to find the right partner for this product. The Company
is also seeking approval for trials to study the use of TroVax for other cancers
as part of the strategy to broaden the market potential of the product.'
-Ends-
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 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.
Further information is available on the World Wide Web at http://
www.oxfordbiomedica.co.uk
2. Gene Therapy Advisory Committee (GTAC)
The Gene Therapy Advisory Committee evaluates gene therapy trial protocols 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, the products can be entered for clinical trials.
This information is provided by RNS
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