Research Update
Oxford Biomedica PLC
03 July 2003
POSITIVE RESULTS FROM METXIA PHASE I/II BREAST CANCER TRIAL AND PLANS FOR
PANCREACTIC CANCER TRIAL
Oxford, UK: 3 July 2003 - Oxford BioMedica (LSE:OXB) announced today encouraging
results from its ongoing Phase I/II trial with MetXia(R) in breast cancer
patients. The Company also announced regulatory progress towards starting a
Phase I/II trial with MetXia in pancreatic cancer.
The current Phase I/II trial in breast cancer is using an improved formulation
of MetXia that effectively increases the dose level. One of the goals of the
trial is to show that this higher potency form is safe. The trial is also
designed to confirm the encouraging responses observed in an earlier clinical
trial of the original formulation of MetXia in breast cancer and melanoma
patients. The ongoing trial seeks to confirm the immune stimulatory properties
of MetXia as well as to determine whether the higher potency version of the
product delivers the therapeutic gene to tumours more efficiently in humans, as
it does in preclinical models. So far, the data suggest that MetXia is meeting
all expectations with respect to safety, gene transfer and immune stimulation.
The patient recruitment for the low dose is now complete and data from the first
patients show that delivery of the therapeutic gene to tumour cells is more than
10-fold better than in the previous trial and also that patients are mounting an
anti-tumour immune response. If this high level of response to MetXia is
maintained, there will be no need to recruit all 12 patients and the study can
be terminated early. Furthermore, if the systemic anti-tumour effect is a
reproducible feature of MetXia as the trial continues, then the product could be
considered for treatment of disseminated metastatic disease, which would greatly
enhance its commercial potential.
In addition, the Company has proceeded with its plans to take MetXia into a
Phase I/II study in pancreatic cancer by seeking approval for the trial from the
UK Gene Therapy Advisory Committee (GTAC). GTAC is currently considering the
application. The proposed trial is expected to enrol 25 patients who have
previously been diagnosed with metastatic pancreatic cancer. The trial will be
conducted at the Royal Liverpool University Hospital and Leicester Royal
Infirmary.
Commenting on progress with MetXia, Oxford BioMedica's Chief Executive, Prof
Alan Kingsman said 'The new data are most encouraging. If they are confirmed in
a few additional patients then we can expand the potential market for MetXia
based on its systemic anti-cancer effects. Notwithstanding these results, we are
pleased to be making progress towards our first trial in pancreatic cancer, a
disease where there is a clear unmet medical need and accelerated product
approval is a possibility.'
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
City/Financial Enquiries:
Mike Wort, Beattie Financial Tel: +44 (0) 7730 418 745
Scientific/Trade Press Enquiries:
Sue Charles, Katja Stout: Northbank Communications Tel: +44 (0)20 7886 8150
Notes to editors
1. 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.
Oxford 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.
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 at http://www.oxfordbiomedica.co.uk
2. MetXia
MetXia is Oxford BioMedica's leading gene-based cancer therapeutic. The product
is based on a highly engineered retrovirus gene delivery system expressing a
specific human cytochrome P450 gene. MetXia converts the tumour into a 'drug
factory', enabling increased local production of the anti-tumour, cytotoxic
derivative of the pro-drug cyclophosphamide. MetXia is potentially useful in the
treatment of all solid tumours and their metastases, particularly those where
cyclophosphamide is commonly used.
Results from an initial Phase I/II trial of MetXia in patients with very
advanced breast cancer or melanoma were reported last year. The trial was
completely successful in that the product was safe and gene delivery was readily
detected in the treated tumours. In addition there was clinical benefit in some
patients, including tumour size reduction. Most remarkable, however, was the
dramatic improvement in one patient of a cancerous lesion that was not treated,
following treatment of tumour nodules elsewhere on the patient's body. One
interpretation of these data is that MetXia was inducing a systemic immune
response, which acted against the untreated lesion. Subsequent studies
demonstrated that this patient did indeed have anti-tumour antibodies and
T-cells. This means that although MetXia must be administered directly to a
tumour, the tumour cell death that it causes may induce an immune response that
will destroy other tumours in the same patient.
This information is provided by RNS
The company news service from the London Stock Exchange