Oxford Biomedica PLC
29 April 2004
FOR IMMEDIATE RELEASE 29 APRIL 2004
OXFORD BIOMEDICA GAINS FDA APPROVAL
FOR A PHASE II TRIAL OF TROVAX(R) IN RENAL CANCER
- Patient Recruitment to Commence Q3 2004-
Oxford, UK: 29 April 2004 - Oxford BioMedica (LSE:OXB.L), the leading gene
therapy company, announces today that the US Food & Drug Administration (FDA)
has approved an Investigational New Drug (IND) application to evaluate
TroVax(R), the Company's proprietary cancer vaccine, in patients with metastatic
renal cancer.
TroVax(R) will be tested in combination with the standard treatment interleukin-
2 (IL-2), an immune stimulator, in patients whose median survival is
approximately 13 months. Safety and immunogenicity will be the primary goals,
but patients will be monitored for clinical benefit including increased
survival. The trial will be conducted at the Columbia Presbyterian Medical
Center in New York and patient recruitment is expected to start in Q3 2004. The
study should be complete, as far as the primary end-points are concerned, within
approximately twelve months of initiation.
There were an estimated 31,900 new cases of renal cancer in the US in 2003
(source: American Cancer Society, Cancer Facts and Figures for 2003). More than
half of these patients have metastatic disease (secondary cancer). After
surgical removal of the primary tumour, treatment with IL-2 has been shown to
have some benefit, suggesting that the tumours may be responsive to
immunological strategies. The rationale for this trial is that the immune
response induced by TroVax(R) may halt or delay the progression of metastases so
increasing survival beyond the estimated median of 13 months. Using TroVax(R) in
combination with IL-2 may enhance that response.
There is a great need for additional therapies for renal cancer as the prognosis
for patients is poor with current treatments. The regulatory strategy for the
development of TroVax(R) will involve seeking fast track approval and opening
discussions about product registration if early data are encouraging.
Commenting on the approval Oxford BioMedica's Chief Executive, Professor Alan
Kingsman said:
'We are delighted to be able to take TroVax(R) into the USA in an indication
that has real unmet medical need. We expect patient recruitment to be faster
than we have seen in previous trials and we are excited about testing TroVax(R)
with an immune stimulator such as IL2.'
-Ends-
For further information, please contact:
Oxford BioMedica plc
----------------------
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
City/Financial Enquiries:
----------------------
Lisa Baderoon/ Mark Court: Buchanan Communications Tel: +44 (0)20 7466 5000
----------------------
Scientific/Trade Press Enquiries:
Sue Charles, Katja Stout: Northbank Communications Tel: +44 (0)20 7886 8150
Notes to editors
1. 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 approximately 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
2. TroVax(R) cancer immunotherapy
TroVax is Oxford BioMedica's leading cancer immunotherapy product. It is
designed specifically to stimulate an anti-cancer immune response and has
potential application in most solid tumour types. TroVax targets the tumour
antigen 5T4, which is broadly distributed throughout a wide range of solid
tumours. The presence of 5T4 is correlated with poor prognosis. The product
consists of a poxvirus (MVA) gene transfer system, which delivers the gene for
5T4 and stimulates a patient's body to produce an anti-5T4 immune response. This
immune response destroys tumour cells carrying the 5T4 protein.
Two Phase I/II trials with TroVax have been completed in the UK in late-stage
colorectal cancer patients. Following these successful Phase I/II trials, TroVax
has entered two Phase II trials in the UK in Stage IV colorectal cancer patients
receiving 5FU plus either oxaliplatin or irinotecan. Approval has now been
obtained for a Phase II trial in the USA in renal cancer. The product is also
expected to enter further trials in colorectal and breast cancer. The renal and
breast cancer trials are to be conducted in the United States under an
Investigational New Drug (IND) application. The renal cancer trial in the US is
expected to start enrolment in quarter 3 2004. Initial data from the first
TroVax Phase II trial in colorectal cancer have confirmed the product's safety
profile. Full results from the colorectal cancer Phase II trials are anticipated
in 2004.
This information is provided by RNS
The company news service from the London Stock Exchange
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