Oxford Biomedica PLC
20 May 2003
20 May 2003
OXFORD BIOMEDICA'S TROVAX(R) RECEIVES CLEARANCE FROM THE UNITED STATES
RECOMBINANT DNA ADVISORY COMMITTEE TO ENTER A CLINICAL TRIAL FOR RENAL CANCER
Oxford, UK: 20 May 2003. Oxford BioMedica announced today that TroVax had passed
a key regulatory hurdle towards its first clinical trial in the USA. A review by
the United States Recombinant DNA Advisory Committee (RAC) provided clearance to
start a clinical trial with TroVax for the treatment of renal cancer. The trial
will be conducted at the Columbian Presbyterian Medical Center in New York.
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 pox virus (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.
Following successful Phase I/II clinical trial results in late stage colorectal
cancer patients in the UK, TroVax is proceeding into Phase II trials in
colorectal cancer and into further trials in renal and breast cancer
respectively. Both the renal and breast cancer trials are to be conducted in the
United States under an Investigative New Drug (IND) application. A prerequisite
for the IND is approval by RAC.
Renal cancer represents a significant market opportunity with about 30,000 cases
per year in the United States. It is generally treated with Interleukin 2 (IL2).
However, the success rate is mixed and median survival is only about 13 months.
There is therefore a significant unmet medical need for an improved therapy for
this type of cancer. TroVax is to be tested with IL2 in a study of 25 patients.
Safety, immunogenicity and clinical benefit will be the primary objectives of
the trial.
Commenting on the news the Company's Senior Vice President for Research and
Development, Dr. Susan Kingsman said 'Survival rates for renal cancer are poor
and there are few novel therapies in development for this disease. We are
delighted that TroVax is proceeding towards its first clinical trial in the
United States for this unmet medical need. This is an important step in
broadening the market potential of the product and thereby increasing its value'.
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
-Ends-
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, 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 on the World Wide Web at http://
www.oxfordbiomedica.co.uk
2. The US Recombinant DNA Advisory Committee
The Recombinant DNA Advisory Committee (RAC) was established on October 7, 1974,
in response to public concerns regarding the safety of manipulation of genetic
material through the use of recombinant DNA techniques. The RAC advises the
Director of the US National Institutes of Health.
The RAC is a technical committee whose goal is to consider the current state of
knowledge and technology regarding recombinant DNA. This includes review of
human gene transfer trials, and an assessment of the ability of DNA recombinants
to survive in nature and the potential for transfer of genetic material to other
organisms. It also considers hypothetical hazards and methods for monitoring and
minimizing risks. Approximately one-third of the 15 members do not have
scientific expertise but represent public interests and attitudes. This balance
is intended to provide a forum for open public debate of social and scientific
issues attendant to recombinant DNA research. The RAC has been overwhelmingly
successful in achieving this goal.
This information is provided by RNS
The company news service from the London Stock Exchange
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