TroVax Update
Oxford Biomedica PLC
14 July 2003
14 July 2003
SECOND TROVAX PHASE I/II TRIAL RESULTS PRESENTED AT MEETING OF THE AMERICAN
ASSOCIATION FOR CANCER RESEARCH
Oxford, UK: 14 July 2003 - Oxford BioMedica announced today that it is
presenting new clinical data on the Company's lead cancer product, TroVax(R), at
the American Association for Cancer Research (AACR) Annual Meeting in
Washington, DC. The results are being presented by Dr. Richard Harrop, Principal
Scientist at Oxford BioMedica. Following on from the earlier Phase I/II trial in
colorectal cancer patients, using intramuscular delivery, that was reported last
year, the Company conducted a small, five-patient Phase I/II study to evaluate
intradermal delivery of TroVax as an alternative method of administration. As
with the intramuscular trial, all the primary end-points of the intradermal
study were achieved, in that the product was found to be safe and all patients
mounted an anti-tumour immune response. This brings the number of patients
treated in the combined Phase I/II studies to seventeen. Sixteen of these
produced the desired immune response.
Vaccines delivered intradermally have been found to give more potent immune
responses for infectious diseases such as AIDS. The Company therefore embarked
on a small trial to determine whether the same was true for its cancer vaccine
in humans. Encouragingly, all five patients in the trial showed an anti-tumour
immune response. Furthermore, two patients who generated high levels of
anti-5T4 antibodies to TroVax, experienced periods of disease stabilisation and
are presently still on study one year after their first TroVax vaccination. All
five patients treated are still alive, 6-12 months after initiation of
treatment. TroVax was well tolerated in all patients treated.
These additional clinical trial data confirm the immunogenic efficacy of TroVax
that was seen in the earlier intramuscular study, and highlight the product's
therapeutic potential. Given that high levels of response were seen with both
the intradermal and intramuscular routes of administration, the Company has
decided to conduct further trials with TroVax using the simpler intramuscular
route. TroVax is currently being assessed in a Phase II trial in late stage
(Stage IV) colorectal cancer patients in conjunction with chemotherapy, and
further Phase II trials in colorectal cancer, renal cancer and breast cancer are
planned for 2003.
Commenting on the presentation, Oxford BioMedica's chief executive, Professor
Alan Kingsman said, 'It is pleasing to see the encouraging data of the first
Phase I/II trial repeated in this additional study. The AACR is the perfect
forum to communicate these data to clinicians and to pharmaceutical companies.'
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 7886 8150
Notes to editors
Oxford BioMedica
Based in Oxford, UK, Oxford BioMedica is a biopharmaceutical company
specialising 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 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 research skill-base, Oxford BioMedica has in-house
clinical, regulatory and manufacturing know-how. The development pipeline
includes two novel anti-cancer products in clinical trials and a gene-based
treatment for Parkinson's disease, which is in late preclinical studies. The
Company is underpinned by an extensive preclinical and research portfolio and
over 70 patent families, about quarter of which are issued.
TroVax(R), which is Oxford BioMedica's lead cancer immunotherapy product, is in
Phase II trials for colorectal cancer (see below). MetXia(R) is Oxford
BioMedica's lead 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. MetXia is being investigated in a Phase I/II trial in breast
cancer, and regulatory submissions are under review for trials in pancreactic
cancer.
Oxford BioMedica has a wholly-owned subsidiary in San Diego, USA. Oxford
BioMedica has corporate collaborations with Wyeth, Intervet, Aliga
Pharmaceuticals, Amersham, Arius Research and Viragen.
TroVax
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.
TroVax has completed two Phase I/II trials in the UK in late-stage colorectal
cancer, one with intramuscular administration and the other with intradermal
administration using the Bioject needle-free injection system. Following these
two successful Phase I/II trials, TroVax has entered two Phase II trials in
Stage IV colorectal cancer patients receiving 5FU plus either oxaliplatin or
irinotecan. The product is also on target to enter further trials in colorectal,
renal and breast cancer. The renal and breast cancer trials are to be conducted
in the United States under an Investigational New Drug (IND) application. Data
from the first TroVax Phase II trial is expected to be available by the end of
2003, in readiness for Phase III trials in colorectal cancer.
This information is provided by RNS
The company news service from the London Stock Exchange