OXFORD
BIOMEDICA
SUCCESSFUL INTERIM PHASE I/II TROVAX® RESULTS
Oxford,
United Kingdom - 15 October 2001. Oxford BioMedica plc
(LSE:OXB) ("BioMedica") today announced interim
results from the Phase I/II trial of its anti-cancer therapeutic
vaccine, TroVax®, at the 9th Annual BioPartnering
Europe conference in London. The results will also be presented
at the SMi conference on Research Based Oncology, also in
London, on 17 October 2001.
Initial
results show TroVax® to be safe and well tolerated
and the vaccine induced an immune response against the tumour
antigen, OBA1 in colorectal cancer. These results represent
the successful achievement of the primary end-points of the
trial.
TroVax®
is a gene-based therapeutic vaccine that is designed to stimulate
the patient's immune system to mount a powerful response to
recognise and destroy cancer cells. The immune system plays
a key role in fighting infections and disease. However with
cancer, the patient's immune system often fails to react to
the existence of a tumour and as a result an effective immune
response is not triggered.
The product
is based on a gene that encodes a protein, OBA1, that exists
on the surface of tumour cells and not on normal cells - such
proteins are known as Tumour Associated Antigens (TAAs). When
the OBA1 gene is expressed by Oxford BioMedica's highly engineered
virus-based delivery system, it induces an anti-tumour response.
OBA1 is present on a wide range of tumours. Although the first
clinical trials of TroVax® have been conducted
in colorectal cancer patients, TroVax® is also
expected to be applicable to many other solid tumours.
In preclinical
model systems the results have been very striking, with TroVax®
breaking immune tolerance to tumours and protecting against
further tumour growth. This first Phase I/II clinical trial
of TroVax®, which started in January 2001,
confirms that TroVax® also causes immune responses
against OBA1 to be raised in cancer patients.
The Phase
I/II TroVax® clinical trial comprises 12 patients
at the Dukes D stage of colorectal cancer. The patients are
divided into low, medium and high dose groups. The low dose
group has now been completed and it is these initial results
that the Company is reporting.
In all
four patients in the low dose group TroVax®
was tolerated well with no adverse effects. In three of these
patients there are anti-OBA1 immune responses. The fourth
patient has, so far, been unable to mount a response to any
antigen tested, for reasons unrelated to the trial. This is
not unusual in patients with advanced cancer that have previously
received other forms of therapy. This means that in all of
the patients within this low-dose group who were immunocompetent,
an anti-OBA1 response was seen.
The Company
has now escalated the dose for the next group which is already
fully enrolled. It is anticipated that preliminary results
covering the medium and high dose groups will be released
in the first quarter of 2002.
Commenting
on the results Chief Executive, Professor Alan Kingsman said:
"We are pleased that the TroVax® trial
has achieved its major goals so early in the programme and
we look forward to results from the other dose groups. We
have released these data now because we have had several requests
to share the results with the scientific and business communities,
however it should be remembered that there is still some way
to go before TroVax® is shown to be effective
in treating human cancer."
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