OXFORD
BIOMEDICA ANNOUNCES POSITIVE INTERIM PHASE II RESULTS WITH
TROVAX IN COLORECTAL CANCER
Oxford BioMedica
(LSE: OXB) announced today that the primary endpoints have
been achieved at the interim stage of two Phase II trials
in patients with Stage IV colorectal cancer receiving TroVax
alongside chemotherapy. TroVax is the Company’s novel
cancer immunotherapy product against the tumour associated
antigen 5T4. The primary endpoints are safety and demonstrable
anti-tumour immune responses against the 5T4 tumour antigen.
The results from
an interim analysis of both trials, initiated in 2003, showed
that the combination of TroVax and standard of care chemotherapy
is safe and that patients mount specific immune responses
to the 5T4 antigen. Full recruitment is imminent across both
trials with 36 of 37 projected patients enrolled. The objective
is to have ten evaluable patients in each setting. The interim
results are based on 13 patients in total, who have reached
an interim analysis point defined as four TroVax immunisations
and more than eight cycles of chemotherapy. There have been
no serious adverse events associated with TroVax treatment
and the product was well tolerated. 11 of the 13 patients
(85%) mounted antibody and/or cellular immune responses to
the 5T4 tumour antigen following four immunisations with TroVax.
The Company expects
to report full safety and immunological data in mid-2005 when
all patients will have received 12 cycles of chemotherapy
and 6 doses of TroVax. At this time, tumour response rates
will also be determined.
TroVax
plus IFL chemotherapy
The protocol of the first Phase II trial is six immunisations
of TroVax alongside chemotherapy cycles of irinotecan, 5-fluorouracil
(5FU) and leucovorin (a combination referred to as IFL). A
total of 19 patients have been enrolled. Ten patients have
reached the interim analysis point. Nine out of ten patients
(or 90%) have mounted specific anti-tumour immunological responses
to the 5T4 antigen.
TroVax
plus FOLFOX chemotherapy
The second Phase II trial protocol is similarly six immunisations
of TroVax alongside cycles of oxaliplatin, 5FU and leucovorin
(referred to as FOLFOX). The trial is fully recruited at 17
patients. Three patients have reached the interim analysis
point and two of these (or 67%) have shown anti-5T4 immune
responses to date.
Commenting
on the Phase II results, Prof. Alan Kingsman, Chief Executive
of Oxford BioMedica, said, “We are very pleased
with the progress of our first Phase II trials with TroVax.
The high number of anti-5T4 responses at this interim stage
suggests that patients are able to mount an anti-tumour immune
response even in the context of chemotherapy treatment. In
our earlier Phase I/II trials, it was clear that anti-5T4
immune responses correlated with improved patient survival.
We now feel confident that TroVax has a role to play in the
treatment of colorectal cancer.”
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