OXFORD
BIOMEDICA ANNOUNCES ENCOURAGING PRELIMINARY PHASE II RESULTS
WITH TROVAX IN RENAL CELL CARCINOMA
Oxford
BioMedica (LSE:OXB.L), the leading gene therapy company, today
announces preliminary data from the Phase II trial of TroVax
in renal cell carcinoma (RCC). The data show that TroVax is
safe and well tolerated in this patient group and that the
product induces a strong anti-tumour immune response against
the 5T4 tumour antigen. Some of these data were referred to
in a presentation made by the principal investigator for this
Phase II trial at the World Vaccine Congress on 5 October
2005.
The Phase II trial in RCC is being conducted
at the New York-Presbyterian Hospital in New York, USA, under
an approved Investigational New Drug protocol. The principal
investigator for the trial is Dr Howard Kaufmann of the New
York-Presbyterian Hospital. Dr Kaufmann is a leading expert
in clinical immunotherapy and is an advisor on TroVax.
The Phase II trial is an open label study
of TroVax in combination with interleukin-2 (IL-2) therapy,
which is an FDA-approved treatment for RCC. Patients receive
five immunisations of TroVax over 12 weeks and up to four
cycles of high dose IL-2. Patients that show an anti-tumour
immune response to TroVax will be offered an additional three
vaccinations. The primary endpoints of the trial are safety
and immunogenicity. Secondary efficacy endpoints include tumour
responses, time to disease progression and overall survival.
The trial is intended to recruit up to 25
patients, in order to gather information on the safety of
TroVax in this setting and also the ability of TroVax to elicit
immune responses to the tumour antigen 5T4. To date, seven
patients have been recruited. There have been no serious adverse
events related to TroVax, which is consistent with the safety
profile of the product across all trials, and TroVax treatment
has been well tolerated. Five patients have reached the preliminary
analysis point for immune responses. This preliminary time
point is after two immunisations with TroVax. All five patients
have shown high anti-tumour antibody responses to 5T4. The
antibody levels were at the top end of the range reported
from the Phase II trials with TroVax in patients with colorectal
cancer undergoing chemotherapy. Anti-tumour cellular responses
against the 5T4 antigen will be analysed and reported in due
course.
Dr Howard Kaufmann gave a presentation on
5 October 2005 at the World Vaccine Congress in Lyon, France,
in a session on Vaccines in Clinical Development. In his presentation,
titled “Poxvirus Vaccine Strategies for the Treatment
of Cancer”, Dr Kaufmann referred to the Phase II trial
with TroVax in RCC and highlighted the potential of the product.
Independently,
there has been a recent publication on the prevalence of 5T4
expression in renal cancer. This was authored by Robert Hawkins
of the Christie Hospital in Manchester (see
Griffiths et al., British Journal of Cancer 2005). In
this publication, most RCC tumours were found to have high
levels of 5T4 expression, both on primary and metastatic sites.
This suggests that the majority of patients with RCC could
benefit from a 5T4-targeted product such as TroVax.
Commenting
on the TroVax results in renal cell carcinoma, Oxford BioMedica’s
Chief Executive, Professor Alan Kingsman said: “It is
very encouraging that the results with TroVax in renal cell
carcinoma are consistent with our data set in colorectal cancer.
We are also grateful for the strong support of TroVax shown
by Dr Kaufmann. Renal cell carcinoma is an aggressive disease
with an unmet need for effective treatments. The high levels
of 5T4 in renal cancer and the paucity of treatment options
make this an ideal setting for further development of TroVax”.
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