New Trovax Clinical Data
Oxford Biomedica PLC
25 March 2008
FOR IMMEDIATE RELEASE 25 MARCH 2008
OXFORD BIOMEDICA REPORT ENCOURAGING NEW PHASE II TRIAL RESULTS WITH TROVAX(R) IN
PROSTATE CANCER
- Presentation at the Symposium on Targeted Anticancer Therapies -
Oxford, UK - 25 March 2008: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, today announces encouraging new data from its first Phase II trial of
TroVax in prostate cancer. TroVax is Oxford BioMedica's lead cancer
immunotherapy product, which is being developed in collaboration with
sanofi-aventis. The Phase II data were presented by the clinical investigators
from the Methodist Hospital in Houston, Texas, at the 6th International
Symposium on Targeted Anticancer Therapies on 20 March 2008 in Bethesda,
Maryland. This event was organised by the NDDO Research Foundation in a
partnership with the US National Cancer Institute (NCI; www.cancer.gov) and the
European Society for Medical Oncology (ESMO; www.esmo.org).
In the Phase II trial, 27 patients with metastatic hormone-refractory prostate
cancer (HRPC) were treated with TroVax alone (n=14) or TroVax in combination
with GM-CSF (n=13). TroVax was well tolerated with no related serious adverse
events. Eligibility for the trial included patients with progressive disease and
pre-treatment with at least one course of chemotherapy. Of 24 evaluable
patients, all mounted robust antibody responses against the targeted tumour
antigen, 5T4, and nine patients also showed strong 5T4-specific T-cell
responses. Twenty patients (83%) experienced disease stabilisation. The duration
of disease stabilisation in patients continues to be assessed and currently
ranges from two to more than ten months. As in previous trials of TroVax, the
anti-tumour immune response induced by TroVax correlated with clinical benefit.
Time to disease progression (TTP) was significantly greater in 5T4-specific
T-cell responders compared to non-responders, with a median TTP of 5.6 months
versus 2.3 months (p = 0.028). The combination of GM-CSF with TroVax showed
similar clinical and immunological responses to TroVax alone.
The principal investigator conducting the trial concluded that the high
frequency of 5T4-specific immune responses and the correlation with enhanced TTP
are encouraging and warrant further investigation. The same clinical team at
the Methodist Hospital has initiated a further Phase II trial of TroVax in
approximately 60 patients with HRPC. The trial is randomised and is designed to
evaluate TroVax in combination with sanofi-aventis' Taxotere(R) (docetaxel) as
first line therapy versus docetaxel alone. Patients who progress on docetaxel
alone will then be treated with TroVax. For more information on this and other
ongoing and planned trials, see www.trovax.co.uk.
Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the new
data: 'We continue to be encouraged by the clinical data from ongoing trials of
TroVax. It is particularly reassuring to see the relationship between the
antigen-specific immune response induced by TroVax and clinical benefit in a
third tumour type, following similar conclusions in trials in renal and
colorectal cancer. We are delighted that the clinical team at the Methodist
Hospital are supporting further development of TroVax in this setting. With our
partner, sanofi-aventis, we believe that TroVax could play an important role in
the treatment of prostate cancer, addressing a significant unmet need for
patients.'
-Ends-
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
JPMorgan Cazenove Limited:
James Mitford/ Gina Gibson Tel: +44 (0)20 7588 2828
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Tel: +44 (0)20 7466 5000
Communications
Scientific/Trade Press Enquiries:
Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7457 2020
College Hill Life Sciences
US Enquiries:
Thomas Fechtner Tel: (646) 378 2900
The Trout Group LLC
Notes to editors
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in
cancer immunotherapy and gene-based therapies. The Company was established in
1995, as a spin-out from Oxford University, and is listed on the London Stock
Exchange.
The Company has a platform of gene delivery technologies, which are based on
highly engineered viral systems. Oxford BioMedica also has in-house clinical,
regulatory and manufacturing know-how. The lead product candidate is TroVax(R),
an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventis
for global development and commercialisation. TroVax is in Phase III
development. Oxford BioMedica has three other products in clinical development,
including ProSavin(R), a novel gene-based treatment for Parkinson's disease, in
a Phase I/II trial. The Company is underpinned by over 80 patent families, which
represent one of the broadest patent estates in the field. The Company has a
staff of approximately 85. Oxford BioMedica has collaborations with
sanofi-aventis, Wyeth, Sigma-Aldrich, MolMed and Virxsys. Technology licensees
include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer.
Further information is available at www.oxfordbiomedica.co.uk
2. TroVax(R)
TroVax is Oxford BioMedica's novel cancer immunotherapy product, which is being
developed in collaboration with sanofi-aventis. 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 Modified Vaccinia
Ankara vector, 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.
This information is provided by RNS
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