Phase II Clinical Trial Data
Oxford Biomedica PLC
02 August 2007
For Immediate Release 2 AUGUST 2007
OXFORD BIOMEDICA: PUBLICATION OF TROVAX(R) PHASE II CLINICAL TRIAL DATA
Oxford, UK: 2 August 2007: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, announced that data from its Phase II clinical trial of TroVax in
colorectal cancer patients who were also receiving chemotherapy under the FOLFOX
regime has been published in the 1 August 2007 edition of Clinical Cancer
Research, a journal of the American Association for Cancer Research ('AACR').
AACR has issued the following announcement:
'Phase II Study of Therapeutic Vaccine Shows Efficacy in Patients with
Metastatic Colorectal Cancer
PHILADELPHIA - A therapeutic cancer vaccine has shown effectiveness when given
alongside chemotherapy to patients with metastatic colorectal cancer in a phase
II trial, according to researchers at Oxford BioMedica (UK) Ltd. The study found
that six of the 17 metastatic colorectal cancer patients in the study showed
tumor shrinkage, classified as complete or partial responses following
independent expert review.
The study, reported in the August 1 issue of Clinical Cancer Research, a journal
of the American Association for Cancer Research, was designed to demonstrate the
safety and immunogenicity of the vaccine, called modified vaccinia
Ankara-encoding 5T4 (TroVax(R)), when used alongside standard chemotherapy. The
research was funded by Oxford BioMedica which is developing the vaccine in
partnership with Sanofi-Aventis.
Unlike preventative vaccines, such as the human papillomavirus vaccine to
prevent cervical cancer, TroVax is a therapeutic vaccine, designed to stimulate
the immune systems of patients who already have cancer. The vaccine consists of
an attenuated (non-disease causing) version of the vaccinia virus modified to
deliver the gene for 5T4, a protein found in many tumors.
'The idea is that the modified virus enters cells, produces the tumor protein
and stimulates the immune system,' said lead study author Richard Harrop, Ph.D.,
vice president of clinical immunology at Oxford BioMedica. 'To give a vaccine
alongside chemotherapy might seem counterintuitive, since chemotherapy can
weaken the immune system, but our study shows that TroVax could be complementary
to standard chemotherapy, enhancing the immune response to tumors.'
The target of this immuno-therapy approach is a tumor antigen called 5T4, a
protein embedded within the membrane of cancer cells. The protein is rarely
found in normal tissues, but is produced at high levels by a wide range of human
cancers, including colorectal, renal, gastric and ovarian. The production of 5T4
has been associated with cancer metastasis and poor prognosis for patients.
'Typically, the immune system doesn't pay attention to this molecule, so by
producing 5T4 artificially in combination with the 'danger signals' associated
with a viral infection, we are demanding that the immune system take notice,'
Harrop said. 'TroVax causes cells at the injection site to produce 5T4 in a way
which agitates the immune system into producing antibodies and killer T cells.
It is hoped that these two components of the immune system then migrate to
tumors and kill them without harming any normal tissues.'
'In essence, it's like turning up your stereo in the hopes that it will attract
the police to your neighbor's rowdy party,' Harrop said.
Harrop and his colleagues administered the vaccine to 17 patients with
metastatic colorectal cancer just before, during and after the patients were
treated with the standard chemotherapy regimen FOLFOX which consists of the
agents: 5-fluorouracil, folinic acid and oxaliplatin.
Through the course of the study, the researchers monitored the patients for an
immune response to 5T4. Eleven of the 17 patients who received the complete
course of vaccinations (six injections) mounted strong immune responses to the
5T4 tumor protein. Of these 11 patients, six exhibited significant shrinkage of
their tumors and one patient no longer had any detectable tumors. Researchers
noted no complications stemming from TroVax vaccination or any other evidence
that would call into question the safety of the vaccine.
While the study was not designed to prove that patients survived longer than
would normally be expected, the researchers noted that, on average, the overall
median survival was 68 weeks in all 17 vaccinated patients and 118 weeks in the
11 patients who received all six vaccinations.
According to Harrop, the researchers are currently testing the vaccine in a
phase III trial in renal cancer patients in the U.S. and Europe and Sanofi
Aventis is planning a phase III study in colorectal cancer.'
-Ends-
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865 783 000
Professor Alan Kingsman, Chief Executive
City/Financial Enquiries: Tel: +44 (0)20 7466 5000
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan
Communications
Scientific/Trade Press Enquiries: Tel: +44 (0)20 7268 3002
Gemma Price/ Holly Griffiths/ Katja Stout
Northbank Communications
Notes to editors
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the
development and commercialisation of novel therapeutic vaccines and gene-based
therapies with a focus on oncology and neurotherapy. 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. In oncology, the lead product candidate
is TroVax(R), an immunotherapy for multiple solid cancers, which is licensed to
sanofi-aventis for global development and commercialisation. A Phase III trial
of TroVax in renal cancer is ongoing and sanofi-aventis is implementing a
development plan for colorectal cancer. Oxford BioMedica's oncology pipeline
includes a specific immunotherapy candidate, Hi-8(R) MEL, for melanoma, which
has completed two clinical trials. In neurotherapy, the Company's lead product,
ProSavin(R), is expected to enter clinical development for Parkinson's disease
in 2007. The neurotherapy pipeline also includes preclinical gene-based
therapeutics for vision loss, motor neuron disease and nerve repair.
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 80 split between its main facilities in Oxford and its wholly
owned subsidiary, BioMedica Inc, in San Diego, California. Corporate partners
include sanofi-aventis for TroVax and Wyeth for the targeted antibody therapy.
The Company also has collaborations with 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 leading 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
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.
In 2006, Oxford BioMedica started a Phase III trial of TroVax in renal cancer
and sanofi-aventis is implementing a development plan for colorectal cancer. The
product has attracted support from Cancer Research UK, the US National Cancer
Institute, and the UK clinical trials network, QUASAR. These organisations are
conducting or plan to conduct clinical trials with TroVax.
For more information on the ongoing phase III study of TroVax visit:
www.trovax.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
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