Phase II Trovax data at ASCO
Oxford Biomedica PLC
04 June 2007
For Immediate Release 4 June 2007
OXFORD BIOMEDICA AND SANOFI-AVENTIS REPORT ENCOURAGING NEW TROVAX(R) PHASE II
TRIAL RESULTS
IN RENAL CANCER
- Presentation at the American Society of Clinical Oncology Annual Meeting -
Oxford, UK; Paris, France, June 3, 2007 - Oxford BioMedica (LSE: OXB) and
sanofi-aventis (EURONEXT: SAN; NYSE: SNY) announced today encouraging new data
from two Phase II trials of TroVax(R) in renal cancer. TroVax(R) is Oxford
BioMedica's lead cancer immunotherapy product, which is being developed in
collaboration with sanofi-aventis. The Phase II data were presented by Oxford
BioMedica and its clinical collaborators from the Methodist Hospital in Houston,
Texas, at the 43rd Annual Meeting of the American Society of Clinical Oncology
(ASCO) on 3 June in Chicago, Illinois (Abstract #3069).
Fifty-three patients with progressive metastatic renal cell cancer (RCC) have
been enrolled and 48 patients are currently evaluable in the Methodist
Hospital's two non-randomised Phase II trials of TroVax(R). The trials are
designed to evaluate TroVax(R) either as a single agent, or in combination with
either interleukin-2 or interferon-alpha. The treatment regimen in the two
trials comprises seven intramuscular injections of TroVax(R) over 41 weeks. The
patients had previously failed various anti-cancer treatments before entering
the trials.
TroVax(R) was well tolerated with no serious adverse events attributable to the
treatment. TroVax(R) induced anti-5T4 antibody responses in 91% of patients. In
patients with clear cell RCC, which is the most common subtype of renal cancer
and is the patient group for the Phase III TRIST study, 24 of 35 (68%) evaluable
patients showed disease control. Two patients had complete responses, three had
partial responses and 19 had stable disease for periods exceeding three months,
including three patients that have been stable for more than 17 months.
Preliminary analysis of clinical benefit shows a statistically significant
relationship between reduction in tumour burden (biologic response) in patients
with clear cell RCC and patients' anti-5T4 antibody responses (p = 0.028). This
is particularly encouraging since it supports the rationale that the
5T4-specific immune response induced by TroVax(R) has therapeutic benefit.
At ASCO, the conclusions presented from this updated analysis of safety,
immunogenicity and clinical benefit parameters were as follows:
• TroVax(R) was well tolerated and immunogenic in the context of these
cytokines and has promising anti-tumour activity
• A significant number of objective responses have been seen in this
heterogeneous group of heavily pre-treated renal cancer patients. These
responses appear to be durable and are notable in the clear cell population.
• A preliminary analysis indicates a trend between 5T4-specific immune
responses induced by TroVax(R) and clinical benefit in clear cell patients.
• These studies provide further support for the ongoing randomised Phase
III TRIST study in renal cancer.
Dr. Bob Amato of the Genitourinary Oncology Centre, the Methodist Hospital in
Houston, USA, who is the Principal Investigator for these two Phase II trials of
TroVax(R) in renal cancer, said: 'TroVax(R) continues to give encouraging
indications of benefit in this heavily pre-treated renal cancer population.
Although these are small, non-randomised studies, there have been a significant
number of responders in this patient population. The ongoing analysis supports
the notion that TroVax(R) may have activity in this indication and further
justifies the ongoing Phase III study, TRIST.'
Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the new
data: 'Oxford BioMedica continues to be encouraged by the clinical data from
ongoing trials of TroVax(R). This updated analysis from the renal cancer trials
at the Methodist Hospital supports our development strategy with sanofi-aventis,
which includes the Phase III TRIST trial in renal cancer and a randomised
registration trial in metastatic colorectal cancer. Over 300 patients have been
enrolled in trials of TroVax(R) in various cancer types and stages of disease.
The data suggest that the product was well tolerated, immunogenic and
potentially clinically active in all settings evaluated.'
Dr Marc Cluzel, Senior Vice President, Science and Medical Affairs of
sanofi-aventis commented: 'TroVax(R) is a very exciting compound that
complements sanofi-aventis' oncology and sanofi pasteur's vaccine activities. We
are very encouraged by these further positive data on TroVax(R) and looking
forward to developing it in collaboration with Oxford BioMedica'.
The abstract may be accessed online at http://www.asco.org at the conclusion of
the meeting.
-Ends-
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
Sanofi-aventis
Salah Mahyaoui Tel: + 33 6 73 68 78 88
Anne Bancillon Tel: + 33 6 86 31 03 89
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Tel: +44 (0)20 7466 5000
Buchanan Communications
Scientific/Trade Press Enquiries:
Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7268 3002
Northbank Communications
About renal cancer
Renal cancer includes renal cell carcinoma (cancer that forms in the lining of
very small tubes in the kidney that filter the blood and remove waste products)
and renal pelvis carcinoma (cancer that forms in the centre of the kidney where
urine collects). It also includes Wilms' tumour, which is a type of kidney
cancer that usually develops in children under the age of 5. More than 36.600
new cases in the US and 38.400 in Europe were diagnosed in 2004 and almost
12.500 patients in the US and 18.100 patients in Europe died. There were more
males than females.
About 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(R) 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. In
addition, the Company has a platform technology for therapeutic vaccines for
infectious diseases.
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 75 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(R) and Wyeth for a targeted antibody therapy.
The Company also has collaborations with Intervet, Sigma-Aldrich, Viragen,
MolMed and Virxsys. Technology licensees include Merck & Co, Biogen Idec,
GlaxoSmithKline and Pfizer.
Further information is available at www.oxfordbiomedica.co.uk
About TroVax(R)
TroVax(R) 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(R) 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(R) 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(R).
About sanofi-aventis
Sanofi-aventis is one of the world leaders in the pharmaceutical industry,
ranking number one in Europe. Backed by a world-class R&D organisation,
sanofi-aventis is developing leading positions in seven major therapeutic areas:
cardiovascular, thrombosis, oncology, metabolic diseases, central nervous
system, internal medicine and vaccines. Sanofi-aventis is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, as amended. Forward-looking statements
are statements that are not historical facts. These statements include financial
projections and estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to future events,
operations, products and services, and statements regarding future performance.
Forward-looking statements are generally identified by the words 'expects,'
'anticipates,' 'believes,' 'intends,' 'estimates,' 'plans' and similar
expressions. Although sanofi-aventis' management believes that the expectations
reflected in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and generally
beyond the control of sanofi-aventis, that could cause actual results and
developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These risks and
uncertainties include those discussed or identified in the public filings with
the SEC and the AMF made by sanofi-aventis, including those listed under 'Risk
Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in
sanofi-aventis' annual report on Form 20-F for the year ended December 31,
2006. Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking information or
statements.
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