DSMB Interim Analysis-TroVax
Oxford Biomedica PLC
25 July 2007
For Immediate Release 25 JULY 2007
OXFORD BIOMEDICA ANNOUNCES DATA SAFETY MONITORING BOARD RECOMMENDATION TO
CONTINUE TROVAX(R) PHASE III TRIAL IN RENAL CANCER AS PLANNED
Oxford, UK: 25 July 2007: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, announced today that the independent Data Safety Monitoring Board
(DSMB) for the Phase III TRIST study of TroVax in renal cancer has completed its
first scheduled interim analysis. The DSMB concluded that the trial should
continue as planned without modifcation. The DSMB reviewed safety and anticancer
immune responses from the first 50 patients enrolled. TroVax is Oxford
BioMedica's novel cancer immunotherapy product, which is being developed in
collaboration with sanofi-aventis.
The role of the DSMB is to evaluate data from the ongoing trial to determine
whether there are safety issues or efficacy issues that would warrant
modification of the protocol or early termination of the study. The DSMB is
independent of Oxford BioMedica and sanofi-aventis and is comprised of leading
clinicians and biostatisticians with relevant expertise in the treatment of
renal cancer and the conduct of clinical trials.
TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial of TroVax
in patients with locally advanced or metastatic clear cell renal carcinoma. The
trial is a randomised, placebo-controlled, two-arm study comparing TroVax in
combination with standard of care to placebo with standard of care. The standard
of care therapies are interleukin-2, interferon-alpha or Sutent(R) (sunitinib).
The protocol stratifies treatment between the standard of care options to ensure
that the allocation of TroVax and placebo is rigorously balanced.
The trial started in November 2006. To date, over 250 patients have been
randomised of a target enrolment of approximately 700 patients. Approximately
100 sites of 150 identified centres in the USA, European Union and Eastern
Europe are open for recruitment. The primary endpoint for the trial is survival
improvement and secondary endpoints include progression-free survival, tumour
response rates and quality of life scores. The trial is being conducted under a
Special Protocol Assessment (SPA) agreement from the US Food and Drug
Administration (FDA). The SPA agreement ensures that the design, conduct,
analysis and endpoints of the trial are all acceptable to the FDA. The trial is
expected to complete in early 2009.
Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the
DSMB recommendation: 'We are pleased that the immunology data from this first
analysis of the Phase III TRIST study meet the pre-set criteria for
continuation. The safety profile remains encouraging. Recruitment into TRIST has
been rapid and we are on track to complete patient enrolment during Q1 2008.'
-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.
3. Renal cancer
Renal cell carcinoma (RCC) is the most common form of kidney cancer in the USA.
More than 150,000 people are newly diagnosed with RCC worldwide each year.
Prognosis is very poor. If RCC has metastasised to other organs at the time of
first diagnosis, the five-year survival rate is less than 5%. In the USA and
Europe, RCC accounts for more than 33,000 deaths each year. Data from IMS
suggest that over 5,000 patients in the UK received treatment for metastatic RCC
in 2005.
This information is provided by RNS
The company news service from the London Stock Exchange
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