Trovax Phase III Trial
Oxford Biomedica PLC
10 December 2007
For immediate release 10 December 2007
OXFORD BIOMEDICA ANNOUNCES DATA SAFETY MONITORING BOARD RECOMMENDATION TO
CONTINUE TROVAX(R) PHASE III TRIAL IN RENAL CANCER
Oxford, UK: 10 December 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 second planned interim analysis. The DSMB concluded that the trial
should continue as planned without modification. 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, more than 500 patients have been
randomised of a target enrolment of approximately 700 patients. Over 100 sites
in the USA, European Union and Eastern Europe are recruiting patients. The
primary endpoint for the trial is overall survival in the TroVax-treated group
versus the placebo group. Secondary endpoints include progression-free survival
at 26 weeks, 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.
Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the
DSMB recommendation: 'This interim analysis by the DSMB is an important step in
the progress of the TRIST study. It is the first analysis that compares the
safety and efficacy of the TroVax and placebo arms of the study. We are
delighted by the positive recommendation. We remain on track to complete patient
enrolment during Q1 2008 and we anticipate final results in 2009.'
-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 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 two Phase III trials in colorectal
cancer are planned. Oxford BioMedica has two other anti-cancer product
candidates in Phase II development for melanoma and pancreatic cancer
respectively. In neurotherapy, the Company has submitted a Clinical Trial
Application to start a Phase I/II trial of its gene-based treatment for
Parkinson's disease, ProSavin(R). 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 an anti-cancer 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.
Oxford BioMedica and Sanofi-aventis entered a global development and
commercialisation agreement for TroVax in March 2007. The companies are
co-funding a Phase III trial of TroVax in renal cancer and sanofi-aventis is
implementing a Phase III development plan for colorectal cancer. The product has
also attracted support from Cancer Research UK, the US National Cancer
Institute, and the UK clinical trials network, QUASAR.
3. Phase III TRIST study
The Phase III TRIST (TroVax Renal Immunotherapy Survival Trial) study commenced
in November 2006 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 Sutent(R) (sunitinib),
interferon-alpha or interleukin-2. The trial is being conducted at centres in
the USA, European Union and Eastern Europe. The primary endpoint for the trial
is survival improvement. The trial, which commenced enrolment in November 2006,
is being conducted under a Special Protocol Assessment (SPA) agreement from the
US Food and Drug Administration (FDA). The trial is expected to complete in
2009.
For more information on the ongoing Phase III TRIST study of TroVax visit:
www.trovax.co.uk
4. Renal cancer
Renal cell carcinoma (RCC) is the most common form of kidney cancer in the USA,
accounting for nine out of ten cases of the disease. 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. Treatment options for patients with kidney cancer are
limited. Surgical removal of the tumour tends only to be successful in
early-stage disease. As the disease progresses, there are several commonly used
therapies including immunostimulatory cytokines and kinase inhibitors.
This information is provided by RNS
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