Milestone in Trovax
Oxford Biomedica PLC
11 September 2007
For Immediate Release 11 SEPTEMBER 2007
OXFORD BIOMEDICA REACHES FIRST MILESTONE IN TROVAX(R) COLLABORATION WITH
SANOFI-AVENTIS
Oxford, UK - 11 September 2007: Oxford BioMedica (LSE: OXB), a leading gene
therapy company, announced that it has reached the first development milestone
in its collaboration with sanofi-aventis for TroVax, the cancer immunotherapy,
which triggers a payment of €9 million. The milestone relates to the successful
enrolment of 350 patients in the Phase III TRIST study of TroVax in renal
cancer. This represents half of the anticipated 700 patients to be enrolled into
the trial.
Oxford BioMedica and sanofi-aventis entered a global development and
commercialisation agreement for TroVax in March 2007. Under the terms of this
agreement, Oxford BioMedica received an initial payment of €29 million. This
first development milestone of €9 million is part of a potential €19 million in
near-term milestone payments linked to the Phase III TRIST study. The Company
could receive a total of €518 million in initial and milestone payments if
development and registration targets are met for certain defined indications.
The agreement includes additional undisclosed regulatory milestone payments for
other cancer types; undisclosed commercial milestones when sales reach certain
levels; and escalating royalties on global sales. Sanofi-aventis and Oxford
BioMedica are co-funding the ongoing TRIST study and sanofi-aventis is committed
to fund all other research, development, regulatory and commercialisation
activities. Furthermore, Oxford BioMedica retains an option to participate in
the promotion of TroVax in the USA and the European Union.
Professor Alan Kingsman, Chief Executive of Oxford BioMedica, commented: 'The
clinical team at Oxford BioMedica is doing an excellent job in its management of
the TRIST study. The trial remains on track to complete recruitment in the first
quarter of 2008. It is encouraging that we have reached this milestone of
recruiting half of the anticipated patients within a few months of our
collaboration with sanofi-aventis.'
-Ends-
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
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
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.
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). It is expected to complete in 2009. In
July 2007, the independent Data Safety Monitoring Board (DSMB) for the TRIST
study completed its first scheduled interim analysis. The DSMB concluded that
the trial should continue as planned without modification.
For more information on the ongoing Phase III TRIST 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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