RNS Number : 8486Y
Oxford Biomedica PLC
11 July 2008
For Immediate Release 11 JULY 2008
OXFORD BIOMEDICA ANNOUNCES DATA SAFETY MONITORING BOARD RECOMMENDATION FOR TROVAX® PHASE
III TRIST STUDY
Oxford, UK - 11 July 2008: 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
recommended that the trial should continue but that
further vaccinations be discontinued. TroVax is Oxford BioMedica*s novel therapeutic cancer
vaccine, which is being developed in
collaboration with sanofi-aventis.
Following its fourth interim review of the TRIST study, the DSMB advised that TroVax
administered according to the protocol will not meet
the predefined primary efficacy endpoint, but there is important scientific merit and more to
be learned by additional follow up of all
patients. Hence, the DSMB*s recommendation is to continue the study but discontinue further
vaccinations. Oxford BioMedica has implemented
the DSMB*s recommendation. In addition, the Company intends to amend the statistical plan of
the study to determine whether patient outcome
is dependent on the number of TroVax doses administered.
Oxford BioMedica and, its partner, sanofi-aventis, will evaluate the available data and the
implications on the development plan for TroVax,
including the planned Phase III trials in colorectal cancer. The companies will discuss the
proposed TRIST protocol amendments with the
regulatory authorities. With these amendments, a focus of the ongoing TRIST study will be to
explore the number of doses that provide
optimal benefit. In particular, it may be that the optimal benefit-to-risk ratio is delivered
without the requirement for as many
vaccinations as specified in the original TRIST study protocol. It is unlikely that the TRIST
study alone will support registration of
TroVax in renal cancer, although the trial may ultimately demonstrate a survival advantage for
TroVax, and the results may form part of a
regulatory submission alongside an additional confirmatory trial.
The role of the DSMB is to monitor, periodically, the data emerging from the study to
determine whether there are issues arising that would
warrant modification of the protocol or early termination of the study. The DSMB is
independent of Oxford BioMedica and sanofi-aventis.
The TRIST (TroVax Renal Immunotherapy Survival Trial) study is a randomised and
placebo-controlled Phase III trial, designed to evaluate
TroVax in combination with standard of care in locally advanced or metastatic clear cell renal
carcinoma. The trial was initiated in
November 2006 and completed recruitment of 733 patients in March 2008 in more than 100 sites
in the USA, European Union and Eastern Europe.The original trial protocol, which was the subject of a Special Protocol Assessment by the US
Food and Drug Administration (FDA), allowed
for patients to receive up to 13 immunisations over 73 weeks.
Dr Mike McDonald, Chief Executive of Oxford BioMedica, said: *This news is clearly
disappointing. However, there is good reason to continue
the study and potentially a late survival benefit for TroVax may still be demonstrated. The
proposed trial amendment will assess whether the
maximum benefit-to-risk ratio is dependent on an optimal number of doses. We remain optimistic
that TroVax may show benefit in this
population after these protocol amendments. With our partner, sanofi-aventis, we will provide
an update on the TRIST study and the
development plan for TroVax in due course.*
Dr McDonald added: *In addition to TroVax, we have a broad pipeline of innovative drug
candidates and we will continue to focus our
resources on deriving maximum value for both patients and shareholders, while maintaining the
Company*s financial strength. In particular,
we look forward to reporting initial results from the Phase I/II trial of ProSavin in
Parkinson*s disease in September. In addition, we are
working diligently towards the start of clinical trials of RetinoStat in neovascular
age-related macular degeneration.*
-Ends-
Conference Call and Audio Web Cast on Friday, 11 July at 10.00am BST
Oxford BioMedica*s management will host a conference call for analysts at 10.00am BST on
Friday, 11 July 2008, to discuss the DSMB*s
recommendation for the TroVax Phase III TRIST study. The dial-in details for analysts are
available from Buchanan Communications (+44 (0) 20
7466 5000). A live audio web cast of the conference call will be available through the
Company*s website at www.oxfordbiomedica.co.uk. This
will also be available for replay shortly after the conference call.
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865 783 000
Mike McDonald, Chief Executive Officer
Nick Woolf, Chief Business Officer
JPMorgan Cazenove Limited:James Mitford/ Gina Tel: +44 (0)20 7588 2828
Gibson
Tel: +44 (0)20 7466 5000
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson
Buchanan Communications
Tel: +44 (0)20 7457 2020
Scientific/Trade Press Enquiries:
Holly Griffiths/ Katja Stout/ Claire Mosley
College Hill Life Sciences
Tel: (646) 378 2900
US Enquiries:
Thomas Fechtner
The Trout Group LLC
Notes to editors
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in cancer
immunotherapy and gene-based therapies. 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. TroVax® is the Company*s
therapeutic vaccine, which is in clinical development for
multiple solid cancers. The product is licensed to sanofi-aventis for global development and
commercialisation. Oxford BioMedica has three
other products in clinical development, including ProSavin®, a novel gene-based treatment for
Parkinson*s disease, in a Phase I/II trial.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 85. Oxford BioMedica has collaborations with sanofi-aventis, Wyeth,
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®
TroVax is Oxford BioMedica*s novel therapeutic cancer vaccine, 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 Modified Vaccinia Ankara vector, 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
antigen.
This information is provided by RNS
The company news service from the London Stock Exchange
END
RESGUUQGMUPRGBU
|