Phase III Trist Study
Oxford Biomedica PLC
10 March 2008
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For Immediate Release 10 MARCH 2008
OXFORD BIOMEDICA COMPLETES PATIENT RECRUITMENT FOR PHASE III TRIST STUDY OF
TROVAX(R) IN RENAL CANCER
Oxford, UK - 10 March 2008: Oxford BioMedica (LSE: OXB), a leading gene therapy
company, announced today that it has successfully completed patient enrolment in
the Phase III TRIST study of TroVax in renal cancer. TroVax is Oxford
BioMedica's novel cancer immunotherapy product, which is being developed in
collaboration with sanofi-aventis. Over 690 patients have been randomised
to-date and a sufficient number of additional patients are being screened for
inclusion such that the total enrolment is expected to slightly exceed the
target of 700 patients. Over 100 sites in the USA, European Union and Eastern
Europe have recruited patients into the trial. The trial started in November
2006, recruitment has been completed on schedule and final results from the
study are anticipated in the first half of 2009.
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. It is being
conducted under a Special Protocol Assessment (SPA) agreement from the US Food
and Drug Administration (FDA). Oxford BioMedica recently announced that the
independent Data Safety Monitoring Board (DSMB) for the TRIST study completed
its third planned interim analysis and recommended that the study continue
without modification.
Dr Mike McDonald, Chief Medical Officer of Oxford BioMedica, said: 'Completing
recruitment so rapidly in such a large Phase III trial is a significant
achievement for us. We are extremely grateful to the clinicians for their
support and, of course, the patients with renal cancer that are participating in
the TRIST study. The trial is on track to reach its final analysis in the first
half of 2009. We, together with our partner sanofi-aventis believe that TroVax
could provide an important treatment option for patients with renal cancer as
well as potentially other common types of cancer. We are delighted that, within
the next few months, sanofi-aventis will broaden the development programme for
TroVax with the start of the first Phase III trial of TroVax in colorectal
cancer.'
-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 Tel: +44 (0)20 7466 5000
Buchanan 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
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. The lead product candidate is TroVax(R),
an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventis
for global development and commercialisation. TroVax is in Phase III
development. Oxford BioMedica has three other products in clinical development,
including ProSavin(R), 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(R)
TroVax is Oxford BioMedica's novel 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 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.
3. Phase III TRIST study
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. Recruitment
of approximately 700 patients is complete at over 100 sites in the USA, European
Union and Eastern Europe. TRIST is being conducted under a Special Protocol
Assessment (SPA) agreement from the US Food and Drug Administration (FDA).
This information is provided by RNS
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