TroVax Phase I and II data

RNS Number : 5657G

Oxford Biomedica PLC

24 October 2008

 

 

 

 

 

For Immediate Release

24 OCTOBER 2008

 

OXFORD BIOMEDICA REPORTS DATA ON ASSOCIATION BETWEEN IMMUNE RESPONSE AND PATIENT SURVIVAL FROM TROVAX^® TRIALS IN COLORECTAL, RENAL AND PROSTATE CANCER

- Presentation at the EORTC-NCI-AACR Symposium -

Oxford, UK – 24 October 2008: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that a cross-trial analysis of Phase I and Phase II trials of TroVax in colorectal, renal and prostate cancer suggests an association between the magnitude of the antibody response to the 5T4 tumour antigen, targeted by TroVax, and increased patient survival. The analysis was presented today by Dr Richard Harrop, Oxford BioMedica’s Vice President Clinical Immunology, at the EORTC-NCI-AACR Symposium on ‘Molecular Targets and Cancer Therapeutics’ being held in Geneva, Switzerland. TroVax is Oxford BioMedica’s novel therapeutic cancer vaccine, which is being developed in collaboration with sanofi-aventis.

The cross-trial analysis was based on survival and immunological response data from nine Phase I or Phase II trials of TroVax in 189 evaluable patients with colorectal (four trials, n=73), renal (four trials, n=89) and prostate (one trial, n=27) cancer. The median number of TroVax vaccinations received was five with a range of one to 12. TroVax was well tolerated in all cancer types and in combination with both chemo and cytokine therapies. Of 180 patients tested for antibody responses post-vaccination, 159 (88%) and 176 (98%) showed positive responses for the 5T4 antigen and the Modified Vaccinia Ankara (MVA) vector respectively. The kinetics of the magnitude of 5T4 antibody responses was similar across all cancer types irrespective of co-medications. Peak median 5T4 antibody titres were detected following four vaccinations of TroVax.

The analysis of all evaluable patients showed a statistically significant association between immune responses to 5T4 and overall survival, which was also evident in an analysis of patients with colorectal cancer alone. There were no correlations between the immune response to MVA and patient survival. Across all nine trials, a doubling in the 5T4 antibody response between the first and third TroVax vaccinations was associated with a reduction in the relative risk of death of 16% (p < 0.002). The effect was strongest in colorectal cancer patients with a reduction in relative risk of death of 19% (p < 0.01).

The European Organisation for Research and Treatment of Cancer (EORTC), the organisers of the Symposium, issued a press release today that highlighted the results of this cross-trial analysis of TroVax. Dr Harrop also participated in the EORTC’s press briefing, which included a discussion of his presentation.

John Dawson, Chief Executive of Oxford BioMedica, said: “We are delighted that the EORTC selected this presentation to be highlighted at their press briefing and that the oncology community’s interest in TroVax remains high. The cross-trial analysis presented today is encouraging and provides further evidence that the anti-tumour immune response, induced by TroVax, may benefit patient outcome. We are optimistic that TroVax may show benefit in a subset of patients in the ongoing Phase III TRIST study in renal cancer. Following our successful meeting with the FDA earlier this month, we are working with our partner, sanofi-aventis, to perform additional exploratory analyses of the TRIST study and then, pending FDA agreement, to move ahead with the two planned Phase III trials in colorectal cancer.”

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For further information, please contact:
Oxford BioMedica plc: John Dawson, Chief Executive Officer Nick Woolf, Chief Business Officer	Tel: [phone]
JPMorgan Cazenove Limited: James Mitford/ Gina Gibson	Tel: [phone]
City/Financial Enquiries: Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications	Tel: [phone]
Scientific/Trade Press Enquiries: Katja Stout/ Holly Griffiths/ John McIntyre College Hill Life Sciences	Tel: [phone]
US Enquiries: Thomas Fechtner The Trout Group LLC	Tel: [phone]

 

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^®, 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^®, 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. 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.

 

 

 

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