SOURCE: Oxford Biomedica Plc

October 24, 2005 09:01 ET

Oxford Biomedica Plc announces Trovax Clarification



Oxford, UK: 24 October 2005 - Oxford BioMedica (LSE: OXB), the leading gene therapy company, provides clarification of its strategy for its lead cancer immunotherapy, TroVax.

Over the past week the Company has made announcements concerning its lead product, TroVax; its second anti-cancer clinical product, MetXia®; its anti-cancer antibody-targeted therapy in preclinical development with Wyeth; a strategic commercial alliance with Sigma-Aldrich; and, most recently, a further licence agreement for its LentiVector technology.

The Company is delighted that it has been able to deliver such positive news to the market and its shareholders. However, it has received a number of enquiries from shareholders over the course of last week suggesting that there may be some confusion in the market as to the Company's strategy regarding TroVax. It therefore wishes to clarify that:-

- in the announcement of encouraging TroVax Phase II data, made on 17 October 2005, the Company stated that it intended to secure a development partner for TroVax within the next 12 months. This is entirely consistent with the previous published guidance that the Company intends to secure such a deal in 2005-06. This guidance is commercially strategic in that it keeps the Company's options open during discussion with potential partners. The statement made last week does not represent a change in the Company's plans;

- based on current ongoing discussions with potential partners, the Company does not envisage any requirement to modify TroVax in order to increase the number of patients that mount anti-cancer immune responses. In comparison with published data for other cancer vaccines in clinical trials, TroVax is highly immunogenic. There are currently no plans to modify the product and all discussions with potential partners are based on taking TroVax forward to product registration in its current form; and

- the Company has spent the last nine months considering the next stage of development of TroVax in various cancer types through detailed consultation with the regulators (FDA), leading international clinicians and potential partners. Although the outcome of this process is yet to be finalised, the overwhelming body of opinion is that TroVax is ready for Phase III development and the nature of such trials is a key point of discussion with potential partners. The consensus view is that a Phase IIb study is not required before proceeding to Phase III and this is consistent with the Company maintaining its expectation of product registration of TroVax in 2009.


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 Buchanan Tel: +44 (0)20 7466 5000

Scientific/Trade Press Enquiries:
Sue Charles/ Katja Stout/ Ashley Lilly                Tel: +44 (0)20 7886 8150
Northbank Communications

Notes to editors

1. Oxford BioMedica

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on the areas of oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange.

Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes an immunotherapy and a gene therapy in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. In neurotherapy, the Company's lead product is a gene therapy for Parkinson's disease, which is expected to enter clinical trials in 2006, and four further preclinical candidates. 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 70 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec and Pfizer.

Further information is available at

2. TroVax® cancer immunotherapy

TroVax is Oxford BioMedica's leading cancer immunotherapy product. 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 protein.

In over 70 patients treated, TroVax has been safe and well tolerated, and induced a strong anti-5T4 immune response. In the completed Phase I/II trials, the immune response correlated, with high significance, to time to disease progression, which translated into a correlation with improved overall survival. Four Phase II trials are underway and data to date have been encouraging. Further trials including Phase III trials are planned.

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