31st Jul 2006 07:02
Oxford Biomedica PLC31 July 2006 For immediate release 31 July 2006 OXFORD BIOMEDICA PLC ("Oxford BioMedica" or "the Company") UPDATE AND CLARIFICATION on TROVAX Oxford, UK - 31 July 2006: Oxford BioMedica (LSE:OXB), a leading gene therapycompany, today issues an update on TroVax, the Company's leading cancerimmunotherapy product. The update provides information on progress withclinical trial programmes and a marketing partner deal for TroVax. The Board is pleased to confirm that the TroVax clinical development plan is ontrack with appropriate regulatory submissions being made and trial centres forthe phase III TRIST study being set up in the US and Western and Eastern Europe.Other product development programmes are also progressing according to plan. Afull update will be given with the Company's interim results on 5 September2006. A number of shareholders have asked for information on progress towards a TroVaxdeal. The Company is in active discussions with a number of potential commercialpartners for TroVax. Inevitably those discussions are highly sensitive. All thepotential partners are substantial companies and have the capability to supportthe Company's plans for TroVax and the successful marketing of this product. Clarification as regards Therion Biologics The Company has noted some speculation in the market that the failure ofclinical trials of PANVAC-VF, developed by the privately owned United Statescompany, Therion Biologics, might suggest that phase III trials of TroVax willnot be successful. Although the Directors do not have access to detailed information on thePANVAC-VF study, they wish to make the following comments: • While PANVAC-VF uses a similar viral delivery system to TroVax, the active antigenic components of TroVax are completely different to those used in PANVAC-VF. PANVAC-VF comprises CEA and Muc-1 whereas TroVax comprises the Company's proprietary antigen, 5T4. • The PANVAC-VF phase III study was in pancreatic cancer patients who had already failed chemotherapy. This is a particularly challenging target where no product has shown a survival benefit. In the case of a vaccine the problem is that the patients' disease advances significantly before a strong immune response has time to be established by the product. The planned TroVax phase III TRIST trial is in advanced renal cell cancer patients who will have received no prior therapy for their metastatic disease and who have a median survival, with current care, of about 12 months. As has been shown in a number of phase I/II and phase II studies of TroVax, this is ample time for an immune response to be established. In summary, the Directors do not believe that data from the PANVAC-VF trial havea significant bearing on the future of TroVax. -Ends- For further information, please contact:Oxford BioMedica plc: Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000City/Financial Enquiries: Lisa Baderoon/ Mark Court/Mary-Jane Johnson Tel: +44 (0)20 7466 5000Buchanan CommunicationsScientific/Trade Press Enquiries: Katja Stout/ Susan Yu/Gemma Bradley Tel: +44 (0)20 7886 8150Northbank Communications Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in thedevelopment of novel gene-based therapeutics with a focus on oncology andneurotherapy. The Company was established in 1995 as a spin out from OxfordUniversity, and is listed on the London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-houseclinical, regulatory and manufacturing know-how. In oncology, the pipelineincludes two candidates in multiple Phase II trials, and a preclinical targetedantibody therapy in collaboration with Wyeth. A Phase III trial in renal cancerwith TroVax, the lead cancer immunotherapy candidate, is expected to start inthe second half of 2006. In neurotherapy, the Company's lead product is a genetherapy for Parkinson's disease, which is expected to enter clinical developmentin 2006, and four further preclinical candidates. The Company is underpinned byover 80 patent families, which represent one of the broadest patent estates inthe field. The Company has a staff of approximately 70 split between its main facilities inOxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California.Oxford BioMedica has corporate collaborations with Wyeth, Intervet,Sigma-Aldrich, Viragen, MolMed, VIRxSYS and Kiadis; and has licensed technologyto a number of companies including Merck & Co, Biogen Idec and Pfizer. Further information is available at www.oxfordbiomedica.co.uk 2. TroVax(R) TroVax is Oxford BioMedica's leading cancer immunotherapy product. It isdesigned specifically to stimulate an anti-cancer immune response and haspotential application in most solid tumour types. TroVax targets the tumourantigen 5T4, which is broadly distributed throughout a wide range of solidtumours. The presence of 5T4 is correlated with poor prognosis. The productconsists of a poxvirus (MVA) gene transfer system, which delivers the gene for5T4 and stimulates a patient's body to produce an anti-5T4 immune response. Thisimmune response destroys tumour cells carrying the 5T4. TroVax has attractedexternal support from Cancer Research UK and the US National Cancer Institute.Over 120 patients have now been treated with TroVax in eight clinical trials(collectively over 450 doses). The Company is targeting colorectal cancer andrenal cell carcinoma (RCC) as lead indications for the development of TroVax.Renal cell carcinoma is an indication where TroVax might achieve a rapid routeto product registration. A clinical trial in prostate cancer is also underwayand a trial in breast cancer is planned. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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