25th Mar 2008 10:06
Oxford Biomedica PLC25 March 2008 FOR IMMEDIATE RELEASE 25 MARCH 2008 OXFORD BIOMEDICA REPORT ENCOURAGING NEW PHASE II TRIAL RESULTS WITH TROVAX(R) IN PROSTATE CANCER - Presentation at the Symposium on Targeted Anticancer Therapies - Oxford, UK - 25 March 2008: Oxford BioMedica (LSE: OXB), a leading gene therapycompany, today announces encouraging new data from its first Phase II trial ofTroVax in prostate cancer. TroVax is Oxford BioMedica's lead cancerimmunotherapy product, which is being developed in collaboration withsanofi-aventis. The Phase II data were presented by the clinical investigatorsfrom the Methodist Hospital in Houston, Texas, at the 6th InternationalSymposium on Targeted Anticancer Therapies on 20 March 2008 in Bethesda,Maryland. This event was organised by the NDDO Research Foundation in apartnership with the US National Cancer Institute (NCI; www.cancer.gov) and theEuropean Society for Medical Oncology (ESMO; www.esmo.org). In the Phase II trial, 27 patients with metastatic hormone-refractory prostatecancer (HRPC) were treated with TroVax alone (n=14) or TroVax in combinationwith GM-CSF (n=13). TroVax was well tolerated with no related serious adverseevents. Eligibility for the trial included patients with progressive disease andpre-treatment with at least one course of chemotherapy. Of 24 evaluablepatients, all mounted robust antibody responses against the targeted tumourantigen, 5T4, and nine patients also showed strong 5T4-specific T-cellresponses. Twenty patients (83%) experienced disease stabilisation. The durationof disease stabilisation in patients continues to be assessed and currentlyranges from two to more than ten months. As in previous trials of TroVax, theanti-tumour immune response induced by TroVax correlated with clinical benefit.Time to disease progression (TTP) was significantly greater in 5T4-specificT-cell responders compared to non-responders, with a median TTP of 5.6 monthsversus 2.3 months (p = 0.028). The combination of GM-CSF with TroVax showedsimilar clinical and immunological responses to TroVax alone. The principal investigator conducting the trial concluded that the highfrequency of 5T4-specific immune responses and the correlation with enhanced TTPare encouraging and warrant further investigation. The same clinical team atthe Methodist Hospital has initiated a further Phase II trial of TroVax inapproximately 60 patients with HRPC. The trial is randomised and is designed toevaluate TroVax in combination with sanofi-aventis' Taxotere(R) (docetaxel) asfirst line therapy versus docetaxel alone. Patients who progress on docetaxelalone will then be treated with TroVax. For more information on this and otherongoing and planned trials, see www.trovax.co.uk. Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the newdata: "We continue to be encouraged by the clinical data from ongoing trials ofTroVax. It is particularly reassuring to see the relationship between theantigen-specific immune response induced by TroVax and clinical benefit in athird tumour type, following similar conclusions in trials in renal andcolorectal cancer. We are delighted that the clinical team at the MethodistHospital are supporting further development of TroVax in this setting. With ourpartner, sanofi-aventis, we believe that TroVax could play an important role inthe treatment of prostate cancer, addressing a significant unmet need forpatients." -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 Buchanan Tel: +44 (0)20 7466 5000Communications Scientific/Trade Press Enquiries:Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7457 2020College Hill Life Sciences US Enquiries:Thomas Fechtner Tel: (646) 378 2900The Trout Group LLC Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising incancer immunotherapy and gene-based therapies. The Company was established in1995, as a spin-out from Oxford University, and is listed on the London StockExchange. The Company has a platform of gene delivery technologies, which are based onhighly 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-aventisfor global development and commercialisation. TroVax is in Phase IIIdevelopment. Oxford BioMedica has three other products in clinical development,including ProSavin(R), a novel gene-based treatment for Parkinson's disease, ina Phase I/II trial. The Company is underpinned by over 80 patent families, whichrepresent one of the broadest patent estates in the field. The Company has astaff of approximately 85. Oxford BioMedica has collaborations withsanofi-aventis, Wyeth, Sigma-Aldrich, MolMed and Virxsys. Technology licenseesinclude 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 beingdeveloped in collaboration with sanofi-aventis. It is designed specifically tostimulate an anti-cancer immune response and has potential application in mostsolid tumour types. TroVax targets the tumour antigen 5T4, which is broadlydistributed throughout a wide range of solid tumours. The presence of 5T4 iscorrelated with poor prognosis. The product consists of a Modified VacciniaAnkara vector, which delivers the gene for 5T4 and stimulates a patient's bodyto produce an anti-5T4 immune response. This immune response destroys tumourcells carrying the 5T4. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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