6th Oct 2005 07:00
Oxford Biomedica PLC06 October 2005 FOR IMMEDIATE RELEASE 6 OCTOBER 2005 OXFORD BIOMEDICA ANNOUNCES ENCOURAGING PRELIMINARY PHASE II RESULTS WITH TROVAX IN RENAL CELL CARCINOMA Oxford, UK: 6 October 2005 - Oxford BioMedica (LSE:OXB.L), the leading genetherapy company, today announces preliminary data from the Phase II trial ofTroVax in renal cell carcinoma (RCC). The data show that TroVax is safe and welltolerated in this patient group and that the product induces a stronganti-tumour immune response against the 5T4 tumour antigen. Some of these datawere referred to in a presentation made by the principal investigator for thisPhase II trial at the World Vaccine Congress on 5 October 2005. The Phase II trial in RCC is being conducted at the New York-PresbyterianHospital in New York, USA, under an approved Investigational New Drug protocol.The principal investigator for the trial is Dr Howard Kaufmann of the NewYork-Presbyterian Hospital. Dr Kaufmann is a leading expert in clinicalimmunotherapy and is an advisor on TroVax. The Phase II trial is an open label study of TroVax in combination withinterleukin-2 (IL-2) therapy, which is an FDA-approved treatment for RCC.Patients receive five immunisations of TroVax over 12 weeks and up to fourcycles of high dose IL-2. Patients that show an anti-tumour immune response toTroVax will be offered an additional three vaccinations. The primary endpointsof the trial are safety and immunogenicity. Secondary efficacy endpoints includetumour responses, time to disease progression and overall survival. The trial is intended to recruit up to 25 patients, in order to gatherinformation on the safety of TroVax in this setting and also the ability ofTroVax to elicit immune responses to the tumour antigen 5T4. To date, sevenpatients have been recruited. There have been no serious adverse events relatedto TroVax, which is consistent with the safety profile of the product across alltrials, and TroVax treatment has been well tolerated. Five patients have reachedthe preliminary analysis point for immune responses. This preliminary time pointis after two immunisations with TroVax. All five patients have shown highanti-tumour antibody responses to 5T4. The antibody levels were at the top endof the range reported from the Phase II trials with TroVax in patients withcolorectal cancer undergoing chemotherapy. Anti-tumour cellular responsesagainst the 5T4 antigen will be analysed and reported in due course. Dr Howard Kaufmann gave a presentation on 5 October 2005 at the World VaccineCongress in Lyon, France, in a session on Vaccines in Clinical Development. Inhis presentation, titled "Poxvirus Vaccine Strategies for the Treatment ofCancer", Dr Kaufmann referred to the Phase II trial with TroVax in RCC andhighlighted the potential of the product. Independently, there has been a recent publication on the prevalence of 5T4expression in renal cancer. This was authored by Robert Hawkins of the ChristieHospital in Manchester (see Griffiths et al., British Journal of Cancer 2005).In this publication, most RCC tumours were found to have high levels of 5T4expression, both on primary and metastatic sites. This suggests that themajority of patients with RCC could benefit from a 5T4-targeted product such asTroVax. Commenting on the TroVax results in renal cell carcinoma, Oxford BioMedica'sChief Executive, Professor Alan Kingsman said: "It is very encouraging that theresults with TroVax in renal cell carcinoma are consistent with our data set incolorectal cancer. We are also grateful for the strong support of TroVax shownby Dr Kaufmann. Renal cell carcinoma is an aggressive disease with an unmet needfor effective treatments. The high levels of 5T4 in renal cancer and the paucityof treatment options make this an ideal setting for further development ofTroVax". -Ends- For further information, please contact: Oxford BioMedica plc: Tel: +44 (0)1865 783 000Professor Alan Kingsman, Chief Executive City/Financial Enquiries: Tel: +44 (0)20 7466 5000Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications Scientific/Trade Press Enquiries: Tel: +44 (0)20 7886 8150Sue Charles/ Katja Stout/ Ashley LillyNorthbank Communications Notes to editors 1. Oxford BioMedicaOxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in thedevelopment of novel gene-based therapeutics with a focus on the areas ofoncology and neurotherapy. The Company was established in 1995 as a spin outfrom Oxford University, 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 an immunotherapy and a gene therapy in multiple Phase II trials, and apreclinical targeted antibody therapy in collaboration with Wyeth. Inneurotherapy, the Company's lead product is a gene therapy for Parkinson'sdisease, which is expected to enter clinical trials in 2006, and four furtherpreclinical 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 65 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, Viragen,MolMed and Kiadis; and has licensed technology to a number of companiesincluding Merck & Co, Biogen Idec and Pfizer.Further information is available at http://www.oxfordbiomedica.co.uk 2. TroVax(R) cancer immunotherapyTroVax 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 protein. In over 70 patients treated, TroVax has been safe and well tolerated, andinduced a strong anti-5T4 immune response. In the completed Phase I/II trials,the immune response correlated, with high significance, to time to diseaseprogression, 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. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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