4th Jun 2007 07:02
Oxford Biomedica PLC04 June 2007 For Immediate Release 4 June 2007 OXFORD BIOMEDICA AND SANOFI-AVENTIS REPORT ENCOURAGING NEW TROVAX(R) PHASE II TRIAL RESULTS IN RENAL CANCER - Presentation at the American Society of Clinical Oncology Annual Meeting - Oxford, UK; Paris, France, June 3, 2007 - Oxford BioMedica (LSE: OXB) andsanofi-aventis (EURONEXT: SAN; NYSE: SNY) announced today encouraging new datafrom two Phase II trials of TroVax(R) in renal cancer. TroVax(R) is OxfordBioMedica's lead cancer immunotherapy product, which is being developed incollaboration with sanofi-aventis. The Phase II data were presented by OxfordBioMedica and its clinical collaborators from the Methodist Hospital in Houston,Texas, at the 43rd Annual Meeting of the American Society of Clinical Oncology(ASCO) on 3 June in Chicago, Illinois (Abstract #3069). Fifty-three patients with progressive metastatic renal cell cancer (RCC) havebeen enrolled and 48 patients are currently evaluable in the MethodistHospital's two non-randomised Phase II trials of TroVax(R). The trials aredesigned to evaluate TroVax(R) either as a single agent, or in combination witheither interleukin-2 or interferon-alpha. The treatment regimen in the twotrials comprises seven intramuscular injections of TroVax(R) over 41 weeks. Thepatients had previously failed various anti-cancer treatments before enteringthe trials. TroVax(R) was well tolerated with no serious adverse events attributable to thetreatment. TroVax(R) induced anti-5T4 antibody responses in 91% of patients. Inpatients with clear cell RCC, which is the most common subtype of renal cancerand is the patient group for the Phase III TRIST study, 24 of 35 (68%) evaluablepatients showed disease control. Two patients had complete responses, three hadpartial responses and 19 had stable disease for periods exceeding three months,including three patients that have been stable for more than 17 months.Preliminary analysis of clinical benefit shows a statistically significantrelationship between reduction in tumour burden (biologic response) in patientswith clear cell RCC and patients' anti-5T4 antibody responses (p = 0.028). Thisis particularly encouraging since it supports the rationale that the5T4-specific immune response induced by TroVax(R) has therapeutic benefit. At ASCO, the conclusions presented from this updated analysis of safety,immunogenicity and clinical benefit parameters were as follows: • TroVax(R) was well tolerated and immunogenic in the context of these cytokines and has promising anti-tumour activity • A significant number of objective responses have been seen in this heterogeneous group of heavily pre-treated renal cancer patients. These responses appear to be durable and are notable in the clear cell population. • A preliminary analysis indicates a trend between 5T4-specific immune responses induced by TroVax(R) and clinical benefit in clear cell patients. • These studies provide further support for the ongoing randomised Phase III TRIST study in renal cancer. Dr. Bob Amato of the Genitourinary Oncology Centre, the Methodist Hospital inHouston, USA, who is the Principal Investigator for these two Phase II trials ofTroVax(R) in renal cancer, said: "TroVax(R) continues to give encouragingindications of benefit in this heavily pre-treated renal cancer population.Although these are small, non-randomised studies, there have been a significantnumber of responders in this patient population. The ongoing analysis supportsthe notion that TroVax(R) may have activity in this indication and furtherjustifies the ongoing Phase III study, TRIST." Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the newdata: "Oxford BioMedica continues to be encouraged by the clinical data fromongoing trials of TroVax(R). This updated analysis from the renal cancer trialsat the Methodist Hospital supports our development strategy with sanofi-aventis,which includes the Phase III TRIST trial in renal cancer and a randomisedregistration trial in metastatic colorectal cancer. Over 300 patients have beenenrolled in trials of TroVax(R) in various cancer types and stages of disease.The data suggest that the product was well tolerated, immunogenic andpotentially clinically active in all settings evaluated." Dr Marc Cluzel, Senior Vice President, Science and Medical Affairs ofsanofi-aventis commented: "TroVax(R) is a very exciting compound thatcomplements sanofi-aventis' oncology and sanofi pasteur's vaccine activities. Weare very encouraged by these further positive data on TroVax(R) and lookingforward to developing it in collaboration with Oxford BioMedica". The abstract may be accessed online at http://www.asco.org at the conclusion ofthe meeting. -Ends- For further information, please contact: Oxford BioMedica plc:Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 Sanofi-aventisSalah Mahyaoui Tel: + 33 6 73 68 78 88Anne Bancillon Tel: + 33 6 86 31 03 89 City/Financial Enquiries:Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Tel: +44 (0)20 7466 5000Buchanan Communications Scientific/Trade Press Enquiries:Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7268 3002Northbank Communications About renal cancer Renal cancer includes renal cell carcinoma (cancer that forms in the lining ofvery small tubes in the kidney that filter the blood and remove waste products)and renal pelvis carcinoma (cancer that forms in the centre of the kidney whereurine collects). It also includes Wilms' tumour, which is a type of kidneycancer that usually develops in children under the age of 5. More than 36.600new cases in the US and 38.400 in Europe were diagnosed in 2004 and almost12.500 patients in the US and 18.100 patients in Europe died. There were moremales than females. About Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in thedevelopment and commercialisation of novel therapeutic vaccines and gene-basedtherapies with a focus on oncology and neurotherapy. The Company was establishedin 1995 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. In oncology, the lead product candidateis TroVax(R), an immunotherapy for multiple solid cancers, which is licensed tosanofi-aventis for global development and commercialisation. A Phase III trialof TroVax(R) in renal cancer is ongoing and sanofi-aventis is implementing adevelopment plan for colorectal cancer. Oxford BioMedica's oncology pipelineincludes a specific immunotherapy candidate, Hi-8(R) MEL, for melanoma, whichhas completed two clinical trials. In neurotherapy, the Company's lead product,ProSavin(R), is expected to enter clinical development for Parkinson's diseasein 2007. The neurotherapy pipeline also includes preclinical gene-basedtherapeutics for vision loss, motor neuron disease and nerve repair. Inaddition, the Company has a platform technology for therapeutic vaccines forinfectious diseases. The Company is underpinned by over 80 patent families, which represent one ofthe broadest patent estates in the field. The Company has a staff ofapproximately 75 split between its main facilities in Oxford and its whollyowned subsidiary, BioMedica Inc, in San Diego, California. Corporate partnersinclude sanofi-aventis for TroVax(R) and Wyeth for a targeted antibody therapy.The Company also has collaborations with Intervet, Sigma-Aldrich, Viragen,MolMed and Virxsys. Technology licensees include Merck & Co, Biogen Idec,GlaxoSmithKline and Pfizer. Further information is available at www.oxfordbiomedica.co.uk About TroVax(R) TroVax(R) is Oxford BioMedica's leading cancer immunotherapy product, which isbeing developed in collaboration with sanofi-aventis. It is designedspecifically to stimulate an anti-cancer immune response and has potentialapplication in most solid tumour types. TroVax(R) targets the tumour antigen5T4, which is broadly distributed throughout a wide range of solid tumours. Thepresence of 5T4 is correlated with poor prognosis. The product consists of apoxvirus (MVA) gene transfer system, which delivers the gene for 5T4 andstimulates a patient's body to produce an anti-5T4 immune response. This immuneresponse destroys tumour cells carrying the 5T4. In 2006, Oxford BioMedica started a Phase III trial of TroVax(R) in renal cancerand sanofi-aventis is implementing a development plan for colorectal cancer. Theproduct has attracted support from Cancer Research UK, the US National CancerInstitute, and the UK clinical trials network, QUASAR. These organisations areconducting or plan to conduct clinical trials with TroVax(R). About sanofi-aventis Sanofi-aventis is one of the world leaders in the pharmaceutical industry,ranking number one in Europe. Backed by a world-class R&D organisation,sanofi-aventis is developing leading positions in seven major therapeutic areas:cardiovascular, thrombosis, oncology, metabolic diseases, central nervoussystem, internal medicine and vaccines. Sanofi-aventis is listed in Paris(EURONEXT: SAN) and in New York (NYSE: SNY). Forward Looking Statements This press release contains forward-looking statements as defined in the PrivateSecurities Litigation Reform Act of 1995, as amended. Forward-looking statementsare statements that are not historical facts. These statements include financialprojections and estimates and their underlying assumptions, statements regardingplans, objectives, intentions and expectations with respect to future events,operations, products and services, and statements regarding future performance.Forward-looking statements are generally identified by the words "expects,""anticipates," "believes," "intends," "estimates," "plans" and similarexpressions. Although sanofi-aventis' management believes that the expectationsreflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject to variousrisks and uncertainties, many of which are difficult to predict and generallybeyond the control of sanofi-aventis, that could cause actual results anddevelopments to differ materially from those expressed in, or implied orprojected by, the forward-looking information and statements. These risks anduncertainties include those discussed or identified in the public filings withthe SEC and the AMF made by sanofi-aventis, including those listed under "RiskFactors" and "Cautionary Statement Regarding Forward-Looking Statements" insanofi-aventis' annual report on Form 20-F for the year ended December 31,2006. Other than as required by applicable law, sanofi-aventis does notundertake any obligation to update or revise any forward-looking information orstatements. 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